Transaction Overview
交易概览

• Alphamab Biopharma, 3D Medicines and Glenmark announce the signing of a license agreement for Envafolimab for multiple geographies around the World. 
  康宁杰瑞与思路迪医药共同宣布，授予Glenmark皮下注射PD-L1抗体药物恩维达（通用名：恩沃利单抗注射液）在全球多个地区的肿瘤适应症开发和商业化独家许可权益。
• Alphamab BioPharma (on behalf of the Licensors) will receive a total of $700.8 million from Glenmark consisting of non-refundable upfront payments and milestone payments based on sales performance across the length of the agreement, and a royalty fee of single-to-double-digits percentage according to the level of net sales.
  康宁杰瑞（代表许可人）将向Glenmark收取包含不可退还首付款以及基于恩沃利单抗开发及商业化进展与销售业绩的里程碑付款共计7.008亿美元，并按恩沃利单抗净销售额级别收取单位数至双位数百分比特许权使用费。
• YAFO Capital (Shanghai) acted as transaction advisor on this transaction for Alphamab Biopharma.
  雅法担任康宁杰瑞交易顾问。

January 25, 2024: JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD (Alphamab BioPharma) and 3D MEDICINES (BEIJING) CO., LTD. (3DMed), (together as the Licensors) today announced the signing of a license agreement with Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark) for KN035 (Envafolimab) for India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America (the Territory). 
2024年1月25日，康宁杰瑞生物制药(股票代码：9966.HK)与思路迪医药（股票代码：1244.HK）（统称“许可人”）共同宣布，双方就皮下注射PD-L1抗体药物恩维达®（研发代号：KN035，通用名：恩沃利单抗注射液）与Glenmark达成协议，授予Glenmark在印度、亚太地区（除新加坡、泰国、马来西亚）、中东和非洲、俄罗斯、独联体和拉丁美洲的肿瘤适应症开发和商业化独家许可权益。有关恩沃利单抗开发及商业化费用由Glenmark自行承担。

Under the terms of the agreement, Alphamab BioPharma will be the exclusive supplier of the product. Alphamab BioPharma (on behalf of the Licensors) will receive a total of $700.8 million from Glenmark consisting of non-refundable upfront payments and milestone payments based on sales performance across the length of the agreement, and a royalty fee of single-to-double-digits percentage according to the level of net sales. GSSA will receive from Alphamab BioPharma and 3DMed, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory根据许可协议，许可人将向Glenmark收取包含不可退还首付款以及基于恩沃利单抗开发及商业化进展与销售业绩的里程碑付款共计7.008亿美元，并按恩沃利单抗净销售额级别收取单位数至双位数百分比特许权使用费。许可人各自根据许可协议收取付款（包括预付款、里程碑付款及特许权使用费）的权利须受思路迪医药与江苏康宁杰瑞订立的协议所规限。康宁杰瑞保留全球范围内为任何目的而生产恩沃利单抗的独家权利。思路迪医药保留肿瘤领域除已授权范围的全球范围为任何目的开发权益。

Dr. Ting Xu, Chairman and President of Alphamab BioPharma, said, "This collaboration is very important for the further development of Envolimab. Based on Glenmark's development and commercialization capabilities, we believe Envolizumab will benefit a large number of cancer patients in the cooperation area." Envolizumab's advantages in safety, convenience and compliance make it a competitive product, and we look forward to a successful collaboration."
康宁杰瑞董事长兼总裁徐霆博士表示：“此次合作对于恩沃利单抗的进一步开发非常重要。基于Glenmark的开发和商业化能力，我们相信恩沃利单抗在合作区域内将惠及大量肿瘤患者。恩沃利单抗在安全性、便利性和依从性方面的优势使其成为具有竞争力的产品，我们期待合作成功。”

