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Novotech Acquires US-based Drug Development Consulting Firm, CBR International

SINGAPORE, Jan 12, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific-centered biotech CRO today announced the acquisition of CBR International, a global product development, clinical oversight and strategic regulatory operations group.CBR was founded in 2002 as a consultancy company focused on assisting biotechnology and pharma companies navigate FDA requirements from early-stage development through to approval. CBR adds a group of experts to Novotech to provide US and global regulatory, scientific, quality, and clinical development services. CBR's specific regulatory expertise and services include long-range Regulatory Strategy and Writing, FDA Representation, eSubmissions, and Scientific Affairs to support requirements for cGMP commercial product development.The acquisition will further strengthen Novotech's capabilities in regulatory strategy and US FDA interactions and submissions including IND, IDE, NDA, BLA, Fast-Track, Break-through, and Orphan Drug Applications.Novotech CEO Dr. John Moller said: "CBR will provide decades of FDA regulatory experience for our biotech clients. They have experience across all product types and are highly regarded for their IND expertise having managed approximately 80 INDs through all phases of development. This acquisition, together with Novotech's existing regulatory affairs capability, creates a large global group of experts in toxicology, drug development, and global regulatory submissions support. This regulatory expertise benefits our US, European, and Asia Pacific biotech clients as they progress through the US clinical environment and navigate often complex FDA requirements."CEO and Founder of CBR, Dr. Jeanne Novak said: "We are extremely pleased to be joining a company the size and calibre of Novotech which brings global demand for our regulatory expertise. The US is an important region for global biotech and pharma companies as part of their clinical program development. We have the experience and track-record of directly supporting US approvals for over 10 programs. Navigating novel product development and achieving multiple approvals has built our expertise to support the complex development needs of clients worldwide which will now support Novotech clients. We look forward to working with Novotech clients to support their drug development programs in the US and globally. We are excited to continue working with our clients and bringing Novotech expanded services to our colleagues."Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology combines to deliver a specialist full-service biotech CRO solution.Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world's leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.About NovotechNovotech is the leading Asia-Pacific centered biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific the US, and Europe. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

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Preventing Strokes and Heart Attacks Doesn't Have to Come with the Risk of Life-threatening Bleeding

FREMONT, CA, Dec 14, 2022 - (ACN Newswire via SEAPRWire.com) - Verseon is delighted to announce that the European Journal of Medicinal Chemistry has published a paper (www.sciencedirect.com/science/article/abs/pii/S0223523422007577) describing the company's groundbreaking research that led to promising novel drug candidates for cardiovascular disease. Cardiovascular disease is the leading cause of death and disability in the world. Hundreds of millions of patients worldwide need anticoagulants to prevent clots that lead to life-threatening events like strokes, heart attacks, and pulmonary embolisms. However, currently prescribed so-called novel oral anticoagulants (NOACs) carry well-documented risks of major bleeds, which in many cases require hospitalization and can be life threatening. Developing drugs that prevent unwanted clots while preserving the body's ability to stop excessive bleeding is the "Holy Grail" of anticoagulant drug programs. Verseon is developing a new generation of anticoagulants called PROACs (Precision Oral Anticoagulants) that address this significant unmet medical need.The peer-reviewed paper documents how Verseon's medicinal chemistry team optimized various physicochemical properties -- including potency, selectivity, and in vivo stability -- of compounds from a novel class called N-acylpyrazoles. The resulting reversible covalent thrombin inhibitors are highly effective at preventing clots in vivo. Yet unlike NOACs, they do not inhibit thrombin-mediated activation of platelets, a critical step to stop injury-induced bleeding. Because of their unique mechanism of action, Verseon's drug candidates have demonstrated comparable efficacy to NOACs but with far lower bleeding risks in animal tests. The first lead candidate from this program is currently in clinical trials. "We are pleased to publish the discovery of this novel class of direct thrombin inhibitors with unique pharmacology," commented Dr. David Kita, Verseon's Chief Scientific Officer. "We look forward to describing further work behind the development of our first PROAC clinical candidate (VE-1902), which we expect will address a significant unmet medical need affecting a very large number of cardiovascular patients worldwide."The scientific paper, entitled "Discovery of novel N-acylpyrazoles as potent and selective thrombin inhibitors," is available at https://doi.org/10.1016/j.ejmech.2022.114855.About VerseonVerseon International Corporation (www.verseon.com) is redefining delay, prevention, and treatment of disease. Using its unique physics- and AI-based molecule-engineering platform, Verseon is rolling out a steady stream of life-changing medicines. Each of the company's drug programs features multiple novel candidates with unique therapeutic properties. Verseon's pipeline currently includes seven drug programs spanning major cardiometabolic diseases and cancers.Verseon's precision oral anticoagulants (PROACs) are potent, highly selective, reversible covalent inhibitors of thrombin. PROACs have shown excellent efficacy in multiple preclinical studies. The fact that PROACs do not disrupt platelet function and demonstrate correspondingly low bleeding risk makes them excellent candidates for use in long-term combination anticoagulant-antiplatelet therapy. The first development candidate, VE-1902, is currently in clinical trials. Among other unique properties of PROACs, VE-1902 has very low renal clearance, a highly desirable feature for patients with impaired kidney function. Verseon also has a second anticoagulant development candidate, VE-2851, which is expected to enter clinical trials at a later date.Contact:Walter Jonesmediarelations@verseon.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Novotech Awarded the Asia Pacific CRO of the Year 2022 for Best Practices in Clinical Trials

SYDNEY, AU, Dec 6, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, has been awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006.Frost & Sullivan identifies companies that consistently develop growth strategies based on a visionary understanding of the future, and effectively address new challenges and opportunities.Frost & Sullivan said: "Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market's unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients."In response to the Company of the Year Award announcement, Novotech CEO Dr. John Moller said this award is a credit to our entire global team which has decades of biotech drug development experience."Every day our team supports biotech companies in their drug development programs with unparalleled regulatory knowledge, vast site and investigator networks, technology-driven clinical data management, and a project management approach focused on problem-solving, ownership, and flexibility. Our global clients benefit from access to our expert teams in Asia Pacific, which is the fastest-growing clinical trial region, due to its vast patient populations and sophisticated medical research infrastructure. Our consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution."Novotech regularly produces expert reports on East-West strategies. A new publication is now available for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for global regulatory approvals. The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approvalNovotech has also recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions delivering exclusive benefits for sponsors.About Novotech Novotech is the leading Asia Pacific 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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巨生医MPB-1734抗癌药物新剂型取得成分专利

