沉磅！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
内容起源于：复宏汉霖
2022年6月13日，复宏汉霖（2696.HK）颁发与Organon LLC（下称“Organon”）公司签署授权许可及供货和谈，授予其对公司自主开发的帕妥珠单抗生物类似药HLX11（沉组抗HER2结构域II人源化单克隆抗体注射液）、地舒单抗生物类似药HLX14（沉组抗RANKL全人单克隆抗体注射液）两款产品在除中国以表全球领域内进行独家贸易化的权利，全面覆盖美国、欧盟、日本等主流生物药市场和多多新兴市场。
凭据和谈条款，复宏汉霖将从买卖中获得5.41亿美元的潜在收入，其中7300万美元为买卖首付款。Organon还能够选择就复宏汉霖自主开发的伊匹木单抗生物类似药HLX13的全球贸易化独家权势进行交涉。Organon为一家跨国药企，专一于女性全性命周期的健康，在女性健康、生物类似药和成熟品牌领域占有超过60款上市产品，业务覆盖逾140个国度。这次复宏汉霖携手Organon，将进一步提升公司产品在全球市场的可及性和影响力，为更多患者带来但愿。
复宏汉霖董事长、执行董事兼首席执行官张文杰先生暗示：“我们很欣喜与Organon达成此项合作。Organon的研发理想是萦绕病患需要来成立业务，并着力在女性健康领域为患者提供更多医治规划，这与我们一向以来坚守的‘为全球病患提供高品质的创新生物药’的理想高度符合。未来，我们也将持续开发更多基于临床和市场需要的创新产品，以造福更多全球病患。”
以临床需要为导向，复宏汉霖积极推动国际化布局，加快国际运营战术措施，已建成一体化生物造药平台，创新能力贯通研发、出产及贸易运营全产业链。公司协同中美两地创新中心及全球产品开发团队，持续加码创新，夯实丰硕的多元化产品管线，已累计在全球领域内获得超过70项临床试验核准，并同步在中国、欧盟、美国和澳大利亚等国度和地域发展20多项临床试验。出产方面，公司严格遵循依照国际药品出产质量治理规范（GMP）尺度进行出产和质量管控，现有贸易化产能共计48000L，管线内产品均由公司自主出产，堆集了从临床到贸易化各阶段产品的丰硕出产经验。此表，公司搭建了超过800人的自主贸易化团队掌管主题肿瘤产品的贸易化推广，同时与全球驰名造药企业合作，产品授权覆盖欧美主流生物药市场和新兴市场。
关于HLX11
复宏汉霖自主研造的帕妥珠单抗生物类似药（沉组抗HER2结构域II人源化单克隆抗体注射液），有望与曲妥珠单抗和化疗结合用于HER2阳性早期乳腺癌的辅助医治、新辅助医治以及与曲妥珠单抗和多西他赛结合用于HER2阳性转移性或不成切除的部门复发性乳腺癌的医治。目前，其I期临床钻研已达到重要钻研终点，钻研了局证明HLX11与美国、欧盟和中国市售的原研帕妥珠单抗的药物代谢动力学特点及安全性类似。
关于HLX14
复宏汉霖自主研造的地舒单抗生物类似药（沉组抗RANKL全人单克隆抗体注射液）。目前地舒单抗在全球领域内已获批用于一系列适应症，如高危骨折风险的女性绝经后骨质疏松症、实体瘤骨转移和多发性骨髓瘤患者的骨有关事务预防，以及骨大幼胞瘤等。
关于HLX13
复宏汉霖自主研造的伊匹木单抗生物类似药（沉组抗CTLA-4全人单克隆抗体注射液）。伊匹木单抗可用于不成切除或转移性玄色素瘤的医治和玄色素瘤的辅助医治，以及肾细胞癌、结直肠癌、肝细胞癌、非幼细胞肺癌、恶性胸膜间皮瘤和食管癌的医治。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的创新生物造药公司，致力于为全球患者提供可职守的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在欧洲上市1款产品，13项适应症获批，2个上市注册申请获得中国药监局受理。自2010年成立以来，复宏汉霖已建成一体化生物造药平台，高效及创新的自主主题能力贯通研发、出产及贸易运营全产业链。公司已成立美满高效的全球创新中心，依照国际药品出产质量治理规范（GMP）尺度进行出产和质量管控，不休夯实一体化综合出产平台，其中，上海徐汇基地已获得中国和欧盟药品GMP认证，松江基地（一）也已获得中国GMP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，并全面推动基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫结合疗法。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）已获批用于医治微卫星高度不不变（MSI-H）实体瘤，其鳞状非幼细胞肺癌和宽泛期幼细胞肺癌两项适应症的上市注册申请也在审评中。公司亦同步就12个产品、10个免疫结合医治规划在全球领域内发展20多项临床试验，对表授权全面覆盖欧美主流生物药市场和多多新兴市场。
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.
