国产PD-1加速出海！复宏汉霖与复星医药达成合作，携手推进H药在美商业化

【重磅录像】颜宁：“AI在结构生物学中的未达之地”

国产PD-1加速出海！复宏汉霖与复星医药达成合作，携手推进H药在美商业化

2022年12月27日，复宏汉霖（02696.HK）宣布与复星医药（600196.SH，02196.HK）达成合作，授予其在美国对复宏汉霖自主开发的抗PD-1单抗 H药汉斯状^®（斯鲁利单抗）包括广泛期小细胞肺癌（ES-SCLC）在内的适应症进行独家商业化的权益。

根据协议条款，复星医药将负责H药在美国市场的商业化活动，复宏汉霖将负责H药在美国上市的产品开发、生产和供应，并将从此次交易中获得10亿人民币的首付款、潜在监管和销售里程碑付款及特许权使用费。以患者为中心、临床需求为导向，复宏汉霖与复星医药在产品商业化等方面已建立深度合作，在企业愿景及价值观、全球化发展战略、产品运营及管理沟通等方面沉淀多年共识并积累高度默契。通过此次合作，双方将精耕聚力，整合优势资源，共同推进H药高效快速实现在美国的上市，惠及全球更多患者。

复星医药董事长

吴以芳先生

我们很高兴能充分利用复星医药多年积累的创新能力、国际化优势及商业化能力，推动H药汉斯状在美国市场的商业化，帮助H药惠及全球更多患者。复星医药始终以患者为中心、临床需求为导向，在创新研发、许可引进、生产运营及商业化等维度践行国际化战略，并持续加强全球运营全能力建设。

复宏汉霖董事长兼首席执行官

张文杰先生

我们很高兴能与复星医药针对H药在美国达成合作。H药优异的临床数据登上国际顶级医学期刊JAMA，在全球范围引起了广泛关注，我们将持续推进H药更多适应症在中国、美国和欧盟等地的上市进程。复星医药在美国拥有高速发展的商业化团队和完善的销售体系，我们期待双方携手并肩，加速推动这款具备差异化优势的抗PD-1抗体药物进入美国市场，以优质生物药惠及更多海外患者。

优势协同，共塑出海新动能

复星医药成立于1994年，是一家秉承创新驱动的全球化医药健康产业集团。在持续加强自主创新研发的同时，复星医药亦不断深化外部合作，丰富创新产品管线，强化全球化布局。依托复星医药行业领先的双向许可能力及国际化优势，助力实现合作伙伴创新产品的价值最大化。在国际化布局中，复星医药着力于打造美国经营中心，在美国市场进行研产销全方位的能力建设。谈及此次成为H药汉斯状在美国的合作伙伴的重要性，以及对肺癌患者的潜在影响，复星医药高级副总裁、美国子公司首席执行官杨荣表示：“这对我们来说是非常重要的一步，这是一个成为社区一份子的机会，可以为那些有关键未满足需求的患者提供服务，每天都在做出改变。”

复宏汉霖在生物药领域积累了先进技术和丰富资源，已建成一体化生物制药平台，创新能力贯穿研发、生产及商业运营全产业链，目前已在中国上市5款产品，在国际上市1款产品，在研产品管线覆盖PD-1、HER2、EGFR、BRAF等众多市场广阔的靶点。公司在上海及美国加州建立了完善高效的全球创新中心，并拥有一支具备国际一流水准的临床运营团队，在全球范围内同步开展20多项临床试验，获得70多项临床试验许可；生产方面，公司严格遵照按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，管线内产品均由公司自建生产基地进行生产，具备从临床到商业化各阶段产品的丰富生产经验，并通过国家药品监督管理局（NMPA）、欧洲药品管理局、欧盟质量受权人、公司国际商业合作伙伴进行的多项实地核查及审计，获得中国和欧盟药品GMP认证。复宏汉霖强劲的生物药研发实力、对标国际水准的质量管理体系以及生产能力，为公司产品实现全球商业化提供有力支撑。

