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Asia Pacific Cell & Gene Research: Novotech is Growing 50% Faster than ROW

SYDNEY, AU, Feb 3, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific focused biotech specialist CRO and recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award, said the number of cell & gene therapy trials in the region was growing 50% faster than ROW. The majority of trials are in oncology, specifically for blood cancers, viral infections, and solid tumors.Novotech, which has extensive experience in cell & gene therapy clinical trials, is sponsoring the 6th Annual Cell And Gene Therapy Innovation Summit in Berlin, Germany (15-16 February 2023).The company recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program in Europe and the US.The acquisition means biotech clients can access Novotech's unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials. The latest data shows Asia Pacific is the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region.The region already accounts for over a third of cell & gene therapy trial activity and shows a nearly 50% faster growth rate in cell & gene therapy trials compared to ROW between 2016 and 2021. China shows a 15% faster growth rate than the ROW. After oncology, the majority of cell & gene trials are in infectious diseases, CNS, and cardiovascular diseases.In addition, the Asia Pacific is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022.Novotech CEO Dr. John Moller said: "Cell & gene therapy research typically presents another level of complexity and regulatory processes which means an experienced CRO partner is vital. Our deep experience, exceptional site and investigator relationships - which also translates to patent access - our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the service biotechs need in this specialist sector for success."Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, selected for the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.Download our latest data report:Evolution of Clinical Trials in the Asia Pacific Region Compared to the US and the EU5https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5About Novotech (Novotech-CRO.com)Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. For more information visit https://novotech-cro.com/contactMedia ContactDavid Jamescommunications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

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SinoHytec Successfully Listed on the Main Board of HKEX

HONG KONG, Jan 12, 2023 - (ACN Newswire via SEAPRWire.com) - The leading provider of fuel cell systems in China - Beijing SinoHytec Co., Ltd. ("SinoHytec" or the "Company", Stock Code: 2402), has successfully listed and commenced dealings on the Main Board of the Stock Exchange of Hong Kong Limited ("Hong Kong Stock Exchange" or "HKEX") today, under the stock code of 2402 and the Offer Price is HK$60 per Share in board lots of 50 shares each.SinoHytec is listed on the main board of HKEX, with 17,628,000 shares being offered globally, Among them, the International Offering was moderately over-subscribed, representing approximately 1.84 times the total number of 15,865,200 Offer Shares initially available under the International Offering.The Hong Kong Public Offering was slightly over-subscribed, representing approximately 0.29 times the total number of 1,762,800 Offer Shares initially available for subscription under the Hong Kong Public Offering.The net proceeds from the Global Offering to be received by the Company is estimated to be approximately HK$982.8million, after deduction of the underwriting commissions, fees and other estimated expenses payable in connection with the Global Offering, of which approximately 75% of the net proceeds received from the Global Offering will be used to fund the Company's research and development in the next three years; and about 15% will be used to enhance the Company's brand recognition through product promotion and multi-channel marketing in the next three years; the remaining approximately 10.0% will be used for working capital and other general corporate purposes.SinoHytec adheres to the R&D principles of "Advance Research", "Continuous Development" and "In-depth Promotion". Following a vertically integrated R&D path, it has evolved from integrating the fuel cell system into the fuel cell powertrain assembly, to developing and manufacturing the fuel cell system and the stack, and most recently the bipolar plate (the core component of the stack). In addition, the Company plans to develop and manufacture membrane electrodes, another major fuel cell stack component, through its main associate company, Shanghai Maximfuelcell Technology Co., Ltd.In addition to independent research and development, the Company jointly undertakes research and development projects and jointly develops fuel cell vehicles with research institutions, government departments and well-known automobile manufacturers. The Company's industry competitive advantages derive from its continuous leading position in the fast-growing Chinese fuel cell system market, strong R&D strength, established stable cooperative relations with domestic mainstream commercial vehicle companies, integrated parts supply system and established in-depth cooperation relations with suppliers, as well as the support of experienced senior management team and high-quality staff team, which will help the Company stand out from its many opponents.Mr. Zhang Guoqiang, Chairman, Executive Director and General Manager of SinoHytec said: "Today, SinoHytec is officially listed on the Main Board of the Hong Kong Stock Exchange, which is an important milestone in the Company's development and marks the entry of SinoHytec into the international capital market. We would like to express our gratitude to our investors for their trust and support of SinoHytec. Setting off from a new starting point, we will further promote the research and development of fuel cell systems and core components; Expand the production capacity of fuel cell stacks to meet the growing market demand and achieve economies of scale; economies of scale; strategically expand customer base and regional coverage; expand and strengthen the supply chain; and enhance brand awareness and promote the application of fuel cell systems. We will grasp the future trends and directions of the industry, and leverage our own competitive advantages to further consolidate SinoHytec's market position to create the greatest value for shareholders and investors." Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

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SinoHytec Announces Proposed Listing on the Main Board of the Hong Kong Stock Exchange, Offer Price Between HK$60 and HK$76 per H Share, Raise up to HK$1,540.7 million

HONG KONG, Dec 29, 2022 - (ACN Newswire via SEAPRWire.com) - The leading provider of fuel cell systems in China - Beijing SinoHytec Co., Ltd. ("SinoHytec" or the "Company", Stock Code: 2402), today announced the proposed listing of its shares on the Main Board of the Stock Exchange of Hong Kong Limited ( the "Hong Kong Stock Exchange"). SinoHytec plans to offer an aggregate of 17,628,000 H shares under the Global Offering (subject to the Over-allotment Option), comprising an International Offering of 15,865,200 H shares (subject to Reallocation and the Over-allotment Option), representing 90% of the initial offer shares; and Hong Kong Public Offering of 1,762,800 H shares (subject to Reallocation), representing 10% of the initial offer shares), at a price range between HK$60 and HK$76 per Offer Share. The Hong Kong Public Offering will commence at 9 a.m., December 29, 2022 (Thursday), and close at 12:00 noon on January 5, 2023 (Thursday). Dealings in the shares of SinoHytec on the Main Board of the Hong Kong Stock Exchange is expected to commence on January 12, 2023 (Thursday), with the stock code 2402 and in board lots of 50 Offer Shares each.Guotai Junan Capital Limited and Giraffe Capital Limited are the Joint Sponsors.SinoHytec is a leading provider of fuel cell systems in China, focusing on the design, development and manufacture of fuel cell systems and stacks (a key component of the system) mainly for commercial vehicles, such as buses and trucks. According to the China Insights Industry Consultancy Limited Report ("CIC Report"), the company ranked first in the PRC fuel cell system market in terms of the total power output of fuel cell systems sold* in 2021, with a market share of 27.8%; and in 2021, fuel cell systems accounted for approximately 0.8% of the total sales volume of new energy systems for commercial vehicles, while lithium battery systems accounted for the rest of the total sales volume. As of June 30, 2022, the company's fuel cell systems were installed on 80 models of fuel cell vehicles that are featured in the MIIT New Energy Vehicle Catalogs, ranking us first in the industry.Leader in China's fast growing fuel cell system marketEstablished in 2012, the company is a pioneer in the R&D and commercialization of fuel cell systems in China and started batch production in 2016. The company also participated in the fuel cell vehicle development and commercialization scheme of the United Nations Development Programme in China and witnessed the progress of the PRC fuel cell industry from the R&D phase to pilot testing and to commercialization. The company's fuel cell systems are installed on commercial vehicles operating across various PRC cities, including Beijing, Zhangjiakou, Shanghai, Chengdu, Zhengzhou and Zibo. As of December 20, 2022, the company's fuel cell systems have powered over 2,800 fuel cell vehicles on the road in China. These vehicles had an average mileage of around 40,000 kilometers per vehicle, accumulating over 108.6 million kilometers and 2.3 million hours of operations, which built an industry leading record.Strong research and development capabilitiesThe Company adheres to a R&D principle of "Advance Research", "Continuous Development" and "In-depth Promotion". The key objectives of the Company R&D and product testing activities are to optimize and upgrade the company products' adverse weather capabilities, durability, reliability, efficiency, safety and economy. As of June 30, 2022, the Company has establised an outstanding R&D team of 270 members. The Company also cooperated with leading research universities in China, such as Tsinghua University, to facilitate the development and commercialization of innovative fuel cell technologies so that the Company can respond to the fast-changing market demands.The Company's R&D team has progressively developed the 30kW, 40kW, 50kW, 60kW, 80kW, 100kW, 120kW and 150kW models of fuel cell systems over the years. In particular, the Company launched the 240kW high power output model in December 2021, which is the first automotive fuel cell system in China that can reach a rated power of 240kW.In addition, the Company participated in and achieved significant results in various R&D projects sponsored by the PRC government. As of June 30, 2022, the Company had over 590 patents, including over 210 invention patents, over 360 utility model patents, and 20 design patents. In addition, the Company has more than 590 patent applications that have been accepted by the State Intellectual Property Office of China.* Sales volume of fuel cell systems comprises only direct sales to fuel cell vehicle manufacturers.Solid partnerships with major PRC commercial vehicle manufacturersThe Company has built solid long-term partnerships with major commercial vehicle manufacturers in China, such as Beiqi Foton, Yutong Bus and Geely Commercial Buses, through jointly undertaking national-level R&D projects and codeveloping, demonstrating and testing fuel cell vehicles. In particular, Beiqi Foton and Yutong Bus purchased the Company's fuel cell systems on order basis since 2016 and 2018, respectively, for the production of their fuel cell vehicles. The Company codeveloped with Toyota and Beiqi Foton transit buses using the Company's fuel cell systems which are designated as the official transport vehicles at the Beijing 2022 Olympic Winter Games. As of June 30, 2022, the Company has sold fuel cell systems to over 20 commercial vehicle manufacturers whose total fuel cell vehicles sold in 2021 represented nearly 60% of the market share in China. In addition, Beiqi Group and Yutong Bus have become the company Shareholders and strategic partners, representing the recognition of us by the downstream players of the fuel cell vehicle industry.Integrated components supply system and close cooperation with suppliersAfter years of dedication, the Company built a comprehensive procurement system with local suppliers. During the Track Record Period, the Company has established a relatively stable long-term relationship with over 300 suppliers in China, providing parts such as MEA and air compressors. During the Track Record Period, the company had localized the supply of MEA and procured more raw materials from local suppliers each year.Mr. Zhang Guoqiang, Chairman, Executive Director and General Manager of SinoHytec said, "Our mission is to leverage advanced hydrogen fuel cell technologies to contribute to China's carbon emission peak and carbon neutralitygoal and empower global energy transition. We are committed to becoming a global leader in hydrogen fuel cell technologies for promoting a sustainable and low-carbon future. New energy vehicle development is strategically significant to China's energy security and environmental protections. We intend to achieve this goal by implementing the following strategies: further advance the R&D of fuel cell systems and core components; expand the production capacity of fuel cell stacks to meet the growing market demand and achieve economies of scale; strategically expand our customer base and geographical coverage; expand and strengthen our supply chains; and improve our brand awareness and promote the application of fuel cell systems. We will grasp the opportunities arising in future trend and development of the industry, leverage on our competitive advantages to further consolidate SinoHytec's market position, and create the greatest value for shareholders and investors."Beijing SinoHytec Co., Ltd.Fact SheetInformation on the Global Offering:Number of Offer Shares under the Global Offering: 17,628,000 H Shares (subject to the Over-allotment Option)Number of Hong Kong Offer Shares: 1,762,800 H Shares (subject to reallocation)Number of International Offer Shares: 15,865,200 H Shares (subject to reallocation and the Over-allotment Option)Maximum Offer Price: HK$76.00 per H Share, plus brokerage fee of 1.0%, SFC transaction levy of 0.0027%, AFRC transaction levy of 0.00015% and Stock Exchange trading fee of 0.00565% (payable in full on application in Hong Kong dollars and to refund)Board Lot: 50 H SharesStart of the Hong Kong Public Offering: 9:00 a.m., December 29, 2022 (Thursday)End of the Hong Kong Public Offering: 12:00 noon, January 5, 2023 (Thursday)Announcement of Allotment Results: January 11, 2023 (Wedsnesday)Expected Listing Date: January 12, 2023 (Thursday)Stock Code: 2402Use of Proceeds:The Company estimates that it will receive net proceeds of approximately HK$1121.8 million from the Global Offering, after deducting the underwriting commissions, fees and estimated expenses payable by the Company in connection with the Global Offering, assuming that the Over-allotment Option is not exercised and assuming an Offer Price of HK$68 per Share (being the mid-point of the indicative Offer Price range). The Company intends to use the net proceeds for the following purposes: 1) Approximately 75.0% (approximately HK$841.2 million) will be used to fund the research and development in the next three years;2) Approximately 15.0% (approximately HK$168.4 million) will be used for improving the brand recognition through product promotion and multi-channel marketing in the next three years; 3) Approximately 10.0% (approximately HK$112.2 million) will be used for working capital and other general corporate purposes. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Malaysian Genomics Sees Rise in Profit Margins for 1Q

