值得关注的是，诺诚健华此次和Zenas就三款自免管线达成授权许可合作，其中奥布替尼治疗进展型多 发性硬化（MS）进入全球III期临床开发。据公司2024年年报，奥布替尼去年实现收入10.00亿元，同比 增长49.14%。此外，资料显示，Zenas于去年9月在纳斯达克证券交易所挂牌上市，当前总市值约11亿美 元，聚焦自身免疫性疾病领域，现有产品均处于临床阶段。 诺诚健华(09969)再挫逾8%，该股昨日大跌超11%。截至发稿，跌8.84%，报15.15港元，成交额4.35亿港 元。 消息面上，诺诚健华日前公告称，全资子公司InnoCare Pharma Inc.（简称"公司"）与Zenas BioPharma, Inc.（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。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，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。 ...

消息面上，诺诚健华日前公告称，全资子公司InnoCare Pharma Inc.（简称"公司"）与Zenas BioPharma, Inc.（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。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，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。 智通财经APP获悉，诺诚健华(09969)再挫逾8%，该股昨日大跌超11%。截至发稿，跌8.84%，报15.15港 元，成交额4.35亿港元。 值得关注的是，诺诚健华此次和Zenas就三款自免管线达成授权许可合作，其中奥布替尼治疗进展型多 发性硬化（MS）进入全球III期临床开发。据公司2024年年报，奥布替尼去年实现收入10.00亿元，同比 增长49.14%。此外，资料显示，Zenas于去年9月在纳斯达克证券交易所挂牌上市，当前总市值约11亿美 元，聚焦自身免疫性疾病领域，现有产品均处于临床阶段。 ...

Core Viewpoint - The innovative drug concept has seen a significant surge in the market, with several companies experiencing notable stock price increases [1] Group 1: Company Performance - Changchun High-tech has risen over 8% [1] - Xinghao Pharmaceutical and Wanbangde have both increased by over 5% [1] - Other companies such as Tibet Pharmaceutical, Rongchang Bio, Xinlitai, Guangsheng Tang, and Nuocheng Jianhua have also shown upward movement in their stock prices [1]

Core Viewpoint - The Hong Kong pharmaceutical sector experienced a significant decline on October 9, with the Hang Seng Biotechnology Index dropping over 5%, influenced by external factors such as U.S. tariff announcements on pharmaceutical products [1][3]. Group 1: Market Performance - The Hang Seng Hong Kong Stock Connect Innovative Drug ETF (520880) saw a decline of over 1% after initially opening up 1.75% [1]. - The Hang Seng Hong Kong Stock Connect Innovative Drug Selective Index fell to a low of 6.14%, with major stocks like Innovent Biologics and China Biologic Products dropping over 10% and 7% respectively [1]. - During the previous week (September 29 - October 3), the index had gained 6.54%, reflecting a positive trend before the recent downturn [1]. Group 2: External Influences - On September 25, U.S. President Trump announced a 100% tariff on any brand or patented pharmaceutical products starting October 1, 2025, unless companies establish manufacturing facilities in the U.S. [1][3]. - This announcement is expected to directly impact Chinese innovative pharmaceutical companies that rely heavily on the U.S. market and do not have manufacturing plants in the U.S. [3]. Group 3: Future Outlook - Analysts from Southwest Securities predict that companies with high dependence on the U.S. market will face short-term pressure, while those utilizing business development (BD) strategies for international expansion will be less affected [3]. - Upcoming industry conferences, such as ESMO (October 17-21) and ASH (December), are anticipated to serve as catalysts for the innovative drug sector [3]. - The fund manager of the Hong Kong Stock Connect Innovative Drug ETF noted that the current market adjustment may provide a buying opportunity for high-quality innovative drug companies [3]. Group 4: ETF Characteristics - The Hong Kong Stock Connect Innovative Drug ETF (520880) is the first ETF tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Selective Index, focusing exclusively on innovative drug research and development companies [4]. - The ETF has shown a year-to-date increase of 119.75%, outperforming other innovative drug indices, and aims to avoid the influence of contract research organizations (CROs) on its performance [5].

