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: | 2025年7月31日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 信達生物製藥 | | | | | | 呈交日期: | 2025年8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) | 01801 | 說明 | 普通股 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | ...

Core Insights - The report from JPMorgan highlights that external licensing has become one of the most significant driving forces in the domestic biopharmaceutical industry this year [1] - The firm identifies Innovent Biologics as the most capable company to benefit from this trend among those covered by the bank [1] Company Summary - Innovent Biologics has a strong product pipeline that includes assets in oncology, cardiovascular, autoimmune, and ophthalmology, creating a diversified portfolio of early and late-stage assets [1] - The company is expected to continue achieving external licensing deals in the coming years [1] - JPMorgan has raised its forecast for potential licensing revenue as a percentage of total revenue to 5% to 7%, which is anticipated to positively impact gross margin expansion [1] - The valuation of early-stage assets has been increased by 43% due to growing market recognition of the company's R&D capabilities [1] - The target price for Innovent Biologics has been raised from HKD 90 to HKD 109, with a rating of "Overweight" and classified as a top pick in the industry [1]

Core Insights - The article highlights the significant progress of Chinese innovative pharmaceuticals, particularly focusing on the outbound licensing strategy and business development (BD) as key drivers for growth in the global market [1][2][3] Group 1: Company Developments - Heng Rui Pharmaceutical has completed 13 outbound licensing deals from 2018 to 2024, involving 16 molecular entities with a potential total transaction value of approximately $14 billion and upfront payments totaling around $600 million [1] - In 2025, Heng Rui's momentum continues with a $19.7 billion deal with Merck for its Lp(a) oral small molecule project and a partnership with GSK that brings in $5 billion upfront and a potential future revenue of $12 billion [1] - The company reported a revenue of 27.985 billion yuan in 2024, a year-on-year increase of 22.63%, and a net profit of 6.337 billion yuan, up 47.28% [9] Group 2: Industry Trends - The Chinese innovative pharmaceutical sector is experiencing a surge in outbound licensing deals, with the total value of BD transactions reaching $64.08 billion in 2024, marking a historical high [4][5] - The global pharmaceutical industry is facing a "patent cliff" with a total risk exposure of $354 billion due to patent expirations, creating a heightened demand for quality innovative assets from China [3][4] - The number of active innovative drug R&D pipelines in China reached 3,575 in 2024, surpassing the U.S. for the first time, with a significant increase in the number of first-in-class (FIC) drugs [8] Group 3: Strategic Shifts - The BD model has evolved from a tactical choice to a core pillar of globalization strategy for Chinese pharmaceutical companies, enabling them to secure immediate funding and share risks [5][6] - Companies like Bai Li Tian Heng and Kang Ning Jie Rui have achieved remarkable revenue growth through strategic partnerships, with Bai Li Tian Heng reporting a staggering 1,685.19% year-on-year increase in revenue following a major licensing deal [5][6] - The article emphasizes the importance of building strong commercialization capabilities as a foundation for long-term competitiveness, moving beyond reliance on BD for survival [9][10] Group 4: Policy and Capital Support - The growth of BD transactions is supported by a decade of favorable policies and capital influx, including reforms in drug approval processes and financing mechanisms for biotech companies [7][8] - The Chinese pharmaceutical industry has seen a significant increase in the number of companies going public, with over 56 firms raising more than 110 billion HKD since the introduction of new listing rules [7] - The article notes that the combination of policy support and capital investment has led to a qualitative leap in innovative drug development in China [8][9] Group 5: Future Outlook - The future of Chinese innovative pharmaceuticals is characterized by a focus on global clinical trials, tighter international collaborations, and the emergence of differentiated products [15] - The industry is moving towards a more collaborative ecosystem, aiming for a balance between individual company growth and collective industry advancement [15] - The article concludes that the ongoing transformation in the Chinese pharmaceutical sector is paving the way for a historic leap from "global follower" to "global leader" in innovation [10][15]