引领中国生物药创新，厚植国际化发展优势

H药汉斯状^®（斯鲁利单抗）是复宏汉霖首款自主研发的创新生物药，目前2项适应症获批上市，2项适应症上市申请获受理。自2022年3月获批上市以来，H药已在中国获批用于治疗微卫星高度不稳定（MSI-H）实体瘤和鳞状非小细胞肺癌，惠及逾10,000名中国患者。复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展12项肿瘤免疫联合疗法临床试验，广泛覆盖肺癌、食管癌、头颈鳞癌和胃癌等适应症，全面覆盖肺癌一线治疗。H药用于一线治疗ES-SCLC的国际多中心III期临床试验结果于全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA，影响因子：157.3）在线发表，成为全球首个登上JAMA主刊的小细胞肺癌免疫治疗临床研究。此外，H药治疗小细胞肺癌（SCLC）已获得美国食品和药品监督管理局（FDA）和欧盟委员会（EC）的两项孤儿药资格认定。

同时，复宏汉霖通过高效运营海外临床试验，积累了丰富的国际临床试验数据，持续推进产品加速走向全球。此前，公司已与PT Kalbe Genexine Biologics（KG Bio）达成合作协议，授予其H药首个单药疗法及两项联合疗法在东南亚地区10个国家的独家开发和商业化权利。而通过此次与复星医药达成合作，H药对外授权将进一步扩展到美国市场。基于FDA针对H药治疗ES-SCLC递交上市申请的正向反馈及FDA C类咨询会议的讨论结果，公司亦在美国启动了一项H药对比一线标准治疗阿替利珠单抗用于广泛期小细胞肺癌的头对头桥接试验并于近期完成首例患者入组，该试验拟招募200名美国受试者参与此项桥接临床试验，以评估H药在美国ES-SCLC患者中的疗效，有望进一步支持H药在美国的申报上市。随着H药海外开发进程的推进，复宏汉霖全面的国际化步伐再提速，将为全球患者带去更多高品质、可负担的治疗方案。

关于H药汉斯状^®

H药汉斯状^®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），是复宏汉霖首个自主研发的创新型单抗，目前有2项适应症获批上市，2项适应症上市申请获受理，10余项临床试验同步在全球开展。

2022年3月，H药正式获批上市，目前可用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC)。围绕H药，复宏汉霖积极推进其与公司其他产品的协同以及与创新疗法的联合，相继获得中国、美国、欧盟等国家及地区的临床试验许可，在全球同步开展12项肿瘤免疫联合疗法临床试验，广泛覆盖肺癌、食管癌、头颈鳞癌和胃癌等适应症，全面覆盖肺癌一线治疗。截至目前，H药已于中国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超3100人，其中2项国际多中心临床试验入组白人的比例超过30%，是拥有国际临床数据较多的抗PD-1单抗之一。H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC）的NDA已获得NMPA受理，H药有望成为全球首个一线治疗小细胞肺癌（SCLC）的抗PD-1单抗。此外，该药入选《2022 CSCO小细胞肺癌诊疗指南》作为ES-SCLC治疗推荐，针对ES-SCLC的国际多中心临床研究ASTRUM-005成为全球首个登上JAMA的小细胞肺癌免疫治疗临床研究。H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。

关于复星医药

上海复星医药（集团）股份有限公司（“复星医药”，股票代码：600196.SH，02196.HK）成立于1994年，是一家植根中国、创新驱动的全球化医药健康产业集团，直接运营的业务包括制药、医疗器械、医学诊断、医疗健康服务，并通过参股国药控股覆盖到医药商业领域。

