百济神州与勃林格殷格翰宣布就PD-1抗体Tislelizumab达成商业供应协议

        美国麻省剑桥／中国北京和上海（2018年1月9日）百济神州（纳斯达克：BGNE）与勃林格殷格翰生物药业（中国）有限公司今日宣布双方就百济神州的在研PD-1抗体tislelizumab签署了一项商业供应协议。作为百济神州和勃林格殷格翰探索实践“药品上市许可持有人制度”的一部分，tislelizumab将在位于上海的世界一流的勃林格殷格翰生物制药生产基地进行生产。

       “随着tislelizumab项目在中国向潜在注册批准及上市的不断推进，我们非常高兴能通过全球顶尖的生物制药合同生产商勃林格殷格翰BioXcellence™来确保产品的商业供应。过去数年，我们与勃林格殷格翰团队在临床药品供应方面通力合作，在为患者提供高质量药物的共同承诺基础上，双方已经建立起了坚实的合作伙伴关系。”百济神州创始人、首席执行官兼董事长欧雷强先生说道。“在与勃林格殷格翰的合作之外，我们也与广州开发区创建了合资公司，正在广州建设生物药生产基地，期待进一步扩大产能，以满足tislelizumab及其他在研生物药预期的生产需求。”

     基于供应协议条款，勃林格殷格翰将在数年内拥有tislelizumab的独家生产权（期限有可能延长）。除此之外，百济神州也获得了未来勃林格殷格翰在中国为其扩大产能的数项优先权。

       “这项协议标志着我们将成为中国第一个‘药品上市许可持有人制度’下生物制药进入商业化生产的企业。”勃林格殷格翰生物药业（中国）有限公司总经理罗家立博士说道。“我们致力于生产创新治疗药物旨在为全球患者未被满足的医疗需求提供治疗方案。我们的质量竞争力及合同生产能力世界一流，这一点我们信心十足。Tislelizumab作为单药和组合疗法都有潜力为患有一系列不同癌症的患者带来福音，能够为tislelizumab提供商业规模的生产供应，我们感到非常激动。”

Tislelizumab(BGB-A317)

Tislelizumab (BGB-A317)是一种正处于临床试验阶段的人源化单克隆抗体，属于一种被称为“免疫检查点”抑制剂的肿瘤免疫制剂。Tislelizumab的作用机制是与细胞表面的PD-1受体结合；后者是一种重要的免疫抑制分子，它可抑制T细胞的活化，从而降低免疫系统的作用。Tislelizumab对PD-1有很高的亲和性和特异性。它与目前获批的PD-1抗体的差异性在于其Fc区域的设计，我们认为可在最大程度上减少由其他免疫细胞带来的负面调节作用。Tislelizumab正在开发作为单一疗法以及与其它治疗组合的疗法用以治疗实体瘤和血液系统癌症。百济神州与新基公司在tislelizumab的实体肿瘤领域存在全球战略合作关系。

关于百济神州

百济神州是一家全球性的、商业阶段的、以研发为基础的生物科技公司，专注于分子靶向和免疫肿瘤疗法的研发。百济神州目前在中国大陆、美国、澳大利亚地区拥有超过850名员工，在研产品线包括新型口服小分子类和单克隆抗体类抗癌药物。百济神州目前也正在打造抗癌治疗的药物组合方案，旨在为癌症患者的生活带来持续、深远的影响。在新基公司的授权下，百济神州在华销售ABRAXANE®注射用紫杉醇（纳米白蛋白颗粒结合型）、瑞复美®（来那度胺）和VIDAZA®（注射用阿扎胞苷）。[i]

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[i] ABRAXANE®、瑞复美®和VIDAZA®是新基公司的注册商标。

勃林格殷格翰

在过去130多年里，研发驱动的制药公司勃林格殷格翰一直致力于为人类与动物带来创新的药物。勃林格殷格翰公司是全球前20大制药企业之一，至今仍是家族企业。每天，在人用药品、动物保健和生物制药合同生产三个业务领域，约5万名员工都在努力通过创新展现价值。2016年，勃林格殷格翰公司实现净销售额约159亿欧元。研发支出超过30亿欧元，相当于净销售额的19.6％。