Core Viewpoint - The recent licensing agreement between Nuo Cheng Jian Hua and Zenas has led to a significant market reaction, with Nuo Cheng Jian Hua's stock dropping while Zenas's stock surged, indicating a divergence in market sentiment regarding the deal's value and potential [1][2]. Summary by Sections Licensing Agreement Details - Nuo Cheng Jian Hua has licensed its BTK inhibitor, Oubutini, for multiple sclerosis and other autoimmune diseases to Zenas, receiving an upfront payment of $100 million, milestone payments, and 7 million shares of Zenas stock, with a total potential deal value exceeding $2 billion [1][2]. - The upfront payment and stock value combined amount to $280 million, which is considered reasonable compared to industry standards, where the average upfront payment ratio is around 8% [3]. Market Reaction and Sentiment - The market's cautious sentiment towards the deal stems from two main concerns: the upfront payment not meeting expectations and the perceived lack of recognition of Zenas as a partner [2][5]. - Nuo Cheng Jian Hua's stock fell by 6.24% in A-shares and 11.64% in Hong Kong shares, while Zenas's stock rose by 24.22% following the announcement [1]. Strategic Considerations - Nuo Cheng Jian Hua had previously engaged with multinational corporations (MNCs) but ultimately chose Zenas due to smoother communication and Zenas's strong clinical development capabilities, particularly in the field of multiple sclerosis [5][10]. - Zenas, founded in 2019 and listed on NASDAQ in 2024, currently has no commercial products but has a promising pipeline, including a dual-function monoclonal antibody that complements Oubutini [7][8]. Industry Context - The collaboration reflects a shift in the global innovation drug landscape from one-time licensing deals to deeper collaborative models, where local pharmaceutical companies can retain equity in new ventures [12]. - Nuo Cheng Jian Hua's previous partnership with Biogen ended after about 18 months, highlighting the challenges in securing long-term collaborations in the industry [11]. Future Outlook - The partnership aims to advance the development of Oubutini in treating primary and secondary progressive multiple sclerosis, with significant market opportunities projected in the U.S. alone [8]. - The success of this collaboration will depend on Zenas's ability to progress its pipeline and the overall market performance of its shares [12].

Summary of the Conference Call for 诺诚健华 (Nocera Biopharma) Company Overview - **Company**: 诺诚健华 (Nocera Biopharma) - **Partner**: Xenios BioPharma - **Industry**: Biopharmaceuticals, focusing on autoimmune diseases and central nervous system disorders Key Points and Arguments Strategic Partnership - 诺诚健华 has entered a significant global licensing agreement with Xenios BioPharma, covering the global rights for 奥布替尼 (Obutinin) in multiple sclerosis (MS) and two preclinical drugs outside Greater China and Southeast Asia, with a total potential deal value exceeding $2 billion [2][3][5] - The deal includes an upfront payment of $100 million, milestone payments, and approximately $180 million worth of 7 million shares of Zyno common stock, totaling $280 million in upfront and near-term milestone payments [2][5] - 诺诚健华 will receive royalties of up to 17% to 19% on net product sales [2][5] Rationale for Partnership - The choice of Xenios BioPharma was based on its clinical development experience in autoimmune diseases, its Nasdaq listing, and strong execution capabilities, which are expected to maximize the global development potential of 奥布替尼 and other assets [2][6] - The partnership is expected to accelerate the clinical development of 奥布替尼 and other products in the global market, supporting 诺诚健华's internationalization efforts and enhancing long-term value through equity exchange [2][8] Development Stage and Future Plans - 诺诚健华 is entering a 2.0 development phase, focusing more on internationalization, commercialization, and differentiated product development, with plans to strengthen these capabilities through flexible business models and partnerships with international companies [4][11] - The company has over 10 products in various stages of development and aims to increase revenue through business development (BD) partnerships, with a focus on internationalization over the next three years [11][12] Clinical Development and Market Potential - 奥布替尼's global oncology rights remain with 诺诚健华, which is expanding into tumor indications and plans to submit applications in countries like Australia and Canada [13] - The company is also advancing clinical studies for ITP and SLE, which are particularly relevant in Asian populations [13] - The partnership with Xenios is expected to enhance the success potential of 奥布替尼 in global Phase III clinical trials and facilitate expansion into more autoimmune disease areas [8] Financial Implications - The cash component of the deal includes the $100 million upfront payment and milestone payments, with the stock component being part of the transaction price [16] - The transaction is anticipated to have a positive impact on the company's revenue and asset profit and loss statements [16] Additional Insights - The 7 million shares of Zyno common stock were issued at a nominal value of $0.001 per share, resulting in a minimal cost of approximately $700 [10] - The partnership with Zenith for 奥布替尼 development is based on their strong clinical development capabilities and successful track record in the autoimmune disease sector [8][12] - The collaboration is expected to create synergies and enhance the execution capabilities of both companies [12][18] Market Competition - Genesys is developing a dual antibody for MS, which may have a differentiated profile compared to 奥布替尼, but 诺诚健华 believes its Aurora kinase B inhibitor has higher success rates and market potential in treating MS [18] Conclusion The partnership between 诺诚健华 and Xenios BioPharma represents a strategic move to enhance the development and commercialization of innovative therapies in the autoimmune disease space, with significant financial implications and a focus on international growth. The collaboration is expected to leverage both companies' strengths to maximize the potential of their product pipelines.

