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].

诺诚健华(09969)发布公告，本公司于美国注册成立的全资附属公司InnoCare Pharma Inc.(InnoCare)已就 奥布替尼及另外两项临床前资产(统称"许可产品")的开发、生产及商业化与Zenas BioPharma,Inc.(Zenas; 纳斯达克代码：ZBIO)订立独占许可协议及认购协议。 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。在多发性硬化症(MS)领域，InnoCare已于2025年第三季度启动针对 原发进展型多发性硬化症(PPMS)的III期临床试验，并预计于2026年第一季度启动继发进展型多发性硬 化症(SPMS)的III期临床试验。上述III期PPMS及SPMS临床试验方案已获得美国FDA及欧洲EMA的指导 意见并达成共识。在其他自身免疫疾病领域，其在中国针对免疫性血小板减少症(ITP)的III期注册性试 验已完成患者入组，计划于2026年上半年提交新药上市申请;针对系统性红斑狼疮(SLE)的IIb期试验正在 进行中，预计于2025年第四季度获得顶线数据。 Zenas是一家处于临床阶段的全球生物 ...

根据许可协议条款，公司已授予Zenas独占许可，用以开发、生产及商业化：(i)奥布替尼(一款BTK抑制 剂)在全球多发性硬化症领域("多发性硬化症领域")的应用，以及在大中华地区(包括中国大陆、香港、 澳门及台湾)和东南亚地区以外所有区域非肿瘤领域的应用。公司保留全球肿瘤领域的完整权利以及在 大中华地区和东南亚地区非肿瘤领域的权利；及(ii)首项临床前资产(一款口服IL-17AA/AF抑制剂)在大 中华地区及东南亚地区以外所有区域的应用，以及第二项临床前资产(一款口服透脑的TYK2抑制剂)在 全球的应用。 根据许可协议，Zenas将向Inno Care支付达1亿美元现金的首付款及近期里程碑付款，其中包括预期在 2026年达到的里程碑，以及向Inno Care发行达7,000,000股Zenas普通股，其中包括预期在2026年初达到 里程碑时可予发行的股份。包括开发、监管和商业里程碑付款在内，本次交易潜在总价值超过20亿美 元。此外，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。 Zenas是一家处于临床阶段的全球生物制药公司，致力于成为自身免疫疾病领域变革性疗法开发与商业 化的领导者 ...

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。 ...

| A | 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2025-036 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于子公司与 Zenas BioPharma, Inc.签署 授权许可协议的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 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。 1 协议生效条件及履行期限：许可协议自双方签订之日起生效。除非根据合同 约定提前终止（而若提前终止，在终止范围内的所有知识产权及许可将返还公司）， 该协议将持续到所 ...

Core Insights - Zenas BioPharma has entered a transformative license agreement with InnoCare Pharma for the global development and commercialization rights to orelabrutinib, a highly selective oral BTK inhibitor for Multiple Sclerosis (MS) [1][4][12] - Orelabrutinib is currently in Phase 3 trials for Primary Progressive MS (PPMS) and is expected to begin trials for Secondary Progressive MS (SPMS) in Q1 2026 [2][21] - Zenas has also secured rights to two additional promising molecules: an oral IL-17AA/AF inhibitor and a TYK2 inhibitor, both expected to enter Phase 1 trials in 2026 [1][4][9] Company Developments - Zenas announced a private placement financing of approximately $120 million to support its operations and clinical development [1][13][16] - The license agreement includes upfront and milestone payments to InnoCare totaling up to $100 million in cash and up to 7 million shares of Zenas common stock, with total potential payments exceeding $2 billion [10][11] - Zenas aims to leverage this collaboration to enhance its position as a fully integrated biopharmaceutical company focused on autoimmune diseases [4][5] Clinical Trials and Pipeline - The Phase 3 trial for PPMS has been initiated, while the SPMS trial is set to start in early 2026 [2][21] - Orelabrutinib has shown significant efficacy in previous Phase 2 trials for Relapsing-Remitting MS (RRMS), demonstrating sustained reductions in inflammatory activity [3][21] - Zenas is also advancing obexelimab, which is concluding Phase 3 development for IgG4-RD, and expects to report key trial results in late 2025 and early 2026 [6][8] Market Potential - Orelabrutinib is positioned as a potential blockbuster treatment for progressive forms of MS, addressing a significant unmet medical need [4][5] - The collaboration with InnoCare is expected to enhance Zenas's capabilities in drug development and commercialization, particularly in the global market for autoimmune therapeutics [5][6] Financial Overview - The private placement is expected to provide sufficient funds to support Zenas's operations into Q4 2026, with additional potential funding from milestone payments [16][14] - Zenas's strategic focus on developing a balanced portfolio of therapies aims to maximize clinical and commercial potential across multiple therapeutic areas [6][10]