Core Insights - The company announced a licensing agreement with Zenas BioPharma, granting Zenas rights to develop, produce, and commercialize the product Orelabrutinib and two preclinical assets [1][2] Group 1: Licensing Agreement Details - The agreement includes exclusive global rights for Orelabrutinib in multiple sclerosis (MS) and exclusive rights in other non-MS and non-cancer indications outside Greater China and Southeast Asia [1] - The agreement also covers a preclinical IL-17 inhibitor and a preclinical oral TYK2 inhibitor, with exclusive rights outside Greater China and Southeast Asia for the former and global exclusive rights for the latter [1] Group 2: Financial Terms - Zenas will pay the company a $100 million upfront payment and milestone payments, including cash expected upon achieving milestones in 2026, along with 7 million shares of common stock [2] - The total potential payments from this transaction, including upfront, milestone, and commercial payments, could exceed $2 billion [2] - The company is entitled to receive tiered royalties of up to the high teens percentage based on the annual net sales of the licensed products [2]

Core Insights - 诺诚健华 and Zenas BioPharma have entered into a significant licensing agreement, granting Zenas global development and commercialization rights for 奥布替尼 in multiple sclerosis and other non-oncology indications outside Greater China and Southeast Asia [1][2] - The total transaction value exceeds $2 billion, including an upfront payment of up to $100 million, milestone payments, and the issuance of 7 million shares of Zenas common stock [1][2] - 奥布替尼 is a potential best-in-class oral BTK inhibitor with strong CNS penetration, aimed at addressing challenges in the progression of multiple sclerosis [2][3] Company Developments - Zenas will initiate a Phase III clinical trial for 奥布替尼 in primary progressive multiple sclerosis (PPMS) in Q1 2026, following a successful Phase II trial that demonstrated significant efficacy [2][3] - The collaboration is seen as a crucial milestone for 诺诚健华 in its globalization efforts, with expectations of enhancing the clinical and commercial value of 奥布替尼 [3][4] - Zenas aims to advance two additional preclinical molecules, a novel oral IL-17AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor, into clinical development by 2026 [1][4] Market Potential - 奥布替尼 has shown promising clinical data, significantly reducing the number of new lesions in patients with relapsing-remitting multiple sclerosis (RRMS) [3][4] - The strategic partnership is expected to accelerate the clinical development of 奥布替尼 and maximize its market potential, particularly in the underserved areas of PPMS and secondary progressive multiple sclerosis (SPMS) [3][4] - Zenas is positioned to become a global, integrated biopharmaceutical company focused on the development and commercialization of treatments for autoimmune diseases, leveraging its collaboration with 诺诚健华 [3][4]

Core Insights - Orelabrutinib is a potential best-in-class oral small molecule BTK inhibitor with strong CNS penetration, currently in global Phase III clinical development for progressive forms of multiple sclerosis (MS) [1][2][3] - A Phase III trial for primary progressive MS (PPMS) has been initiated, while a trial for secondary progressive MS (SPMS) is expected to start in Q1 2026 [1][2][6] - Zenas BioPharma has entered a significant licensing agreement with InnoCare Pharma, acquiring global rights for Orelabrutinib in MS and other non-oncological indications outside Greater China and Southeast Asia [1][11] Clinical Development - The Phase III trial for PPMS is a global, multicenter, randomized, double-blind, placebo-controlled study assessing the safety and efficacy of Orelabrutinib at a daily dose of 80 mg [2][6] - The SPMS Phase III trial is also designed as a global, multicenter, randomized, double-blind, placebo-controlled study, expected to start in Q1 2026 [6][14] - Previous Phase II trials demonstrated significant reductions in Gd+ T1 MRI brain lesions at 12 and 24 weeks, with sustained effects up to 96 weeks [2][4] Strategic Collaboration - The collaboration between InnoCare and Zenas is seen as a milestone in global development, enhancing the clinical and commercial value of Orelabrutinib [3][4] - Zenas aims to leverage this partnership to advance its pipeline, including two additional preclinical molecules: a novel oral IL-17AA/AF inhibitor and a CNS-penetrant oral TYK2 inhibitor, both expected to enter clinical trials in 2026 [3][7][8] Financial Terms - Under the licensing agreement, Zenas will pay InnoCare up to $100 million in upfront and milestone payments, with total transaction value exceeding $2 billion [11] - Zenas will also issue 7 million shares of common stock to InnoCare, along with tiered royalties based on annual net sales of the licensed products [11] Company Profiles - InnoCare Pharma is a biopharmaceutical company focused on innovative drug development for oncology and autoimmune diseases, with a strong pipeline of products at various stages [16] - Zenas BioPharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for autoimmune diseases, with a focus on Orelabrutinib and Obexelimab [17][18]

