表格類別： 股票 狀態： 新提交 FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 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10日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | 事件 | | 已發行股份（不包 ...

Group 1 - Tibet Pharmaceutical's Zolbetuximab has been officially commercialized in the first half of this year, focusing on advanced non-small cell lung cancer with CNS metastasis [1] - The product is the first EGFR TKI designed to penetrate the blood-brain barrier, achieving 100% permeability [1] - The company is preparing for medical insurance negotiations, but the expected revenue impact for this year is minimal [1] Group 2 - Jianerkang emphasizes the importance of accounts receivable management, with dedicated sales personnel responsible for tracking and collecting payments [2] - Performance evaluations for sales staff are strictly linked to payment collection [2] - The company has a risk control specialist who organizes monthly meetings to establish collection plans and follow up on key accounts [2] Group 3 - Tonghua Dongbao has completed the first patient dosing in the Phase II clinical trial for THDBH120, showing good safety and efficacy trends [3] - The company's insulin formulation is still in preclinical research, with future updates to be disclosed as per regulations [3] Group 4 - XinNuoWei is planning to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and competitiveness [4] - The board has approved the proposal to seek shareholder authorization for the overseas listing [4] Group 5 - Bailitiheng has received clinical trial approval for its innovative drug BL-ARC001, aimed at treating advanced solid tumors [5] - BL-ARC001 is the company's first class I innovative drug in the antibody-radiolabeled conjugate field, with potential first-in-class status [5] - The drug is expected to offer better specificity and tumor accumulation compared to traditional radiolabeled drugs [5] Group 6 - Nocare and Zenas have reached a licensing agreement for three autoimmune pipeline products, with a potential total transaction value exceeding $2 billion [6][7] - Zenas will pay up to $100 million in upfront and milestone payments, along with issuing shares to Nocare [7] - Nocare retains global rights for the oncology application of the licensed products while granting Zenas exclusive rights in specific regions [7]

Core Viewpoint - The collaboration between domestic biotech company InnoCare (诺诚健华) and US-based Zenas BioPharma is a significant licensing deal, valued at over $2 billion, aimed at advancing InnoCare's autoimmune pipeline products internationally, particularly the core product Obexelimab [1][8]. Group 1: Financial Aspects - The total deal value exceeds $2 billion, including an upfront payment and near-term payments totaling approximately $294 million, which consists of $100 million in cash and 7 million shares of Zenas stock valued at around $194 million [8][10]. - InnoCare is also entitled to receive additional milestone payments based on clinical development, registration, and commercialization achievements, with potential royalties on net sales reaching up to 19% [8][10]. Group 2: Strategic Rationale - InnoCare chose Zenas due to its strong alignment in the autoimmune disease space, particularly in multiple sclerosis, which complements the development of Obexelimab [3][4]. - Zenas's leadership, particularly CEO Lonnie Moulder, brings extensive experience in clinical development and commercialization, enhancing the potential for successful international product development [5][6]. - The collaboration is seen as a strong partnership that could significantly increase the chances of success for Obexelimab in global Phase III clinical trials and expand its application to more autoimmune indications [4][5]. Group 3: Market Reception - Analysts from Goldman Sachs have maintained a "Buy" rating for InnoCare, raising the price targets for its Hong Kong and A-shares by 21.7% and 54.6%, respectively, indicating strong market confidence in the deal [2][1]. - Zenas has received a "Strong Buy" rating from Wall Street analysts, with an average target price of $33.25, reflecting positive sentiment regarding its potential in the autoimmune sector [6][7]. Group 4: Industry Impact - This licensing agreement sets a new record for external licensing in China's autoimmune sector, showcasing InnoCare's ability to attract international partnerships and recognition for its innovative drug pipeline [8][12]. - The successful international collaboration is viewed as a testament to the growing strength of Chinese biotech firms in the global market, enhancing confidence in the internationalization of China's biopharmaceutical industry [12].

