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 玩法源头于: 浏览量:

• 进行合作扩大亚洲、海外、英国及英国,即将1HLX13在癌肿免疫细胞联席冶疗方向的国内可及性

• 复宏汉霖将获3百万元首支支付宝付款、不确定里程数碑支付2.7亿元

2025年4月29日,复宏汉霖(2696.HK)宣告与世界各国仿制药和微生物工程像药科技领域干部者山德士(Sandoz,SIX:SDZ/OTCQX:SDZNY)完成许可加盟意向书,授勋后面对公转账司个性化研发项目管理的伊匹木单抗微生物工程像药HLX13(抗CTLA-4单抗)在新加坡、海外41个发展中国家和各地、日本队、德国及澳洲的独代工世俗化财产权。


不同服务协议条款内容,复宏汉霖将承接HLX13的新企业产品开发、产量及其业务化供货,并从成交中赢得3.02亿澳元的潜在性的薪水,但其中350万澳元为成交购车首支付。用作亚洲仿制药与微海洋生物制品接近药前沿技术的老板者,山德士一直以来都以“让绿色随手可及”为责任担当,要借助约1,300款企业产品连续劳有所得亚洲9亿人群。本次复宏汉霖一同山德士,将彻底的借助其较为成熟的亚洲系统与微海洋生物制品接近药业务化优势,加速度HLX13在亚洲流行的微海洋生物制品药销售市场的可及性。


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复宏汉霖实施程序高管、总裁实施程序官

朱俊硕士生写出


让质优生物工程药惠及世间上最大病员,是复宏汉霖矢志不渝的任务。我局与山德士的合作的,将进而骤提高了单位的产品的世间上最大可及性。公司仍旧确信,唯此将患病者获利放入世间上最大化全球战略的层面,就要真实实现目标‘中产品开发,世间共享设备’的商业价值闭环控制。




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复宏汉霖首席霸道总裁商务旅行发展趋势官兼高等 副经理裁

曹平男式说道


自己很好开心与山德士促成的合作。要借助复宏汉霖优质的海洋生态学药研发团队种植专业能力,及及山德士稳重的世界各国网络信息和充足的业务化体力,两人之间将优质推广HLX13的世界各国选址,相互保驾护航最前沿方法计划方案在海洋生态学药中端专业市场的所覆盖。


HLX13是复宏汉霖自研微生物这样药管网的重要性组建,其原研药伊匹木单抗(Yervoy®)用作世界排名首批CTLA-4抑制作用剂,已在很多个一个国家和东南部将建,应用症其中包括连合纳武利尤单抗使用一样素瘤、肝组织细胞癌等一系例应用症。复宏汉霖已勾勒打了个体化世界排名研发培训、药政办理及临床试验開發运营推广平台网站,并设计规划了贴合世界排名药品监督操作规范要求的制造和水平操作操作标准,成就驱动4款厂品在国外投资市扬将建开卖。厂家将全面的有序推进HLX13的世界排名開發阶段,专注于于共话加盟盟友为世界排名我们打造更加优质化量操作可经济负担的治療设计。

就复宏汉霖

复宏汉霖(2696.HK)是一种家国.际化的多元化生态学药业工司,强院于为全国性女性给予可负税的高茶叶品质生态学药,企业物品包含癌症、自己本身免疫力疫情、眼科医生疫情等层面,以有6款企业物品在国家获准推出,4款企业物品在国.际获准推出,8个推出注册依次获国家国家药监局局、美利坚共和国FDA和欧共体委员会EMA结案。自2015年开办开始,复宏汉霖已建起分立式化生态学药业游戏app平台,高效益、性价比最高及多元化的独立自主内在力影响新产品研发、研发及金融业推广全文化产业集群。工司已设立健全完善高效益、性价比最高的全国性多元化中央,决定国.际药物研发的品质服务管理规定(GMP)标准规范开展研发和的品质控制,源源不断狠抓分立式化网络综合研发游戏app平台,至少,工司金融业化研发园区已依次赚取国家、欧共体委员会和美利坚共和国GMP安全认证。


复宏汉霖预测性格局半个个多块化、优质化量的软件管路,归属于约50个原子,并推行改革推行依托于自己抗PD-1单抗H药汉斯状®的癌症抗体联合技术治疗。到现如今,单位已获准市场销售护肤品其中包括内部首只生态学比如药汉利康®(利妥昔单抗)、自行研究开发的中国和美国欧将大陆与香港。澳门紧紧地联系起来应用单抗生物技术一样药汉曲优®(曲妥珠单抗,国外货物名:HERCESSI™,荷兰货物名:Zercepac®)、汉达远®(阿达木单抗)、汉贝泰®(贝伐珠单抗)、世界上第一个将建闽东南疗法小组织细胞肺肿瘤的抗PD-1单抗汉斯状®(斯鲁利单抗,澳大利亚的商品名:Hetronifly®)相应汉奈佳®(奈拉替尼)。集团公司亦数据同步就19个的产品在全世界比率内进行30多种临床实验冲击试验,一般品牌授权全方面包裹欧洲比较主流生物制品药的市场中和多如牛毛新的市场中。


 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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