和铂医药与Cullinan Oncology就B7H4x4-1BB双特异性抗体签订授权及合作协议

EQS 新闻 via SEAPRWire.com / 2023-02-14 / 11:12 UTC+8 和铂医药与Cullinan Oncology就B7H4x4-1BB双特异性抗体签订授权及合作协议   HBM7008是一款针对B7H4x4-1BB的双特异性抗体,由和铂医药创新的免疫细胞衔接器HBICE®平台开发   和铂医药将获得2500万美元预付款和最高达6亿美元里程碑付款,以及最高近20%销售额百分比的分级特许使用权费   和铂医药保留美国地区以外HBM7008的所有权利,以此为前提,Cullinan Oncology亦有权在欧盟或澳大利亚进行人体临床研究,并与和铂医药共享相关临床资料   和铂医药(股票代码:02142.HK)今日宣布与Cullinan Oncology, Inc.(纳斯达克:CGEM)签订授权及合作协议,授予Cullinan Oncology在美国(包括哥伦比亚特区和波多黎各)开发及商业化HBM7008(Cullinan Oncology产品代号为CLN-418)的独家许可权。HBM7008是一款针对B7H4x4-1BB的双特异性抗体,由和铂医药创新的免疫细胞衔接器HBICE®平台开发,目前正处于I期临床开发阶段。   根据协议,和铂医药将获得2500万美元预付款和最高达6亿美元里程碑付款,以及最高近20%销售额百分比的分级特许使用权费。Cullinan Oncology将承担在美国地区开发及商业化HBM7008的所有费用,和铂医药保留美国地区以外HBM7008的所有权利。此外,Cullinan Oncology亦有权在欧盟或澳大利亚进行人体临床研究(前提为和铂医药将保留HBM7008的所有权利)并与和铂医药共享相关临床资料。   和铂医药创始人、董事长兼首席执行官及HBMAT董事会主席王劲松博士表示:“此次合作是全球领先的合作伙伴对我们的技术平台和创新能力的又一次认可,也是和铂医药向这一潜在全球首创肿瘤免疫疗法迈出的坚实脚步。得益于其独特的肿瘤表达特异性和免疫调控活性,HBM7008表现出强大的抗肿瘤疗效,我们相信Cullinan Oncology是进一步开发HBM7008的最佳合作伙伴,他们拥有专业的临床开发团队、强大的肿瘤药物开发能力以及配套的设备资源。我们期待与Cullinan Oncology紧密合作将这个具有巨大潜力的创新产品全速推进。”   Cullinan Oncology 首席执行官Nadim Ahmed先生表示:“我们很高兴将HBM7008(CLN-418)这款潜在全球首创且进入临床阶段的双特异性抗体引入Cullinan Oncology多元化的产品管线。B7H4是一种肿瘤相关抗原,在多种癌症中高表达,与PD-L1的表达重叠度极小,我们相信B7H4x4-1BB是针对B7H4的最佳通路之一。HBM7008的引进是Cullinan Oncology战略布局的一部分,将充分发挥我们在双特异性方面的专长,巩固我们在针对实体瘤的双特异性抗体开发领域的地位。和铂医药拥有丰富的抗体疗法创新能力并具备广泛的全球合作网络,我们期待与其共同推进CLN-418/HBM7008的临床开发工作,从而最大化激发该产品的潜力与价值。”   关于HBM7008 HBM7008是一种针对肿瘤相关抗原B7H4x4-1BB的双特异性抗体,由于其高度依赖以肿瘤相关抗原为介导,与T细胞活化进行交叉链接,因此在T细胞共刺激及抑制肿瘤生长方面的功效显著,同时提高安全性。HBM7008基于和铂医药创新的HBICE®平台开发的全人源双特异性抗体,也是目前全球针对这两个靶点的唯一双特异性抗体。其独特的肿瘤表达特异性和免疫调控活性,有望在PD-L1阴性或对PD-1/PD-L1免疫治疗药物具耐药性的患者中,产生更好的疗效。凭借其新型生物学作用机制及双抗设计,有望避免4-1BB可能引发的肝毒性风险。   关于和铂医药 和铂医药(股票代码:02142.HK)是一家专注于肿瘤及免疫性疾病领域创新药研发及商业化的全球化生物制药企业。公司通过自主研发、联合开发及多元化的合作模式快速拓展创新药研发管线。 和铂自有的抗体技术平台Harbour Mice®可生成双重、双轻链(H2L2)和仅重链(HCAb)形式的全人源单克隆抗体。基于HCAb抗体平台开发的免疫细胞衔接器(HBICE®)能够实现传统药物联合疗法无法达到的抗肿瘤疗效。Harbour Mice®,HBICE®与单B细胞克隆筛选平台共同组成了和铂的下一代创新治疗性抗体研发引擎。 更多资讯,请访问 www.harbourbiomed.com   关于CULLINAN ONCOLOGY, INC Cullinan Oncology, Inc.(纳斯达克:CGEM)是一家生物制药公司,致力于为癌症患者创造新的护理标准。其无国界地开展创新,寻找最具前景的可用于临床的癌症疗法,无论是通过自身的发现努力或通过与学术和行业伙伴的特别合作。基于对免疫肿瘤学和癌症转化医学的深刻理解,其利用在小分子和生物制剂方面的科学优势,创造出与众不同的想法,确定独特的目标,并选择最佳方式来开发各种癌症适应症的转型疗法。在新型研究模式的推动下,其突破了从候选药物选择到癌症治疗的传统界限,应用严格的早期实验,只将最具前景的研究成果快速推向临床,最终实现商业化。因此,其多元化的管线是以激活免疫系统或抑制各种模式的关键致癌因素的研究成果策略性地构建而成,每项研究成果均有可能成为同类产品中最佳的或第一产品。 其员工拥有深厚的科学专业知识,寻求开放式创新,并发挥创造力,加紧研发工作,以实现为癌症患者带来新的治疗方案的承诺。 文件: 和铂医药与Cullinan Oncology就B7H4x4-1BB双特异性抗体签订授权及合作协议 2023-02-14 此财经新闻稿由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

Novotech at ESMO Congress 2022 – New Data Shows 100% Oncology Trials Growth in APAC

SYDNEY, Sep 5, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, will attend ESMO Congress 2022 with new data showing Asia Pacific has seen a 100% growth in oncology trials during 2017 to 2021 and contributes to more than a third of the global clinical development of immune-oncology drugs.Novotech has experienced CRO operations across APAC and the US offering a unique and unparalleled suite of services for early to late phase biotech clinical research.The clinical data compiled by GlobalData for Novoteoch also found that: "By the end of 2021 40% of active immuno-oncology clinical trials involved at least one location in the Asia-Pacific region, with majority of trials conducted in China, followed by Australia, South Korea, Japan and Taiwan. In the APAC region, the proportion of oncology trials doubled during 2017-2021. In China, the growth in oncology trials was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immune-oncology, and leadership in cell therapy."Download the Reports Here:IMMUNO-ONCOLOGY - ASIA PACIFIC - CLINICAL TRIAL LANDSCAPE https://novotech-cro.com/whitepapers/immuno-oncology-asia-pacific-clinical-trial-landscapeEVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5 https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5According to Yooni Kim, Vice President, Global Clinical Services Novotech: "Asia-Pacific offers a compelling solution for expedited clinical trials with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition, regulatory reforms have accelerated approval processes. Novotech's service delivery model is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasizes problem-solving, ownership and flexibility, and our investments in data and technology ensure clients have real-time access to trial performance."Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.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)

Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China

SYDNEY, Jun 6, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, is sponsoring the Endpoints ASCO22 "Accelerating clinical development in China and the US".Register here https://asco22.endpts.com/TUESDAY, JUNE 711:00am - 11:45am ET (1:00 - 1:45 local time)Novotech Booth at ASCO #14115The virtual session will cover the latest on the clinical trial landscape and infrastructure in China and includes Novotech's DCT partner, Obvio Health, on DCT strategies for patient-centric, oncology study design and execution.According to the Endpoints ASCO session: "China and the US are the world's largest oncology research destinations, and the clinical research bridge between them supports accelerated clinical development from early to late phase trials while ensuring the inclusion of MRCT data packages in future regulatory applications. With experienced clinical teams in both regions, Novotech will share real-world success strategies for biotechs undertaking global clinical development programs."The expert panel features:- Jin Li, Professor of the Department of Oncology, Shanghai East Hospital- Peter Luo, Co-Founder, Chief Executive Officer and Chairman, Adagene- Vivian Gu, Head of CDR China CMO Novotech- Nancy Snowden, Head of US Operations, Novotech- Susan Dallabrida, CEO and Chairman SPRIM, ObvioHealthModerated by: Arsalan Arif, Publisher & Founder Endpoints NewsChina offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations and world-class KLOs. According to Global Data whitepaper: EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5*, over the past 5 years the growth of oncology trials (CAGR of 25%) in China outpaced other countries. This growth was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immuno-oncology, and leadership in cell therapy. China also recorded the largest number of new trials, followed by the US. In China, the number of new trials doubled during 2017-2021. Notably, China's regulatory reforms have accelerated drug approval by reducing the overall review and process. In addition, over the last five years more 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%).The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, low cost of conducting studies, high-quality standards and the presence of top clinical institutions acting as sites. Earlier this month, Novotech announced the acquisition of US CRO, NCGS as part of a US service expansion program for its global base of clients. Novotech, which has a reputation for delivering full-service, high-quality expedited clinical trials in Asia-Pacific, can now offer its biotech clients clinical services in the US to support later phase global studies. NCGS was established in 1984 in South Carolina and has a workforce of about 300 professionals across the US.Novotech CEO Dr. John Moller said: "This is a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs." "Clients will receive seamless service, with a unified approach to systems and SOPs," Moller said. Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.With more than 2,000 highly experienced professionals, clients benefit from strong site and Key Opinion Leader relationships, deep regulatory expertise, and the ability to accelerate clinical trials across the Asia Pacific and in particular China. Novotech recently announced a partnership and investment in tech firm Prospection to support accelerated clinical trials with healthcare data analytics using real-world data. Novotech has also partnered with virtual research organisation ObvioHealth to expedite trials leveraging remote technologies. This patient-centric approach improves subject retention and allows sponsors to reach populations outside major cities for clinical trial participation.* https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5About Novotech Health HoldingsNovotech Health Holdings Pte. Ltd. ("Novotech") is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. It has been instrumental in the success of approximately 3,700 clinical trials across all trial phases and broad range of therapeutic areas. Novotech is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. 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 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Novotech Sponsors Pre-ASCO China Summit Expert Panels on Early Phase Oncology Trials and Regulatory Strategy for China and US

