重磅！总金额超5.4亿美元，复宏汉霖就两款单抗生物药与Organon达成授权合作
的内容特征于：复宏汉霖
复宏汉霖副董事长会成员长、进行副董事长会成员兼总裁进行官张文杰叔叔表述：“我门很高兴地与Organon达到目标因此配合。Organon的研发部以人为本是着眼于病人要求来建立联系金融的产品，并着力解决在男性身体健康范围为患儿展示 多调理措施，这与我门老是来党坚守底线的‘为高病人展示 高茶叶品质的的的创新生物制品药’的以人为本高融合度。之后，我门也将持续时间开发管理多来源于临床药学和茶叶市场要求的的的创新的产品，以造福一方多高病人。”
以监床实验各种需求为层面，复宏汉霖乐观推进项目建设國際金化选址，快速增长國際金经营战略目标方法，已成立 合二为一化海洋生物体医药集团工作平台，科学专业化化性能围绕研发管理团队协作、产生加工及房地企业主经营全企业主链。有限工厂的联动中与马来西亚这两地科学专业化化中心及全.球类类服务发展管理团队协作，维持拉动科学专业化化，夯实基层基础极为丰富的的专业化化类类服务的管道，已显示器在全.球范畴内可以获得高达70项监床实验校正批复，并时候进行在中、欧洲共同体、马来西亚和马来西亚等的国家和省市展开20多选题监床实验校正。产生加工领域，有限工厂的严厉严格执行依据國際金消毒服务产生加工水平工作管理国家标准的（GMP）标准的进行产生加工和水平监督控制，目前有房地企业主化产能分析共分48000L，的管道内类类服务均由有限工厂的独立有意识的主动产生加工，积聚了从监床实验到房地企业主化各分阶段类类服务的极为丰富的产生加工经验丰富。最后，有限工厂的构造了高达800人的独立有意识的主动房地企业主化管理团队协作全权负责中心肿癌类类服务的房地企业主化品牌宣传，时候与全.球有名的医药集团企业主合作的，类类服务授权管理遮盖外国流行海洋生物体药市扬和兴新市扬。
关于HLX11
关于HLX14
关于HLX13
关于复宏汉霖
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20多种创新单克隆抗体，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。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤，其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就12个产品、10个免疫联合治疗方案在全球范围内开展20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 and Organon Enter into a License and Supply Agreement for Henlius’ Two Biologics in ex-China Countries
Shanghai, China, June 13, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license and supply agreement with Organon LLC (“Organon”) for the exclusive commercialization of Henlius’ independently developed HLX11 (a pertuzumab biosimilar candidate) and HLX14 (a denosumab biosimilar candidate) in ex-China countries, covering mature markets such as the United States, the European Union and Japan, as well as a number of emerging markets.
Under the agreement terms, Henlius may receive up to a total of $541 million, including a $73 million upfront payment. Organon also has an option to negotiate an exclusive license for global commercialization rights for HLX13, an ipilimumab biosimilar candidate developed by Henlius. Organon, a global healthcare company, focuses on improving the health of women throughout their lives, with a presence in more than 140 countries and more than 60 products across its Women's Health, Biosimilars, and Established Brands portfolios. This collaboration will further boost the accessibility and influence of Henlius' products in the global market and bring hope to more patients.
Mr. Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, “We are excited to partner with Organon. Organon’s R&D philosophy is to build a business around patient needs and to advance healthcare options for women, which is in line with our mission of 'offering high-quality, affordable and innovative biologics for patients worldwide'. Going forward, Henlius will continue to develop more products based on clinical and market needs, benefiting more patients worldwide.”
Rooted in unmet clinical needs, Henlius has been actively promoting internationalization and accelerating the pace of its international operations. Henlius has built a vertically integrated biopharmaceutical platform with core capabilities of high efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. Synergising its innovation centres in China and the US and global product development teams, the company continues the momentum for a diversified innovation product pipeline and has conducted more than 20 clinical trials in China, the EU, the US, Australia, etc. with more than 70 clinical trial approvals worldwide. In terms of manufacturing, the company strictly follows the International Good Manufacturing Practice (GMP) standards for production and quality control. It has a total commercial manufacturing capacity of 48,000L currently, and all the products in the pipeline are produced in-house, accumulating rich production experience from clinical stages to commercialized products. In addition, Henlius has built a top in-house commercial team of over 800 employees for the commercialization of the company's core products and expanded the company’s presence in major and emerging markets by partnering with reputable global pharmaceutical companies.
About HLX11
About HLX14
About HLX13
About Henlius
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 10 combination therapies.