EQS 新闻 via SEAPRWire.com / 2022-11-15 / 10:41 UTC+8 【巨生生医(6827)巨生医MPB-1734取得成分专利新闻稿】 发布日期：2022年11月15日 巨生医MPB-1734抗癌药物新剂型取得成分专利 巨生生医股份有限公司（以下简称”巨生医”，台湾柜买中心股票代码：6827）宣布奈米微胞技术平台下产品MPB-1734抗癌药物新剂型正式获得美国成分专利，MPB-1734且已获得美国及台湾FDA核准临床1/2期试验，目前已完成收治2位受试者。 巨生医执行副总许源宏博士表示，奈米微胞技术平台应用于药物传输系统 (drug delivery systems，DDS) 开发，利用本公司独家高分子奈米微胞技术，可将难溶于水的疏水性药物，利用奈米微胞技术改良后，可稳定分散于水中并提高溶解度1,000倍以上，且能直接注射至人体中，大幅改善目前市售剂型注射时，需要使用有致敏性疑虑的乳化剂溶解并以类固醇预先治疗的缺点；另外由于奈米化的特性，改变了药物在体内的分布，大幅降低了化疗药物的副作用。同时因为具有避开 P-Glycoprotein drug efflux pump的特性，让MPB-1734 药物有机会用在已产生化疗抗药性的病人。 另外巨生医指出，在头颈癌的动物实验中发现，MPB-1734的治疗可大幅增加免疫细胞在肿瘤的浸润能力(例如:CD8+ T细胞等免疫细胞指标)，此肿瘤微环境的变化也反应在治疗效果上，MPB-1734并用免疫疗法的组别其肿瘤抑制效果显著优于单用免疫疗法及单用MPB-1734组别，具有加成性。MPB-1734未来有机会结合免疫疗法，除了本身的治疗效果，也可藉由改变肿瘤的微环境，让原本认为对免疫治疗无效的冷肿瘤(cold tumor)改变为热肿瘤(hot tumor)，达到最佳的合并治疗效果。 巨生医进一步表示，MPB-1734目前针对晚期的实体肿瘤病患进行临床试验，公司未来将针对高复发率的卵巢癌及病人数众多的头颈癌为目标，尤其对那些因为产生严重的白血球低落副作用，而无法继续接受治疗的病患，有一个新的可以使用的药物。日后也将以向美国FDA申请505(b)(2)新剂型新药与孤儿药等快速审查方式加速取得药证时程，希望能加惠病患，得到新的治疗机会。   关于巨生医： 巨生医（股票代号：6827）成立于2014年，由工研院分割成立，主要从事利基型奈米药物开发的新药技术公司。拥有两个奈米技术平台-「奈米微粒」及「奈米微胞」，并开发出奈米氧化铁产品。目前进度最快是应用于缺铁性贫血之注射型铁剂补充剂与肝癌显影剂。目前巨生医已发展出三大产品，分别为MPB-1514缺铁性贫血铁剂，MPB-1523磁振造影诊断用显影剂肝细胞癌，及MPB-1734新剂型抗癌药物。 更多公司介绍详见官网：https://www.megaprobio.com/   声明： 本文件及同时发布之相关信息内含有预测性叙述。除针对已发生事实，所有对巨生医(以下简称本公司)未来经营业务、可能发生之事件及展望（包括但不限于预测、目标、估算和营运计划）之叙述皆属预测性叙述。预测性叙述会受不同因素及不确定性的影响，造成与实际情况有相当差异，这些因素包括但不限于价格波动、实际需求、汇率变动、市占率、市场竞争情况，法律、金融及法规架构的改变、国际经济暨金融市场情势、政治风险、成本估计等，及其他本公司控制范围以外的风险与变量。这些预测性叙述是基于现况的预测和评估，本公司不负日后更新之责。     文件: 巨生医MPB-1734抗癌药物新剂型取得成分专利 2022-11-15 此新闻稿由EQS Group via SEAPRWire.com转载。本公告内容由发行人全权负责。原文链接: http://www.todayir.com/sc/index.php

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Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination

TOKYO, Nov 2, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has received notification that Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies that was discovered and developed in-house, has been granted Category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with Lewy bodies (DLB) in Japan. In conjunction with this, Eisai plans to promptly submit an application for a partial change to label regarding dosage and administration. The indication for DLB remains unchanged. The indication of "suppression of progression of dementia symptoms in DLB" was approved in September 2014, primarily based on a Phase II study (Study 431) and Phase III study (Study 341) conducted by Eisai on people living with DLB in Japan. In accordance with the condition for the approval of this indication, "a clinical trial to verify the efficacy and safety of the drug in patients with DLB should be conducted and the results of the trials and analyses should be submitted promptly after completion," Eisai conducted a post-marketing clinical study (Study 419) to evaluate the efficacy and safety of the drug in patients with DLB. The results of Study 419 did not show a statistically significant difference between the placebo group and the Aricept group in the primary endpoint of global function (CIBIC-plus** comprehensive assessment), but the re-examination based on post-marketing studies, including the results of Study 419, stated that "at present, the evaluation of clinical function in DLB using CIBIC-Plus is not always sufficiently established as an evaluation method, and it is difficult to comprehensively evaluate the efficacy of this drug for DLB, although efficacy was seen in some patients. On the other hand, treatment with this drug showed a trend toward improvement in cognitive function (MMSE***), and this result is consistent with the results of the clinical trial at the time of approval of the drug. Since there are a certain number of patients who can be expected to benefit from the administration of this drug, it was concluded that the efficacy should be evaluated after the start of administration, and administration should only continue if efficacy is confirmed."Therefore, it was concluded that the approved label (dose and administration) and package insert should be appropriately revised (Category 2).The condition of the approval was lifted as of the date of receipt of the reexamination results. Along with this prompt application for a partial change to label regarding dosage and administration for the DLB indication, Eisai will place the highest priority on the provision of proper use and safety information for this drug, and will make continued contributions to address the diversified needs of, and increase the benefits provided to people living with DLB and their families. For more information, visit www.eisai.com/news/2022/news202274.html. Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Hua Medicine’s Innovative First-In-Class Glucokinase Activator (GKA) HuaTangNing Is Approved, New Type 2 Diabetes Treatment Paradigm to Begin in China