SYDNEY, Jun 2, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, has sponsored expert panels at the Pre-ASCO China Summit 2022 bringing together leaders in oncology drug development in China and the US. The Pre-ASCO series was watched by more than 20,000 people globally.The Novotech sponsored Summit sessions are:- Go/No Go Decisions Based on Early Phase Oncology Trials (Watch here: https://tinyurl.com/novotech-webinars)- Development and Regulatory Strategy for China & US (Watch here: https://tinyurl.com/novotech-whitepapers)China offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations and world-class KOLs.-- According to Global Data whitepaper, EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5 (https://tinyurl.com/novotech-whitepapers)- Over the past 5 years, growth of oncology trials (CAGR of 25%) in China outpaced other countries.- This growth was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immuno-oncology, and leadership in cell therapy- China also recorded the largest number of new trials, followed by the US. In China, the number of new trials doubled during 2017-2021. Notably, China's regulatory reforms have accelerated drug approval by reducing the overall review and process.- In addition, over the last five years more 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%).- The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, low cost of conducting studies, high-quality standards and the presence of top clinical sites. Earlier this month, Novotech announced the acquisition of US CRO, NCGS as part of a US service expansion program for its global base of clients.Novotech, which has a reputation for delivering full-service, high-quality expedited clinical trials in Asia-Pacific, can now offer its biotech clients clinical services in the US to support later phase global studies.NCGS was established in 1984 in South Carolina and has a workforce of about 300 professionals across the US.Novotech CEO Dr. John Moller said:"This is a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs.""Clients will receive seamless service, with a unified approach to systems and SOPs," Moller said.Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.With more than 2,000 highly experienced professionals, clients benefit from strong site and Key Opinion Leader relationships, deep regulatory expertise, and the ability to accelerate clinical trials across the Asia Pacific and in particular China.Novotech recently announced a partnership and investment in tech firm Prospection to support accelerated clinical trials with healthcare data analytics using real-world data.Novotech has also partnered with virtual research organisation ObvioHealth to expedite trials leveraging remote technologies. This patient-centric approach improves subject retention and allows sponsors to reach populations outside major cities for clinical trial participation.About Novotech Health HoldingsNovotech Health Holdings Pte. Ltd. ("Novotech") is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. It has been instrumental in the success of approximately 3,700 clinical trials across all trial phases and broad range of therapeutic areas. Novotech is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. For more information visit https://novotech-cro.com/contactMedia ContactDavid Jamescommunications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Edison Oncology和冠科美博(Apollomics)宣布EO1001(APL-122) I/IIa 期临床试验中首例患者接受治疗

MENLO PARK, Calif., FOSTER CITY, Calif. and HANGZHOU, China, Oct 1, 2021 - (亚太商讯 via SEAPRWire.com) - Edison Oncology Holding Corp. (Edison Oncology),一家致力于开发针对癌症的新疗法的公司,和冠科美博(Apollomics Inc.),一家致力于发现和开发肿瘤靶向和免疫新药及其组合疗法的创新生物制药公司,今天宣布,EO1001 (APL-122)已经完成首例患者研究给药,这是一项在晚期实体瘤患者中进行的 I/IIa 期临床试验, EO1001是一款高效不可逆酪氨酸激酶抑制剂 (TKI),在实验室研究中已经证实作为单药对EGFR(ErbB1)、HER2 (ErbB2) 和 HER4 (ErbB4) 有不可逆的抑制作用。Edison Oncology联合创始人兼首席执行官Jeffrey Bacha表示,“我们很高兴看到我们的首位患者接受了EO1001治疗,希望我们在临床前研究中显示出的安全性和疗效潜力能够转化为对癌症患者的临床获益。我们的临床前研究表明,EO1001对EGFR细胞内结构域的多个激活突变有效。我们期待首次人体临床试验的结果,我们相信EO1001有潜力解决许多瘤种尚未满足的医疗需求,包括非小细胞肺癌、乳腺癌和胶质母细胞瘤。”I/IIa 期临床试验将招募最多 50 名患者,由 Senz Oncology Pty Ltd.以服务合同外包的形式在澳大利亚进行。这项首次人体临床试验的目的是评估EO1001在转移性或晚期ErbB-1 (EGFR)、ErbB-2 (HER2) 和/或 ERbB-4 (HER4) 阳性癌症患者中的安全性和耐受性。