PETALING JAYA, Malaysia, Nov 23, 2022 - (ACN Newswire via SEAPRWire.com) - Malaysian Genomics Resource Centre Berhad, a leading genomics and biopharmaceutical specialist, today reported a revenue of RM3.81 million for the first quarter ended 30 September 2022 (1Q 2023) versus a revenue of RM9.32 million in 1Q 2022, as the Group refocuses on immunotherapy and cell therapies under the biopharmaceutical business and pushes for organic growth of its genetic screening business.Independent Non-Executive Chairman, Dato' Seri Dr Chen Chaw MinThe Group recorded a 254.16% increase in profit before tax (PBT) to RM0.85 million for 1Q 2023, compared with RM0.24 million in the corresponding quarter of the previous financial year, on higher profit margins and revenue contributions from the new biopharmaceutical business.Earnings per share for 1Q 2023 stood at 0.68 sen compared with 0.20 sen in 1Q 2022.Dato' Seri Dr Chen Chaw Min, Independent Non-Executive Chairman of Malaysian Genomics said, "The Group's pivot to immunotherapy and cell therapies from vaccine distribution continues to pay off as PBT improves on higher profit margins. We expect more improvements to the biopharmaceutical business as the Group's expansion of its distribution network and footprint overseas in the Middle East and Southeast Asia takes shape.""We are pushing the genetic screening business as the Group continues to reach out through business-to-consumer channels for a wider market reach. We believe better awareness and education is prompting more people to take action on how they can enhance their health, and the Group will leverage on this through catering to the different needs and groups from our suite of healthcare-related solutions. We are also seeking to acquire assets or invest in businesses that will support the expanded market reach of our products and services.""The Group is well positioned to be a leading provider of genetic screening, genome analysis, and biopharmaceutical products in Southeast Asia, as we are equipped with a high-throughput sequencing lab, an advanced microarray facility, and a new state-of-the-art cGMP cell processing lab for cell therapies, including immunotherapy for various types of cancers. We are confident that we are in a position to provide patients with better access to the latest precision and personalised healthcare solutions."Malaysian Genomics Resource Centre Berhad: 0155 [BURSA: MGRC] [RIC: MGRC:KL] [BBG: MGRC:MK], http://www.mgrc.com.my/ Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Novotech presented with Cell & Gene Excellence Award 2022 at 6th Cell & Gene Therapy World Asia Conference

SYDNEY, AU, Sep 15, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, has been awarded the Cell & Gene Therapy Clinical Trials award at the 6th Cell & Gene Therapy World Asia 2022 conference.Novotech has extensive experience in cell & gene therapy clinical trials across Asia Pacific. The Asia Pacific accounts for over a third of cell & gene therapy trial activity with China being the leading location in APAC. In addition, APAC has nearly a 50% faster growth rate in cell & gene therapy trials than ROW. Blood cancers (ALL, NHL, DLBCL, lymphomas), solid tumors, viral infections, liver and gastrointestinal tract cancers are the top indications in China-based cell & gene therapy trials between 2016 and 2021.Watch our recent Endpoints News webinar for more information:EVOLUTION OF CELL & GENE THERAPY IN CHINA: THE CASE FOR UNIVERSAL CAR-Thttps://novotech-cro.com/webinars/evolution-cell-gene-therapy-china-case-universal-car-tThe award was presented to Novotech during the 6th Cell & Gene Therapy World Asia 2022 conference (14th - 15th September) at the Sheraton Towers, Singapore.Novotech CEO Dr. John Moller said, "We are extremely pleased our team has been recognized with this prestigious award at the 6th Cell & Gene Therapy World Asia 2022 conference. Cell & gene therapy is driving recent innovations in biotech and it is an honour to be recognized as the CRO at the forefront in Asia-Pacific supporting this vital clinical research. Cell & gene therapy research typically presents another level of complexity and regulatory processes which means an experienced CRO partner is vital. Our deep experience, exceptional site and investigator relationships - which also translates to patent access - our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the service biotechs need in this specialist sector for success."Novotech has recently also been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.Download our latest data reports here:EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5About Novotech Novotech is the leading Asia-Pacific centered, globally capable, biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Malaysian Genomics Forms Partnership for Expansion in Saudi Arabia

PETALING JAYA, Malaysia, Jul 13, 2022 - (ACN Newswire via SEAPRWire.com) - Malaysian Genomics Resource Centre Berhad (Bursa: MGRC, 0155), a leading genomics and biopharmaceutical specialist, announced today that it has entered into a strategic partnership with United Doctors Hospital (UDH) for collaboration in genomics and cell therapies.Azri Azerai, Executive Director of Malaysian GenomicsUDH, located in Jeddah, Saudi Arabia, is accredited by the Saudi Central Board for Accreditation of Healthcare Institutions. UDH has also won numerous awards for social responsibility, including the King Khalid Award for Social Responsibility in 2018, and is certified with the SA8000, the world's leading social certification programme, by Social Accountability International (formerly known as Social Accountability Accreditation Services), a United States-based charitable organisation, in 2016.Under the partnership, which is valid for three years, Malaysian Genomics and UDH will take the necessary steps to encourage and promote cooperation in the sales and marketing of genetic screening tests and cell therapy products; collaboration in research and development (R&D), and other areas of cooperation in the genomics and cell therapies to be mutually decided by both parties. Encik Azri Azerai, Executive Director of Malaysian Genomics, said, "This strategic partnership with UDH enables us to expand the geographical reach of our products and services beyond Malaysia to the Middle East and North Africa region. It will also enable us to collaborate on R&D with various domain specialists to enhance our suite of genetic screening tests and cell therapies."Dr. Hefny Moustafa Hefny, Medical Doctor at UDH, said, "Among the areas being explored by Malaysian Genomics and UDH are opportunities to develop genetic screening tests for hereditary conditions and diseases that are prevalent in the Middle East or Northern Africa, which may be different from other parts of the world."Malaysian Genomics is actively expanding its business-to-consumer channels as part of the Group's growth strategy. The Group recently acquired a 51% stake in kidney dialysis operator Aquahealth Sdn Bhd to offer personalised kidney care that also involves nutrition management, lifestyle changes, and genetic testing. It is also collaborating with AirAsia's Asean Super App online shopping platform and Speedoc to provide genetic screening services.Malaysian Genomics Resource Centre Berhad: 0155 [BURSA: MGRC] [RIC: MGRC:KL] [BBG: MGRC:MK], http://www.mgrc.com.my/ Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Weichai Power Announces 2021 Annual Results