Summary of Key Points from the Conference Call Industry Overview - The report focuses on the **China Healthcare** sector, particularly the **innovative drug out-licensing** activities in China compared to global trends [1][4][8]. Performance Metrics - The **Hang Seng Healthcare Index** has increased by over **75% YTD**, significantly outperforming the broader **Hang Seng Index**, which rose by approximately **23%** [1]. - China's out-licensing deals accounted for about **15%** of total global deals and **21%** of multinational corporation (MNC) deals in the last two years [4][11]. Strategic Insights - The analysis indicates that foreign companies are not solely attracted to China for low-cost benefits; they are increasingly interested in the **quality of assets**. Upfront payments for Chinese deals are often comparable to or exceed global averages, with **US$213 million** for oncology compared to **US$195 million** globally [4][11]. - **Oncology** remains the primary focus for MNCs in both global and China-specific agreements, followed closely by **cardiometabolism** [4][11]. Licensing Potential - There is significant potential for out-licensing in areas beyond oncology, particularly in **autoimmune diseases** and **cardiometabolism**. The report suggests that investments in **CNS (central nervous system)** could lead to more out-licensing deals from China [4][5][24]. - Advanced drug modalities such as **ADCs (antibody-drug conjugates)** and **bsAb (bispecific antibodies)** are becoming prominent in out-licensing from China [5][24]. Company-Specific Insights - **Innovent** has been highlighted as a top pick in the biotech sector due to its strong out-licensing potential and asset quality. The price target for Innovent has been increased based on favorable licensing income projections [1][5]. - **AstraZeneca** and **Merck** are leading companies in terms of licensing deals from China, with AstraZeneca having the highest number of deals and Merck leading in total upfront payments [4][30]. Financial Health of MNCs - Despite macroeconomic uncertainties, MNCs like **Pfizer** and **Merck** are in strong financial positions, with significant free cash flow available for business development activities, including licensing and M&A [22][23]. Emerging Trends - The report notes a shift in focus for MNCs towards **autoimmune** and **metabolic diseases**, driven by the expiration of patents on blockbuster drugs and the rising sales of **GLP-1** drugs [24][25]. - The average deal value for Chinese assets in oncology is on par with global averages, while the average upfront payment for oncology and immunology is higher than the global average [30]. Conclusion - The findings underscore the growing competitiveness of Chinese biotech assets and the increasing interest from MNCs in out-licensing deals, indicating a robust future for the China healthcare sector [1][4][11].

Regulatory Changes - The National Health Commission has issued a notice prohibiting medical institutions from using misleading names for outpatient services that imply efficacy, emphasizing the need for clear and accurate naming practices [1] Drug Procurement - The National Medical Insurance Administration announced that 480 pharmaceutical companies are competing in the 11th batch of national drug procurement, with 55 drugs proposed for inclusion, averaging 15 companies per drug, and some drugs having over 40 participating companies [2] Legal Actions Against Fraud - The Supreme People's Court reported a significant increase in the prosecution of medical insurance fraud cases, with 1,156 cases involving 2,299 individuals concluded in 2024, marking a 131.2% year-on-year increase and recovering over 402 million yuan in lost funds [3] Drug Approvals - Innovent Biologics announced that its oral GLP-1R agonist IBI3032 has received FDA approval for clinical trials, with plans to initiate Phase I trials in mid-2025 targeting overweight or obese individuals [4] - Dyne Therapeutics received breakthrough therapy designation from the FDA for its investigational therapy DYNE-251 for Duchenne muscular dystrophy, with data expected by the end of 2025 [5] - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received a drug registration certificate for Finasteride tablets, which are included in the national medical insurance drug list [6][7] Mergers and Acquisitions - Shanghai TuoJing announced the acquisition of 82% of Wuhan Kanglu Biological for 328 million yuan, focusing on advancements in molecular diagnostics [8] Financial Performance - Jiuzhou Pharmaceutical reported a 3.86% increase in revenue to 2.871 billion yuan and a 10.7% increase in net profit to 526 million yuan for the first half of 2025 [10] Strategic Investments - Yabao Pharmaceutical plans to acquire a traditional Chinese medicine project for 22 million yuan, enhancing its R&D pipeline and competitive edge [11] Shareholder Actions - Chenshin Pharmaceutical announced that a major shareholder plans to reduce their stake by up to 3% through market transactions, which is not expected to significantly impact the company's governance or operations [12]

智通财经APP获悉，8月1日,盈富基金（02800）、恒生中国企业（02828）、南方恒生科技（03033）南 向资金净流入金额位列市场前三，分别净流入29.96 亿、17.92 亿、13.11 亿 | 股票名称 | 净流出(元)↓ | 净流出比 | 收盘价 | | --- | --- | --- | --- | | 信达生物(01801) | -4.26 亿 | -18.68% | 93.000（-5.10%） | | 中国太保(02601) | -3.03 亿 | -34.21% | 30.750（-2.84%） | | 药明合联(02268) | -2.56 亿 | -48.96% | 55.500（-3.81%） | | 康方生物(09926) | -2.55 亿 | -14.89% | 156.300（+1.10%） | | 三生制药(01530) | -2.24 亿 | -11.32% | 30.200（-5.92%） | | 新华保险(01336) | -2.12 亿 | -20.41% | 48.450（-3.68%） | | 中国宏桥(01378) | -2.09 亿 | -30.08% | ...