澳大利亚的几个临床研究中心将入组复发性ErbB 阳性实体瘤患者,包括中枢神经系统受累的患者。冠科美博联合创始人兼总裁 Sanjeev Redkar 博士补充道,“我们很高兴EO1001实现开发过程中的这一重要里程碑,EO1001在我们公司代号为APL-122。在临床前模型中,APL-122 在 ErbB 阳性肿瘤中表现出活性,以及穿透血脑屏障治疗中枢神经系统肿瘤的能力,因此,I/IIa期临床试验纳入了脑转移的肿瘤患者。进入人体临床试验阶段标志着该前景非常看好的癌症疗法迈出了关键一步。”本项临床试验的主要研究者,澳大利亚墨尔本Monash Cancer Center 的肿瘤学专家兼临床研究员 Sophia Frentzas 博士表示:“ErbB 阳性肿瘤代表着一个重要的医疗需求未满足的患者人群,其中包括对一线靶向治疗难治或获得性耐药的 HER2(ErbB2)阳性乳腺癌和 EGFR(ErbB1)突变肺癌患者,还包括那些逐渐被证明 ErbB 通路起着重要致癌驱动作用的其它肿瘤(例如多形性胶质母细胞瘤、子宫内膜癌、卵巢癌和膀胱癌等)。ErbB 家族成员之间的串扰和耐药相关,而中枢神经系统转移发生率的增长在患者发病和死亡中发挥着重要作用,特别是后者目前可用的靶向治疗有限。EO1001 是一种口服、可穿透脑屏障、独特高效的广谱 ErbB 抑制剂,我们期待在这项首次人体试验中探索它的安全性和疗效。”2021年2月9 日,Edison Oncology和冠科美博宣布了一项独家许可协议,据此冠科美博将在全球(中国大陆、香港和台湾除外)开发和商业化 EO1001 (APL-122)。关于 APL-122(EO1001)EO1001是一款不可逆酪氨酸激酶抑制剂 (TKI),已在实验室研究中证实作为单药对 EGFR (ErbB1)、HER2 (ErbB2) 和 HER4 (ErbB4) 的抑制作用。EO1001 不仅可以抑制 EGFR 细胞内结构域中的突变,如非小细胞肺癌 (NSCLC) 中典型的 T790M、L858R 和 d746-750 突变,以及乳腺癌中的重要的 HER2 (ErbB2) 突变,还能抑制胶质母细胞瘤中典型的 EGFR-突变株 III (EGFRvIII) 突变。在临床前试验中,EO1001具有良好的耐受性,并被证明在口服给药后能够进入中枢神经系统 (CNS),在体内实验中对EGFR-突变株III (EGFRvIII) 突变驱动的肿瘤(包括中枢神经系统恶性肿瘤)具有活性。EO1001在冠科美博的代号为 APL-122。关于 Edison OncologyEdison Oncology 成立于 2018 年,由一个在生命科学行业经验丰富的团队创立,致力于抗肿瘤新疗法的开发和商业化。Edison Oncology利用对癌症生物学和癌症药理学的深入理解,识别和挖掘有潜力克服耐药性的未开发候选药物,以改善癌症患者生存结果和生活质量。关于冠科美博(Apollomics Inc.)冠科美博( Apollomics Inc.)是一家创新型生物制药公司,致力于研发肿瘤靶向和免疫单药及其组合疗法。公司产品管线有多个处于不同开发阶段的项目,包括为恢复机体免疫系统识别能力和杀死癌细胞的新型人源化单克隆抗体和针对失控的生长信号通路的靶向疗法。公司在中国杭州市、上海市和美国加州福斯特市均有运营实体。欲了解更多信息,请访问www.apollomicsinc.com。Edison Oncology 联系方式:公司联系人:Jeffrey Bacha首席执行官电话: (650) 690-1927Email: jb@eohc.com媒体和投资者关系联系人:Amato & Partners, LLC投资者关系顾问Email: admin@amatoandpartners.com冠科美博联系方式:投资人联系人:Wilson W. Cheung首席财务官电话: (650) 209-4436Email: wcheung@apollomicsinc.com公司联系人:张立平高级市场总监电话: (86) 0571-83521933Email: liping.zhang@apollomicsinc.com中国媒体联系:博达浩华国际财经传讯集团冯嘉莉总经理电话: (852) 3150 6763Email: kelly.fung@pordahavas.com冯静仪副总裁电话: (852) 3150 6773Email: phoenix.fung@pordahavas.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)

Edison Oncology and Apollomics Announce Treatment of First Patient with EO1001 (APL-122) in a Phase I/IIa Clinical Trial

MENLO PARK, CA and HELSINKI, FINLAND, Oct 1, 2021 - (ACN Newswire via SEAPRWire.com) - Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop new therapies targeting the fight against cancer, and Apollomics Inc. ("Apollomics"), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination oncology therapies, reported that the first patient was dosed with EO1001 (APL-122) in a Phase I/IIa clinical trial in patients with advanced solid tumors. EO1001 is a potent irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies."We are thrilled to see our first patient treated with EO1001 and hope that the potential safety and efficacy suggested by our preclinical data has the potential to translate into clinical benefits for patients suffering from cancer," said Jeffrey Bacha, B.Sc., MBA, Co-Founder and Chief Executive Officer of Edison Oncology. "Our preclinical studies have shown that EO1001 is potent against multiple activating mutations in the intracellular domain of EGFR. We look forward to the results from this first clinical trial as we believe EO1001 has the potential to address unmet medical needs in many types of cancer including non-small cell lung cancer, breast cancer and glioblastoma."The Phase I/IIa clinical trial will enroll up to 50 patients and is being conducted in Australia under contract service provided by Senz Oncology Pty Ltd. The objective of this first-in-human clinical trial is to examine the safety and tolerability of EO1001 in patients with metastatic or advanced stage ErbB-1(EGFR), ErbB-2(HER2) and/or ERbB-4 (HER4) positive cancer. Patients with relapsed ErbB-positive cancers in solid tumors, including patients with central nervous system (CNS) involvement, will be enrolled at several clinical sites in Australia.Sanjeev Redkar, PhD, Co-Founder and President of Apollomics, added, "We are pleased to achieve this important milestone in the development of EO1001 which we refer to as APL-122. In preclinical models, APL-122 demonstrated activity in ErbB positive tumors and the ability to penetrate and treat cancers in the CNS. Therefore, this Phase I/IIa study is inclusive of patients with brain metastases. Advancing into human clinical trials marks a pivotal step in our development of this promising cancer therapy."Dr. Sophia Frentzas, medical oncologist