HONG KONG, Mar 31, 2022 - (ACN Newswire via SEAPRWire.com) - Weichai Power Company Limited ("Weichai Power" or the "Company", SEHK stock code: 2338.HK; Shenzhen Stock Exchange stock code: 000338.SZ) announced its annual results for the year ended 31 December 2021 (the "year") on 30th March, prepared in accordance with PRC accounting standards.Steady growth in operating performance and continued to increase shareholder returnsDuring the reporting period, the Company focused on its established strategic objectives and main business, gave full play to its diversification advantages, continued to increase investment in research and development, accelerated breakthroughs in key core technologies, continuously strengthened its product competitiveness and improved operational efficiency, firmly stabilized its fundamental and supported its future development, to achieve the Company's leading growth and gather a win-win situation. In 2021, the Company overcame the adverse impact such as commodity price increases, with a steady increase in gross margin level and high turnover efficiency, demonstrating strong operational resilience. During the reporting period, operating revenue of RMB 203.55 billion was achieved, representing a year-on-year growth of 3.2%. Net profit attributable to the shareholders of the parent was RMB 9.25 billion, with an increase of 0.3% year-on-year. Basic earnings per share were RMB 1.1. The Company attaches great importance to shareholder returns and paid a total dividend of RMB 3.7 per 10 shares throughout the year. Powertrain market share increased, and the product structure was significantly optimizedDuring the reporting period, the Company's powertrain business maintained positive and steady development, with annual sales of 1.02 million engines, increased by 3% year-on-year. Sales of 1.153 million gearboxes, including 1.01 million gearboxes for heavy trucks, with the market share increased by 5.3 percentage points to 72.4% year-on-year. And sales of 938,000 axles, including 697,000 axles for medium and heavy truck.The engine series had significant advantages in all fields, with the proportion of non-road engines in total sales increased by 5.3 percentage points to 34.4%, and maintaining the industry's top position in the markets of loaders, cranes and bulldozers. Seizing the opportunity of upgrading emission standards, the Company's China VI engine sale volume ranked top position in the industry, with 429,000 heavy truck engines sold and the market share increased by 2.8 percentage points year-on-year to 30.7%.Strategic high-end products continued to gain momentum, achieving revenue of RMB1.41 billion, increased by 49.3% year-on-year. High-end hydraulics achieved domestic revenue of RMB560 million, increased by 11.8% year-on-year. Relying on the differentiated advantages of products, the Company has achieved rapid growth in market segments such as crawler excavation and agricultural equipment. The commercialization of CVT powertrain has been accelerated, and it has been matched to Lovol 240hp CVT intelligent tractor, achieving a 15% increase in overall operating efficiency and a 10% reduction in fuel consumption.Technology leads industry development, diversified power all-round championThe Company continued to increase its investment in research and development around its core technologies and products. During the reporting period, the amount of investment in R&D was RMB 8.57 billion, and the ratio of R&D investment to revenue was 4.2%. The Company has made multiple efforts to firmly keep traditional high-end power and new energy power in the forefront. For the first time in the world, the base engine thermal efficiency of diesel engines reached 51.09%, which can reduce fuel consumption and CO2 emissions by 10% respectively and reach a new peak in power; For new energy, the Company actively laid out multiple technical routes such as fuel cell, pure electric, hybrid, hydrogen internal combustion engine and methanol to meet the diversified needs of the market, among which the core performance indicators of hydrogen fuel cell products are industry-leading.Outstanding achievements in new energy, accelerating industrializationThe Company has developed a full range of fuel cell product platforms from 30-200kW and released them for mass production. The new energy product testing center has obtained the laboratory accreditation certificate issued by the China National Accreditation Service for Conformity Assessment (CNAS), becoming the first laboratory in the industry to pass the testing certification for both hydrogen fuel cell and solid oxide fuel cell products at the same time. Relying on the National Fuel Cell Technology Innovation Center, heavy trucks equipped with the Company's hydrogen fuel cell products have been used in ports, industrial parks, steel mills, highways, and other scenarios.Heavy trucks pursued progress while ensuring stability, and overseas sales have increased significantlyIn 2021, the Company continued to adjust and optimize its product mix by focusing on the upgrading of the China VI emission regulations and sold a total of 150,000 heavy-duty trucks. Seizing the opportunity of China VI switchover, the market share of major segments continued to increase. Port tractors, muck trucks and coal and gravel transporters continued to maintain leading position in the industry, and the 480 hp model for standard load logistics had the highest growth rate in the industry; Export volume grew significantly, with over 19,000 units exported in the year, increased by 72% year-on-year. Innovation-driven development, comprehensive shaping of new advantages of the heavy truck.Intelligent logistics reaches new highs, profit contribution continues to increaseThe Company's Intelligent Logistics business achieved the high targets set, demonstrating its key position in the industry and contributing significantly more profit to the Company. During the reporting period, sales revenue of EUR 10.29 billion was achieved, increased by 23.4% year-on-year; Net profit of EUR 570 million increased by 169% year-on-year; Meanwhile, the increased share of supply chain solution business drove profitability to continue to improve, with the adjusted EBIT margin increased by 1.6 percentage points year-on-year to 8.2%. At the end of the reporting period, orders on hand amounted to EUR 6.66 billion, increased by 49.9% compared to the beginning of the year. With the completion of the new forklift plant in Jinan and the start of construction of a new plant for supply chain solutions, KION is fully committed to exploiting the business potential in the Asia-Pacific market in the future to promote sustainable and high-quality growth.Technological revolution boosts industrial transformation, and make precise efforts to promote structural adjustment. Looking into the future, Weichai Power will continue to consolidate its dominant position in the main business, further enhance product competitiveness and market share, and lead the industry to the high-end. Weichai Power will scale up efforts to promote new business formats, significantly increase the profit contribution of large-bore engines, and achieve rapid production volume increase in hydraulic products. Weichai Power will promote synergetic development of export business, the steady growth of intelligent logistics, and the take-off of overseas business. Weichai Power will also accelerate the technological breakthrough and industrialization of the fuel cell industry chain to demonstrate the new advantages of its high-quality development.About Weichai Power Co., Ltd (Stock Code: 2338.HK, 000338.SZ)Founded in 2002, Weichai Power is one of the strongest comprehensive automotive and equipment manufacturing industry groups in China. It owns Shaanxi Heavy Duty Automobile Co.,Ltd., Shaanxi Fast Gear Co. Ltd., Weichai Torch Technology Co., Ltd., KION Group AG, and Linde Hydraulics GmbH & Co. KG, Dematic, and other dozens of high-quality companies in a cluster, building a new pattern of synergistic development of three major industrial segments, namely, the complete machine segment, the powertrain segment and the intelligent logistics segment, forming the most complete and competitive industrial chain in the national automobile industry. The Company was listed on the Main Board of the Hong Kong Stock Exchange on 11 March 2004 and returned to the mainland A-share market by way of a share swap on 30 April 2007. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Honda to Install Stationary Fuel Cell Power Station on California Campus as First Step Toward Commercialization of Zero-Emission Backup Power Generation