SHANGHAI, CHINA, Oct 10, 2022 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", HKEx Stock Code: 2552.HK) today announces that the New Drug Application (NDA) of HuaTangNing (dorzagliatin tablets, HMS5552), a first-in-class glucokinase activator (GKA) developed by the Company has been approved by the National Medical Products Administration (NMPA) of China on October 8th for two indications, both to improve blood glucose control for Type 2 diabetes (T2D) patients, as monotherapy for drug-naive T2D patients, or in combination with metformin in metformin tolerated T2D patients to control blood glucose level. For those patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. At the same time, clinical trials have shown that HuaTangNing in combination with empagliflozin (SGLT-2 inhibitor) and sitagliptin (DPP-IV inhibitor) is expected to better improve blood glucose control and pancreatic islet functions in T2D patients than either empagliflozin or sitagliptin taken alone.HuaTangNing is the first approved glucokinase activator (GKA) worldwide. Accordingly, the commercialization of HuaTangNing represents the first time globally in almost ten years that a new mechanism of action to treat Type 2 diabetes is introduced, and the first time in history that a global first-in-class drug for Type 2 diabetes is introduced first in China. This milestone represents unprecedented progress in the application of innovative scientific concepts in the Chinese biopharmaceutical industry to meet the clinical needs of Chinese patients. HuaTangNing is the first innovative first-in-class drug developed using the operation model of "Integration of global pharmaceutical research and development resources, to achieve joint innovation," and whereby China has led pharmaceutical innovation into a new historical stage.With the mission of "For Patients, Global Innovation, Effective Medicines", Hua Medicine has independently developed HuaTangNing, a first-in-class drug based on the characteristics of Chinese diabetic patients. Since the beginning of its scientific development, the research and development project of HuaTangNing has been highly valued by the new drug R&D community and national drug regulators. The project was selected as a national key scientific and technological project during the "12th Five-Year Plan" and the "13th Five-Year Plan" periods. HuaTangNing is a drug with new concept, new mechanism, new efficacy, new structure and new technology. It is led by a Chinese R&D team and Chinese clinical researchers from pre-clinical to Phase I, II, and III clinical trials. Therefore, it is not only a major R&D breakthrough in translating innovative concepts into innovative products, but also a pioneering path for China in developing first-in-class drugs independently. The approval of HuaTangNing also represents the first approved GKA drug, after many large and small pharmaceutical companies globally have spent over 2 decades of R&D resources on the glucokinase activator class, thereby achieving a breakthrough from zero. Going forward, Hua Medicine will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families.Globally, the incidence of diabetes has been on the rise. According to the International Diabetes Federation (IDF), the number of adult diabetes patients worldwide reached 537 million in 2021, which was an increase of 74 million or 16% from 2019. Global health spending due to diabetes and its complications stood at USD 966 billion in 2021. China is no exception. There were over 140 million diabetic patients in 2021, 51.7% of which (around 72.83 million) have not been diagnosed or treated. In addition, fluctuating blood glucose levels lead to a series of diabetic complications such as cardiovascular and cerebrovascular, kidney, eye diseases, and diabetic feet, etc., which greatly affect the survival and life quality of diabetic patients, and exert a heavy pressure on their families. Therefore, stabilizing the T2D patient's blood glucose level at a good TIR (Time in Range) is an important goal in diabetes treatment and management. According to the 14th Five-Year National Health Planning issued by the General Office of the State Council, improving the prevention and treatment capacity of diabetes and other major chronic diseases is a key health-care topic for the country. It is estimated that over 65% of T2D patients will be covered by the health management service of community-level medical institutions during the 14th Five Year Plan period. The NDA approval and HuaTangNing adheres closely to the national strategy of developing the pharmaceutical industry and improving citizens' health.A rapidly growing population of diabetic patients and a huge market for diabetes drugs clearly establish strong unmet medical needs. With the original concept of "repairing the sensor, restoring homeostasis, and treating the underlying cause of diabetes", Hua Medicine boldly aims at directly addressing the root cause of the failure of blood glucose sensors in T2D patients. Clinical studies have shown that HuaTangNing can restore the impaired glucokinase sensor function and improve the ability of T2D patients to regulate blood glucose autonomously, thus potentially control the progression and complications of Type 2 diabetes from its source.As a new class of T2D treatment drug, the R&D of HuaTangNing has received continuous attention from the academic community worldwide. In 2018, the results of its Phase II clinical trial were published in The Lancet Diabetes and Endocrinology, a top international medical journal, which was the first time for the journal to publish the clinical research results of a T2D original innovative drug from China. In May 2022, Nature Medicine, a top international medical journal, simultaneously published two peer-reviewed papers on the results of our two Phase III clinical trials, describing the results of our monotherapy trial (the SEED study), and in combination with metformin trial (the DAWN study), respectively. It fully recognized HuaTangNing as a first-in-class diabetic drug with significant safety advantages and the characteristics of improving pancreatic islet functions in T2D patients. The unique advantages of HuaTangNing in T2D patients with nephropathy suggested by the clinical trials was also highlighted. Other clinical research also showed that HuaTangNing safely creates clear synergies in combination therapy with DPP-4 inhibitors and SGLT-2 inhibitors in blood glucose control, suggesting its broader potential in T2D patients with different needs in glycemic control and at different stages of disease progression. By potentially restoring early-phase insulin secretion and improving beta-cell function, HuaTangNing is expected to be a key path in diabetes remission. In the future, Hua Medicine will continue to explore HuaTangNing's potential in the remission of T2D drug discontinuation and the combination therapies with the other nine existing types of diabetes drugs. Hua Medicine is committed to addressing the needs of diabetic prevention, remission and complication control, and bringing Chinese innovation to the world.Xiaolan Zhou, Executive Vice President, Pharmaceuticals Division, Bayer AG and President of Bayer Pharmaceuticals China, said, "Bayer has been working on diabetes treatment and contributing to the development of diabetes prevention and treatment in China for years. HuaTangNing and Glucobay, the first oral hypoglycemic drug with impaired glucose tolerance (IGT), together with continuous glucose monitoring systems (CGMs), establish end-to-end course management from prevention to treatment for Chinese T2D patients. Real-time blood glucose monitoring helps achieve the goal of 'steady blood glucose control'. At the same time, Bayer proactively explores digital solutions to help hundreds of millions of Chinese patients to achieve the vision of diabetes-free."Dr. Li Chen, the founder, CEO and Chief Scientific Officer of Hua Medicine, said, "the NDA approval of HuaTangNing is a major milestone for Hua Medicine, as it also marks that the innovative drug industry in China has entered a new stage of new development. Diabetes chronic disease management is strategically important for China's economy and people's livelihood. Hua Medicine adheres to our original intention of 'China leading pharmaceutical innovation'. Amid fierce international competition, researchers and partners of Hua Medicine have spent 10 years of hard work to develop the first-in-class new diabetes drug - first in the world and start from China, achieving a breakthrough from zero. This achievement is attributed to all Chinese scientists, clinicians and partners participated in the R&D of HuaTangNing. We are proud of HuaTangNing and grateful to everyone for their hard work and wholehearted dedication. At the same time, Hua Medicine looks forward to in-depth integration and full vitality with Bayer in the commercialization of HuaTangNing, which will bring new hope of diabetes prevention, treatment and relief to up to one hundred million Chinese T2D patients, establish standards for diabetes prevention and treatment, and contribute to the national strategy of achieving Healthy China 2030."About HuaTangNingHuaTangNing (dorzagliatin tablets) is a first-in-class glucokinase allosteric activator (GKA) with a brand-new mechanism. It can be used alone or in combination with metformin hydrochloride (when using metformin hydrochloride alone is ineffective in controlling blood glucose), to improve blood glucose control for T2D adult patients with diet and exercise. HuaTangNing targets at restoring the impaired glucose sensor glucokinase (GK) in pancreas, intestine and liver, to achieve one target with multiple points and coordinated blood glucose control. It regulates glucose stimulated secretion of the glycemic controlling hormones insulin, GLP-1 and glucagon in diabetes patients, which leads to the improvement of early-phase insulin secretion and disposition index. It has potential in restoring glucose homeostasis and diabetes remission. Results from two Phase III registered trials of HuaTangNing monotherapy and combination therapy with metformin in metformin tolerated T2D patients have shown that HuaTangNing significantly improves glycemic control with effective reduction of post prandial glucose, low risk of hypoglycemia, well tolerance and safety. HuaTangNing demonstrated a linear correlation between drug dose and plasma exposure, with high target organs distributed in pancreas, intestine and liver. It showed low renal excretion and similar pharmacokinetic profiles at End Stage Renal Disease (ESRD) patients and healthy subjects, which suggest it can be readily used in those patients with renal insufficiency without dose adjustment. The unique mechanism of action, desirable pharmacokinetic, and good safety and tolerability profile establish HuaTangNing as a differentiated new class of anti-diabetes therapy.About Hua MedicineHua Medicine is an innovative drug development company found in China, focused on developing novel therapies for patients worldwide with unmet medical needs. Based on global resources, Hua Medicine teams up with global high-caliber people to develop breakthrough technologies and products, which contribute a global innovation in diabetes care. Targeting the glucose sensor, glucokinase, HuaTangNing (dorzagliatin tablets) as Hua Medicine's cornerstone product, restores glucose sensitivity in T2D patients and has completed registered SEED and DAWN Phase III trials in China. The NDA (New Drug Application) of HuaTangNing has been officially approved by the China National Medical Products Administration (NMPA). This first-in-class glucokinase activator has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.About BayerBayer is a global enterprise with core competencies in health and agriculture of life science. Its products and services are designed to help human and the earth thrive by supporting the efforts to overcome major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable growth and having a positive impact on business. At the same time, Bayer aims to increase its profitability and create value through innovation and growth. Globally, the brand of Bayer stands for trust, reliability and quality. In the fiscal year of 2020, Bayer had around 100,000 employees, 41.4 billion euros of sales, and 4.9 billion euros of R&D expenses (excluding special programs). For more information, please visit www.bayer.com.About the cooperation between Hua Medicine and BayerIn August 2020, Bayer, a multinational pharmaceutical company, and Hua Medicine, a Chinese innovative drug research and development company, announced a strategic partnership on dorzagliatin, a first-in-class diabetes treatment drug, in China. This partnership aims at leveraging Bayer's prominent advantages in diabetes management in China and Hua Medicine's R&D expertise in diabetes treatment. Both parties are committed to benefiting hundreds of millions of China diabetic patients through new therapeutic options. Under the terms of the agreement, Hua Medicine as the market authorization holder (MAH) shall be responsible for clinical development, registration, product supply and distribution, while Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China. The Pharmaceuticals China Innovation Center of Bayer facilitated this collaboration. As a global pharmaceutical leader, Bayer is committed to cooperating with external partners to promote breakthrough innovations, bring positive changes to patients, and achieve the goal of "cooperative innovation and joint cure". Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Apollomics Inc. Expands Leadership Team with Appointment of Jane Wang, PhD as Chief Scientific Officer

