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总金额超3亿美元复宏汉霖与山德士就伊匹木单抗生物类似药达成授权合作

发布时间:2025-04-30 内容来源于：浏览量：

• 合作覆盖北美、欧洲、日本及澳大利亚，有望加速HLX13在肿瘤免疫联合治疗领域的全球可及性

• 复宏汉霖将获3100万美元首付款、潜在里程碑付款2.7亿美元

2025年4月29日，复宏汉霖（2696.HK）宣布与全球仿制药和生物类似药领域领导者山德士（Sandoz，SIX:SDZ/OTCQX:SDZNY）达成授权合作协议，授予后者对公司自主研发的伊匹木单抗生物类似药HLX13（抗CTLA-4单抗）在美国、欧洲42个国家和地区、日本、加拿大及澳大利亚的独家商业化权益。

根据协议条款，复宏汉霖将负责HLX13的研发、生产以及商业化供应，并从交易中获得3.01亿美元的潜在收入，其中3100万美元为交易首付款。作为全球仿制药与生物类似药领域的领导者，山德士始终以“让健康触手可及”为使命，凭借约1,300款产品累计惠及全球9亿患者。此次复宏汉霖携手山德士，将充分借力其成熟的全球网络与生物类似药商业化优势，加速HLX13在全球主流生物药市场的可及性。

复宏汉霖执行董事、首席执行官

朱俊博士表示

“

让优质生物药造福全球病患，是复宏汉霖矢志不渝的使命。此次与山德士的合作，将进一步提升公司产品的全球可及性。我们始终相信，唯有将患者获益置于全球化战略的核心，才能真正实现‘中国研发，世界共享’的价值闭环。

”

复宏汉霖首席商务发展官兼高级副总裁

曹平女士表示

“

我们很高兴与山德士达成合作。凭借复宏汉霖高效的生物药研发生产能力，以及山德士成熟的全球网络和丰富的商业化经验，双方将高效推进HLX13的全球布局，共同助力前沿治疗方案在生物药主流市场的覆盖。

”

HLX13是复宏汉霖自研生物类似药管线的重要组成，其原研药伊匹木单抗（Yervoy ^{^®} ）作为全球首个CTLA-4抑制剂，已在多个国家和地区获批，适应症包括联合纳武利尤单抗用于黑色素瘤、肝细胞癌等一系列适应症。复宏汉霖已构建了一体化全球研发、药政注册及临床开发运营平台，并建立了符合全球药监要求的生产和质量管理体系，成功推动4款产品在海外市场获批上市。公司将全面推进HLX13的全球开发进程，致力于携手合作伙伴为全球患者提供更多高质量可负担的治疗方案。

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，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA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，公司商业化生产基地已相继获得中国、欧盟和美国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，涵盖约50个分子，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。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康 ^{^®} （利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优 ^{^®} （曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac ^{^®} ）、汉达远 ^{^®} （阿达木单抗）、汉贝泰 ^{^®} （贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状 ^{^®} （斯鲁利单抗，欧洲商品名：Hetronifly ^{^®} ）以及汉奈佳 ^{^®} （奈拉替尼）。公司亦同步就19个产品在全球范围内开展30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 Enters into License Agreement with Sandoz for Proposed Ipilimumab Biosimilar

• Partnership covers North America, Europe, Japan, and Australia to accelerate global access of HLX13 in immuno-oncology combinations

• Henlius to receive $31 million upfront, and up to $270 million in milestones

On April 29, 2025, Shanghai Henlius Biotech, Inc. (2696.HK) announced a licensing agreement with Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in generic and biosimilar medicines, granting exclusive commercialization rights for its self-developed ipilimumab biosimilar HLX13 in the United States, 42 European countries and regions, Japan, Canada, and Australia.

Under the agreement, Henlius will be responsible for development, manufacturing and commercial supply of HLX13, and is eligible to receive up to a total of $301 million, including a $31 million upfront and additional milestone payments. As the global leader in generic and biosimilar medicines, Sandoz is committed to its purpose of “pioneering access for patients” and has benefited over 900 million patients worldwide with approximately 1,300 products. This collaboration will leverage Sandoz’s established global network and commercialization expertise to accelerate the accessibility of HLX13 in mainstream biopharma markets.

“At Henlius, we remain deeply committed to delivering high-quality biologics to patients around the world,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “Our collaboration with Sandoz marks another important step toward enhancing the global accessibility of our therapies. We believe that putting patients at the core of our globalization strategy is key to fulfilling our vision of ‘Developed in China, Access for the World.’”

“We’re excited to join forces with Sandoz,” said Ping Cao, Chief Business Officer and Senior Vice President of Henlius. “By combining Henlius’ proven strengths in biologics R&D and manufacturing with extensive global reach and commercialization expertise of Sandoz, we aim to accelerate the worldwide expansion of HLX13 and bring advanced treatment options to more patients across key markets.”

HLX13 is a key component of Henlius’ self-developed biosimilar pipeline. Its reference product, Yervoy ^{^®} , the world’s first CTLA-4 inhibitor, has been approved in various countries and regions in combination with nivolumab for the treatment of melanoma and hepatocellular carcinoma, among other indications. Henlius has established an integrated global platform for R&D, regulatory registration, and clinical operations, backed by a manufacturing and quality management system that meets global regulatory standards. The company has successfully launched four products in markets beyond China. Henlius is committed to advancing the global development of HLX13 and working with partners to provide more high-quality, affordable treatment options for patients worldwide.

* Yervoy ^{^®} is a registered trademark of Bristol-Myers Squibb (US)

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, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac ^{^®} in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly ^{^®} in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.