Torrance, Calif., Mar 15, 2022 - (JCN Newswire via SEAPRWire.com) - Honda today announced plans to install a stationary fuel cell power station on its corporate campus in Torrance, Calif. by early 2023. The station will serve as a proof of concept for the future commercialization of a power generation unit for use as a zero-emission backup power source for facilities such as data centers, which require reliable and clean auxiliary power generation to continue operations even in emergency situations. This new initiative will leverage Honda's fuel cell technology expertise as part of the company's global goal to achieve carbon neutrality for all products and corporate activities by 2050. Honda's proof of concept fuel cell power station will utilize fuel cell components from Honda Clarity Fuel Cell vehicles in a flexible, four-quad parallel stationary fuel cell power generation system capable of generating up to 1152kW-DC/1MW-AC from an inverter. A unique advantage of the four-quad design is the flexibility to change the layout of the four individual fuel cell units to suit the installation environment, accommodating a cuboid, L-shape, Z shape or other packaging requirements. The station will be connected to the data center on the American Honda campus in early 2023, providing a real-world power generation application to verify performance. This will enable Honda to advance its know-how in the power supply area, as well as supply chain development, grid connection access, construction specifications, AC/DC connection requirements and other critical areas."We will leverage the expertise Honda has established in creating multiple generations of fuel cell systems for the development of a fuel cell power generation station," said Mitsuru Kariya, senior vice president in charge of the R&D Business Unit of American Honda. "This project is an opportunity to further utilize our strengths in fuel cell technology to more quickly create, assess and advance a clean power generation system for potential commercial customers."While Honda remains committed to developing fuel cell systems for passenger vehicles, the market for fuel cell systems to power larger trucks and transport ships, as well as stationary generation, is expanding rapidly in the U.S. and is expected to grow to over $86.7 billion annually by 2030. Data centers in particular require high-quality and reliable power, where any disruption in power supply can lead to downtime or problems such as data corruption and damage to servers. Typical stationary backup generators rely on diesel fuel, which result in higher carbon emissions and local air pollutants. Backup power systems utilizing hydrogen fuel cells offer a promising future for clean, yet reliable and high-quality power generation, especially when operating on so-called "green" hydrogen made from renewable sources, with water vapor as the only emission. Honda Fuel Cell Technology LeadershipHonda has led the industry over the past quarter-century in the development and deployment of fuel cell technology, including extensive real-world testing and customer deployments. - In July 2002, the Honda FCX became the first fuel-cell vehicle certified by the U.S. Environmental Protection Agency (EPA) and California Air Resources Board (CARB). - In December 2002, Honda introduced the world's first production fuel-cell vehicle, to both the U.S. and Japan markets. - In 2003, Honda became the first automaker with a fuel-cell vehicle to start and operate in sub-freezing temperatures.- In 2005, Honda became the first automaker to lease fuel cell vehicles to individual retail customers.- In 2008, Honda became the first manufacturer to build and produce a dedicated fuel-cell vehicle (FCX Clarity) on a production line specifically made for fuel-cell vehicles.- In 2013, Honda and GM began working together on the co-development of a next-generation fuel cell system and hydrogen storage technologies.- In 2017, Honda introduced the Honda Clarity Fuel Cell vehicle.- In 2020, Honda Motor Co., Ltd. and Isuzu Motors Ltd. signed an agreement for joint research of the use of hydrogen fuel cells to power heavy-duty trucks, looking to expand fuel cell use by applying the zero-emission technology to larger vehicles. In 2021, Honda announced its collaboration with Japan Aerospace Exploration Agency (JAXA) to develop a fuel cell system combined with a high differential pressure water electrolysis system that will help support a "circulative renewable energy system" to supply space and lunar stations with electricity, oxygen and water.At FC Expo held in Japan during March 16 and 18, 2022, Honda will display a prototype of FC Power Unit co-developped with General Motors, a portable FC generator concept model. Honda Commitment to the EnvironmentHonda is committed to addressing global environmental and energy issues by striving to realize carbon neutrality for all products and corporate activities by 2050. Honda proudly has the highest fleet average fuel economy and lowest CO2 emissions of any full-line automaker in America, according to the U.S. Environmental Protection Agency's (EPA) latest data. To reduce CO2 emissions even further, Honda will strive to make battery-electric and fuel cell electric vehicles represent 100% of auto sales in the U.S. and globally by 2040. Honda also is working to reduce the environmental impact of its business operations. To slash CO2 emissions from its North American manufacturing operations, Honda has entered into long-term virtual power purchase agreements (VPPAs) for renewable wind and solar power seeking to cover more than 60% of the electricity that Honda uses in North America. This enables the company to fully offset the remaining carbon intensive grid-supplied electricity used in its Ohio, Indiana, and Alabama automobile manufacturing operations. Honda also promotes environmentally responsible business practices with its suppliers and retail dealer partners across North America.Learn more at https://csr.honda.com/environment/na-environmental-report/ Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Fujitsu and Tokyo Medical and Dental University leverage world’s fastest supercomputer and AI technology for scientific discovery to shed light on drug resistance in cancer treatment

TOKYO, Mar 7, 2022 - (JCN Newswire via SEAPRWire.com) - Fujitsu and the Tokyo Medical and Dental University (TMDU) today announced a new technology that uses AI to discover new causal mechanisms of drug resistance in cancer treatments from clinical data. Leveraging the world's fastest supercomputer "Fugaku,"(1) the new technology enables high-speed calculation of 20,000 variables of data within a single day and allows for the discovery of previously unknown causal relationships relating to drug resistance in cancer cells from 1,000 trillion different possibilities.Fujitsu and TMDU applied this technology to gene expression level(2) data obtained from cancer cell lines in order to analyze drug resistance(3) against anticancer drugs, and succeeded in extracting a new causal mechanism of a previously unknown gene that suggests a cause of resistance to lung cancer drugs. The new technology is expected to contribute to the acceleration of drug discovery and the realization of cancer therapies individualized for each patient.The technology was developed under the theme of "elucidation of the cause and diversity of cancer using large-scale data analysis and AI technology," an initiative supported by TMDU, Kyoto University and Fujitsu as part of the supercomputer Fugaku achievement acceleration program(4).BackgroundEven if a patient receives a targeted cancer drug(5) therapy, the appearance of drug-resistant cancer cells represents an ongoing threat to full remission. The mechanism for how certain cancers become drug resistant remains unclear, however, and researchers continue to work on new methods of analysis that shed light on how cells that have multiple driver mutations(6) acquire drug resistance. In drug development and clinical trials involving drug repositioning(7), it is important to identify patients for whom drugs are anticipated to have an effect. However, the effectiveness of drugs may differ depending on the organ and the individual and variations in gene expression, and the number of patterns combining expression levels of multiple genes exceeds 1,000 trillion(8). A comprehensive search of all 20,000 genes in the human genome would thus take more than 4,000 years with a conventional computer and finding ways to accelerate the process represents a major challenge.Newly developed technologyFujitsu implemented parallel conditional and causal algorithms to maximize computational performance with the supercomputer Fugaku to analyze the human genome within a timeframe needed for practical research. By utilizing Fujitsu's "Wide Learning"(9) AI technology to extract combinations of potential genes relating to the emergence of drug resistance based on statistical information, Fujitsu developed a novel technology that makes it possible to conduct a comprehensive search within a day.ResultsAs a result of running data of the Dependency Map (DepMap)(10) portal using this technology on the supercomputer Fugaku, Fujitsu and TMDU were able to search the entire human genome for conditions and causality within a single day and determine the genes that cause resistance to drugs used to treat lung cancer(11).Comment from Prof. Seiji Ogawa, Graduate School of Medicine, Kyoto UniversityPromising technologies like Fujitsu's AI technology for scientific discovery ("Wide Learning") may one day contribute to the discovery of biomarkers, which represent an area of growing interest in drug development. The key to the success of new drug development is to identify patients who are expected to benefit from new drugs and conduct clinical trials. If the marker that predicts who will benefit from the drug is known, the cost of clinical trials can significantly be reduced and the probability of success by conducting individual clinical trials can be increased. From this point of view, pharmaceutical manufacturers and others are expected to be very interested in this technology. The fact that it has been implemented using Fugaku has also raised expectations.Future PlansMoving forward, Fujitsu and TMDU will conduct a multilayered and comprehensive analysis that combines various data including time axis and location data with the aim of accelerating medical research, including in the field of drug efficacy, as well as to shed light on the causes of cancer. Fujitsu and TMDU will also collaborate in experimental research in the fields of drug discovery and medicine. TMDU will further utilize the technology developed in this research to promote research on strategies for intractable diseases such as cancer. In addition to medical care, Fujitsu will utilize the new technology to resolve challenges in a variety of fields, including marketing, system operations and manufacturing.AcknowledgementsThis research was conducted as part of Ministry of Education, Culture, Sports, Science and Technology's Fugaku Achievement Acceleration Program "Understanding the Origin and Diversity of Cancer through Large-scale Data Analysis and Artificial Intelligence Technologies" (JPMXP 1020200102). A part of the research was conducted with the computational resources of supercomputer Fugaku (Issue #: hp 200138, hp 210167).(1) Supercomputer "Fugaku":A computer installed at RIKEN as a successor to the supercomputer "K." From June 2020 to November 3, it ranked first in 4 categories in the supercomputer rankings for 4 consecutive years. Full operation started on March 9, 2021.(2) Gene expression level :Amount of RNA copied from DNA (the same nucleic acid as DNA synthesized by transcription using some DNA sequences as templates).(3) Drug resistance :A phenomenon in which the effect of a drug weakens while the drug is being administered.(4) Supercomputer Fugaku Achievement Acceleration Program :Program started in May 2020 by the Ministry of Education, Culture, Sports, Science and Technology with the aim to achieve early results.(5) Targeted drug :A drug designed to act only on the molecule (protein, gene, etc.) that is causing the disease.(6) Driver mutations :A genetic mutation that directly causes the development or progression of cancer.(7) Drug repositioning :The application of existing drugs developed and approved for the treatment of one disease to the treatment of another disease.(8) More than 1,000 trillion :Even if the expression level of each gene is restricted to a combination of 50 major genes known to be related to cancer and the expression level of each gene is classified into 2 categories (e.g., "high" or "low" gene expression), the condition number is 2 to the power of 50, which exceeds 1,000 trillion.(9) Wide Learning :Official site "Hello, Wide Learning!"(10) Dependency Map (DepMap) :Data on the sensitivity and resistance of approximately 4,500 drugs to approximately 600 different cancer cell lines, provided by the American Broad Institute. Mutation information of cancer cell lines and expression data of all genes are included.(11) Fujitsu and TMDU analyzed gene expression data from DepMap of approximately 300 cancer cell lines, sensitivity and resistance data of Gefitinib (molecularly targeted drug used to treat lung cancer and other cancer types), and comprehensively searched for conditions and mechanisms of cancer cell lines that do not respond to Gefitinib. Fujitsu and TMDU identified conditions under which the expression levels of three transcription factors (genes that control gene transcription (synthesis of RNA)), ZNF516, E2F6, and EMX1, were low. In lung cancer cell lines that meet these conditions, a mechanism triggered by the transcription factors SP7 and PRRX1 was discovered as further potential causes of drug resistance in cancer cells (see reference image).About FujitsuFujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Approximately 126,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.6 trillion yen (US$34 billion) for the fiscal year ended March 31, 2021. For more information, please see www.fujitsu.com.About Tokyo Medical and Dental UniversityTokyo Medical and Dental University (TMDU) is Japan's only comprehensive medical university and graduate school, and has provided advanced medical treatment through a fusion of the medical and dental fields and worked to cultivate "professionals with knowledge and humanity." TMDU contributes to human health and the well-being of society by fostering outstanding healthcare professionals with a humane and global outlook. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Technological Revolution and Industrial Transformation, Weichai Power Releases the World’s First Diesel Engine with a Base Engine Thermal Efficiency of 51.09%, along with Major Hydrogen Energy Technology Achievements

