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 方面原因于: 浏览量:

• 协议覆盖率亚洲、美国、日本的及马来西亚,已成定局促进HLX13在癌肿抗体聯合治療这个领域的全球最大可及性

• 复宏汉霖将获3200万元按揭款、隐藏的里程表碑结账2.7亿元

2025年4月29日,复宏汉霖(2696.HK)表态与世界仿制药和微菌物有些相似药科技领域领军者山德士(Sandoz,SIX:SDZ/OTCQX:SDZNY)达到目标授权管理相互合作协商,给予普通地域公户司数字化研发管理的伊匹木单抗微菌物有些相似药HLX13(抗CTLA-4单抗)在美利坚、南美洲41个欧洲国家和地域、岛国、菲律宾及英国的独代商业区化基本权利。


可根据协议模板免责条款,复宏汉霖将管理HLX13的研发项目管理、产量同时商业楼运作化批售,并从交易价格价格中提升3.01000万澳元的隐性薪资,但其中31000万澳元为交易价格价格分期支付款款。看作欧洲仿制药与微生物学体有些相似药行业的官员者,山德士依然以“让更健康无法触及”为初心,得益于约1,300款产品的总共使用受惠欧洲9亿提高。我县复宏汉霖联手山德士,将有力借助其成长期的欧洲数据网络与微生物学体有些相似药商业楼运作化竞争优势,下载加速HLX13在欧洲新趋势微生物学体药市扬的可及性。


图片

复宏汉霖施行监事、首席总裁施行官

朱俊搏士写出


让更优质生物工程药谋福利高度各地病人,是复宏汉霖矢志不渝的史命。旨在与山德士的进行合作,将进一大步加强公司的的产品的高度各地可及性。公司仍然我相信,莫过于将提高收益移至高度各地化方法的主要,才行正真推动‘我们创新,这个世界远程管理’的意义反馈控制。




图片

复宏汉霖小说总裁商务接待快速发展官兼高级工程师总经理裁

曹平男士表达出来


当我们很非常高兴与山德士完成率合作协议。仅凭复宏汉霖提更高效率的动物技术药制造研发制造技能,甚至山德士稳定的世界各国微信网络和充实的商务化的经验,两者将提更高效率深化HLX13的世界各国功能分区,同样助推器科技前沿控制方案设计在动物技术药流行的市场的的重叠。


HLX13是复宏汉霖自研怪物像药供水管的至关重要构成,其原研药伊匹木单抗(Yervoy®)作欧洲首批CTLA-4抑制性剂,已在数个国家各地和各地应用,适应能力环境症分为共同纳武利尤单抗用作黑灰着色剂瘤、肝癌细胞癌等一品类适应能力环境症。复宏汉霖已勾勒了体化欧洲技术创新、药政注册账号及医学制作运营策划的平台,并打造了完全符合欧洲药品监督操作请求的分娩和效率操作制度,成功的驱动4款设备在在美国市厂应用面市。公司的将新一轮助推HLX13的欧洲制作应用程序,全力于联手合作方式朋友们为欧洲我们提供数据大多高效率可额外负担的调理预案。

并于复宏汉霖

复宏汉霖(2696.HK)也是家国.际化的技术科技特色化动物化工品牌,秉承打造于为欧洲病患者提供数据可损失的高口感动物药,成品涉及肿癌、自己的免疫性病症、眼科医生病症等研究方向,已经存在6款成品在我国获准纳斯达克主板退市,4款成品在国.际获准纳斯达克主板退市,五类纳斯达克主板退市个人申请区分获我国食药监局、意大利FDA和欧盟委员会委员会EMA审批。自20五年创立之后,复宏汉霖已开建分立式化动物化工工司网站,极有效率及技术科技特色化的自主性价值体系力量实现产品开发、产生及商业性的圈在运营全加工业链。品牌已树立完整极有效率的欧洲技术科技特色化心中,依照规定国.际放射性药品产生线水平维护规范化(GMP)要求实施产生和线水平监督控制,不停的增强分立式化综合管理产生工司网站,中间,品牌商业性的圈化产生产业园已再度兑换我国、欧盟委员会委员会和意大利GMP认证证书。


复宏汉霖高瞻性布局合理一个多个函数的凹凸性化、高水平量的品牌管路,归属于约50个氧分子,并新一轮力促基本概念自己有抗PD-1单抗H药汉斯状®的肿癌免疫抗体携手治疗方式。截止日前日前,品牌已将建开卖软件具有中国大陆正式启动生物工程相似药汉利康®(利妥昔单抗)、选择研发培训的中国美国欧将大陆与香港。澳门紧紧地联系起来新批单抗动物类式药汉曲优®(曲妥珠单抗,芬兰餐品名:HERCESSI™,澳大利亚餐品名:Zercepac®)、汉达远®(阿达木单抗)、汉贝泰®(贝伐珠单抗)、全国第一例获准一二线手术治疗小人体细胞1.肺癌的抗PD-1单抗汉斯状®(斯鲁利单抗,美国商品种类名:Hetronifly®)还有汉奈佳®(奈拉替尼)。总部亦搜集就19个货品在全.球依据内深入开展30多种临床治疗耐压,外呼授权许可完全盖住西方等流行的海洋生物药市面和众所新起市面。


 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.



分亨
x

抖音二维码

扫扫扫