复星医药以患者为中心、临床需求为导向，通过自主研发、合作开发、许可引进、深度孵化等多元化、多层次的合作模式，丰富创新产品管线。围绕肿瘤及免疫调节、代谢及消化系统、中枢神经系统等重点疾病领域，复星医药已搭建和形成了小分子创新药、抗体药物、细胞治疗技术平台，并积极探索RNA、基因治疗、ADC、靶向蛋白降解等前沿技术领域，提升创新能力。

在“4IN”（创新Innovation、国际化Internationalization、智能化Intelligentization、整合Integration）战略的指导下，复星医药将秉承“创新转型、整合运营、稳健增长”的发展模式以及为股东创造价值的信念，不断加强自主研发与外部合作，丰富产品管线，强化全球化布局，提升运营效率。同时，积极推进医疗健康产业线上线下布局，致力于成为全球医疗健康市场的一流企业。

了解公司更多资讯可登录官网：www.fosunpharma.com

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在国际上市1款产品，15项适应症获批，4个上市注册申请获得中国药监局受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，上海徐汇基地已获得中国和欧盟药品GMP认证，松江基地（一）也已获得中国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药汉斯状^®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康^®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优^®（曲妥珠单抗，欧洲商品名：Zercepac^®，澳大利亚商品名：Tuzucip^®和Trastucip^®）、汉达远^®（阿达木单抗）和汉贝泰^®（贝伐珠单抗）相继获批上市，创新产品汉斯状^®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌，其广泛期小细胞肺癌和食管鳞状细胞癌2项适应症的上市注册申请也正在审评中。公司亦同步就15个产品、12个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Henlius and Fosun Pharma Entered into an Exclusive License Agreement for HANSIZHUANG in the US

Shanghai, China, Dec 27^th, 2022 – Shanghai Henlius Biotech, Inc. (02696.HK) today announced it has entered into an exclusive license agreement with Fosun Pharma（600196.SH，02196.HK） for the commercialisation of Henlius independently developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG in the United States (US).

According to the terms of the agreement, Fosun Pharma will have the right to commercialise HANSIZHUANG upon approval in the US, and Henlius will retain responsibility for development, manufacturing, and supply. Henlius will receive RMB 1 billion as upfront payment and milestone payments and is entitled to receive royalties in the partnered territory. For many years, the two companies have worked closely on product commercialisation and other areas, developing consensus in terms of corporate vision and values, global development strategy, product operations, and management communication while focusing on patients’ and clinical needs. Through this collaboration, the two parties aim to intensively develop HANSIZHUANG, integrate superior resources, and promote its rapid launch in the United States to benefit more patients.

Mr. Wu Yifang, Chairman of Fosun Pharma, said “We are very happy to make full use of Fosun Pharma’s accumulated innovation capabilities, internationalization advantages and commercialization capabilities over the years to promote the commercialization of the anti-PD-1 mAb HANSIZHUANG in the US market and help benefit more patients around the world. Fosun Pharma has always been patient-centered and clinical needs-oriented. We have been practicing internationalization strategies in the dimensions of innovative R&D, license introduction, production operation and commercialization, and continuously strengthening the construction of full capacity in global operations.”

Mr. Wenjie Zhang, Chairman and CEO of Henlius, said, “We are excited to partner with Fosun Pharma in the United States on HANSIZHUANG. The impressive clinical data of HANSIZHUANG was published in the top international medical journal and has gained international attention. As we move forward, we’ll seek approvals for additional indications in China, the US, and the European Union. In the US, Fosun Pharma has a fast-growing commercialisation team and a dedicated sales network. Together, we will accelerate the launch of this differentiated anti-PD-1 mAb in the US market and benefit more overseas patients with high-quality biological drugs.”