and clinical researcher at Monash Cancer Center in Melbourne, Australia and Principal Investigator for the clinical trial said, "ErbB positive tumors represent a significant patient population with unmet clinical needs. These include patients with HER2 (ErbB2) positive breast cancer and EGFR (ErbB1) mutant lung cancer who have acquired resistance, or are refractory, to frontline targeted therapy. They also include those patients with other tumour types where the ErbB pathway has been increasingly shown to be a clinically significant oncogenic driver (e.g. GBM, endometrial, ovarian, bladder cancer and others). Cross-talk between ErbB family members is implicated in resistance to treatment and the growing incidence of central nervous system metastases plays a significant role in patient morbidity and mortality. In particular, the latter presents a significant limitation with currently available targeted therapies. EO1001 is an oral, brain-penetrating, uniquely potent, pan-ErbB inhibitor. We look forward to exploring its safety and efficacy in this first-in-human trial."On February 9, 2021, Edison Oncology and Apollomics announced an exclusive licensing agreement whereby Apollomics will develop and commercialize EO1001 (APL-122) globally, except in Mainland China, Hong Kong and Taiwan.About EO1001EO1001 is an irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, HER2 (ErbB2) which is prominent in breast cancer, and against the EGFR-variant III (EGFRvIII) that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well-tolerated and demonstrated the ability to enter the central nervous system (CNS) following oral dosing and activity against treatment-resistant EGFRvIII-driven tumors, including malignancies in CNS, in vivo. EO1001 is referred to as APL-122 by Apollomics.About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients.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 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.Edison Oncology Contacts:Company Contact:Jeffrey BachaChief Executive Officer(650) 690-1927jb@eohc.comMedia and Investor Relations Contact:Amato & Partners, LLCInvestor Relations Counseladmin@amatoandpartners.comApollomics Contacts:Investor Contact:Wilson W. CheungChief Financial Officer(650) 209-4436wcheung@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.comPhoenix FungVice President(852) 3150 6773phoenix.fung@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

Apollomics, Inc. and Edison Oncology Announce Licensing Agreement for Novel Protein Tyrosine Kinase Inhibitor Targeting Solid Tumors

FOSTER CITY, Calif. and HANGZHOU, China and MENLO PARK, CA, Feb 10, 2021 - (ACN Newswire) - Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Edison Oncology Holding Corp., today announced that Apollomics has been granted worldwide rights, excluding China, Hong Kong and Taiwan, for the development and commercialization of EO1001. EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. "We are excited to add EO1001 to our clinical development portfolio as its pan-erbB inhibition and well-tolerated preclinical safety profile makes it a potential targeted therapy for the treatment of solid tumor malignancies that overexpress EGFR and/or HER2," said, Sanjeev Redkar, PhD, Co-Founder and President of Apollomics. "In preclinical models, EO1001 is potent against mutations in both the intracellular and extracellular domain of EGFR and has demonstrated activity in tumors with the ability to penetrate the central nervous system. As we advance our clinical development pipeline, we continue to seek assets like EO1001 with clearly defined mechanisms of action and differentiating attributes that we believe can make a difference for cancer patients worldwide. Looking ahead, a Clinical Trial Notification (CTN) Application in Australia will be submitted to initiate a clinical trial in the second quarter of this year."Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan. Edison Oncology will receive an upfront cash payment and will be eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for EO1001 in the territories. "Our extensive and successful preclinical work with EO1001 has led us to this collaboration with Apollomics who will now advance the asset into clinical trials with their experienced development team. Over 90% of solid tumors overexpress erbB pathways, and with the data we have produced to date, we are confident that EO1001 has the potential to improve treatment outcomes for patients suffering from life-threatening cancers," concluded Jeffrey A. Bacha B. Chief Executive Officer of Edison Oncology.About EO1001 EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, and against mutations in the extracellular domain of EGFR including the EGFR-variant III (EGFRvIII) mutation that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well tolerated and demonstrated activity against treatment-resistant ErbB-driven tumors, including malignancies in the central nervous system, in vivo. About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients. About Apollomics, Inc.Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets, including 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. For more information, please visit www.apollomicsinc.com.Edison Oncology Contacts:Company Contact:Jeffrey BachaChief Executive Officer(650) 690-1927jb@eohc.comMedia and Investor Relations Contact:Amato and Partners, LLCInvestor Relations Counseladmin@amatoandpartners.comApollomics Contacts:Investor Contact:Wilson W. CheungChief Financial Officer(650) 209-4436wcheung@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.comPhoenix FungAssistant Vice President(852) 3150 6773phoenix.fung@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. www.acnnewswire.com

Sino Biopharmaceutical Announces 2020 Third Quarterly Results

HONG KONG, Nov 30, 2020 - (ACN Newswire) - Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading and innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited third quarterly results for the nine months ended 30 September 2020 (the "review period"). During the review period, the Group accelerated new drug development and established an internet ecosystem to strategically pursue its transformation by capturing opportunities arising from industry policies. These efforts were reflected in significant sales growth from new products of 66.9% to RMB6.66 billion, marking a step forward in its transformation.Development Highlights- The Group has achieved considerable sales growth from a number of new products and oncology products, with sales from new products soaring by 66.9% to RMB6.66 billion, representing 36.7% of the total revenue.- The proportion of innovative medicines increased from approximately 20% same period last year to approximately 25%, and a large number of important products will be launched soon.- Sales of oncology medicines amounted to approximately RMB 5,792.06 million, an increase of approximately 37.8% over the same period last year.- Satisfactory progress in R&D has been achieved and 11 new production approvals were obtained. For the nine months ended 30 September 2020, the total R&D expenditure accounted for approximately 11.6% of the Group's revenue.- The Group had 13 newly launched products in 2018, 26 newly launched products in 2019, and has 26 newly launched products since 2020.- The Group has facilitated convenient communications between doctors and patients via various Internet platforms. It has also commenced Internet marketing activities through a number of qualified platforms, reaping satisfactory results.- The Group's member company, CT Tianqing, has achieved a top 20 ranking on the list of "Top 100 Pharmaceutical Enterprises in China" by China National Pharmaceutical Industry Information Center for the sixth consecutive year. It has also been named "Chinese Pharmaceutical Enterprise with the Best Drug Pipeline in 2020". - Sino Biopharmaceutical has been ranked 2nd on the "Top 100 Chemical Pharmaceutical Enterprises" among the "2019 Top 100 Series of Pharmaceutical Industries in China", which was announced during the "2020 National Pharmacy Week, China Pharmaceutical Industry Top 100 Annual Conference, and China Pharmaceutical Internet Economy Annual Conference". ResultsDuring the review period, the Group recorded revenue of approximately RMB18.13 billion (9M2019: RMB19.32 billion). The proportion of new product sales to total revenue increased from approximately 20.6% in the same period last year to approximately 36.7% during the review period. Profit attributable to the owners of the parent was approximately RMB1.85 billion (9M2019: RMB2.26 billion). Basic earnings per share were approximately RMB9.81 cents (9M2019: RMB11.95 cents). Excluding