药明生物与瑞士AC Immune公司扩大战略合作 加速抗TDP-43抗体临床研发

中国, 上海

瑞士，洛桑

2020年11月9日

全球领先的开放式生物制药技术平台公司药明生物（WuXi Biologics, 2269.HK）与围绕神经退行性疾病建立丰富研发管线的瑞士临床阶段生物制药公司AC Immune SA（纳斯达克股票代码：ACIU，以下简称AC Immune）今日宣布双方扩大战略合作关系，加速AC Immune公司用于治疗罕见神经疾病的TDP-43抗体进入临床研发。

早在2018年12月，AC Immune公司就与药明生物达成了生物药发现、开发及生产等独家战略合作（相关阅读）。通过此次合作，双方将进一步扩大战略关系，继续发挥各自在药物研发平台以及创新生物药生产领域的专业经验，助力AC Immune公司开发出具有高亲和力、可有效阻止相关蛋白聚集的TDP-43抗体，从而控制疾病进展。目前业界尚无靶向TDP-43的疾病修饰疗法，该领域存在高度未满足的医疗需求以及巨大市场潜力。

此次双方扩大战略合作是基于AC Immune公司出席今年国际阿尔茨海默病及帕金森病大会（AAT-AD/PD^TM）报告的数据。该数据展示了AC Immune公司利用SupraAntigen^TM平台开发的抗TDP-43候选抗体的治疗潜力，并将支持其递交新药临床试验申请（IND）。根据新合作协议，药明生物将通过领先的细胞系开发平台等一体化生物技术平台为TDP-43单克隆抗体提供临床样品生产等支持，AC Immune公司将保留相关抗体的知识产权。

TDP-43异常聚集是许多神经退行性疾病的标志，靶向TDP-43的抗体疗法可以有效减缓或阻断大脑内TDP-43异常聚集的病理学过程，有望治疗老年痴呆、边缘系统为主年龄相关的TDP-43脑病（LATE）、肌萎缩性脊髓侧索硬化症（ALS）以及TDP相关的额颞叶变性（FTLD-TDP），几乎一半的FTLD病例以TDP-43为主要病理学标志。

AC Immune SA是一家在纳斯达克上市的瑞士临床阶段生物制药公司，致力于成为全球神经退行性疾病精准医疗领域领军者。AC Immune SA公司基于SupraAntigen^TM和Morphomer^TM两个领先的专利技术平台，设计和开发了小分子药物、生物药和诊断产品用于诊断、预防和治疗由于蛋白质错误折叠导致的神经退行性疾病。公司产品线包括9个治疗产品和3个候选诊断产品，其中6个产品处于临床试验阶段。公司与基因泰克（罗氏集团旗下企业）、礼来以及杨森等大型制药企业建立了合作关系。如需更多信息，请访问：www.acimmune.com。

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2020年6月30日，在药明生物平台上研发的综合项目达286个，包括141个处于临床前研究阶段，125个在临床早期（I期，II期）阶段，19个在后期临床（III期）以及1个在商业化生产阶段。预计到2023年后，公司在中国、爱尔兰、美国、德国和新加坡规划的生物制药生产基地合计产能将超过28万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：

www.wuxibiologics.com。

SHANGHAI 

LAUSANNE, SWITZERLAND

November 9, 2020 

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, and AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today unveiled plans to accelerate advancement of AC Immune's TDP-43 antibody into clinical development for NeuroOrphan indications.

This next phase of the strategic partnership between the companies builds on the industry leading know-how of AC Immune's proprietary drug discovery and development platforms and WuXi Biologics' expertise in manufacturing innovative biologics. A particular focus is developing AC Immune's clinical antibody candidate to ensure it has high-affinity for TDP-43 and is capable of preventing the intercellular spread of toxic species. With no disease modifying therapies currently available that target TDP-43 there is significant unmet need and market potential.

The expansion of the partnership between the companies with the new agreement, follows data presented at this year's AAT-AD/PD^TM conference on AC Immune's SupraAntigen^TM-derived anti-TDP-43 therapeutic antibody candidate, which supported advancement into IND-enabling studies. Through the new agreement, AC Immune gains access to WuXi Biologics' proprietary platforms including cell line development platform, for the clinical manufacturing of AC Immune's TDP-43 monoclonal antibodies. Under the agreement, AC Immune retains all intellectual property rights to molecules.

The aggregation of pathological forms of TDP-43 is a hallmark of numerous neurodegenerative diseases. Effectively slowing or stopping the spread of TDP-43 pathology throughout the brain could provide the first antibody-based TDP-43 targeted therapeutic approach for treating conditions such as age-related dementia, limbic-predominant age-related TDP-43 encephalopathy (LATE), amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP), with almost half of all FTLD cases exhibit TDP-43 pathology.

AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigen^TM and Morphomer^TM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly ONE-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 280,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit: www.wuxibiologics.com.