Foster City, CA, and Hangzhou, China, Jul 26, 2022 - (ACN Newswire via SEAPRWire.com) - Apollomics Inc. an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced the appointment of Jane Wang, PhD as Chief Scientific Officer. In this role, Dr. Wang will lead the drug discovery pipeline for the Company. She will also serve as Apollomics' China General Manager and will report to the Chief Executive Officer. "We are very excited to have Jane join our team," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "Jane is a drug discovery expert in a number of therapeutic areas, including oncology, with a proven track record advancing compounds from the laboratory to clinical development. With her broad experience, she will make significant contributions to our global research strategy.""I am pleased to join a Company dedicated to the discovery, research, and clinical development of novel agents targeting multiple oncology indications. I look forward to growing our global team to discover and advance new compounds into the clinic," added Jane Wang, Ph.D., Chief Scientific Officer. Dr. Wang brings over 20 years of drug discovery experience in the biopharmaceutical industry. Most recently, she served as Vice President, Medicinal Chemistry at WuXi AppTec where she worked to enhance RNA drug discovery and led multiple teams in medicinal chemistry and synthetic organic chemistry. Prior to WuXi, Dr. Wang spent 12 years on the drug discovery team at Pfizer, Inc. as a senior principal scientist, focusing on diseases in oncology, inflammation, and the central nervous system Previously, she did her postdoc at the U.S. National Institute of Health and at Schering-Plough. Dr. Wang earned a Ph.D. from the University of Maryland Baltimore County and a B.S. in Applied Chemistry from Fudan University. She is an inventor/co-inventor of over 50 patent applications and an author of over 35 publications. About Apollomics Inc.Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The Company's product pipeline has several programs at different stages of development, including a novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, California, USA, Hangzhou and Shanghai, China. For more information, please visit www.apollomicsinc.com.Contact Information:Investor Contact:Raymond LowVP Finance, Corporate Controller(925) 451-0712Raymond.Low@apollomicsinc.comU.S. Media Contact:Remy BernardaCorporate Communications(415) 203-6386remy.bernarda@apollomicsinc.comChina Media Contact:Porda Havas International Finance Communications GroupKelly FungGeneral Manager(852) 3150 6763kelly.fung@pordahavas.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Fujitsu and RIKEN start joint research on next-generation IT drug discovery technology using the supercomputer Fugaku and simulation integrated AI

TOKYO, May 17, 2022 - (JCN Newswire via SEAPRWire.com) - Fujitsu Limited and RIKEN today launched a joint research project on next-generation IT drug discovery technology utilizing the supercomputer Fugaku(1), aiming to accelerate DX (digital transformation) in drug discovery, explore promising new areas in this process, and dramatically reduce development period and costs for new drug development.The joint research project will leverage high performance computing technologies and the supercomputer Fugaku to accelerate simulation integrated AI that combines Fujitsu's DeepTwin AI technology, which accurately acquires quantitative features from complex data by unsupervised learning, with molecular dynamics simulation using RIKEN's AI drug discovery simulation technology. It is expected that this approach makes it possible to improve the accuracy and speed of molecular simulation and establish innovative technologies that can predict changes in the structure of target proteins over a wide range.Based on this research, the two parties aim to develop a next-generation IT drug discovery technology with world-leading capabilities by the end of fiscal 2026. Fujitsu and RIKEN anticipate that this technology will perform analysis of target protein and drug candidate molecule complex and predict large-scale structural changes of molecules with high speed and high accuracy to contribute to the development of middle-molecular drugs and large-molecular drugs, which are expected to have high efficacy and low side effects.BackgroundRecently, in the search to create vaccines and new drugs to counter the threat posed by emerging diseases such as COVID-19, researchers are strengthening efforts to develop middle-molecular drugs and large-molecular drugs, which offer the promise of high efficacy with relatively few side effects. Fujitsu and RIKEN will initiate joint research to explore new areas in the drug discovery process and dramatically reduce the development period and cost by enabling the prediction of unknown complex structures of target proteins and drug candidate molecules through the fusion of the cutting-edge molecular simulation, computing, and both partners' AI technologies for drug discovery, as well as the supercomputer Fugaku.Period of joint researchMay 17, 2022 to March 31, 2025 (scheduled to continue after April 2025)Roles of Fujitsu and RIKENFujitsu- Development of technology to obtain quantitative features of protein data with the unsupervised AI technology DeepTwin- Development of high-performance computing technology to integrate and efficiently operate molecular dynamics simulation and AI on the supercomputer FugakuRIKEN- Development of a new drug discovery simulation technology that reproduces large-scale structural changes with high accuracy and low computational cost- The development of the new technology which combined simulation and AI and experiment for estimating various structuresFuture PlansBy the end of fiscal 2026, the two parties will leverage jointly developed next-generation IT drug discovery technology utilizing the supercomputer Fugaku to create a new IT drug discovery process that emphasizes middle-molecular drugs and large-molecular drugs and disseminate it to pharmaceutical companies and other stakeholders in the medical field. Furthermore, Fujitsu is promoting initiatives to advance its concept of "Healthy Living" initiatives under its business brand Fujitsu Uvance, which aims to realize a sustainable future for humanity. Through this joint research, Fujitsu aims to contribute to the solution of challenges in the medical field by developing technologies that combine its strengths in AI and HPC. Fujitsu will simultaneously work to create use cases in the drug discovery field to integrate into its Fujitsu Computing as a Service (CaaS) portfolio, a suite of cloud services that makes advanced computing and software technologies readily available to everyone.Comment from Seishi Okamoto, Fujitsu Research Fellow, Senior Vice President of Research Unit, Fujitsu Limited:As demand for the rapid development of effective drugs increases, expectations are mounting for the successful introduction of IT drug discovery. At present, however, major challenges persist in the full-scale implementation of IT drug discovery in society, including the time and accuracy of calculations, and limitations surrounding target diseases and drugs. RIKEN and Fujitsu will work together to transform the drug discovery process by truly integrating computing technologies such as the supercomputer Fugaku with leading edge AI and machine learning technologies.Comment from Yasushi Okuno, Director of HPC- and AI-driven Drug Development Platform Division, RIKEN Research Center for Computational Science:While the importance of AI and DX is being emphasized in various fields, efforts are being made worldwide to accelerate drug discovery research using these digital technologies in the drug discovery field. In this joint research project, Fujitsu and RIKEN will collaborate to develop the world's best computational technology for drug discovery using the world-class supercomputer Fugaku. We will work to ensure that the result of this joint research is useful to patients around the world who expect new drugs.(1) The supercomputer Fugaku:A computer installed at RIKEN as a successor to the K computer. From June 2020 to November 2021, it ranked first in 4 categories in the supercomputer rankings for 4 consecutive terms. Full operation started on March 9, 2021.About FujitsuFujitsu's purpose is to make the world more sustainable by building trust in society through innovation. As the digital transformation partner of choice for customers in over 100 countries, our 124,000 employees work to resolve some of the greatest challenges facing humanity. Our range of services and solutions draw on five key technologies: Computing, Networks, AI, Data & Security, and Converging Technologies, which we bring together to deliver sustainability transformation. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.6 trillion yen (US$32 billion) for the fiscal year ended March 31, 2022 and remains the top digital services company in Japan by market share. Find out more: www.fujitsu.com.About RIKENRIKEN is Japan's largest comprehensive research institution renowned for high-quality research in a diverse range of scientific disciplines. Founded in 1917 as a private research foundation in Tokyo, RIKEN has grown rapidly in size and scope, today encompassing a network of world-class research centers and institutes across Japan. https://www.riken.jp/en/about/ Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan

TOKYO, May 10, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. today announced that it has initiated preparation on a New Drug Application for ultrahigh-dose mecobalamin (development code: E0302) for amyotrophic lateral sclerosis (ALS) in Japan, based on a favorable clinical results of the JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS: JETALS), an investigator-initiated Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset ALS patients, published by a research team led by Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences. Eisai submitted an application for an orphan drug designation of this agent to the Ministry of Health, Labour and Welfare (MHLW) in March 2022, and plans to submit a new drug application in fiscal year 2023. For ultrahigh-dose mecobalamin, Eisai submitted a new drug application as treatment for ALS in May 2015 based on the results of a Phase II/III clinical trial (Study 761) for ALS, but withdrew the application in March 2016 after receiving the opinion about the application package not being sufficient from the Pharmaceuticals and Medical Devices Agency (PMDA). However, an additional analysis of Study 761 suggested that ultrahigh-dose mecobalamin prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset. In order to re-examine its efficacy and safety in ALS patients within 1 year of onset, JETALS was conducted as an investigator-initiated clinical trial by the research team led by the Tokushima University with the support of the Japan Agency for Medical Research and Development (AMED). The results of the study showed the efficacy, safety, and tolerability of ultrahigh-dose mecobalamin, which have now been published in the peer-reviewed journal JAMA Neurology(New Window). Based on the results of JETALS, in consultation with the Tokushima University, Eisai has decided to newly submit the application for approval of ultrahigh-dose mecobalamin for ALS in Japan. Eisai considers neurology a therapeutic area of focus and is committed to new drug development in this field in order to fulfill unmet medical needs and further contribute to increasing the benefit for patients and their families. About Amyotrophic Lateral Sclerosis (ALS)ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction. As the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within approximately 3 to 6 years from the onset of the disease. According to the number of patients issued a Certificate of the Recipient of Specified Disease Treatment, there were 10,514 patients with ALS in Japan in 2020. Currently, there is no curative treatment established for ALS, and since there are only limited number of medicines approved in Japan and abroad, this is a disease with significant unmet medical needs.About MecobalaminMecobalamin (development code: E0302) is approved and marketed as Methycobal, a 500 microgram injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency. Methycobal is also approved as a tablet formulation as well as a fine granule formulation indicated for the treatment of peripheral neuropathies. While the mechanism of action of mecobalamin in ALS is not known, it has been suggested in non-clinical research that mecobalamin may have efficacy through a neuroprotective effect and regeneration of nerve axons. Since the 1990s, clinical research has been carried out on ultrahigh-dose mecobalamin in ALS by a study group on neurodegenerative disease, funded through the Ministry of Health, Labour and Welfare's Specified Disease Treatment Research Program. Short- and long-term trials of intramuscular injection of mecobalamin at 25 mg and 50 mg per day, which is respectively 50 and 100 times the approved dosage of Methycobal, suggested that ultrahigh-dose mecobalamin could have a clinical effect in ALS.Therefore, Eisai had conducted the Phase II/III clinical trial (Study 761) since 2006 and submitted a new drug application for ultrahigh-dose mecobalamin as treatment for ALS in May 2015 but withdrew the application in March 2016 after the Pharmaceuticals and Medical Devices Agency (PMDA) indicated that additional clinical trials were necessary.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 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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Lepu Biopharma Co., Ltd. Successfully Listed on the Main Board of HKEX

HONG KONG, Feb 23, 2022 - (ACN Newswire via SEAPRWire.com) - The biopharmaceutical company focusing on oncology therapeutics - Lepu Biopharma Co., Ltd. ("Lepu Biopharma" or the "Company", stock code: 2157.HK), has successfully listed and commenced dealings on the Main Board of the Stock Exchange of Hong Kong Limited ("Hong Kong Stock Exchange") today, under the stock code of 2157 and in board lot of 1,000 H shares each. The share price of the Company closed at HK$7.14 per H share, with an intra-day high of HK$7.34 per H share. A total of approximately 15.8 million H shares were traded, with an aggregate turnover of approximately HK$112 million.Lepu Biopharma is listed on the main board of HKEX, with 126,876,000 H shares being offered globally, including 12,688,000 Hong Kong Offer Shares, 114,188,000 International Placing Shares. The net proceeds received are estimated at approximately HK$804.2 million from the Global Offering, after deduction of underwriting fees, commissions and other estimated expenses payable by the Company in connection with the Global Offering. The net proceeds are intended for funding the core products, funding the other key clinical-stage drug candidates and the key pre-clinical drug candidates, acquiring potential technologies and assets and expand our pipeline of drug candidates, including discovery of new drug candidates and business development activities and to fulfill the continuous payment obligation under the acquisition of HX008 from HanX, and general corporate purposes.Lepu Biopharma has three synergistic core technology platforms around its pipeline specializing in ADC technology, antibody discovery and advanced process and analytical development. The company also advances the clinical development of its candidates including ADC candidates, oncolytic virus candidates and combination therapies, plans to stay focused on the development of innovative products, create a pipeline for novel therapies, design and develop innovative products and build advanced technology platforms.While Lepu Biopharma advancing its drug candidates, it has mapped out and is implementing the manufacturing and commercialization strategies. Company commenced the operation of a 2,000L GMP-compliant antibody production line in Beijing in 2019 in support of clinical trials for the antibody products. It is building a production line for oncolytic virus drugs in Beijing with a designed capacity of 200L, as well as a biologics manufacturing center in Shanghai Biotech Park, including a production line with a designed capacity of 12,000L initially, coupled with laboratories and manufacturing facilities, and one production line with capacity of 6,000L under construction.The Founder, Chairman and Executive Director of Lepu Biopharma Co., Ltd. Dr. Pu Zhongjie said, "Today, we are very delighted to witness Lepu Biopharma to be officially listed on the Hong Kong Stock Exchange. This is an important milestone in our history of development as well as a starting point of our new journey. We sincerely appreciated the long-term trust and cooperation from customers and shareholders. We would also like to thank our partners, the Hong Kong Stock Exchange and the Securities and Futures Commission for all the great support. With solid R&D capabilities, advanced development platforms and comprehensive pipeline, we will seize the future trend of the whole industry, strengthen our position in the market with our competitive advantages and create greater value for shareholders and investors."About Lepu Biopharma Co., Ltd.Lepu Biopharma was incorporated in 2018 and is a biopharmaceutical company focusing on oncology therapeutics. The Company has designed pipeline with a range of oncology products. As of [the Latest Practicable Date], the Company had pipeline including eight clinical-stage drug candidates, three pre-clinical drug candidates and three clinical-stage combination therapies of the candidates in the pipeline. In addition, the Company focus on the development of innovative drugs including ADC and oncolytic virus. According to Frost & Sullivan, the Company house the leading ADC drug candidate pipeline in China in terms of the number of clinical-stage ADC drug candidates. As of [the Latest Practicable Date], the Company had initiated 28 clinical trials, among which three had entered registration trial phase and two were ongoing in the U.S. In terms of patents, as of [the Latest Practicable Date], Company had 11 issued patents in China, 20 in the U.S., nine in Japan, seven in the European Union and one in each of South Korea, Australia, Chile, India, Colombia, Indonesia, New Zealand and Israel, and 74 pending patent applications, consisting of 15 in Mainland China and 59 in overseas jurisdictions such as the U.S., Japan, India, South Korea, Australia, Israel, India and the European Union. Patentportfolio of the Company spans across mAb structure, targeted epitope, CMC, usage, biopharmaceutical formulation and indications.For more information on Lepu Biopharma, please visit the website https://www.lepubiopharma.com/ Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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AstraZeneca’s antibody drug for Covid-19 treatment to arrive in S’pore by end of the year