HONG KONG, Jan 13, 2022 - (ACN Newswire via SEAPRWire.com) - At 9:00 am on January 8, 2022, Weichai Power (Stock codes: 2338.HK; 000338.SZ) released the world's first diesel engine with a base engine thermal efficiency of 51.09% and major achievements in hydrogen technology achievements.Tan Xuguang, CPC Secretary and Chairman of Shandong Heavy Industry Group, Chairman of Weichai Power and Director of the Academic Committee of the National Fuel Cell Technology Innovation Center, reported the research findings of the world's first diesel engine with a base engine thermal efficiency of 51.09% developed by Weichai Power, the operation of the National Fuel Cell Technology Innovation Center and the "Hydrogen for Every Home" technology demonstration project. TuV SuD, an world-renowned test authority, issued a certificate of thermal efficiency of 51.09% to Weichai Power. Then the delivery ceremony of hydrogen-powered heavy-duty truck delivery for demonstrative operation between Shandong Heavy Industry and Shandong Port was held.FISITA, MIT, AVL, FEV, SwRI, Bosch Group and Vitesco Technology, as well as the China Mechanical Engineering Society, the China Automotive Engineering Society, the China Internal Combustion Engine Society and the China Internal Combustion Engine Industry Associations extended congratulations on the release of the diesel engine by message or video link.Challenging Limits, Scaling New HeightsToday when green and low carbon development has become a global consensus, China has set the strategic goal of achieving carbon peak by 2030 and carbon neutralization by 2060. Transportation is an important field for this target, and the internal combustion engine industry plays an important role in this process.Thermal efficiency is the yardstick for the fuel efficiency of internal combustion engines: higher thermal efficiency represents lower fuel consumption and better effects of energy conservation and emission reduction. It is also a reflection of a country's technical strength in diesel engines. Improving thermal efficiency has been the common pursuit of the global diesel engine industry since diesel engines emerged 125 years ago. Weichai Power released the world's first commercial diesel engine with a base engine thermal efficiency of 50.23% in Jinan on September 16, 2020, establishing a new thermal efficiency benchmark for global diesel engines, just like the first time in human history that a 100-meter sprint was completed in 10 seconds. Just 480 days later, Weichai set a new world record by increasing the base thermal efficiency to 51.09% just as a 100-meter race was completed in 9 seconds, further enhancing China's significance in the global internal combustion engine industry.The base engine thermal efficiency of 51.09% is another significant revolution of traditional engines, as well as a technical preparation for the implementation of the "China VII" emission standard. The application of this technology will help Weichai Power lead the world in a full spectrum of diesel engines, be of great strategic significance to promoting the energy-efficient and green development of China's traditional internal combustion engine industry, and play a significant leading role in the global internal combustion engine industry.According to estimation, compared with existing key products (diesel engines with thermal efficiency of 46%) on the market, those with a thermal efficiency of 51% can lead to a reduction of 10% in fuel consumption and carbon dioxide emissions alike, saving fuel consumption by 16 million tons and costs by approximately 140 billion yuan annually, and reducing carbon dioxide emissions by 50 million tons annually. With the massive use of the top technology in the industry, it will generate huge economic and social benefits.Hydrogen-powered Future, Shandong Model for Hydrogen IndustryWhile promoting the innovative and low-carbon development of traditional engines, Weichai Power has taken the new energy industry as an important strategy. The first batch of Sinotruk hydrogen-powered heavy-duty tractor trucks with Weichai's high-power hydrogen fuel cell systems are powerful, eco-friendly, safe, reliable and efficient for full-time use. In 2021, the National Hydrogen Cell Technology Innovation Center, the only of its kind in China, was established under the initiative of Weichai Power. Meanwhile, the Ministry of Science and Technology (MOST) and Shandong entered into a framework agreement on the "Hydrogen for Every Home" technology demonstration project. Based on the center, the ministry has carried out multi-scenario demonstrative application of hydrogen energy in Shandong, and sped up breakthroughs in key hydrogen technologies and the development of the hydrogen industry, thereby creating a duplicable Shandong sample for the hydrogen industry.Since the launch of the "Hydrogen for Every Home" technology demonstration project, with the strong support of MOST and Shandong, the National Hydrogen Cell Technology Innovation Center has established an innovation consortium centered on Weichai Power and constituted by enterprises, universities and research institutes, to accelerate technical breakthroughs and industrialization, and successfully develop 15-200kW hydrogen fuel cell systems. The company's 200kW fuel cell systems were selected for the National Exhibition on Sci-tech Achievements in the "13th Five-Year" Period in October 2021. The company was the first to conduct an environmental adaptability test of fuel cell vehicles in extreme cold, achieving one-time successful start-up at a temperature of 34 degrees Celsius below zero. The company was the first in the industry to turn out products lasting 30,000 hours, pioneering the industrialization of Chinese fuel cells.Based on its highly reliable fuel cell products, Weichai Power has carried out multi-scenario demonstrative application. In terms of hydrogen-powered parks, the company's first large-power container-type hydrogen fuel cell heating and power generation system and 30kW solid oxide fuel cell heating and power system, both the first of its kind in China, were put into operation in Weifang; the company developed China's first 3t hydrogen fuel cell forklift, creating a zero-carbon-emission logistics handling environment. In terms of hydrogen-powered ports, China's first 80-seat hydrogen fuel cell passenger ship developed by the company was tested successfully with zero carbon emission in the Xueye Lake, Jinan; and the company launched China's first hydrogen fuel cell heavy-duty truck demonstration project at Qingdao Port. In terms of hydrogen-powered highways, China's first highway hydrogen fueling station constructed by the company went into operation; a 49t fuel cell heavy-duty truck powered by Weichai operated for more than 5,000 kilometers from Taishan Steel, Jinan to Dongjiakou Area of Qingdao Port. On October 27, 2021, a Chinese original, world leading and fully-homemade Sinotruk Huanghe ski-waxing truck with a Weichai 162kW hydrogen fuel cell system was delivered for use during the Winter Olympic Games Beijing 2022. On January 4, General Secretary Xi Jinping inspected the ski-waxing truck. A series of outcomes marks that the "Hydrogen for Every Home" technology demonstration project is turning from blueprint into reality.Tan said the base engine thermal efficiency of the internal combustion engines being up to 51.09%, massive application of new energy in products, and the "dual driving force" strategy, have kept Weichai Power ahead in the development of traditional high-end engines and new energy engines, and opened up a new path for diversified energy transformation under the national strategy of carbon peak and carbon neutralization. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Adult Patients With Advanced Renal Cell Carcinoma

