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倚 賴該等內容而引致的任何損失承擔任何責任。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 瑪仕度肽獲中國國家藥品監督管理局 批准用於成人2型糖尿病患者的血糖控制 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈，瑪仕度肽注射液（胰高血糖素[GCG]╱胰高 血糖素樣肽-1[GLP-1]雙受體激動劑）的第二項適應症新藥上市申請（「NDA」）獲 中國國家藥品監督管理局（「NMPA」）批准上市，用於成人2型糖尿病患者的血糖 控制。瑪仕度肽是全球首個獲批的用於2型糖尿病的GCG/GLP-1雙受體激動劑， 有望助力中國廣大2型糖尿病患者人群疾病管理，實現血糖控制、減重及心肝腎 指標多重獲益。 中國2型糖尿病患者人數居世界首位，長期血糖管理及併發症防治需求嚴峻 中國 ...

Market Overview - The Hong Kong stock market showed a volatile trend, with the Hang Seng Index closing flat after briefly surpassing 27,000 points during the day [1] - The Hang Seng Index remained at 26,545.10, with a slight change of 0.00% and a 5-day increase of 0.59% [2] - The Hang Seng China Enterprises Index rose by 0.17%, closing at 9,472.35, with a 5-day increase of 1.15% [2] - The Hang Seng Tech Index increased by 0.37%, closing at 6,294.42, with a 5-day increase of 5.09% [2] Sector Performance - Large technology stocks showed mixed performance, with NIO, SenseTime, and Hua Hong Semiconductor rising over 4%, while Tencent Music and Horizon Robotics fell over 4% [4] - Gaming stocks performed strongly, with major players like Melco International Development, Sands China, and Wynn Macau rising over 6% [6] - Gold and precious metal stocks saw gains, with Shandong Gold rising over 6% and other gold-related stocks following suit [7] - Automotive parts stocks led the gains, with New Morning Power surging over 27% [9] - Tesla-related stocks were active, with Ganfeng Lithium rising by 9% and Li Auto also showing positive movement [10] Notable Stock Movements - The top gainers included: - NIO-SW: +4.45% [5] - SenseTime-W: +4.58% [5] - Shandong Gold: +6.13% [8] - New Morning Power: +27.66% [9] - Conversely, notable decliners included: - Tencent Music: -4.04% [5] - Orange Sky Golden Harvest: -8.54% [12] - Innovent Biologics: -5.50% [13] Capital Flows - Southbound funds recorded a net inflow of HKD 9.838 billion, with HK Stock Connect (Shanghai) contributing HKD 5.283 billion and HK Stock Connect (Shenzhen) contributing HKD 4.555 billion [14] Future Outlook - The market outlook suggests that the Hong Kong stock market may perform stronger following the Federal Reserve's potential interest rate cuts, particularly in sectors like healthcare, technology, and consumer goods [15]

Group 1 - The overnight SPDR S&P Biotech ETF (XBI) rose by 3.1%, while the Hong Kong pharmaceutical sector (159718.SZ) opened high but continued to weaken, currently down by 0.93% [1] - Among the constituent stocks, Haijia Medical (06078) led the gains with an increase of 7.41%, while Innovent Biologics (01801) saw the largest decline at 6.57% [1] - Industrial insights suggest that the innovative drug sector's prosperity is sustainable, with a focus on "innovation + internationalization" as the core direction of the pharmaceutical sector [1] Group 2 - The innovative drug industry is expected to continue receiving policy support, enhancing the global competitiveness of Chinese innovative drugs and realizing commercial profitability [1] - There is an improvement in the fundamentals of the innovative drug supply chain, with overseas orders and performance beginning to recover, and domestic business showing a self-controllable logic [1] - The demand in the domestic market is anticipated to recover by 2025, with potential improvements in the consumption medical field and medical devices [1] Group 3 - Institutions remain confident in high-quality innovation and the innovative industry chain, viewing any external disturbances as buying opportunities [2] - The Hong Kong pharmaceutical ETF is well-balanced, including innovative drugs, CXO, internet healthcare, and innovative devices, serving as a convenient standardized tool for investors [2] - Recommendations are made to pay attention to the Hong Kong pharmaceutical ETF (159718.SZ) and its connected funds (Class A: 019598, Class C: 019599) [2]

Group 1 - The Hong Kong innovative drug sector experienced a decline in the afternoon session on September 13, with notable drops in stock prices [1] - Innovent Biologics saw a decrease of over 7%, while Rongchang Biopharmaceutical and Green Leaf Pharmaceutical fell by more than 4% [1] - Other companies such as WuXi Biologics, Junshi Biosciences, and Kelun Pharmaceutical also experienced declines [1]

港股创新药板块午后走弱，信达生物跌超7%，荣昌生物、绿叶制药跌超4%，药明生物、君实生物、凯 莱英等跟跌。 ...

Core Viewpoint - The innovative drug sector in Hong Kong has become a market focus again, with significant stock price increases following a prolonged period of adjustment and low valuations [2][3]. Group 1: Market Performance - Beihai Kangcheng-B (01228.HK) has surged nearly 19 times, while other companies like Deqi Pharmaceutical-B (06996.HK) and Hengrui Medicine (01276.HK) have also shown impressive gains, with some stocks increasing over four times [2]. - The overall profitability of the Hong Kong innovative drug sector has significantly improved in 2025, with many companies reporting substantial increases in net profit [6][7]. Group 2: Policy Support - The Chinese government has included "innovative drugs" in key emerging industries, with policies introduced to support the development of innovative drugs, including price management and financing [3]. - In June 2025, the National Healthcare Security Administration and the National Health Commission launched measures to support the high-quality development of innovative drugs, providing robust policy backing [3]. Group 3: Company Performance - Hengrui Medicine reported a 29.67% increase in net profit to 4.45 billion RMB in the first half of the year, achieving record highs in revenue and profit [4]. - Baijie Shenzhou's net profit increased by 115.63% to 450 million RMB, marking its first half-year profit, primarily due to the strong performance of its core product [5]. Group 4: Financing Trends - Many innovative drug companies are launching placement financing plans to raise funds for ongoing research and daily operations, driven by improved stock prices [8][10]. - As of 2025, nearly 60 companies in the Hong Kong medical and biopharmaceutical sectors have announced placement financing plans, with innovative drug companies being the main contributors [8]. Group 5: Future Outlook - The innovative drug sector is expected to continue its rapid development, supported by favorable external conditions and ongoing policy support [12][14]. - The recent interest rate cuts by the Federal Reserve may facilitate easier financing for innovative drug companies, which is crucial for those yet to achieve commercialization [13].