智通财经APP讯，诺诚健华(688428.SH)发布公告，公司全资子公司InnoCare Pharma Inc.与 ZenasBioPharma, Inc.(以下简称"Zenas")签署授权许可协议，将具有自主知识产权的产品奥布替尼及2项 临床前资产有偿许可给Zenas，使其可以开发、生产、商业化或以其他方式利用该等产品。 此次交易金额：Zenas将向公司支付1亿美元的首付款和近期里程碑付款，包括预计在2026年实现里程碑 时支付的现金，以及授予公司700万普通股股票，包括预计在2026年初实现里程碑时发行的股票。本次 交易首付款及近期里程碑付款，潜在的研发及注册里程碑付款，以及潜在的商业化里程碑付款总额合计 超过 20 亿美元。此外，本公司有权按许可产品年度净销售额收取最高达高百分之十几的分层特许权使 用费。 ...

此次交易金额：Zenas将向公司支付1亿美元的首付款和近期里程碑付款，包括预计在2026年实现里程碑 时支付的现金，以及授予公司700万普通股股票，包括预计在2026年初实现里程碑时发行的股票。本次 交易首付款及近期里程碑付款，潜在的研发及注册里程碑付款，以及潜在的商业化里程碑付款总额合计 超过20亿美元。此外，本公司有权按许可产品年度净销售额收取最高达高百分之十几的分层特许权使用 费。 诺诚健华(688428.SH)发布公告，公司全资子公司InnoCare Pharma Inc.与ZenasBioPharma,Inc.(以下简 称"Zenas")签署授权许可协议，将具有自主知识产权的产品奥布替尼及2项临床前资产有偿许可给 Zenas，使其可以开发、生产、商业化或以其他方式利用该等产品。 ...

Core Viewpoint - InnoCare Pharma Inc., a wholly-owned subsidiary of Innovent Biologics, has signed a licensing agreement with Zenas BioPharma, allowing Zenas to develop, produce, and commercialize the product Orelabrutinib and two preclinical assets, which is expected to accelerate the global development and commercialization of these products [1] Group 1: Licensing Agreement Details - The agreement includes an upfront payment of $100 million and 7 million shares of common stock, with potential milestone payments exceeding $2 billion [1] - The company is entitled to receive tiered royalties of up to a high double-digit percentage based on the annual net sales of the licensed products [1] - The agreement is effective from the date of signing and will last until the expiration of the sales license for the licensed products [1] Group 2: Product Information - Orelabrutinib (also known as Ibrutinib) is a late-stage clinical product that is a highly CNS-penetrant, selective, irreversible oral small molecule BTK inhibitor with potential best-in-class advantages [1] - The licensing agreement is expected to have a positive impact on the company's future performance [1]

