| 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]

公告显示，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，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。 北京商报讯（记者 丁宁）10月8日晚间，诺诚健华（688428）发布公告称，公司的全资子公司InnoCare Pharma Inc.与Zenas BioPharma, 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。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 （股份代號：9969） 內幕消息公告 與ZENAS BIOPHARMA達成全球戰略合作及許可協議 本公告乃由諾誠健華醫藥有限公司（「本公司」）根據香港聯合交易所有限公司 證券上市規則（「上市規則」）第13.09(2)(a)條及證券及期貨條例（香港法例第571章） 第XIVA部項下之內幕消息條文（定義見上市規則）而作出。 本公司董事會（「董事會」）欣然宣佈，本公司於美國註冊成立的全資附屬公司 InnoCare Pharma Inc. （「InnoCare」）已就奧布替尼及另外兩項臨床前資產（統稱「許 可產品」）的開發、生產及商業化與Zenas BioPharma, Inc.（「Zenas」；納斯達克代 碼：ZBIO）訂立獨佔許可協議及認購協議（單獨稱為「許可協議」及「認購協議」， 合稱為「協議」）。 – 1 – 根據許可協議條款，本公司已授予Zenas獨佔許可，用以開發、生產及商業化： InnoCare ...

Core Insights - InnoCare Pharma Inc., a wholly-owned subsidiary of Innovent Biologics, signed a licensing agreement with Zenas BioPharma, granting Zenas rights to multiple products including Orelabrutinib, with a total deal value exceeding $2 billion [1] Group 1: Financial Terms - Zenas will pay an upfront fee of $100 million and make milestone payments, along with granting 7 million shares of common stock [1] - The agreement includes royalties based on net sales, which could provide additional revenue for the company [1] Group 2: Strategic Implications - The licensing agreement is expected to accelerate the global development and commercialization of the products involved [1] - The deal is anticipated to positively impact future performance, enhancing the company's market position [1] Group 3: Risks and Considerations - The high risk and long cycle associated with new drug development remain a concern [1] - Payment amounts are conditional, introducing uncertainty into the financial projections for the company [1]

致：香港交易及結算所有限公司 公司名稱: 諾誠健華醫藥有限公司（於開曼群島註冊成立的有限公司） 呈交日期: 2025年10月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 202 ...

"每一款创新药的诞生，都极其不容易。"诺诚健华企业传播执行总监陆春华一语道破创新医药行业 的"残酷"。近日，新京报贝壳财经记者走进北京诺诚健华医药科技有限公司，了解创新药的研发情况。 陆春华表示，创新药从靶点发现到上市销售，平均耗时10年、烧掉10亿美元，成功率却不足10%。陆春 华告诉记者："这几年，中国的创新药已经成为世界创新的名片，创新药是新质生产力的典型代表。" ...

Core Viewpoint - The event "Innovation Source, Health Navigation" highlights Beijing's strategic focus on the pharmaceutical and health sectors, showcasing the city's efforts to drive high-quality economic development through innovation and clinical needs [1][3][19]. Group 1: Event Overview - The event was organized by the Beijing Municipal Cyberspace Administration and featured a visit to various innovative pharmaceutical companies and research centers [1][2]. - The media delegation explored the complete path of innovative drugs from target discovery to clinical approval, emphasizing the importance of clinical needs and policy support in driving pharmaceutical innovation [2][3]. Group 2: Industry Development - The Zhongguancun Life Science Park has become a hub for innovation in China's life sciences, housing over 1,000 innovative pharmaceutical companies and several national-level research institutions [3][4]. - The park includes significant medical facilities with over 3,000 beds, supporting clinical research and the development of innovative drugs and medical devices [3]. Group 3: Company Highlights - Wantaibio invests over 1 billion yuan annually in R&D, with over 30% of its workforce dedicated to research, resulting in hundreds of innovative products, including six global firsts [12]. - Huahui Anjian focuses on developing competitive innovative drugs in virology and oncology, with several drugs in different clinical development stages, including a breakthrough therapy for hepatitis B [14]. - Nuo Cheng Jian Hua has over ten innovative drugs in clinical stages, with significant trials ongoing in China and globally, including a BTK inhibitor and a humanized monoclonal antibody [16][18]. Group 4: Innovation Ecosystem - The event emphasized the importance of a supportive research policy and industrial ecosystem in Beijing, which provides fertile ground for the growth of innovative pharmaceutical companies [19]. - The ongoing monthly thematic visits aim to promote the achievements of high-quality economic development in Beijing, focusing on key sectors such as advanced manufacturing and biomedicine [19].

每经AI快讯，9月30日，港股诺诚健华(09969.HK)涨超6%，截至发稿，涨6.55%，报18.87港元，成交额 1.15亿港元。 ...

Core Viewpoint - Nuo Cheng Jian Hua (09969) has seen a stock increase of over 6%, currently up 6.55% at HKD 18.87, with a trading volume of HKD 115 million [1] Company Developments - The company announced that its CD19 monoclonal antibody, Tafa-sitamab, has received its first prescriptions in multiple hospitals across various provinces in China, marking its official entry into clinical application [1] - Tafa-sitamab is the first and only CD19 monoclonal antibody approved globally for the treatment of lymphoma, and it is also the first approved CD19 monoclonal antibody for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in China [1] - This development fills a gap in CD19 targeted therapy in China and is expected to provide better treatment options for DLBCL patients [1]