TOKYO and KENILWORTH, N.J., Nov 29, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA (KISPLYX in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus, KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the first-line treatment of adult patients with advanced RCC.The approval for advanced RCC is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32- 0.49]; p"A key focus of our collaboration with Eisai is to advance our clinical development program to evaluate the potential of KEYTRUDA plus LENVIMA to improve responses across different types of cancer, including renal cell carcinoma," said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "Today's approval of KEYTRUDA plus LENVIMA brings a new treatment option to patients with advanced renal cell carcinoma in Europe, and further validates our efforts to research this promising combination of an immunotherapy and tyrosine kinase inhibitor for some of the most difficult-to- treat cancers.""Renal cell carcinoma is the most common type of kidney cancer in both men and women, marking the significance of the European approval for the LENVIMA plus KEYTRUDA combination," said Corina Dutcus, M.D., Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "We remain committed to continuing to explore this combination therapy with the goal of improving care for people living with cancer. The participation of many patients, families and healthcare providers made this approval possible, for which we are very grateful."In the CLEAR/KEYNOTE-581 trial, the most common adverse reactions (≥30%) for LENVIMA plus KEYTRUDA* were diarrhoea (61.8%), hypertension (51.5%) fatigue (47.1%), hypothyroidism (45.1%), decreased appetite (42.1%), nausea (39.6%), stomatitis (36.6%), proteinuria (33.0%), dysphonia (32.8%), and arthralgia (32.4%).This approval allows marketing of LENVIMA plus KEYTRUDA in all 27 EU member states plus Iceland, Liechtenstein, Norway and Northern Ireland. LENVIMA plus KEYTRUDA is now approved by the European Commission for two different types of cancer: for the first-line treatment of adult patients with advanced renal cell carcinoma and for advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum- containing therapy in any setting and who are not candidates for curative surgery or radiation. *According to the information listed in the SmPC (Summary of Product Characteristics)About CLEAR/KEYNOTE-581 TrialThe approval was based on data from the CLEAR(Study 307)/KEYNOTE-581 trial (ClinicalTrials.gov, NCT02811861), a Phase 3, multicenter, open-label, randomized trial conducted in 1,069 patients with advanced RCC with clear cell component including other histological features such as sarcomatoid and papillary in the first-line setting. Patients were enrolled regardless of PD-L1 tumor expression status. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. Randomization was stratified by geographic region (North America and Western Europe vs. "Rest of the World") and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic groups (favorable vs. intermediate vs. poor). The primary efficacy outcome measure was PFS based on Blinded Independent Central Review (BICR) using RECIST 1.1, and PFS results were consistent across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumor expression status. Key secondary efficacy outcome measures were OS and ORR.Patients were randomized 1:1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks for up to 24 months), or LENVIMA (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment). Treatment continued until unacceptable toxicity or disease progression as determined by investigator and confirmed by BICR using RECIST 1.1. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. KEYTRUDA was continued for a maximum of 24 months; however, treatment with LENVIMA could be continued beyond 24 months. Assessment of tumor status was performed at baseline and then every eight weeks.About Renal Cell Carcinoma (RCC)1,2,3,4,5,6Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In Japan, there were more than 25,000 new cases and 8,000 deaths in 2020. In Europe, it is estimated there were more than 138,000 new cases of kidney cancer diagnosed and more than 54,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis. Survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 13% for patients diagnosed with metastatic disease.About LENVIMA (lenvatinib); available as 10mg and 4mg capsulesLENVIMA, discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRalpha), KIT, and RET. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti- angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it is approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.About KEYTRUDA (pembrolizumab) Injection, 100mgKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.Merck & Co., Inc., Kenilworth, N.J., U.S.A. has the industry's largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.Eisai's Focus on CancerEisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.About EisaiEisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. We strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society's toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S. and EMEA).Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s Focus on CancerOur goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck & Co., Inc., Kenilworth, N.J., U.S.A., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck & Co., Inc., Kenilworth, N.J., U.S.A. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.About Merck & Co., Inc., Kenilworth, N.J., U.S.A.For over 130 years, Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck & Co., Inc., Kenilworth, N.J., U.S.A. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases - as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USAThis news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2020 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).(1) International Agency for Research on Cancer, World Health Organization. "Kidney Fact Sheet." Cancer Today, 2020. bit.ly/3D0XjVA.(2) International Agency for Research on Cancer, World Health Organization. "Japan Fact Sheet." Cancer Today, 2020. bit.ly/32LnzH7 .(3) American Cancer Society. Key Statistics About Kidney Cancer. bit.ly/3xwCY9i.(4) Seattle Cancer Care Alliance. "Kidney Cancer Fact." bit.ly/3o1PIBL(5) Richard E. et al. Renal Cell Carcinoma: Diagnosis and Management. American Family Physician. 2019 Feb 1;99(3):179-184. bit.ly/3FPRZG4 (6) Cancer. Net. "Statistics, 2021." Kidney cancer. bit.ly/3riwN7S Copyright 2021 JCN Newswire. All rights reserved. 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Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Positive EU CHMP Opinions for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) in Two Different Types of Cancer

TOKYO and KENILWORTH, N.J., Oct 18, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinions recommending approval of the combination of LENVIMA (marketed as Kisplyx in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for two different indications. One positive opinion is for the first-line treatment of adult patients with advanced RCC, and the other is for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation. Decisions on the CHMP's recommendations will be given by the European Commission for marketing authorization in the EU, and are expected in the fourth quarter of 2021. If approved, this would be the first combination of an anti-PD-1 therapy with a tyrosine kinase inhibitor approved for the treatment of two different types of cancer in the EU.The positive CHMP opinions are based on data from two pivotal Phase 3 trials: CLEAR (Study 307)/KEYNOTE-581 evaluating the combination in adult patients with advanced RCC and Study 309/KEYNOTE-775 evaluating the combination in certain patients with advanced EC.In CLEAR/KEYNOTE-581, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of overall survival (OS), reducing the risk of death by 34% (HR=0.66 [95% CI, 0.49-0.88]; p=0.0049) versus sunitinib, and progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32-0.49]; pIn Study 309/KEYNOTE-775, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in the study's dual efficacy outcome measures of OS, reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p"KEYTRUDA plus LENVIMA demonstrated a survival benefit for advanced renal cell carcinoma in the first-line setting and represents an important potential new treatment option for these patients. Additionally, KEYTRUDA plus LENVIMA is the first anti-PD-1 and tyrosine kinase inhibitor combination to demonstrate a survival benefit in advanced endometrial carcinoma patients, and the benefit was shown regardless of mismatch repair status," said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "We are pleased that the CHMP has recognized the important role of the combination therapy in these difficult-to-treat cancers.""We appreciate the positive opinions rendered by the EU CHMP recommending approval of LENVIMA plus KEYTRUDA in advanced renal cell carcinoma and advanced endometrial carcinoma, underscoring the potential significance of the outcomes observed in the CLEAR/KEYNOTE-581 and Study 309/KEYNOTE-775 trials," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "We are grateful to the patients who participated in these studies, their families and clinicians. Their commitment made these meaningful milestones possible."In CLEAR/KEYNOTE-581, the most common adverse reactions (≥30%) for LENVIMA plus KEYTRUDA* were diarrhoea (61.8%), hypertension (51.5%) fatigue (47.1%), hypothyroidism (45.1%), decreased appetite (42.1%), nausea (39.6%), stomatitis (36.6%), proteinuria (33.0%), dysphonia (32.8%), and arthralgia (32.4%).In Study 309/KEYNOTE-775, the most common adverse reactions of these patients (≥20%) for LENVIMA plus KEYTRUDA* were hypertension (63%), diarrhoea (57%), hypothyroidism (56%), nausea (51%), decreased appetite (47%), vomiting (39%), fatigue (38%), decreased weight (35%), arthralgia (33%), proteinuria (29%), constipation (27%), headache (27%), urinary tract infection (27%), dysphonia (25%), abdominal pain (23%), asthenia (23%), palmar-plantar erythrodysaesthesia syndrome (23%), stomatitis (23%), anaemia (22%), and hypomagnesaemia (20%).*According to the information listed in the SmPC (Summaries of Product Characteristics)About Renal Cell Carcinoma (RCC)1,2,3,4,5,6Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In Japan, there were more than 25,000 new cases and 8,000 deaths in 2020. In the U.S. alone, it is estimated there will be approximately 76,000 new cases of kidney cancer diagnosed and almost 14,000 deaths from the disease in 2021. In Europe, it is estimated there were more than 138,000 new cases of kidney cancer diagnosed and more than 54,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC. RCC is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis. Survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 13% for patients diagnosed with metastatic disease.About Endometrial Cancer2,7,8,9Endometrial cancer begins in the inner lining of the uterus, which is known as theendometrium and is the most common type of cancer in the uterus. Worldwide, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers in 2020 (these estimates include both endometrial cancers and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates). In Japan, there were more than 17,000 new cases of uterine body cancer and more than 3,000 deaths from the disease in 2020. In Europe, it is estimated there were more than 130,000 new cases and more than 29,000 deaths in 2020. The five-year relative survival rate for metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.About LENVIMA (lenvatinib); available as 10mg and 4mg capsulesLENVIMA, discovered and developed by Eisai, is a multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, the combination of lenvatinib with an anti-PD-1 monoclonal antibody decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity compared to either treatment alone.Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It has been also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in United States. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.About KEYTRUDA (pembrolizumab) Injection, 100mgKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.Merck & Co., Inc., Kenilworth, N.J., U.S.A. has the industry's largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.About the Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.Eisai's Focus on CancerEisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.About EisaiEisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. We strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society's toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S. and EMEA).Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s Focus on CancerOur goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck & Co., Inc., Kenilworth, N.J., U.S.A., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck & Co., Inc., Kenilworth, N.J., U.S.A. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.About Merck & Co., Inc., Kenilworth, N.J., U.S.A.For over 130 years, Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck & Co., Inc., Kenilworth, N.J., U.S.A. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases - as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USAThis news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2020 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).(1) International Agency for Research on Cancer, World Health Organization. "Kidney Fact Sheet." Cancer Today, 2020. https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf .(2) International Agency for Research on Cancer, World Health Organization. "Japan Fact Sheet." Cancer Today, 2020. https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf .(3) American Cancer Society. Key Statistics About Kidney Cancer. https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html.(4) Thomas A. Z. et al. The Role Of Metastasectomy In Patients With Renal Cell Carcinoma With Sarcomatoid Dedifferentiation: A Matched Controlled Analysis. The Journal of Urology. 2016 Sep; 196(3): 678?684. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5014677/pdf/nihms773463.pdf .(5) Shinder B. et al. Surgical Management of Advanced and Metastatic Renal Cell Carcinoma: A Multidisciplinary Approach. Frontiers in Oncology. 2017; 7: 107. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5449498/#__ffn_sectitle .(6) Padala, S. A., Barsouk, A., Thandra, K. C., Saginala, K., Mohammed, A., Vakiti, A., Rawla, P., & Barsouk, A. (2020). Epidemiology of Renal Cell Carcinoma. World Journal of Oncology, 11(3), 79?87. https://doi.org/10.14740/wjon1279 .(7) American Cancer Society, Facts & Figures 2020 pdf:https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2020.html(8) International Agency for Research on Cancer, World Health Organization. "Corpus uteri Fact Sheet." Cancer Today, 2020. https://gco.iarc.fr/today/data/factsheets/cancers/24-Corpus-uteri-fact-sheet.pdf .(9) American Cancer Society website, accessed 3/1/2021:https://www.cancer.org/cancer/endometrial-cancer/detection-diagnosis-staging/survival-rates.html Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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Shanghai Announced: 100 Hydrogen Fueling Stations Will Be Established and the Industry Scale Will Be 100 Billion Yuan