Core Viewpoint - InnoCare Pharma Inc., a wholly-owned subsidiary of Innovent Biologics, has signed a licensing agreement with Zenas BioPharma, granting Zenas rights to develop, produce, and commercialize the drug Orelabrutinib and two preclinical assets, with total payments exceeding $2 billion [1][2][4]. Group 1: Licensing Agreement Details - The agreement includes global exclusive rights for Orelabrutinib in multiple sclerosis (MS) and other non-MS indications outside Greater China and Southeast Asia, as well as exclusive rights for a preclinical IL-17 inhibitor and a preclinical oral TYK2 inhibitor [2][3]. - Zenas will pay an upfront fee of $100 million, milestone payments, and grant 7 million common shares to Innovent, with total potential payments exceeding $2 billion [2][4]. Group 2: Strategic Importance - This licensing deal marks the second business development (BD) initiative for Innovent in 2023, emphasizing the company's focus on international expansion and product commercialization over the next three years [1][7]. - The management has indicated that BD will be a priority, aiming to accelerate the global development and commercialization of Orelabrutinib and other pipeline products [4][7]. Group 3: Market Reaction - Following the announcement, Innovent's stock price fell by 6.24% on October 9 and continued to decline by 9.16% on October 10, indicating market skepticism regarding the licensing of non-core indications for Orelabrutinib [3][4]. Group 4: Previous Collaborations - Innovent has a history of international collaborations, including a previous agreement with BeiGene for Orelabrutinib, which was terminated in June 2023, but the company remains committed to exploring the drug's potential in various B-cell lymphomas [5][6][7].

Core Viewpoint - Pharmaceutical stocks have declined again, with significant drops in various companies' stock prices, indicating a challenging market environment for the sector [1] Group 1: Stock Performance - Nocera Health (09969) fell by 11.37%, trading at HKD 14.73 [1] - Saint Noble Pharmaceuticals-B (02257) decreased by 11.05%, trading at HKD 13.36 [1] - Rongchang Biopharmaceutical (09995) dropped by 10.4%, trading at HKD 95.15 [1] - Gilead Sciences-B (01672) declined by 8.57%, trading at HKD 9.6 [1] - Viatris (01873) fell by 8.14%, trading at HKD 2.82 [1] Group 2: Investment Trends - According to CMB International, domestic investors have increased their holdings in pharmaceutical stocks through the Hong Kong Stock Connect since September, while foreign investment has slightly decreased since mid-year [1] - The overall trend of increasing investment in innovative drugs remains unchanged for both domestic and foreign investors [1] Group 3: Future Outlook - The ESMO conference is scheduled for mid to late October, with a recommendation to focus on companies like CanSino Biologics, Kelun-Biotech, Rongchang Biopharmaceutical, and Hengrui Medicine (600276) that are expected to release significant data [1] - The pharmaceutical sector in Hong Kong has shown relatively flat performance in September, but with the increase in industry catalysts (various academic conferences and favorable policies), the market is expected to rebound in October [1] Group 4: Market Analysis - Dongguan Securities reports that the pharmaceutical and biotechnology sector has consistently underperformed compared to the CSI 300 index, with some previously high-performing innovative drug companies experiencing corrections [1] - The medical research outsourcing sector has been strengthening due to improved expectations of U.S. interest rate cuts and better financing data, entering a performance vacuum period [1] - Future investment opportunities are suggested in innovative drugs and sectors with expected business development catalysts [1]

Core Viewpoint - The pharmaceutical sector is experiencing a decline, with significant drops in stock prices for various companies, while there is an increasing trend in domestic investment through the Hong Kong Stock Connect, indicating a mixed sentiment in the market [1]. Group 1: Stock Performance - Notable declines in pharmaceutical stocks include: - Innovent Biologics (09969) down 11.37% to HKD 14.73 - Sanofi (02257) down 11.05% to HKD 13.36 - Rongchang Biopharmaceutical (09995) down 10.4% to HKD 95.15 - Galenica (01672) down 8.57% to HKD 9.6 - Viatris (01873) down 8.14% to HKD 2.82 [1]. Group 2: Investment Trends - According to CICC, since September, the proportion of domestic investors holding pharmaceutical stocks through the Hong Kong Stock Connect has been increasing, while foreign investment has slightly decreased since mid-year [1]. - Despite the decline, the overall trend of increasing investment in innovative drugs remains unchanged [1]. Group 3: Future Outlook - The upcoming ESMO conference in mid-October is highlighted as a key event, with recommendations to focus on companies like CanSino Biologics, Kelun-Biotech, Rongchang Biopharmaceutical, and Heng Rui Medicine, which are expected to release significant data [1]. - Dongguan Securities reports that the pharmaceutical and biotechnology sector has underperformed compared to the CSI 300 index, with some previously high-performing innovative drug companies experiencing corrections [1]. - The medical research outsourcing sector is showing strength due to improved financing data and expectations of catalysts in innovative drugs, suggesting potential investment opportunities [1].