Joining Forces for a Global Blueprint

Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma strengthens its independent R&D and external cooperation and enriches its product pipelines, as well as promotes global networks. Thanks to its industry-leading two-way licensing capabilities and international advantages, Fosun Pharma helps maximize the value of innovative products of partners. In the international layout, Fosun Pharma focuses on building the US operation center and conducts all-around capacity building in R&D, production, and sales in the local market. On the important partnership in the US for serplulimab, and the potential impact on patients with lung cancer, Rong Yang, Senior Vice President of Fosun Pharma and CEO of Fosun Pharma USA Inc. said, “It is a very important step for us, an opportunity to be a part of the community, and serving patients with critical unmet needs, and making a difference every day. ”

Fully leveraging the experience of biologics development and harnessing the power of innovation, Henlius has built a vertically integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle, including R&D, manufacturing and commercialisation, laying the solid foundation for a diversified and robust innovation pipeline. Up to date, 5 products have been successfully marketed in China, and 1 approved for marketing in overseas markets. The pipeline of products under development covers targets with great market potential, such as PD-1, HER2, EGFR, BRAF, etc. Synergising the innovation centres in China and the US and global product development teams, the company continues the momentum for a diversified innovation product pipeline and has conducted more than 20 clinical trials in China, the EU, the US, Australia, etc. with more than 70 clinical trial approvals worldwide. In terms of manufacturing capabilities, the company strictly follows the International Good Manufacturing Practice (GMP) standards for production and quality control. The products in the pipeline are produced by the company’s self-built manufacturing facilities, with rich production experience from clinical stages to commercialised products. Also, the manufacturing facilities have successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency, the EU qualified person, and multiple international business partners, and are certified by China and EU GMP. Henlius’ strong R&D capabilities, international-standard quality management system, and production capacity enable the company to boost the global commercialisation of its products.

Chinese Biologics in Global League

HANSIZHUANG is the first innovative mAb developed by Henlius. To date, 2 indications are approved for marketing in China, and 2 NDAs have been accepted by the National Medical Products Administration (NMPA). Since launched in March 2022, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer, benefiting more than 10,000 Chinese patients. Henlius actively promotes the synergy between HANSIZHUANG and other in-house products and innovative therapies and carries out 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, including lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer. Moreover, HANSIZHUANG has covered the full range of first-line treatments for lung cancers. The results of ASTRUM-005, a phase 3 study of HANSIZHUANG as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), became the first immunotherapy clinical study of SCLC to be published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. Also, HANSIZHUANG has been granted Orphan Drug Designation (ODDs) for the treatment of small cell lung cancer (SCLC) by the FDA and the European Commission (EC), respectively.

Furthermore, Henlius has collected an extensive collection of global clinical trial data through the efficient operations of overseas clinical trials and continues to promote products to accelerate their globalisation. Previously, Henlius has reached a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialise HANSIZHUANG in relation to its first monotherapy and two combination therapies in 10 Asia Pacific countries. Following the license granted in Southeast Asia, it is now further extended to the US market. Based on the positive feedback of the US Food and Drug Administration (FDA) Biologics License Application (BLA) submission for HANSIZHUANG for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and the discussion results of the FDA’s Class C consultation meeting, Henlius plans to recruit 100 pairs of US patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG, which is expected to propel the product towards US market approval further. Through overseas development of HANSIZHUANG, Henlius will accelerate the pace of global internationalisation and deliver more high-quality, affordable treatment options to patients.

About HANSIZHUANG

HANSIZHUANG (recombinant humanised anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 2 indications are approved for marketing in China, 2 NDAs have been accepted by the NMPA, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer (sqNSCLC). Its synergy with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended for the treatment of ES-SCLC in the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC), and the associated clinical trial became the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designations by the FDA and EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, as well ascentral nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, gene therapy, ADC and PROTAC, to enhance its innovation capabilities.

Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth”, with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global medical and health market.

For more information, please visit our official website: www.fosunpharma.com.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 approved for marketing in overseas markets, 15 indications approved worldwide, and 4 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and squamous non-small cell lung cancer (sqNSCLC). Its NDAs for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC) are under review. What’s more, Henlius has conducted over 20 clinical studies for 15 products and 12 immuno-oncology combination therapies, expanding its presence in major markets as well as emerging markets.