SINGAPORE - Singapore has signed a new purchase agreement with AstraZeneca for its antibody drug for the treatment of Covid-19, with supply expected to arrive in Singapore by the end of the year. Known as Evusheld, the drug cocktail is a combination of two "long" antibodies - which take longer to metabolise in the body and can provide longer lasting protection for up to a year, compared with monoclonal antibodies. Monoclonal antibodies are lab-manufactured proteins which act like antibodies to help the immune system fight the virus. AstraZeneca said phase 3 clinical trials showed that the drug is able to reduce the risk of severe Covid-19 or death by 88 per cent when given to patients with mild-to-moderate Covid-19 within three days of the onset of symptoms. Preliminary findings in the lab have also shown the drug's effectiveness against variants of concern, including the Delta variant. The company said that currently available pre-clinical data also suggests the drug's efficacy should not be "significantly impacted" by the new Omicron variant. The two antibodies in the drug are derived from antibody-producing B-cells that were donated by convalescent or recovering Covid-19 patients. Both antibodies have been modified to provide long-lasting protection of up to a year in those who receive the drug as treatment. Mr Vinod Narayanan, the country president of AstraZeneca Singapore, said: "Evusheld provides healthcare professionals and patients in Singapore with a new option to fight the virus. Additionally, Evusheld will provide another prevention option for high-risk populations, alongside vaccines, including for people who are immuno-compromised and unable to develop the needed degree of protective response following Covid-19 vaccination." AstraZeneca has this week received Emergency Use Authorisation for Evusheld from the United States' Food and Drug Administration (FDA) for the prevention of Covid-19 and has filed for regulatory approvals in other countries. The FDA had said that the drug is authorised for use in preventing Covid-19 in people who have weakened immune systems and may not be adequately protected by vaccines. New AstraZeneca drug 'prevents and treats Covid' More on this topic   Related Story AstraZeneca's new treatment drug lowers risk of severe form of Covid-19 or death by up to 88%   Related Story AstraZeneca antibody drug important as preventive Covid-19 therapy: Executive

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Justin Lee is fifth Nanyang Poly student caught in LSD trap over a two-year period

SINGAPORE - The 17-year-old who died while facing drug trafficking charges involving lysergic acid diethylamide (LSD) is the fifth student connected to Nanyang Polytechnic (NYP) to be caught up in drug offences. Justin Lee, who was arrested by Central Narcotics Bureau (CNB) officers on Feb 3 for trafficking 131 LSD stamps, was charged in court on June 24. He died on Sept 16 from injuries sustained in a fall from height. Please subscribe or log in to continue reading the full article. Get unlimited access to all stories at $0.99/month Latest headlines and exclusive stories In-depth analyses and award-winning multimedia content Get access to all with our no-contract promotional package at only $0.99/month for the first 3 months* Subscribe now *Terms and conditions apply.

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Most first-time drug abusers are young

SINGAPORE - Young people under 30 years old continued to make up the bulk of first-time drug abusers last year. In February, the Central Narcotics Bureau (CNB) said that 62 per cent of all new abusers arrested last year were aged below 30. Please subscribe or log in to continue reading the full article. Get unlimited access to all stories at $0.99/month Latest headlines and exclusive stories In-depth analyses and award-winning multimedia content Get access to all with our no-contract promotional package at only $0.99/month for the first 3 months* Subscribe now *Terms and conditions apply.

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TOT BIOPHARM 2021 Interim Revenue Surges 78% to RMB23.13 million

HONG KONG, Aug 13, 2021 - (ACN Newswire via SEAPRWire.com) - TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Group"; stock code: 1875.HK), a biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its unaudited interim results for the six months ended 30 June 2021.KEY MILESTONES IN 2021 1HIn the first half of 2021, on the back of by national policies and driven by innovative R&D, the oncology drug market in China boomed and continued to gather growth momentum. The Group continued to implement its strategic plans drawing on its own strengths and competitive advantages, striving to become a leading player in the domestic ADC market. The Group speeded up R&D of ADC drugs and industrial planning and grasped market opportunities, enabling it to achieve breakthroughs in the realm of innovative drug CDMO/CMO.Approval for Two Products Launching in the Market:-- TOZ309 (temozolomide capsules) was approved for launch in China by the NMPA in May 2021. It is a first-line medication for newly diagnosed and recurrent glioma as well as recurrent anaplastic astrocytoma. TOZ309 is the first self-developed chemical drug of TOT BIOPHARM. Together with other pharmaceutical companies in China to hasten market penetration of the product. It will at the same time prepare for renewal of the fourth round of drugs for centralized procurement in China in 2022.-- TOM218 (Megaxia(R) - megestrol acetate oral suspension) is imported by the Group, it owns the exclusive agency of the drug in mainland China, Hong Kong and Macau. The drug can alleviate the cachexia status of AIDS and cancer patients, including loss of appetite and body weight, and nausea and vomiting that sometimes occur. Compared to the solid dosage forms, oral suspensions can reduce the discomfort of patients in swallowing. Megaxia(R) had been approved for sale in the United States in 2014 and is the first high concentration megestrol acetate oral suspension approved for sale in China. Major milestones of key products in clinical trial-- Core product TAB008 - Application for Marketing Approval Submitted and Being Processed: TAB008 is a bevacizumab biosimilar self-developed by TOT BIOPHARM for treating malignant tumors including advanced, metastatic and recurrent NSCLC and metastatic colorectal cancer. The new drug application (NDA) of TAB008 was filed in September 2020 and currently being processed by NMPA, which completed an on-site inspection and GMP-compliance inspection in January 2021. the Group expects to receive approval for marketing of the drug by end of 2021. As bevacizumab covers a number of cancers common in China, market demand would be huge.-- TAA013 - Smooth Progress of Phase III Clinical Trial: TAA013 is an ADC candidate containing trastuzumab and an emtansine derivative (Trastuzumab-MCC-DM1) for treating advance-stage or metastatic HER2+ breast cancer which could not be cured by trastuzumab and be surgically removed. In July 2020, the drug was given to the first patient in the Phase III clinical trial. To date, over 70 clinical research centers in the country are involved in the Phase III clinical trials making satisfactory progress.Key milestones of commercial production planning-- In the first half of 2021, TOT BIOPHARM actively deployed for ADC pilot production and commercial production. It has put together highly competitive GMP-compliant pilot production facilities for mAb and ADC liquid formulation and drug substance, including the OEB-5 potency-level freeze-dried powder/liquid injection formulation (Capacity of ADC drug substance: 1g~300g/batch; Capacity of ADC formulation line: 500~5,000 vials/batch) and a GMP-compliant ADC commercial production workshop (Capacity of ADC drug substance: 1,000g-3,000g/batch; Capacity of ADC formulation line: 10,000~15,000 vials/batch).Prominent Competitiveness of ADC DrugsTOT BIOPHARM possesses core conjugation process technologies, a complete ADC analysis technology platform and independent analysis capabilities in respect of ADC critical metric attributes. Accordingly, we have achieved technical breakthroughs in the regulation of glycoforms, enabling precise control of the composition of each glycoform. It attributes to ensure the successful development of ADC processes and produce high quality of products.TOT BIOPHARM has established an expert team for the R&D of conjugation process technologies of ADCs and an analysis team for complex ADC molecule structure. Boasting their extensive practical experience, successful exemplary cases and their comprehensive experience ranging from R&D, process development, clinical trials, registration and filing for approval to commercial production, and our products are at the leading position among ADCs in China.CDMO/CMO BUSINESS ACHIEVES LEAPFROG BREAKTHROUGHDevised One-stop Innovative Drug CDMO SolutionDespite the intense competition in the biomedical sector, TOT BIOPHARM has been able to effectively seize market opportunities and by giving full play to its open technological platform and commercial production capability, it has speeded up development of its "one-stop, localized" CDMO/CMO business, particularly in the ADC sector. It is able to capture first opportunities in the market and secure cooperation opportunities.-- TOT BIOPHARM owns core conjugation process technologies and has the ability to scale up technologies. With that advantage and capable of independent analysis of ADC critical metric attributes, the Group can guarantee the high quality of its product R&D work.-- It possesses "perfusion-batch hybrid technology" that can support commercial production of mAb drugs, including scaling up production from 25L to 2,000L directly, helping simplify the production process and shorten the production cycle, in turn enhance markedly the economic return of commercial CDMO/CMO projects.-- Priding long-term trusting relationship with partners, the Group took on various new CDMO/CMO projects in the first half of 2021, and saw substantial increase in terms of number of partners and business scale with the relevant revenue recording a substantial year-on-year growth of 330%.-- Being able to complete all the stages from R&D to putting out the end products in one plant and one place within the same production base at its Suzhou headquarter, TOT BIOPHARM managed to reduce much of the risks and difficulties in management, transportation and technological from outsourcing different procedures to different suppliers.Strengthened Cooperation and ExchangeTOT BIOPHARM cherishes its long-term relationship and various kinds of cooperation with diverse partners and aiming to enhance core competitiveness of CDMO services.-- On 19 July, TOT BIOPHARM and BrightGene Bio-Medical Technology Co., Ltd. (688166.SH) became strategic cooperation partners, which has seen its one-stop for ADC drug CDMO service platform strengthen in favor of R&D and commercialization of innovative drugs. Pursuant to the agreement, the two parties will work together to provide clients with services starting with development of production craftsmanship, moving on to scaling up production and eventually GMP-compliant production. The cooperation realized seamless connection of industrial chains, removing the risks from cross-regional regulation, and is a marriage of strengths in terms of technologies and resources, allowing further upgrade of the CDMO service platform for ADC drugs to provide one-stop solutions to innovative drug corporations to help them reduce R&D risks and make commercialization more efficient.CORE BUSINESS ADVANTAGESTOT BIOPHARM has developed three core business advantages, providing a solid foundation for development of and cooperation in relation to innovative drugs.-- Three Technology Platforms and Comprehensive Industrial Value Chain TOT BIOPHARM has three integrated technology platforms and a proven international quality Management and Registration System and registration team, plus a comprehensive industrial value chain that covers from R&D, process development, clinical trials, registration and filing to commercial production, giving it a solid foundation to speed up R&D, lay out international market presence and for its for its CDMO/CMO business.-- A Packed Product Pipeline with Huge Market PotentialAt present, the Group has 12 drug candidates in the pipeline, including monoclonal antibody drugs such as TAB008 (anti-VEGF mAb), TAB014 (anti-VEGF mAb) and TAY018 (anti-CD47 mAb), and ADCs such as TAA013 (anti-HER2 ADC), for indications involving various high incidence cancers, such as non-small-cell lung cancer, breast cancer, gastric cancer, cerebral gliomas cancer and cervical cancer.-- Rare Capability of Commercially Producing mAb and ADCAgreeing with the industrial upgrade of the Company and to meet market demand, the Group kicked off effort to expand production capacity in 2021, continuing to bolster the commercial production capacity of its antibody drugs and ADC products to prepare for the continuous expansion of the CDMO/CMO business. According to our strategic plan, we will keep on expanding our production capacity of mAb drugs to more than 16,000L. Future DevelopmentDr. Liu Jun, Chief Executive Officer, Chief Science Officer and Executive Director of TOT BIOPHARM, said, "We expect TAB008, our first biological drug, to be approved for launch to market in 2021, hence we will corporate with sizable pharmaceutical plants to roll out our marketing plan. At the same time, we will push forward clinical procedures of ADC TAA013 to enrich the ADC product pipeline. With biological drug CDMO business in China at large booming, leverage on our advantage of "one-base" CDMO/CMO value chain, we will allocate our resources to optimize CDMO business in ADC field, strengthen our brand image as well as consolidate our market position. "Looking ahead, we believe the competitive advantages of TOT BIOPHARM will become more and more obvious. We will keep presenting employees with ample room for development, and to our partners, with the best strategic solutions, and for shareholders, create value."FINANCIAL HIGHLIGHTS (as at 30 June 2021)Hong Kong Financial Reporting Standards Measures:-- Revenue was RMB23.132 million, representing a year-on-year growth of 78% thanks to the Group's proactive expansion of CDMO/CMO business heeding market changes, with relevant revenue up year-on-year growth by a substantial 330%.-- R&D expenses were RMB88.749 million, representing a year-on-year decrease of 11%, mainly attributable to the completion of Phase III clinical trials for the TAB008 project in the second half of 2020, which resulted in a year-on-year decrease in costs of clinical trials, also, R&D work completed for the TOZ309 project, there was a significant reduction of relevant expenses on R&D consumables. -- Selling expenses were RMB11.202 million, representing a year-on-year decrease of 18%, mainly attributable to the Company's sales strategy adjustments, resulting in reduction of relevant costs and expenses. -- General and administrative expenses were RMB26.823 million, representing a year-on-year increase of 11%, mainly attributable to the increase in operating and management expenses related to related to employee, administration and taxation, etc..-- The above mentioned all in account, net loss of the Group for the first half of 2021 reached RMB115.005 million, representing a year-on-year decrease of 11%. Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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All 71 Singapore mosques will support anti-drug fight by CNB and Muis