Market Performance - The Hong Kong stock market continued its decline, with notable drops in several biotech companies [1] - Innovent Biologics (09969) fell by 11.19%, closing at 14.760, with a market capitalization of 26.021 billion and a year-to-date increase of 141.18% [2] - Rongchang Biologics (09995) decreased by 10.22%, with a latest price of 95.350 and a total market value of 53.74 billion, reflecting a year-to-date increase of 562.15% [2] - WuXi AppTec (02268) and WuXi Biologics (02269) experienced declines of 5.68% and 5.32%, respectively, with market caps of 89.818 billion and 1585.28 billion [2] - Other companies such as Fuhong Hanlin (02696) and Kelun-Biotech (06990) also saw declines of over 4% [1][2] Company Highlights - Innovent Biologics has shown a significant year-to-date performance increase of 141.18% despite the recent drop [2] - Rongchang Biologics has the highest year-to-date increase among the listed companies at 562.15% [2] - WuXi Biologics and WuXi AppTec have maintained strong year-to-date increases of 120.84% and 138.50%, respectively [2] - Fuhong Hanlin and Kelun-Biotech also reported substantial year-to-date increases of 205.49% and 199.33% [2]

Core Viewpoint - The Hong Kong biopharmaceutical stocks continued to decline, with significant drops in several key companies, indicating a bearish trend in the sector [1]. Group 1: Stock Performance - Innovent Biologics (09969) experienced a decline of 11.19%, with a latest price of 14.760 and a total market capitalization of 26.021 billion, despite a year-to-date increase of 141.18% [2]. - Rongchang Biologics (09995) fell by 10.22%, with a latest price of 95.350 and a market cap of 53.747 billion, showing a remarkable year-to-date increase of 562.15% [2]. - WuXi AppTec (02268) saw a decrease of 5.68%, with a latest price of 73.100 and a market cap of 89.818 billion, maintaining a year-to-date increase of 138.50% [2]. - WuXi Biologics (02269) dropped by 5.32%, with a latest price of 38.780 and a market cap of 158.528 billion, reflecting a year-to-date increase of 120.84% [2]. - Fuhong Hanlin (02696) declined by 4.42%, with a latest price of 72.400 and a market cap of 39.349 billion, showing a year-to-date increase of 205.49% [2]. - Kelun-Biotech (06990) decreased by 4.25%, with a latest price of 488.800 and a market cap of 113.981 billion, with a year-to-date increase of 199.33% [2]. - WuXi AppTec (02359) fell by 4.19%, with a latest price of 114.400 and a market cap of 339.275 billion, reflecting a year-to-date increase of 109.21% [2]. - Gendicine (09688) saw a decrease of 2.83%, with a latest price of 25.440 and a market cap of 28.432 billion, with a year-to-date increase of 21.72% [2]. - CanSino Biologics (09926) declined by 2.05%, with a latest price of 128.800 and a market cap of 118.643 billion, reflecting a year-to-date increase of 112.19% [2]. - Junshi Biosciences (01877) fell by 2.02%, with a latest price of 29.100 and a market cap of 29.877 billion, showing a year-to-date increase of 151.30% [2].