勃林格殷格翰公司一贯非常重视社会责任。公司参与了“创造更多健康”等社会项目。勃林格殷格翰公司还积极地推动员工多元化，并从员工的不同经验与技能中获益。此外，公司的一切行为都以环境保护和可持续发展为重点。

欲了解更多关于勃林格殷格翰的信息请访问：

www.boehringer-ingelheim.com 

或者访问我们的年度报告：

http://annualreport.boehringer-ingelheim.com

关于勃林格殷格翰BioXcellence™

勃林格殷格翰是全球最大的生物制药生产商之一。公司在生物制药领域拥有超过35年的深厚经验。做为行业先驱，勃林格殷格翰已经为全球市场生产超过25种生物制药产品。以勃林格殷格翰BioXcellence™ 的品牌名为代表，公司为行业提供量身定制的合同开发和生产服务，完整的生产技术链覆盖从DNA（脱氧核糖核酸）到在德国比伯拉赫、奥地利维也纳、美国弗里蒙特和中国上海的生产网络完成罐装的全过程。勃林格殷格翰BioXcellence™确保整个产品生命周期的供应，可在任何阶段对客户项目进行转移，对各类规模进行供货，以保证药品委托生产的便利。更多内容请点击www.bioxcellence.com查看。

英文版新闻稿如下:

BeiGene andBoehringer Ingelheim Announce Commercial Supply Agreement for Anti-PD-1Antibody Tislelizumab

CAMBRIDGE, Mass., U.S.; BEIJING and SHANGHAI, China – (January 9, 2018) -- BeiGene, Ltd. (NASDAQ: BGNE) and Boehringer Ingelheim Biopharmaceuticals (China) Ltd. today announced that the two companies have entered into a commercial supply agreement for tislelizumab, BeiGene’s investigational anti-PD-1 antibody. Tislelizumab will be manufactured in Boehringer Ingelheim’s world-class biopharmaceutical manufacturing facility in Shanghai as part of a Marketing Authorization Holder (MAH) trial project pioneered by BeiGene and Boehringer Ingelheim.  

“As we advance tislelizumab towards potential regulatory approval and commercialization in China, we are pleased to have secured our commercial product supply from Boehringer Ingelheim BioXcellence, one of the world’s leading biopharmaceutical contract manufacturers. Over the years, working with the Boehringer Ingelheim team for our clinical supply, we have built a strong partnership based on a shared commitment to providing high-quality medicine to patients,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. “In addition to working with Boehringer Ingelheim, we are also building our manufacturing facility for biologics commercial supply in Guangzhou, China, in a joint venture with the Guangzhou Development District, that we expect will further expand our capacity to meet anticipated demand for tislelizumab and other biologics in our pipeline.” 

Under the terms of the supply agreement, Boehringer Ingelheim will manufacture tislelizumab in China under an exclusive multi-year arrangement, with contract extension possible. In addition, BeiGene also obtained certain preferred rights for future capacity expansion by Boehringer Ingelheim in China.

“The agreement marks the first biopharmaceutical MAH trial project entering into commercial supply in China,” said Dr. Jiali Luo, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Ltd. “Boehringer Ingelheim is focused on manufacturing innovative therapeutics to treat unmet medical needs of patients around the world. We are confident that our quality competence and contract manufacturing capabilities are best-in-class, and excited to plan for the commercial supply of tislelizumab, which has the potential to help patients with a broad array of cancers as both a monotherapy and in combination with other therapies.”

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).   

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 850 employees in China, the United States, and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license from Celgene Corporation. 

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[i] ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks ofCelgene Corporation.

Boehringer Ingelheim

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. 

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

About Boehringer Ingelheim BioXcellence^™

Boehringer Ingelheim is one of the world’s largest manufacturers of biopharmaceuticals. With over 35 years of experience in this field, the company is an industry pioneer and has produced more than 25 biopharmaceuticals for global markets. Represented by the brand Boehringer Ingelheim BioXcellence™, it offers tailor-made contract development and manufacturing services to the industry, providing the entire production technology chain from DNA to fill and finish through its network in Biberach (Germany), Vienna (Austria), Fremont (USA) and Shanghai (China). Boehringer Ingelheim BioXcellence™ secures supply throughout the entire product lifecycle — transferring customer projects at any stage, delivering to almost any scale and thereby making outsourcing easy. For more information please visit www.bioxcellence.com.

（转自：百济神州）

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