Dr. Zhaolong Gong, Chairman and CEO of 3D Medicines, said: "We are very excited to see that Envolizumab can help more cancer patients, and this collaboration is good news for cancer patients in emerging markets. Patients in emerging markets demand more convenient and innovative treatments. I hope we can work together to serve more cancer patients and help them live longer and better."
3D Medicines的董事长兼首席执行官龚兆龙博士表示：“我们非常高兴看到恩沃利单抗能够帮助更多的癌症患者，这次合作对于新兴市场的广大癌症患者是一个重要的好消息。新兴市场的患者需要更方便、更创新的治疗药物。希望我们一起努力，为更多的癌症患者服务，帮助他们活得更久更好。”

“This is an important milestone for Glenmark, as through this transformational deal, we gain access to the first recombinant humanized single domain antibody against PD-L1 in a Sub-Q formulation for a wide territory globally. We are excited at the opportunity to take this innovative immuno-oncology product to cancer patients across the emerging markets and meaningfully contribute towards improving their access to potentially life-saving treatments.” remarked Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd. 
Glenmark董事长兼总经理Glenn Saldanha表示：“此次合作对Glenmark来说是一个重要的里程碑，通过这一交易，我们获得了全球首个皮下注射PD-L1重组人源化单域抗体的区域推广权。我们很期待引进这款创新产品，为肿瘤免疫治疗领域做出积极贡献，帮助新兴市场的肿瘤患者。”

YAFO Capital (Shanghai) acted as transaction advisor on this transaction for Alphamab Biopharma.
雅法资本（上海）在本合作中担任康宁杰瑞交易顾问。

About KN035 (Envafolimab Injectable) (brand name: ENWEIDA, 恩維達®)
关于恩维达®（恩沃利单抗注射液）

KN035 (Envafolimab Injectable) is a recombinant single domain antibody against PD-L1 fused with human Fc, a drug independently invented by Alphamab Oncology and co-developed with 3DMed Beijing since 2016. On December 20, 2019, TRACON Pharmaceuticals, Inc., the shares of which are listed on the Nasdaq Global Select Market (ticker symbol: TCON), was granted the exclusive and nontransferable license in the U.S., Canada, Mexico and each of their dependent territories for KN035 in the field of human therapeutic applications for sarcoma. On March 30, 2020, Alphamab BioPharma, a wholly owned subsidiary of Alphamab Oncology, Jiangsu Simcere Pharmaceutical Co., Ltd.* (江蘇先聲藥業有限公司) (“Jiangsu Simcere”), a subsidiary of Simcere Pharmaceutical Group Limited, the shares of which are listed on the Stock Exchange (stock code: 2096), and 3DMed Beijing entered into a cooperation agreement (the “Simcere Agreement”). Pursuant to the Simcere Agreement, Jiangsu Simcere has been granted an exclusive marketing right in respect of oncology indications of KN035 and the rights of first refusal for in-licenses or transfers in mainland China. And it has been approved by the National Medical Products Administration of China (國家藥品監督管理局) as the global-first subcutaneous injection PD-L1 inhibitor in November 2021.
恩维达®（恩沃利单抗注射液）由康宁杰瑞自主研发，2016年起与思路迪医药共同开发，2020年3月30日，康宁杰瑞、思路迪医药、先声药业三方达成战略合作，康宁杰瑞作为原研方负责生产和质量，思路迪医药负责肿瘤领域的临床开发和商业化，先声药业负责产品在中国大陆的独家商业推广。基于其独特设计，恩维达®在有效性、安全性、便利性、依从性方面具有优势，患者无需进行静脉滴注，同时有望降低医疗成本。目前在中国、美国和日本针对多个肿瘤适应症同步开展临床试验，多个适应症已进入注册/Ⅲ期临床。恩维达®已被美国FDA授予晚期胆道癌孤儿药资格、软组织肉瘤孤儿药资格。2021年11月，恩维达®正式在中国率先获批上市，适用于不可切除或转移性微卫星高度不稳定(MSI-H)或错配修复基因缺陷型(dMMR)的成人晚期实体瘤患者的治疗，包括既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者以及既往治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者。