the impact of amortization expenses of new identifiable intangible assets arising from the acquisition of 24% interests in Beijing Tide (net of related deferred tax and non-controlling interests), the unrealized fair value losses (net) on equity investments and financials assets, as well as the fair value loss of Convertible Bond embedded derivative component and effective interest expenses of Convertible Bond debt component, underlying profit would have been approximately RMB2.29 billion (9M2019: RMB2.60 billion). Based on underlying profit, the earnings per share were approximately RMB12.16 cents (9M2019: RMB13.77 cents). The Group has maintained a strong financial position with cash and bank balances reaching approximately RMB16.10 billion at the period end.The Board of Directors declared a quarterly dividend of HK2 cents per share. Together with the first quarterly dividend of HK2 cents per share and the second quarterly dividend of HK2 cents paid, the total dividend of the three quarters amounted to HK6 cents per share (9M2019: 6 cents).COVID-19 hits the whole world, industry policies expedite business reformDuring the review period, the pandemic crisis remained far from over. However, China has implemented strict anti-epidemic measures, production and businesses gradually returns to normal. As a result, the number of outpatients and inpatients began to climb, resulting in the improvement in drug sales.The government published several documents to establish a tiered diagnosis and treatment model, and partnerships between medical institutions operating, so as to facilitate initial consultations at the lower tier. To encourage "Internet + Health Care" and medical informatization, restrictions on the coverage of online consultations have been further relaxed, trying to include eligible medical services in the medical insurance reimbursement list.The government also intensified its reforms of medical expenses control. At the diagnosis end, national trials of multiple-payment models such as Diagnosis-Related Groups payment or disease category-based payment have commenced. Measures for managing essential drugs covered by medical insurance have also been published to enhance pertinent controls. Also, the third centralized drug procurement program has been expanded to cover a greater variety of drugs, with average prices down by 53%, and some even falling by more than 90%. In expanding the coverage of the centralized drug procurement program, establishing its relevant methodology, and making it a regular practice, competition will intensify, profitability and product structure of the industry will be notably impacted, reform of drug sales and marketing model will accelerate, and the business landscape will be polarized. Adjustments to the National Reimbursement Drug List ("NRDL") have also commenced, which marks the beginning of dynamic adjustments of the list to come. Innovative drugs and oncology drugs have higher chances to be included quickly. As the NRDL expands its coverage, the coverage for outpatient reimbursement will also be expanded, hence, accessibility to and fairness of the products above are likely to be enhanced. During the review period, the National Medical Products Administration published three technical documents, including the Working Procedures for the Review and Approval of Breakthrough Therapy Designed Drugs (for Trial Implementation) to expedite the filing and assessment of innovative drugs, and facilitate the implementation of the assessment and approval policy that encourage innovation.Pursue product mix transformation in response to policy changesDuring the review period, with a rebound in the number of hospitalized patients, the Group gradually resumed its work on sales of pharmaceutical products. Also, implementation of the third round of the centralized drug procurement program, which covered a number of the Group's key products in the hepatitis, cardio-vascular and analgesic therapeutic areas, had differing effects on sales of the Group's various products. For newly approved products such as the oncology medicines, Qingkeshu, Anxian, Jizhi, and Weishou; the respiratory system medicine, Tianqingsuchang; the cardio-vascular medicines, Anbeining, Taishule, Anxinfen and Beilishu; and the osteoarthritis medicines, Taiyan and Sulibao, their sales volume have increased rapidly