Group 1: Hong Kong Stocks - Nocera Biotech (09969) fell over 8% after announcing a licensing collaboration with Zenas for three self-immune pipeline products [1] - Pop Mart (09992) rose over 2% as new products sold out immediately, with Morgan Stanley optimistic about the company's sales momentum [1] - Bluec (00325) increased over 8% after launching new "building block cars" and "building block figures" at the WF2025 exhibition [1] - Huaxin Cement (06655) rose over 7% after announcing a name change to "Huaxin Building Materials" and a restricted stock incentive plan [1] - Mixue Group (02097) gained over 5% after announcing an investment of nearly 300 million in the fresh beer industry, potentially opening up long-term growth opportunities [1] - CATL (03750) dropped nearly 6% as the cornerstone lock-up period is set to expire on the 19th of next month, with both Morgan Stanley and others downgrading the company's H-share rating [1] - Dazhong Public Utilities (01635) rose over 9%, stating that its operations are normal and previously mentioned its stake in Shenzhen Capital Group [1] - Jinli Permanent Magnet (06680) increased nearly 1%, forecasting a year-on-year increase of 157%-179% in net profit attributable to shareholders for the first three quarters [1] Group 2: Gold Stocks - Gold stocks opened lower collectively, with China Gold International (02099) down over 7%, Zijin Mining International (02259) down over 1%, Shandong Gold (01787) down over 6%, and Chifeng Jilong Gold Mining (06693) down over 6% due to easing geopolitical tensions leading to a pullback in precious metals [2] Group 3: US Stocks - AMBO Education (AMBO.US) surged 61.06% after announcing the launch of a real-time translation platform, WeSpeak, for enterprises [3] - CenturyLink (VNET.US) fell 3.13% as Goldman Sachs included it in a "strong buy" list for the Asia-Pacific region [3] - UiPath (PATH.US) rose 18.81% after announcing multiple collaborations with major tech companies like NVIDIA, OpenAI, Google, Microsoft, and Snowflake [3] - Tuniu (TOUR.US) decreased by 0.51%, despite a double-digit increase in user travel during this year's "Double Festival" holiday compared to last year [3] - Tesla (TSLA.US) fell 0.72% after reports that production of its humanoid robot, Optimus, has been paused [3] - Toyota (TM.US) dropped 2.97% after a recall of over 390,000 vehicles in the US due to software errors [3] - Lloyds Bank (LYG.US) decreased by 3.67% as it may need to increase provisions following a compensation plan for mis-sold auto loans [3] - Ferrari (RACE.US) fell 14.99%, reaching a six-month low as long-term profit guidance fell below expectations [4] - TSMC (TSM.US) decreased by 1.52%, projecting a consolidated revenue of approximately NT$330.98 billion for September 2025, a 1.4% decrease quarter-on-quarter but a 31.4% increase year-on-year [4] - PepsiCo (PEP.US) rose 4.23% with Q3 net revenue increasing by 2.7% to $23.94 billion, and core EPS of $2.29, both exceeding expectations [4]

Core Insights - The collaboration between Innovent Biologics and Zenas for three self-immune pipeline products marks a significant milestone in the internationalization of the drug Orelabrutinib and sets a new record for small molecule transactions in China's self-immune field, with a total potential transaction value exceeding $2 billion [1] - The development of the first-class new drug HH-003 (Libevev) by Huahui Anjian, targeting chronic hepatitis D, is expected to receive approval for market launch around the first quarter of 2026, representing a major milestone in the company's growth [2][3] Company Developments - Huahui Anjian has been developing HH-003 since its inception, with significant funding rounds supporting its clinical trials, including a recent A++ round financing and breakthrough therapy designation from the FDA for treating chronic hepatitis D [3][4] - The drug HH-003 has shown promising results in clinical trials, demonstrating good safety and antiviral activity, with a notable decrease in HBV DNA and hepatitis B surface antigen levels observed in patients [3][4] Industry Context - The Zhongguancun Life Science Park, where both Innovent Biologics and Huahui Anjian are based, is a key area for biotechnology innovation in Beijing, having produced significant drugs like Orelabrutinib and Zebutinib [1][5] - The park is recognized for its comprehensive industry chain, facilitating the transition from laboratory research to clinical application, thus fostering a competitive pharmaceutical health industry [10] Product Pipeline and Market Potential - Innovent Biologics has developed Orelabrutinib, a BTK inhibitor that has been approved in China and Singapore, with plans for further clinical trials targeting multiple sclerosis [6][7] - The company is also advancing its pipeline with a new generation TRK inhibitor, demonstrating a strategic focus on expanding its product offerings in oncology and autoimmune diseases [7][8] Competitive Landscape - The competitive landscape for BTK inhibitors in China includes several products, with Orelabrutinib positioned to capture market share due to its rapid development and broad application potential [6] - WanTai Biologics, another company in the park, is expanding its vaccine pipeline, including the world's first marketed hepatitis E vaccine, showcasing the diverse innovation occurring within the Zhongguancun Life Science Park [9][10]