About Alphamab Biopharma
关于康宁杰瑞

Alphamab Biopharma is a leading biopharmaceutical company committed to the discovery, development, manufacturing, and commercialization of cutting-edge biotherapeutics for the treatment of cancer. On December 12, 2019, the company was successfully listed on the Main Board of the Hong Kong Stock Exchange, trading under the stock code 9966.Their integrated platform seamlessly combines research, development, and manufacturing capabilities for biologics. Distinguished by a globally competitive pipeline, Alphamab Biopharma specializes in antibody-drug conjugation, single domain antibody/monoclonal antibodies, and multi-functional antibodies.
For more information, please visit https://www.alphamabonc.com/
康宁杰瑞是一家创新型生物制药公司，致力于发现、开发、生产和商业化世界一流的抗肿瘤药物，为患者提供创新生物疗法。2019年12月12日，公司在香港联交所主板上市（股票代码：9966.HK）。康宁杰瑞创建了具有自主知识产权的蛋白质/抗体工程、抗体筛选、多模块/多功能抗体修饰等生物大分子药物研发和生产技术平台。打造了具有显著差异化优势和强大国际竞争力的产品管线，涵盖单域抗体/单抗、多功能抗体及抗体偶联物等抗肿瘤创新药：其中1个产品KN035（全球首个皮下注射PD-(L)1抑制剂，恩沃利单抗注射液，商品名：恩维达®）已于2021年在中国获批上市，成为肿瘤患者广泛可及的药物； 3个产品处于后期临床开发阶段；HER2双抗KN026获中国NMPA突破性疗法认定。并且公司拥有丰富的早期研发管线，其中2个新药分子已进入临床研究阶段。
更多信息请访问https://www.alphamabonc.com/

About 3D Medicines, inc.
关于思路迪医药

3D Medicines, Inc. is a commercial-stage biopharmaceutical company. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines has established a pipeline with both biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.
For more information, please visit https://www.3d-medicines.com/
思路迪医药（3D Medicines Inc.）是一家进入商业化阶段专注肿瘤治疗领域的创新药公司。2022年12月15日，公司正式登陆香港交易所主板（股票代码：1244）。公司产品线包括12款具有临床价值的创新药，其中8款已进入临床开发或商业化阶段，包括皮下注射PD-L1单域抗体新药恩维达已获国家药品监督管理局批准上市销售，多个适应症已获得FDA及NMPA孤儿药认定或优先审评。
更多信息请访问https://www.3d-medicines.com/

About Glenmark Pharmaceuticals Ltd.
关于Glenmark

Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries.
For more information, please visit https://glenmarkpharma.com/
Glenmark (BSE: 532296 | NSE: GLENMARK) 是一家以研究为主导的全球制药公司，业务涉及原研药、仿制药和非处方药领域；专注于呼吸、皮肤病学和肿瘤的治疗领域。公司拥有10个世界级的生产基地，遍布四大洲，业务遍及80多个国家。
更多信息请访问https://glenmarkpharma.com/

About YAFO Capital
关于雅法资本

Founded in 2013, YAFO Capital is a Shanghai based boutique investment and advisory firm, with professional team in our China, U.S., and London offices. YAFO Life Sciences is a leading advisory boutique focused on asset transactions. YAFO has built a strong proven track record and closed dozens of in-licensing and out-licensing transactions with global pharma and biotech companies. YAFO has been ranked as the No. 1 advisor for China cross border licensing transactions in the past four years.
For more information, please visit www.yafocapital.com
雅法全球医疗（YAFO Life Sciences）是雅法资本旗下的医疗大健康部门。专注于帮助具有“中国角度”的海外医药企业在中国的授权、战略合作及融资；以及为中国创新药企业提供海外市场授权机会、海外市场咨询、寻找和引进海外标的服务。我们致力于成为全球医疗技术对接中国市场与资本的桥梁。目前海外有超过三十位资深合伙人，深度覆盖美国、欧洲、日本、韩国等全球医疗创新区域。
更多信息请访问 www.yafocapital.com

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Vice President
wxiang@yafocapital.com

参考：https://www.prnewswire.com/apac/news-releases/alphamab-oncology-and-3dmedicines-entered-into-a-licensing-agreement-with-glenmark-for-kn035-302044003.html