Group 1 - The core viewpoint of the news is that the China Securities Hong Kong 100 Pharmaceutical and Health Index has shown significant growth, with a year-to-date increase of 90.32% [1] - The index has risen by 18.48% in the past month and 36.79% in the last three months, indicating strong performance in the pharmaceutical sector [1] - The index is composed entirely of securities listed on the Hong Kong Stock Exchange, with a base date of December 31, 2004, and a base point of 1000.0 [1] Group 2 - The index sample is adjusted biannually, with changes implemented on the next trading day following the second Friday of June and December [2] - Weight factors are generally fixed until the next scheduled adjustment, but can be temporarily modified under special circumstances [2] - Adjustments to the index sample occur in response to events such as delistings, mergers, or changes in industry classification [2]

（文章来源：每日经济新闻） 每经AI快讯，港股创新药板块继续走强，亚盛医药-B涨逾10%，康诺亚-B、乐普生物-B涨逾7%，诺诚 健华、信达生物涨超5%。 ...

Group 1 - Xindong Company (02400) reported a positive earnings forecast, expecting revenue of at least RMB 3.05 billion for the first half of 2025, a year-on-year increase of approximately 37%, and a net profit of at least RMB 790 million, a year-on-year increase of about 215% [1] - Yimai Sunshine (02522) also announced a positive earnings forecast, expecting revenue between RMB 450 million to 480 million for the first half of the year, a year-on-year increase of approximately 8.77% to 16.03%, and a net profit of RMB 14.5 million to 16.5 million, a year-on-year increase of about 1350% to 1550% [1] - Tianli International Holdings (01773) plans to repurchase shares up to a total of HKD 200 million based on market conditions, believing that the share buyback plan is in the best interest of the company and its shareholders [2] Group 2 - Liaogang Co., Ltd. (02880) reported a total operating revenue of RMB 5.693 billion for the first half of 2025, a year-on-year increase of 5.93%, and a net profit attributable to shareholders of RMB 956 million, a year-on-year increase of 110.78% [2] - Yuan Zheng Technology (02488) reported a revenue of RMB 982 million for the first half of 2025, a year-on-year increase of 9.75%, and a net profit of RMB 195 million, a year-on-year increase of 27.74% [2] - Geekplus Technology (02590) expects revenue between RMB 995 million to 1.03 billion for the first half of the year, a year-on-year increase of 27% to 32%, while the net loss is expected to narrow significantly [3] Group 3 - Lee & Man Paper Manufacturing (02314) and other leading companies in the paper industry have initiated a price increase for various products starting August 1, indicating a significant acceleration in price adjustment frequency within the industry [3] - Xinda Biopharmaceutical (01801) announced that its innovative oral small molecule GLP-1R agonist IBI3032 has received IND approval from the FDA [4] - Heyu-B (02256) reported a revenue of RMB 612 million for the first half of the year, a year-on-year increase of 23.1%, and a net profit of RMB 328 million, a year-on-year increase of 58.84% [4] Group 4 - Bilibili (BILI.US) is expected to achieve a revenue growth of 20% year-on-year to RMB 7.3 billion in the second quarter, driven by stable performance in mobile games [5][6] - Li Auto (LI.US) launched the Li Xiang i8, with deliveries starting on August 20, and received positive outlooks from multiple institutions [6] - Xpeng Motors (XPEV.US) achieved a new monthly delivery record in July, delivering 36,717 smart electric vehicles, a year-on-year increase of 229% [7]

考虑到信达生物对授权许可的战略重视及其创新产品线，小摩提高对其潜在授权收入的预期，预计将占 信达生物未来总收入的5-7%。这种有利的销售组合亦正推动集团毛利率的扩张。同时，小摩表示，授 权许可已成为今年中国生物制药行业最重要的推动因素之一，该行认为信达生物是最能从这一趋势中受 益的公司之一。 智通财经APP获悉，摩根大通发布研报称，将集团早期资产的估值上调43%，因考虑到信达生物(01801) 的研发能力，且这些资产越来越得到市场认可。通过提高玛仕度肽(Mazdutide)(GLP-1/GIP)获批后的销 售成功率(PoS)、调整经营费用，上调目标价21%，由90港元升至109港元。并维持"增持"评级。 ...