following implementation of the centralized drug procurement program.The Group actively addressed the impact of centralized drug procurement on its sales cost structure by quickly shifting academic and promotion investments to new products, as well as by building a strong sales portfolio of the selected products and their associated products that are able to capitalize on the centralized drug procurement program. The results from such strategies were encouraging. The Group's new oncology medicines, Anxian, Yinishu, Leweixin, Yijiu, and Qingkeyi; antiemetic medicine associated with chemotherapy, Shanqi; new analgesic medicines, Fenkexin and Yu'an; new anti-infective medications, Tianming, Kangsuping, Fengruineng, and Yiruida; and contrast agents, Xian'ai and Qingliming, all delivered robust results.Sales transformation by building Internet ecosystemAmid the pandemic, the Group has facilitated convenient communications between doctors and patients via various Internet platforms. In addition, it has stepped up efforts in chronic disease management of the cardio-vascular, respiratory, analgesic, hepatitis and oncology therapeutic areas to enhance patients' professional knowledge and awareness of product applications. It has also commenced Internet marketing activities through a number of qualified platforms, reaping satisfactory results.R&DDuring the review period, satisfactory results were achieved in R&D. During the third quarter, the Group was granted 6 clinical trial approvals, 11 production approvals, and 15 approvals for Consistency Evaluation, and made 6 clinical trial applications, 6 applications for Consistency Evaluation and 2 production applications. Cumulatively, a total of 398 pharmaceutical products had obtained clinical trial approval, or were under clinical trial or applying for production approval. Out of these, 37 were for hepatitis medicines, 190 for oncology medicines, 22 for respiratory system medicines, 20 for endocrine, 16 for cardio-cerebral medicines and 113 for other medicines.Over the years, the Group has been placing high importance on R&D and innovation, as well as through collaboration and imitation, to raise both R&D standards and efficiency. Regarding R&D as the lifeblood of the Group's development, the Group continues to devote into more resources. For the nine months ended 30 September, 2020, the total R&D expenditure of approximately RMB2.11 billion, which accounted for approximately 11.6% of the Group's revenue.The Group also emphasizes on the protection of intellectual property rights. During the third quarter, the Group has received 37 authorized patent notices and filed 119 new patent applications. Cumulatively, the Group has obtained 879 invention patent approvals, 30 utility model patents and 115 apparel design patents.ProspectsLooking ahead, the Group will continue to act proactively along with the varying characteristics of times and trends, accelerate its development of new drugs, and continuously optimize products in the R&D pipeline. The Group will also continue to optimize the layout of the Internet ecosystem, while promote the transformation and upgrade of organizational structure, so as to achieve a comprehensive strategic transformation in the Group as soon as possible, which in turn will lay a more solid foundation for the Group's long-term development and create long-term value for shareholders.About Sino Biopharmaceutical Limited (HKEX:1177)Sino Biopharmaceutical Limited is a leading, innovative R&D driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. The Group's products have gained a competitive foothold in various therapeutic categories with promising potentials, comprising a variety of biopharmaceutical and chemical medicines for treating tumors, liver diseases, respiratory system diseases, anti-infectious diseases and orthopedic diseases.Sino Biopharm is a constituent stock of the following indices: MSCI Global Standard Indices - MSCI China Index, Hang Seng Index, Hang Seng Index - Commerce & Industry, Hang Seng Composite Index, Hang Seng Composite Industry Index - Consumer Goods, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng Stock Connect Hong Kong Index. Sino Biopharm was ranked as one of "Asia's Fab 50 Companies" by Forbes Asia for three consecutive years in 2016, 2017 and 2018. Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com