SINGAPORE - All 71 mosques here will be backing an anti-drug campaign this year, with a specially crafted sermon encouraging the community to play an active role. The Dadah Itu Haram initiative was unveiled by Minister for Home Affairs and Law K. Shanmugam and Minister of State for Home Affairs and National Development Muhammad Faishal Ibrahim at the Al-Ansar Mosque in Bedok on Friday (June 25). They were joined by Mr Esa Masood, chief executive of the Islamic Religious Council of Singapore (Muis), and Ustaz Dr Mohammad Hannan Hassan, the deputy Mufti. The annual anti-drug campaign is in conjunction with the International Day Against Drug Abuse and Illicit Trafficking on June 26, and is a collaboration between the Central Narcotics Bureau (CNB) and Muis. The effort, which was launched in 2017, was supported by 15 mosques last year, but is backed by all 71 mosques this year. During Friday prayers, a specially crafted sermon by the Office of the Mufti emphasised the importance of community involvement in the fight against drug abuse. "As one community, we play an important role together in helping and providing the required support, to those who have fallen into the trap of drug abuse, in order to overcome their addiction," read the sermon. "The harmful impact of drug abuse is undeniable. It does not only harm individuals, but also cause family institutions to be affected and hopes to be destroyed. The future of their children will also be neglected." Banners reminding the community of the fight against drugs will be displayed at the mosques. Speaking to the media at the unveiling, Mr Shanmugam thanked Muis for its support over the years. "Today's launch reaffirms the close working relationship, the commitment with Muis and mosques, to raise anti-drug awareness in the community," he said. "The support for this from mosques is important because they are a key focal point, touch point, for many in the community, and we will continue to work with all our community partners including the mosques, send out the message, and strengthen support for offenders." More on this topic   Related Story Youth mentoring programme is part of new anti-drug abuse campaign in Nee Soon Central   Related Story New programme launched to help Malay-Muslim drug offenders get back on their feet

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Two Products of Zhaoke Ophthalmology (6622.HK) Passed The On-Site Inspection for Drug Registration of The National Medical Products Administration and The GMP Compliance Inspection of The Guangdong Medical Products Administration