Shanghai, China / TickerInsider / August 27, 2021 / – In the evening of August 26, Shanghai Economic and Information Commission officially announced that the Shanghai government plans to build close to 100 hydrogen fuel refueling stations, forming an output scale of nearly 100 billion yuan and promoting close to 10,000 fuel cell vehicles. Meijin Energy (000723.SZ) is expected to benefit from this. Shanghai is the second fuel cell vehicle demonstration city cluster approved by China after Beijing. In China, various policies further guide the new energy industry chain to spread out, and in addition the market expects that the Guangdong Fuel Cell Vehicle Demonstration City Cluster project will be approved soon. Meijin Energy (000723.SZ) Meijin Energy (000723.SZ) Obviously, 2021 has become an important year for fuel cell development in China. According to the “White Paper on China’s Hydrogen Energy and Fuel Cell Industry”, it is expected that by 2025, the output value of China’s hydrogen energy industry will reach 1 trillion yuan; by 2050, the demand for hydrogen will be close to 60 million tons, hydrogen energy will account for more than 10% of China’s terminal energy system, and the annual output value of the industry chain will reach 12 trillion yuan. In the evening of 26th, the leading company of “hydrogen energy” concept, Meijin Energy (000723.SZ), released its interim report for 2021. The report shows that in the first half of 2021, Meijin Energy achieved revenue of 8.893 billion yuan, up 69.54% year-on-year; net profit of 1.533 billion yuan, up 1396.04% year-on-year; net profit attributable to shareholders of listed companies of 1.249 billion yuan, up 1909.35% year-on-year; basic earnings per share of 0.29 yuan. Meijin Energy’s share price soared 124% in two months’ time. In the evening of August 26, Shanghai Economic and Information Commission officially released the article “The first batch of fuel cell vehicle demonstration applications in Shanghai city cluster was officially approved” which exploded the investment community. The approved Shanghai Fuel Cell Vehicle Demonstration City Group is a group of six cities (regions), including Shanghai, Jiangsu Province, Suzhou City, Nantong City, Zhejiang Province, Jiaxing City, Shandong Province, Zibo City, Ningxia Ningdong Energy and Chemical Base, and Ordos City in Inner Mongolia Autonomous Region, to form a “1+6” city group. According to the “Notice on the Demonstration and Application of Fuel Cell Vehicles” jointly issued by the Ministry of Finance, the Ministry of Industry and Information Technology, the Ministry of Science and Technology, the National Development and Reform Commission, and the National Energy Administration, the demonstration period will be actively encouraged, and the city groups shortlisted for demonstration will be rewarded according to the completion of their targets, with the demonstration period temporarily set at four years. Subsequently, Shanghai responded positively to the requirements of the document “Notice on the Demonstration and Promotion of Fuel Cell Vehicles” of five national ministries and commissions, and took the lead in actively carrying out the work related to the declaration of fuel cell vehicle demonstration application city clusters. At that time, the market expected that Shanghai was one of the strongest alternative cities, and now the official announcement was approved to a certain extent as expected to land. Shanghai Economic and Information Commission further said that Shanghai city cluster will make every effort to grasp the national fuel cell vehicle demonstration application development opportunity, focus on the core key parts and components technology breakthrough, the scale of vehicle promotion to lead, hydrogen refueling station appropriate ahead of the layout, the award of funds to increase the intensity, etc., accelerate the release of relevant support policies, actively carry out fuel cell vehicle demonstration application, strong support for the transformation and upgrading of the automotive industry, to build a world-class automotive industry center. Analysts pointed out that under the stimulation of preferential policies, the demonstration role of hydrogen fuel city cluster has obvious influence on the industry industry. After Beijing’s official announcement, Shanghai city cluster was also officially announced to be approved, which will further guide the rapid spread of the industry chain, and in addition, the market expects that Guangdong city cluster is also likely to be within the first list. It is reported that Guangdong hydrogen fuel cell vehicle demonstration city group is composed of Guangzhou, Yunfu, Foshan, Shenzhen, Zhuhai, Dongguan, Jiangmen, Yangjiang and Yulin in Shaanxi Province to declare as one city group. Although, fuel cells have not yet reached the stage of generating profits, the trend of industrial data is continuing to be positive. Data show that in the first half of this year, China’s hydrogen production increased by 25% year-on-year, with a 30% increase in the proportion of hydrogen produced using new energy sources. The increase in the scale of hydrogen production from electrolytic water has led to an increase in demand for equipment such as electrolytic cells. In addition, the latest data from the China Association of Automobile Manufacturers (CAAM) shows that from January to July this year, the production and sales of fuel cell vehicles completed 664 and 675 units respectively, with a year-on-year increase of 48.5% and 47.7% respectively. The Beijing Municipal Bureau of Finance said that Beijing has initially established a financial support policy system to promote the development of hydrogen energy industry, covering key technology research and development, hydrogen refueling station construction and operation, vehicle purchase subsidies and other aspects. In April this year, Shandong, a major energy province, has become the first demonstration province in the country for the large-scale promotion and application of hydrogen energy. The person in charge of Shandong Energy Bureau said that during the “14th Five-Year Plan” period, Shandong Province will build 100 hydrogen refueling stations, promote 10,000 fuel cell vehicles, and strive to exceed 100 billion yuan in total output value of hydrogen energy industry. According to the prediction of Gan Yong, the former vice president and academician of Chinese Academy of Engineering, the proportion of hydrogen energy in China’s terminal energy system will reach 10% to 15% in the future, and hydrogen energy will be synergistic and complementary with electricity as the main consumer of the terminal energy system, and drive the formation of a 10 trillion new industry. All kinds of policy trends show that the wind of fuel cell has been scraped up under the background of the era of carbon neutrality. In the “14th Five-Year Plan”, hydrogen energy and energy storage are listed as one of the six future industries to be planned. According to incomplete statistics, up to now, more than 20 provinces and 40 prefectures have issued hydrogen energy plans, and 2021 has apparently become the year for the rapid development of China’s fuel cell industry. According to the “White Paper on China’s Hydrogen Energy and Fuel Cell Industry” released by China Hydrogen Energy Alliance, it is expected that the output value of China’s hydrogen energy industry will reach 1 trillion yuan by 2025; the number of hydrogen refueling stations will exceed 1,500 in 2030; by 2050, the demand for hydrogen will be close to 60 million tons, hydrogen energy will account for more than 10% of China’s terminal energy system, and the annual output value of the industry chain will reach 12 trillion yuan. Under the wind mouth, the capital is excited to move With the capital feast of lithium new energy as a vivid case, the capital has long been eager for the rising fuel cell windfall. According to industry statistics, from January to July 2021, there were more than 80 public investment events in China’s hydrogen energy industry, with a total nominal investment amount of more than 250 billion yuan, an increase of more than 90% year-on-year, among which there were more than 10 projects with tens of billions of investment scale. Facing the windfall of fuel cell, besides China, developed countries such as the United States, Japan and Germany have also raised the planning of hydrogen energy to the height of national energy strategy. According to the previously disclosed “EU Hydrogen Energy Strategy”, the EU plans to invest 575 billion euros (about RMB 4.56 trillion yuan) into the hydrogen energy industry in the next ten years. Meanwhile, India’s decision on the fuel cell industry chain seems to be very big. Earlier, Prime Minister Narendra Modi said India would launch a 100 trillion rupee ($1.35 trillion, or about $8.8 trillion) national infrastructure plan that would help create jobs and expand the use of clean fuels, while setting a goal of achieving energy independence by 2047, saying the goal could be achieved by popularizing electric vehicles, transforming a gas-based economy and making India a hub for hydrogen production. Some analysts suggest that although the policy windfall has arrived and the long-term picture for fuel cells is rosy, there is not much of a profit base to support a sustained upside in the stock price, and many of the fuel cell technologies have not been validated for commercial application in the market, so there is some uncertainty about future technology development, product competitiveness and profitability. SOURCE: https://tickerinsider.com/technologies/shanghai-hydrogen-fueling-stations-will-be-established-100-billion-yuan-meijin-energy-000723/ CONTACT Jason Quintero Industry Insights Dept TickerInsider News Network Email: industry.insights@tickerinsider.com

