Eli Lilly & Co. (LLY), Innovent Biologics to Expand Drug Development Collaboration StreetInsider.com0/12/2015 Eli Lilly & Co. (NYSE: LLY) and Innovent Biologics, Inc. (Innovent) today announced an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company.
Below are details of the expanded agreement: The companies will collaborate to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China. Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China. Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization. Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China. Sales royalties and other payments would occur on certain products if commercialized outside China. Further financial terms were not disclosed. Lilly will create the three preclinical anti-PD-1 based bispecific antibodies using an antibody sequence contributed by Innovent. "We believe that combination therapy in immuno-oncology has the potential to transform the way cancer is treated," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Lilly. "We are pleased to be expanding our collaboration with Innovent to further the development of potential therapies for those fighting cancer in China and around the world." Michael Yu, Ph.D., co-founder, president and CEO of Innovent, stated, "We are honored that Lilly is so quickly expanding our relationship and that Lilly is trusting Innovent to develop and manufacture their newly created bispecific antibodies for China. We are excited to be at the forefront of immuno-oncology drug development and to benefit from Lilly's deep experience in bispecific antibodies."
信达生物制药(苏州)有限公司(以下简称"信达生物制药")，由中组部"千人计划"国家特聘专家俞德超博士等生物制药行业专家于2011年8月创立，并获全球最大的基金投资管理公司─美国富达投资集团（Fidelity）,全球500强企业─美国礼来制药集团(Eli Lilly)亚洲基金, 君联资本,新加坡淡马锡,苏州元禾资本和通和资本共同投资。迄今为止，公司已经引进国外资本2.32亿美元，项目总投资将达2.32亿美元。2015年初，信达生物成功与全球500强公司--美国礼来制药达成国际战略合作。信达生物制药致力于利用生物高新技术，开发用于治疗危及人类健康和生命的各种疑难疾病的高端生物新药。公司正在开发的产品包括10个技术门槛高、生产工艺复杂且具自主知识产权的单克隆抗体新药，主要覆盖肿瘤、糖尿病和自身免疫性疾病等领域。公司位于苏州工业园区生物纳米园内，现有3000平方米的生物药研发实验室和GMP中试车间，并与苏州工业园区生物产业发展有限公司(bioBAY)联手打造总建筑面积9.3万平方米，国内规模最大、符合美国FDA、欧盟EMA和中国cFDA现行GMP标准的单克隆抗体药物产业化技术平台和生产基地。基地集研发、中试生产和产业化于一体，在硬件设施建设、专业人才配备和软件配置上都体现了国际化一流水平。基地建成后，将为广大生物技术公司提供高效率、高质量的公共技术服务平台，帮助其解决生产工艺放大和生物新药产业化的瓶颈问题；将显著提高我国高端生物药的研发和产业化水平，为中国制造的高端生物药的出口奠定坚实的基础。公司拥有在生物新药研发、生产、生产基地建造和高标准运营等方面具有国际一流水平的研发团队，其中包括12位海外学成归国专家。公司计划三年内创建一支500人的生物新药研发和产业化团队。在过去的一年，公司研发团队已成功入选国家"千人计划"、"2014创新中国十大年度人物"、"2014年度热点千人计划专家"、江苏省高层次创新创业人才、姑苏创新创业领军人才、苏州工业园区科技领军人才，最近还成功荣获"江苏省创新团队"的称号，得到政府的认可和资金支持，这是苏州工业园区建成18年以来唯一获得现代服务业领域该项荣誉的国际高水平团队，也是苏州工业园区至今唯一 一支出自企业的创新团队。信达生物制药的发展模式是通过与国际顶尖的大型生物制药公司和研究机构合作，共同研发前期研究相对成熟、市场潜力巨大的生物药产品。在新药开发过程中产生知识产权并申报专利，确保公司技术平台、创新产品和知识产权的领先地位。公司已建立了一支拥有200多位员工的产品研发团队，具备了从细胞株开发、工艺放大、方法学、产品生产到质量控制等产品开发必需的研发能力。信达生物制药这一发展模式，可直接跳过新药的早期研究阶段，进入中试工艺开发及临床前和临床研究阶段，大大缩短新药的开发周期，风险相对较小，成功率较高。目前，公司已经建立了一条包括10个单克隆抗体产品，涉及肿瘤、糖尿病、自身免疫疾病等三大领域，覆盖超过12种重大疾病的丰富产品链。
IBI301—抗CD20单克隆抗体注射液 用于治疗非霍奇金淋巴瘤、慢性淋巴癌细胞白血病、类风湿性关节炎。该产品相较于市场上的同类单抗药物治疗效果更好且副作用更小，上市后可替代进口药物美罗华。美罗华是目前国内销量最高的进口单抗药物。2012年国内销售额达14亿元，是我国销售额最高的单抗产品，在单抗市场占50%的份额。
Lilly Expands China Drug Partnership in Growing Cancer Market Natasha Khan October 12, 2015 — 11:26 AM CST Eli Lilly & Co. is broadening an existing partnership with a biotechnology company in China, seeking to tap rising demand for cancer drugs. Under an expanded deal with Innovent Biologics Inc., the companies will collaborate to develop up to three cancer treatments both inside and outside China, according to a statement today. Suzhou, China-based Innovent could receive payments totaling more than $1 billion if the products reach certain milestones, according to the statement. Cancer rates in China are soaring, partly because of the country's aging population. The nation registers about 3 million new cases each year, according to the World Health Organization. Innovent's pipeline focuses on oncology, along with inflammatory diseases and ophthalmology. The two companies will collaborate on developing and commercializing the drugs over the next decade. Further financial details were not disclosed. Under an initial pact announced in a March statement, Innovent was to receive a total upfront payment of $56 million.
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