HONG KONG, May 24, 2021 - (ACN Newswire via SEAPRWire.com) - Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or the "Company"; stock code: 6622), an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, announced that on 13 May 2021, two pharmaceutical products of the Company, namely Bimatoprost Timolol eye drop (a potential first-to-market generic drug in China targeting glaucoma, a fixed dose combination of a prostaglandin analogue and a beta-blocker) and Epinastine HCl eye drop (a potential first-to-market generic drug in China targeting allergic conjunctivitis with a dual mechanism of action of anti-histamine and mast cell stabilization), passed the on-site inspection for drug registration of the Greater Bay Area Center for Drug Evaluation of NMPA. The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.The Company also passed the Good Manufacturing Practice (GMP) compliance inspection conducted by the Guangdong Medical Products Administration. It confirms that the Company has put in place a GMP management framework, a core team, a complete set of analytical instruments, equipment and facilities, a well-managed documentation system and proper operations of the production and quality systems.Passing the on-site inspection for drug registration and GMP compliance is a major milestone for the Company. The positive result of the on-site inspection for drug registration of the Company as the first by any enterprise to complete such inspection conducted by the Greater Bay Area Center for Drug Evaluation of NMPA signifies NMPA's approval of the capacity of the Company's drug research and development system as well as the quality management system. It also validates that such systems can produce products compliant with the registration requirements in a sustained and consistent fashion.The Company's manufacturing facility occupies approximately 7,600 sq.m. in Nansha New District, Guangzhou. It is designed and built for ophthalmic drugs in compliance with cGMP requirements of China, the United States and the EU with full manufacturing capability and ready for commercial-scale production. The Company is currently expanding its manufacturing capacity and expects to complete the expansion by the end of 2022.Dr. Li Xiaoyi, Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, "The eye is a very sensitive organ of the human body, so we attach great importance to our production quality and safety, and strive to provide patients with the safest and highest quality products. Quality manufacturing is one of the core pillars of Zhaoke, passing the on-site inspection by the NMPA is a strong accreditation for the Company. It affirms all the hard work that we have put in over the years to ensure a quality manufacturing system."The Company has submitted the abbreviated new drug application (ANDA) for both of the aforementioned generic drugs (Bimatoprost Timolol eye drop and Epinastine HCl eye drop) to NMPA. The Company expects to commence commercialization of these two products upon receiving their regulatory approvals in 2022. Their commercialization is expected to address the unmet needs by glaucoma patients and help the Company forge a close bond with downstream strategic channels such as partners, key opinion leaders, ophthalmologists and hospitals.About Zhaoke Ophthalmology LimitedZhaoke Ophthalmology Limited is an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs in China. The Company has built a comprehensive ophthalmic drug pipeline of 25 candidates, comprising 13 innovative drugs and 12 generic drugs, that covers most major ocular indications affecting the front and the back of the eye, through either in-house development or in-licensing. The Company has developed internal capabilities in key aspects of ophthalmic drug development. The Company's specialized in-house research, development, clinical and regulatory capabilities have enabled it to concurrently advance multiple innovative and generic drug candidates through the preclinical and clinical stages. The Company has established a commercial-scale advanced manufacturing facility, which is designed and built for ophthalmic drugs in compliance with cGMP requirements of China, the United States and the European Union. The Company is led by an international management team with decades of industry experience and a track record of research and development, clinical operations, manufacturing, regulatory communications, business development and commercialization of ophthalmic therapies.Zhaoke Ophthalmology has received strong endorsement from blue-chip pre-IPO investors, including GIC, Hillhouse Capital, TPG, Loyal Valley Capital, Orbimed and Aier Eye Hospital. The Company recently completed its HK IPO with cornerstone investors including CaaS Capital, GIC, Golden Valley, Jennison, Mass Ave, Matthews Asia, OrbiMed and VMS Investment. Issued by Porda Havas International Finance Communications Group for and on behalf of Zhaoke Ophthalmology Limited. For further information, please contact:Porda Havas International Finance Communications GroupZhaoke.hk@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Hua Medicine Announces Acceptance of a New Drug Application for Dorzagliatin in China – First Glucokinase Activator (GKA) Globally

SHANGHAI, CHINA, Apr 23, 2021 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", Stock Code: 2552.HK), today announced that the New Drug Application (NDA) for dorzagliatin for the treatment of Type 2 Diabetes (T2D) was accepted by the China National Medical Products Administration (NMPA). Dorzagliatin is the first glucokinase activator (GKA) to submit a NDA for the treatment of diabetes, and has the potential to become the first first-in-class drug to be launched in China. Relying on Hua Medicine's original scientific concept of "repair the sensor, restore homeostasis, and treat the underlying cause of diabetes," the Company has always focused on addressing unmet medical needs since its establishment. The Company is committed to developing breakthrough products with innovative concepts, and advancing and establishing clinical practice and treatment standards globally. Dorzagliatin is the world's first new GKA diabetes drug for which a NDA has been submitted, with a new mechanism of action, new targets, new structures, new formulations and new curative effects. Dorzagliatin is the world's first new oral treatment for diabetes launched by a Chinese biotechnology company. Its mechanism of action directly targets the underlying cause of T2D. By repairing the damaged glucokinase sensor function in diabetic patients, dorzagliatin can significantly improve the beta-cell function and reduce insulin resistance in patients with T2D, effectively control the progress of T2D, and has therapeutic prospects in patients with diabetic nephropathy. Today, diabetes is a major public health problem. According to a survey published by the British Medical Journal (BMJ) in 2020, based on the diagnostic criteria of the American Diabetes Association (ADA), the total number of diabetic patients in China is approximately 130 million. Compared with the large number of patients, the diagnosis rate of T2D in China is only 43.3%, and the treatment rate is only 49.0%. In recent years, China has emphasized the importance of prevention and treatment of diabetes. The "Healthy China Action (2019-2030)" has clearly defined the goal. By 2030, the diagnosis rate of diabetes among citizens aged 18 and above will reach above 60%, and the standardized management rate will reach above 70%. The diabetes treatment rate, control rate and complication screening rate is expected to continue to increase. In the past ten years, the global diabetes market has grown rapidly. In 2019, the global expenditures spent on diabetes was approximately 760 billion USD, and the spending in China alone is approximately 109 billion USD. The market potential is exceptionally large. With the successive launches of the China Type 2 Diabetes Prevention and Treatment Guide (2020 Edition) by the Chinese Diabetes Society and the ADA's Diabetes Diagnosis and Treatment Pathway (2021 Edition), the concept of "glucose homeostasis" has become the standard for treatment of diabetes. The development of glucokinase activator for "glucose homeostasis" as the core has also attracted attention. In December 2020, Hua Medicine announced that it has successfully completed two Phase III registration trials of dorzagliatin, of which SEED (HMM0301) is a monotherapy trial in drug naive T2D patients, and DAWN (HMM0302) is a trial of dorzagliatin combined with metformin in T2D patients who are metformin-tolerant. The two trials demonstrated fast onset, potent, and sustained HbA1c reduction, and significantly reduced 2H-PPG. Dorzagliatin also demonstrated good safety and tolerability, improved beta-cell function and reduced insulin resistance. Two Phase I clinical studies conducted in the first half of 2020 showed that the combination of dorzagliatin with sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor) showed a significant synergistic effect in blood glucose control, indicating that dorzagliatin has broad application potential in T2D patients with different glucose control needs at different disease stages. Another Phase I study conducted in patients with end-stage renal impairment showed that dozagliflozin monotherapy can provide treatment opportunities for diabetic nephropathy (DKD), which accounts for about 20%-40% of the T2D population. It has potential to become a hypoglycemic agent for diabetic nephropathy without dosage adjustment.In the process of preparing for the commercialization of dorzagliatin, in August 2020, Hua Medicine formed a strategic cooperation agreement in China with the global pharmaceutical giant and leader in Chinese diabetes treatment, Bayer. Hua Medicine's innovative capabilities and Bayer's leading advantage in the field of diabetes management in China will enable this world's first innovative drug to benefit Chinese diabetic patients as soon as possible. In September 2020, the Company received the "Drug Manufacturing Permit" for dorzagliatin from the Shanghai Drug Administration, completing the core work of preparation for commercial production.Dr. Li Chen, founder and CEO of Hua Medicine, said: "We are very pleased that dorzagliatin's NDA application has been accepted by the NMPA. This is a major milestone for Hua Medicine. On the path to first-in-class, first-in-China, Hua Medicine has always strived to stand at the forefront of reform and pharmaceutical innovation, and contribute to the development of China's pharmaceutical industry and its people's health. Diabetes chronic disease management is a major work to protect national health, For the past 10 years Hua Medicine has committed to "China Leading Pharmaceutical Innovation", and actively explored the development and review and approval of China's first innovative drug with the Drug Evaluation Center, and achieved significant achievements in the field of innovative drug development with the spirit of "a sword in ten years." We have achieved breakthrough and developed this global innovative drug, allowing China to join the world in first-in-class drug development. We are very proud of this achievement and we look forward to working with our partners to jointly promote dorzagliatin in China."About DorzagliatinDorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted the NDA for dorzagliatin to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.About Hua MedicineHua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.Forward-looking StatementThis article contains the statements regarding the future expectation, plan and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties or other legal requirements.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.comPorda Havas International Finance Communications Group Mr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.comMs. Louisa Chen +86 75523807432 louisa.chen@pordahavas.comMs. Karen Chiu +852 3150 6726 karen.chiu@pordahavas.comMs. Winnie Tan +852 15915975512 winnie.tan@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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