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Toyota Moves Closer to Production with Next Generation Fuel Cell Electric Technology for Zero-Emissions Heavy Duty Trucks

Texas, Dec 11, 2020 - (JCN Newswire) - Toyota's next generation fuel cell electric technology is now powering a new set of Class 8 heavy-duty trucks. Using the same fuel cell system as the all-new 2021 Mirai sedan that goes on sale this month, the engineers at Toyota Motor North America Research and Development have developed a set of production-intent prototype trucks that are being prepared to run drayage routes at the ports of L.A. and Long Beach to validate their performance, efficiency and drivability.Designed to be flexible enough to meet the needs of a wide variety of OEM truck makers, the new fuel cell electric system in the latest prototypes has been adapted to a Kenworth T680 chassis. A more compact hydrogen storage cabinet behind the cab houses six hydrogen tanks with the same capacity as previous prototypes while a new, more powerful lithium-ion battery helps smooth out the power flow to the electric motors. In this configuration, the second generation fuel cell system delivers over 300 miles of range at a full load weight of 80,000 lbs., all while demonstrating exceptional drivability, quiet operation, and zero harmful emissions."This is an important step in the transition to emissions-free heavy-duty trucks," said Andrew Lund, Chief Engineer, Toyota Motor North America Reseach and Development. "Our first prototype trucks proved that a fuel cell electric powertrain was capable of hauling heavy cargo on a daily basis. These new prototypes not only use production-intent hardware, they will also allow us to start looking beyond drayage into broader applications of this proven technology."Reducing airborne pollution at the Ports of L.A. and Long Beach is an important driver of this program. Toyota's Environmental Challenge 2050 aims to almost completely eliminate CO2 emissions from our vehicles, operations and supply chain by 2050. Converting the drayage trucks that currently serve these ports to electric drivetrains would move us closer to that goal while improving the quality of life of operators, workers, and communities in and around the ports. Copyright 2020 JCN Newswire. All rights reserved. www.jcnnewswire.com

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Toyota and Hino Launch Initiative with Seven-Eleven, FamilyMart, and Lawson to Introduce Light-Duty Fuel Cell Electric Trucks

TOKYO, Dec 8, 2020 - (JCN Newswire) - Toyota Motor Corporation and Hino Motors, Ltd., together with Seven-Eleven Japan Co., Ltd., FamilyMart Co., Ltd., and Lawson, Inc., have agreed to jointly consider introducing light-duty fuel cell electric trucks (light-duty FCETs), and to establish an environment for its widespread use in the future, targeting the realization of a sustainable society that takes into account global warming and energy diversification.The main points of the agreement are as follows:- In 2021, Seven-Eleven, FamilyMart, and Lawson will conduct a trial operation of light-duty FCETs (max. payload: 3 tons) jointly developed by Toyota and Hino, to verify its practicality and convenience as part of considerations for its roll out.- In the evaluation of the trial operations, Seven-Eleven, FamilyMart, and Lawson will verify delivery by light-duty FCETs in logistics between multiple distribution centers and stores, to see whether or not continued trials are viable in 2022 and beyond, from the perspectives of businesses and the society.- Following this, in 2022 and beyond, they will work to identify various issues relating to convenience, such as positioning of hydrogen stations, hydrogen supply, filling capability, and operating hours, in their actual use in the market, as well as the purchase of vehicles and cost of hydrogen fuel, toward future popularization.- The parties will propose improvements in addressing these issues, and collaborate with the national and local authorities, and hydrogen station operators, to advance discussions on the necessary support and cooperative systems required to build effective mechanisms that lead to reduced CO2 emissions through the future widespread introduction of FCETs.Truck operations underpin the daily logistics of convenience stores that support people's daily lives. In particular, delivery trucks that distribute products such as pre-packed meals handle multiple delivery operations in one day, and are required to drive long distances over extended hours. Fuel cell vehicles that run on hydrogen, which has a higher energy density, are considered effective under such operating conditions that require them to have sufficient cruising range and load capacity as well as fast refueling capability. The cruising range for light-duty FCETs developed by Toyota and Hino will be set at approximately 400 km, aiming to meet high standards in both environmental performance and transport efficiency expected as a commercial vehicle.To achieve growth in demand for hydrogen, hopes are held for the introduction of fuel cell commercial vehicles, such as trucks and buses, that use more hydrogen compared with passenger vehicles. With commercial vehicles, depending upon their intended use, it is also possible to know the driving range and to plan operations systematically, including handling of refueling with hydrogen. But issues still remain for their full-scale introduction, including reduction of vehicle price and the cost of hydrogen, and improvement of the convenience of hydrogen stations.Given this situation, the five companies are making efforts to promote the establishment of an environment for the popularization of fuel cell vehicles, not only of light-duty trucks, but also of commercial and passenger vehicles. They also aim to collaborate with the national and local authorities, and hydrogen station operators, investigating various measures through the operation of light-duty FCETs in logistics settings, in order to tackle improvements and to resolve issues. Copyright 2020 JCN Newswire. All rights reserved. www.jcnnewswire.com

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BioVaxys Announces 96.4 Percent Positive Antibody Immune Response Results from an In Vivo Murine Model Study of Its SARS-CoV-2 Vaccine

Vancouver, BC, Nov 11, 2020 - (ACN Newswire) - BioVaxys Technology Corp. (CSE: BIOV) (FSE: 5LB) ("BioVaxys") is pleased to announce that results from its preclinical animal study (also known as the "murine model study") of BVX-0320, its Covid-19 vaccine candidate, show that the vaccine elicits a positive immune response against the SARS-CoV-2 s-spike protein. Previous interim data from the study showed it possessed an excellent emerging tolerability profile with no noteworthy clinical observations or observed toxicities in the mice. When the study concluded after 6 weeks, the excellent safety and tolerability profile was maintained.The preclinical study, which began in September 2020 and was conducted by leading independent contract research organization ("CRO") Charles River Laboratories, Inc. under contract with BioVaxys, evaluated the anti-virus immune response elicited by BVX-0320 in a controlled murine model by measuring the development of antibodies to the protein that binds the virus to human cells. Following two injections of BVX-0320 together with the immunological adjuvant, QS21, to 28 mice at four dosage levels, 96.4% developed positive antibody responses detected at week 6. As expected, prior to administering BVX-0320, all animals were antibody-negative, except for one mouse that had a borderline response. Importantly, mice that received the QS21 adjuvant without BVX-0320 developed no antibody responses.Kenneth Kovan, co-founder, President and Chief Operating Officer of BioVaxys spoke to the results, "As the early data shows that BVX-0320 stimulates an antibody response to the SARS2 s-spike protein, we would expect to see a similar response against live virus infection. Although that work remains to be done, this new data is pivotal at this stage of development of our vaccine."BioVaxys and Charles River Laboratories continue to analyze the experimental data to determine the antibody levels induced by each dose and to measure the T cell responses. The latter consists of stimulating T cells obtained from the same mice with viral peptides and measuring the degree of T cell activation using the established analytical method of flow cytometry and the production of cytokines, including IL2 and gamma interferon. In a separate study, the mouse sera (collected from the test animals) will be tested for ability to inactivate live SARS-Cov-2 virus. Results are anticipated within the next month.Upon completion of the data analysis, BioVaxys anticipates taking further steps to pursue regulatory approval for a Phase I study of its BVX-0320 vaccine candidate in humans.James Passin, the CEO of BioVaxys, stated, "Although still early, we are very encouraged that the emerging profile for BVX-0320 is a relatively uncomplicated manufacturing process and a temperature-stable vaccine suitable for broad distribution, which lends itself to address a pandemic." Passin further stated, "We hope to leverage this data to accelerate ongoing discussions with potential pharmaceutical partners on the development of new viral antigen vaccine candidates based on our haptenized viral protein vaccine platform technology."BioVaxys' product pipeline includes BVX-0918A, an IND-stage haptenized cancer cell vaccine for treating late stage ovarian cancer. In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, Dr. David Berd, using an earlier generation of the BioVaxys cancer vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized cell platform showed significant clinical promise.Dr. Berd commented that, "A post-SARS2 infection T cell response appears to be a defining characteristic following recovery in COVID-19 patients. As we have observed significant T cell responses in previous studies following vaccination with haptenized proteins in cancer patients, our belief is that we will see the same clinical results with our haptenized vaccine platform in in viral diseases."BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying proteins with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization "teaches" a patient's immune system to recognize and make target proteins more 'visible' as foreign, thereby stimulating an immune response.For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.About BioVaxys Technology Corp.Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares trade on the CSE under the stock symbol "BIOV" and are listed on the Frankfurt Bourse (FSE: 5LB).ON BEHALF OF THE BOARDSigned "James Passin"James Passin, CEO+1 646 452 7054Media ContactsAndrea Vuturo+1 508 301 3774biovaxys@dittopr.coCautionary Statements Regarding Forward Looking InformationThis press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. Forward-looking statements in this news release relate to, among other things, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys' vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs' vaccines will not prove to be effective and/or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.To view the source version of this press release, please visit https://www.newsfilecorp.com/release/67931 Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com

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