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 游戏内容特征于: 浏览量:

• 协议复盖中美洲、海外、印度及加拿大,已成定局提速HLX13在肿癌免疫性连合疗法行业领域的亚洲可及性

• 复宏汉霖将获350万美金车子首结账、因素飞机航程碑结账2.7亿美金

2025年4月29日,复宏汉霖(2696.HK)发表声明与国际仿制药和动物相近药行业领域官员者山德士(Sandoz,SIX:SDZ/OTCQX:SDZNY)确立授权许可合作关系协商,授与后面一种对公转账司服务性新产品研发的伊匹木单抗动物相近药HLX13(抗CTLA-4单抗)在新加坡、英国4二个发达国家和地段、泰国、新西兰及马来西亚的独特商业区化正当权益。


给出合同范本条款内容,复宏汉霖将有担当HLX13的商品开发、生产制造、服务业运作化厂家直销,并从合作中提升3.0一千万外币的存在盈利,进来3百万外币为合作首结账的款。有所作为高度仿制药与微怪物累似药科技领域的引领者,山德士保持以“让稳定如影随行”为神圣职责,根据约1,300款商品积累劳有所得高度9亿患儿。契机复宏汉霖携起手来山德士,将彻底四两拨千斤其较为成熟的高度网络数据与微怪物累似药服务业运作化优劣势,1HLX13在高度中端微怪物药行业的可及性。


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复宏汉霖继续执行工作执行工作董事、总裁继续执行工作官

朱俊医生说道


让高质量怪物药谋福利国际求美者,是复宏汉霖矢志不渝的历史使命。这一次与山德士的达成合作,将进一点上升公司企业产品的国际可及性。小编始终如一应该,只有这样将求美者收益居于国际化战略定位的价值观体系,能够正确保证 ‘全球研发管理,社会扫码’的价值观开环。




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复宏汉霖总截运用发展趋势官兼高端副总经理裁

曹平男式说明


他们很喜悦与山德士制定战略合作。仰仗复宏汉霖高质量的海洋生物工程药研发项目管理出扩产力,同时山德士成长的全国网路和丰富的的工商业价值生产经验,交易双方彼此将高质量推进项目建设HLX13的全国页面布局,一致电子助力学术前沿冶疗方案设计在海洋生物工程药主要市场中的覆盖面。


HLX13是复宏汉霖自研生态学相似药输油管线的关键性包含,其原研药伊匹木单抗(Yervoy®)最为欧洲首条CTLA-4可抑注射剂,已在2个我国和省份应用,适用症主要包括联合技术纳武利尤单抗在褐色素沉淀瘤、肝组织细胞癌等一款型适用症。复宏汉霖已倡导一体化欧洲研发部门、药政注册会员及临床开展的激发运作的平台,并成立了贴合欧洲国家药监局要的生育和安全性能的管理标准,顺利完成进一步推动4款货品在国外销售市场应用面市。新公司将全方面促进HLX13的欧洲的激发应用程序,得益于于联手合伙夥伴为欧洲提高带来更高高安全性能可负税的开展实施方案。

就复宏汉霖

复宏汉霖(2696.HK)是一种家国.际化的转型升级怪物学医药集团司,得益于于为世界十大病人出具可额外负担的高品牌水平怪物学药,品牌复盖恶性肿瘤、工作中免疫性消化道患病、护眼消化道患病等科技领域,重复6款品牌在华人将建销售,4款品牌在国.际将建销售,几个销售审请区别获华人食药监局、澳大利亚FDA和欧洲经济共同体国家EMA受案。自20二十年创立的话,复宏汉霖已修建二合一化怪物学医药集团渠道,快速及转型升级的人工控制体系化工作能力深入技术创新发展、生育的及商业地产圈运营服务全产业化链。司已开发连续完善快速的世界十大转型升级中间,假设按照国.际医药生育的水平管理系统正确(GMP)规定做好生育的和水平管理控制,连续增强二合一化一体化生育的渠道,中仅,司商业地产圈化生育的集地已陆续的可以获得华人、欧洲经济共同体国家和澳大利亚GMP身份验证。


复宏汉霖高瞻性平面布置打了个个智慧化、高类产品品质量的类产品供水管,包括约50个团伙,并多方位全面推进由于自留抗PD-1单抗H药汉斯状®的淋巴肿瘤免疫性连合的治疗方法。截止日现今,单位已获准销售食品分为内地首只微生物如此药汉利康®(利妥昔单抗)、自由开发的中国与美国欧福彩三d应用单抗怪物相似药汉曲优®(曲妥珠单抗,新加坡产品名:HERCESSI™,西方产品名:Zercepac®)、汉达远®(阿达木单抗)、汉贝泰®(贝伐珠单抗)、全.球首家将建一线城市诊疗小神经细胞肺癌患者的抗PD-1单抗汉斯状®(斯鲁利单抗,欧洲其他国家淘宝产品名:Hetronifly®)包括汉奈佳®(奈拉替尼)。平台亦此次就19个产品设备在亚洲条件内开展业务30很多临床实验现场实验,对德授权文件多方面网络覆盖殴美时代趋势微生物药行业卖场和许多兴盛行业卖场。


 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.



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