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

Heure de publication:2022-06-14 Le contenu provient de： Nombre de vues：

方面从何而来于：复宏汉霖

明年6月13日，复宏汉霖（2696.HK）官宣了与Organon LLC（下称“Organon”）公司签定软件授权许证及供货周期合同书，评为其公账司独立搭建的帕妥珠单抗生物体制品制品近似于药HLX11（并购重组方案抗HER2构成域II人源化单克隆表面抗原注谢液）、地舒单抗生物体制品制品近似于药HLX14（并购重组方案抗RANKL全人单克隆表面抗原注谢液）几款服务在除华人任何全球各地范畴内来全权商业运作化的的权益，周全涉及瑞典、欧盟委员会、日等流行的生物体制品制品药销售市场中和无数新兴起来销售市场中。

要根据协议格式条款内容，复宏汉霖将从消费中取得5.41000万英镑的暗藏年收入，在这当中7三百万英镑为消费首支付宝付款的款。Organon还可抉择就复宏汉霖自由制作的伊匹木单抗海洋微生物有些相似药HLX13的国内排名商业运作化强势来袭选举权做好讨价还价。Organon为这家跨境医药企业，专业专注于的女性不全生命是什么过渡期的营养安全健康，在的女性不营养安全健康、海洋微生物有些相似药与成品熟加盟品牌范围拥有的低于60款香港上市產品，业务部网络覆盖逾140个一个国家。圆满结束复宏汉霖携起手来Organon，将进十步发展工司產品在国内排名餐饮市场的可及性和一定知名度力，为更好患儿受到愿意。
 

复宏汉霖副监事会成员长长、来实施副监事会成员长兼总裁来实施官张文杰叔叔表现：“企业都很欣喜与Organon促成该类合伙。Organon的研发管理经营观念是包围病爱美者工作需要来形成工作，并坚持问题导向在女子键康前沿技术为爱美者打造太多医疗工作方案，这与企业都一直都在开始铸就的‘为中国病爱美者打造高品行的信息化生物体药’的经营观念超高正确。以后，企业都也将将持续开拓太多鉴于药学和卖场工作需要的信息化设备，以做出贡献太多中国病爱美者。”


以监床检验检验药学使用需求为结构优化，复宏汉霖乐观线上营销时代余元化的布置，加速时代國际英文线上营销战术脚步，已建设完工内置式化怪物药业有限厂家的平台，革新效果紧扣货品开拓、分娩及商用线上营销全财产链。厂家分工协作两国两个地方革新中心点及亚洲货品开拓项目队伍，维持赋能革新，压实高的余元化货品线管，已连续在亚洲超范围内领取高于70项监床检验检验药学耐压应力测试批准书，并微信同步中国人人、欧洲共同体、美国的和马来西亚等國家和地域开设20单选监床检验检验药学耐压应力测试。分娩角度，厂家严格的依照可以依照时代國际英文中药饮片分娩質量菅理标准规范规范（GMP）标准规范完成分娩和質量监督控制，总数商用化的种植能力总计48000L，线管内货品均由厂家选择化分娩，1个了从监床检验检验药学到商用化各时间段货品的高分娩经历。显然，厂家可用于了高于800人的选择化商用化项目队伍负责管理层面恶性肿瘤货品的商用化线上营销，还与亚洲有名的药业有限厂家单位协议，货品授权书涵盖欧洲中低端怪物药餐饮市扬和兴新餐饮市扬。

关于HLX11

复宏汉霖专业化科研的帕妥珠单抗生物工程这样药（资产重组抗HER2节构域II人源化单克隆免疫抗体肌内注射液），有机会与曲妥珠单抗和放化疗聯合广泛广泛用于HER2抗体抗体阳性尽早乳房增生癌的铺助软件控制、新铺助软件控制和与曲妥珠单抗和多西他赛聯合广泛广泛用于HER2抗体抗体阳性转换性或不可以肿瘤切除的部位又复发性乳房增生癌的控制。迄今为止，其I期监床理论探索已实现主要理论探索终点站，理论探索效果声明书HLX11与国外、欧盟委员会和中华市售的原研帕妥珠单抗的口服药细胞代谢运转学共同点及安全性能高性相仿。

关于HLX14

复宏汉霖独立自主制造技术的地舒单抗生物体内似药（协同抗RANKL全人单克隆抗原针剂液）。近年地舒单抗在全球最大依据内已应用代替一系统转变症，如潜在扭伤问题的女生绝经后骨质松疏症、物理瘤骨变更和多见性骨髓瘤的人的骨相关内容故事防范，还有骨无状胞瘤等。

关于HLX13

复宏汉霖有意识的主动工业化生产的伊匹木单抗生物技术有些相似药（重组方案抗CTLA-4全人单克隆抵抗能力打瘦脸针液）。伊匹木单抗能用的 于没法摘除或改变性藏青天然色素沉着瘤的进行缓解和藏青天然色素沉着瘤的捕助进行缓解，、肾生殖神经细胞膜癌、结肠道癌、肝生殖神经细胞膜癌、非小生殖神经细胞膜肺癌患者、恶变胸膜间皮瘤和食管癌的进行缓解。

关于复宏汉霖

复宏汉霖（2696.HK）都是家亚太化的革新生态学医药化工企业机构，专注于于为知名最大提高具备可承担的高品質生态学药，货品合并良性肿瘤、自身的免疫系统患病、皮肤科患病等教育领域，已在中发行5款货品，在欧洲地区发行1款货品，13项自我调节症应用，二个发行司注册领取中食药监局业务办理。自2015年揭牌来说，复宏汉霖已建设完工合二为一化生态学医药化工企业游戏软件，高服务性能益及革新的自动目标实力围绕新产品开发、生產销售的销售及服务业运营安全管理全文化价值链。机构已建造落实高服务性能益的知名最大革新中间，遵循亚太产品生產销售的销售服务性能安全管理要求（GMP）原则实行生產销售的销售和服务性能质量管控，不息扎实合二为一化宗合生產销售的销售游戏软件，这当中，西安徐汇基地面积网已领取中和欧盟国家产品GMP身份实名认证，松江基地面积网（一）也已领取中GMP身份实名认证。


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

HLX11 (anti-HER2 domain II humanised monoclonal antibody injection), a biosimilar candidate of pertuzumab, is independently developed by Henlius, which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2 positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2 positive metastatic or unresectable locally recurrent breast cancer patients. To date, HLX11 has met primary endpoint in a Phase 1 clinical trial, showing similar pharmacokinetic and safety profiles to the reference drugs from different sources.

About HLX14

HLX14 (recombinant anti-RANKL human monoclonal antibody injection), a biosimilar candidate of denosumab, is independently developed by Henlius. Denosumab has been approved worldwide for a range of indications such as for the treatment of postmenopausal women with osteoporosis at high risk for fracture, giant cell tumor of bone, skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, etc.

About HLX13

HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection), a biosimilar candidate of ipilimumab, is independently developed by Henlius. Ipilimumab is used for the treatment of certain patients with unresectable or metastatic melanoma, as adjuvant treatment of certain patients with cutaneous melanoma, certain patients with Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma and Esophageal Cancer.

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, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Applications (NDAs) accepted for review in China. 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 centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.


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. 

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