Core Viewpoint - The company, Innovent Biologics, announced a licensing agreement with Zenas for its core product, Orelabrutinib, in the field of multiple sclerosis and other non-oncological indications, marking its second business development (BD) deal of the year [1][2] Group 1: Licensing Agreement Details - Innovent's subsidiary, InnoCare, will receive up to $100 million in upfront and milestone payments from Zenas, along with 7 million shares of Zenas common stock, with the total potential deal value exceeding $2 billion [1][2] - The agreement allows Zenas to develop and commercialize Orelabrutinib globally for multiple sclerosis and other non-cancer treatments, while Innovent retains exclusive rights for oncology indications [2][4] Group 2: Product Pipeline and Market Potential - Orelabrutinib is currently approved for three indications in hematological malignancies in China and has initiated Phase III trials for primary progressive multiple sclerosis (PPMS) [2][5] - The new oral IL-17AA/AF inhibitor and the brain-penetrant oral TYK2 inhibitor are in preclinical stages, targeting autoimmune diseases, aligning with Zenas's focus [3][6] - The market for multiple sclerosis treatments is significant, especially in Europe and North America, where there is a high unmet clinical need for PPMS therapies [5][6] Group 3: Financial Position and Industry Context - As of June 30, 2025, Innovent holds approximately 7.68 billion yuan in cash and equivalents, indicating a strong financial position to support ongoing and future developments [6] - The global landscape for business development in the pharmaceutical industry is shifting, with increased collaboration opportunities between Chinese companies and foreign firms [5]

Core Viewpoint - The domestic innovative drug company, Nuo Cheng Jian Hua, has re-entered the international market with its BTK inhibitor, Obexelimab, through a licensing agreement with Nasdaq-listed Zenas, with a total transaction value exceeding $2 billion [1][2]. Group 1: Licensing Agreement Details - Nuo Cheng Jian Hua has signed a licensing agreement with Zenas, granting exclusive global rights for Obexelimab in multiple sclerosis (MS) and other indications outside Greater China and Southeast Asia [1]. - The agreement includes an upfront payment of $100 million and milestone payments, along with 7 million shares of common stock from Zenas, representing approximately 9.3% of Zenas' issued and outstanding shares [1][2]. - Zenas plans to initiate a Phase 3 study for secondary progressive MS (SPMS) in Q1 2026 and advance the IL-17 and TYK2 inhibitors into clinical stages in 2026 [2]. Group 2: Market Potential and Product Pipeline - The commercial opportunity for SPMS and primary progressive MS (PPMS) in the U.S. is estimated to exceed $12 billion, with SPMS and PPMS accounting for 20% and 10-15% of all MS subtypes, respectively [4]. - Obexelimab is a key product for Nuo Cheng Jian Hua, which has already been approved in China for various hematological malignancies since December 2020 [3][4]. Group 3: Strategic Considerations - Nuo Cheng Jian Hua's choice of Zenas as a partner was influenced by Zenas' clinical development capabilities in the autoimmune field and the successful entrepreneurial background of Zenas' founder, Lonnie Moulder [5][6]. - The collaboration is expected to facilitate the rapid advancement of Obexelimab and other products into international markets, leveraging Zenas' resources and influence [6][7]. Group 4: Financial Performance - In the first half of 2025, Nuo Cheng Jian Hua reported revenue of 731 million yuan, a year-on-year increase of 74.26%, with Obexelimab sales reaching 637 million yuan, up 52.84% [8]. - The company had a cash and cash equivalents balance of 4.701 billion yuan as of mid-2025 [9].

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 截至月份: 2025年9月30日 狀態: 新提交 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 FF301 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 | 第 2 ...

Core Insights - The company, Nuo Cheng Jian Hua, announced a record-breaking over $2 billion external licensing collaboration in the field of autoimmune diseases, marking a significant milestone in China's small molecule licensing history [1][2] Group 1: Licensing Agreement Details - The agreement involves core product Aobutini and two other preclinical small molecules, with Zenas, a US pharmaceutical company, as the partner [1] - Nuo Cheng Jian Hua will receive an upfront payment of $100 million and milestone payments, including those expected to be achieved by 2026, totaling over $2 billion [1] - Zenas will issue 7 million shares of common stock to Nuo Cheng Jian Hua, valued at approximately $181 million based on Zenas' closing price of $25.9 per share on October 8 [1] Group 2: Product Rights and Clinical Trials - Nuo Cheng Jian Hua retains exclusive global rights for Aobutini in oncology while granting Zenas exclusive rights for the development, production, and commercialization of Aobutini in multiple sclerosis and non-oncology areas outside Greater China and Southeast Asia [2] - The company has initiated a Phase III clinical trial for Aobutini targeting primary progressive multiple sclerosis in Q3 2025, with plans to start a trial for secondary progressive multiple sclerosis in Q1 2026 [2] Group 3: Strategic Importance and Market Reaction - This collaboration is the second international deal for Nuo Cheng Jian Hua in 2025, following a $500 million agreement with Kangnuo Ya in January [3] - The company views this licensing deal as a crucial step in its internationalization strategy, aiming to achieve the internationalization of three to four products in the next three to five years [3] - Despite the record transaction amount, the market reacted negatively, with Nuo Cheng Jian Hua's stock price dropping nearly 7% in A-shares and over 11% in Hong Kong shares on October 9 [3]