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
• 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。
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。
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
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)
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