Core Viewpoint - InnoCare Pharma Inc. has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, granting Zenas rights to develop, manufacture, and commercialize certain products, including the BTK inhibitor Orelabrutinib for multiple sclerosis and other preclinical assets [1][2]. Group 1: Licensing Agreement Details - The agreement allows Zenas exclusive rights to develop and commercialize Orelabrutinib for multiple sclerosis globally, while InnoCare retains rights in oncology and certain regions for non-oncology applications [1]. - Zenas will pay InnoCare up to $100 million in upfront and milestone payments, along with issuing up to 7 million shares of Zenas common stock [2]. - The total potential value of the transaction exceeds $2 billion, including tiered royalties based on annual net sales of the licensed products [2]. Group 2: Product Development and Clinical Trials - Orelabrutinib is a late-stage clinical candidate with potential best-in-class advantages, currently undergoing Phase III trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [3]. - InnoCare has completed patient enrollment for a Phase III trial for immune thrombocytopenia (ITP) and plans to submit a new drug application in mid-2026 [3]. - Zenas aims to lead in the development and commercialization of transformative therapies for autoimmune diseases, leveraging an experienced leadership team and a robust product pipeline [3].

Core Viewpoint - InnoCare Pharma Inc. has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, granting Zenas rights to develop, manufacture, and commercialize certain products, including the BTK inhibitor Orelabrutinib for multiple sclerosis and other indications outside of oncology in specified regions [1][2]. Group 1: Licensing Agreement Details - The agreement includes an upfront payment of up to $100 million and milestone payments, with a potential total value exceeding $2 billion [2]. - Zenas will also issue up to 7 million shares of common stock to InnoCare, contingent upon reaching specific milestones [2]. - InnoCare retains full rights in the oncology field globally and non-oncology rights in Greater China and Southeast Asia [1]. Group 2: Product Development and Clinical Trials - Orelabrutinib is a late-stage, orally administered BTK inhibitor with potential best-in-class advantages, currently in Phase III trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [3]. - The Phase III trial for PPMS is set to start in Q3 2025, with the SPMS trial expected to begin in Q1 2026 [3]. - InnoCare has completed patient enrollment for a Phase III trial targeting immune thrombocytopenia (ITP) in China and plans to submit a new drug application in H1 2026 [3].

Core Viewpoint - InnoCare Pharma Inc., a wholly-owned subsidiary of the company, has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, Inc. for the development, production, and commercialization of certain products, including the BTK inhibitor, Orelabrutinib, in multiple sclerosis and other indications [1][2] Group 1 - The licensing agreement grants Zenas exclusive rights to develop, produce, and commercialize Orelabrutinib in the global multiple sclerosis field and in non-oncology indications outside Greater China and Southeast Asia [1] - The company retains full rights in the global oncology field and rights in non-oncology indications within Greater China and Southeast Asia [1] - The agreement also covers two preclinical assets, with one being an oral IL-17AA/AF inhibitor and the other an oral brain-penetrant TYK2 inhibitor, with specific regional rights outlined [1] Group 2 - Zenas will pay InnoCare up to $100 million in upfront and milestone payments, including expected milestones to be reached by 2026, and will issue up to 7 million shares of Zenas common stock [2] - The total potential value of the transaction exceeds $2 billion, including development, regulatory, and commercial milestone payments [2] - The company is entitled to receive tiered royalties of up to the high teens percentage on the annual net sales of the licensed products [2]

市场有风险，投资需谨慎。本文不构成个人投资建议，也未考虑到个别用户特殊的投资目标、财务状况或需要。用户应考虑本文中的任何 意见、观点或结论是否符合其特定状况。据此投资，责任自负。 风险提示及免责条款 诺诚健华公告称，公司全资子公司InnoCarePharmaInc.与ZenasBioPharma,Inc.签署授权许可协议，将具有 自主知识产权的产品奥布替尼及2项临床前资产有偿许可给Zenas，使其可以开发、生产、商业化或以其 他方式利用该等产品。交易金额包括1亿美元首付款和700万普通股股票，以及潜在的研发及注册里程碑 付款，总额超过20亿美元。协议自双方签订之日起生效，持续到所许可产品的销售特许权期限结束为 止。该协议预计将加快奥布替尼及其他管线产品在全球范围内的开发和商业化进程，对公司未来业绩产 生积极影响。奥布替尼（宜诺凯®）为一款处于后期临床阶段、具有潜在同类最佳优势的高中枢神经系 统渗透性、选择性、不可逆口服小分子BTK抑制剂。 ...