Core Viewpoint - The Trump administration is drafting an executive order that will impose three major restrictions on commercial transactions involving Chinese innovative drug patents or rights, focusing on national security reviews by the Committee on Foreign Investment in the United States (CFIUS) [1][2]. Summary by Sections Executive Order Details - The draft includes three main provisions: 1. Inclusion of Chinese innovative drug BD transactions in the CFIUS mandatory review list, ending the previous "low-risk automatic exemption" practice [2]. 2. FDA will implement "racial sensitivity supplementary reviews" for drugs relying on Chinese clinical data, requiring at least 20% comparative data from non-Asian populations [2]. 3. Establishment of a "key drug domestic production fund" to provide production subsidies for 15 categories of drugs, including antibiotics and acetaminophen, while implementing a "domestic priority" principle in federal procurement [2]. Market Reaction - The market reacted swiftly to the policy risks, with the Hong Kong innovative drug index (HK1105) dropping 3.82% on September 11, 2025, and the A-share innovative drug sector (BK1106) declining 2.17%, with over 80% of stocks in the sector experiencing pullbacks [3]. - The following day, the indices showed signs of recovery, indicating investors' responses to policy uncertainties and rational corrections [3]. Globalization Trends - Despite the geopolitical risks, the trend of Chinese innovative drugs going global remains intact, with total license-out transactions to Europe and the U.S. reaching $9.43 billion as of September 2025 [3]. - Major transactions include a $950 million licensing deal between BeiGene and Royalty Pharma, and a $6 billion global licensing agreement between 3SBio and Pfizer, highlighting a shift towards milestone payments and regional licensing [3]. Industry Challenges - The domestic market faces challenges, with annual growth in medical insurance fund spending (approximately 12%) lagging behind the growth in innovative drug R&D investment (approximately 25%) [4]. - The average reduction in medical negotiations remains high at 54%, and commercial health insurance coverage for innovative drugs is below 15%, creating a supply-demand imbalance that necessitates going global [4]. Risk Resilience Assessment - Goldman Sachs has categorized Chinese innovative drug companies into three risk resilience tiers based on their sensitivity to policy changes and operational capabilities [4][5]. - Companies with mature global layouts exhibit the strongest resilience, while those heavily reliant on domestic markets show the weakest resilience [5][10]. Strategic Defense Framework - A three-dimensional defense system is proposed to address risks associated with the executive order, focusing on transaction review, data compliance, and supply chain security [13]. - Strategies include conducting national security risk pre-assessments for transactions over $50 million and establishing partnerships with U.S. law firms to navigate regulatory challenges [14][15]. Conclusion - The construction of a quantifiable "risk resilience index" is essential for Chinese innovative drugs in the global 2.0 era, emphasizing the need for companies to embed policy hedging clauses in transaction structures and consider racial diversity data in clinical stages [23].

Core Insights - Innovent Biologics, in partnership with Ollin, is advancing IBI324 (OLN324), a bispecific antibody targeting VEGF and Ang2, currently in Phase 1b clinical trials for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) [1][2][3] - The JADE study has enrolled over 150 patients, with topline results expected in Q1 2026, indicating significant progress in the clinical development of OLN324 [1][3] Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncology and ophthalmology [5] - The company has launched 16 products and has multiple assets in various stages of clinical trials, showcasing a robust pipeline [5] Product Development - OLN324 is designed to have higher potency and durability compared to the current market leader, faricimab, potentially establishing it as a first-line treatment option [2][3] - The dual targeting mechanism of OLN324 aims to improve clinical outcomes for patients suffering from wAMD and DME, addressing significant unmet medical needs [3][2] Clinical Trial Progress - The successful completion of patient enrollment in the JADE study marks a key milestone for both Innovent and Ollin, reflecting their strong collaboration [3][1] - Previous studies have shown promising results for IBI324 in improving vision and anatomical outcomes in DME patients, alongside a favorable safety profile [3]

Key Points - The top three stocks with net inflow of southbound funds are Alibaba-W (09988) with 5.278 billion, Yingfu Fund (02800) with 2.782 billion, and Hang Seng China Enterprises (02828) with 1.566 billion [1] - The top three stocks with net outflow of southbound funds are Xiaomi Group-W (01810) with -0.721 billion, Innovent Biologics (01801) with -0.466 billion, and Pop Mart (09992) with -0.458 billion [1] - In terms of net inflow ratio, Yuexiu Transportation Infrastructure (01052) leads with 63.76%, followed by Crystal International (02232) with 56.34%, and China Resources Gas (01193) with 53.63% [1] - The stocks with the highest net outflow ratio include QuanFeng Holdings (02285) at -59.36%, Yadea Group (01585) at -54.53%, and TCL Electronics (01070) at -54.28% [1] Net Inflow Rankings - The top ten stocks by net inflow include Alibaba-W (09988) with 5.278 billion, Yingfu Fund (02800) with 2.782 billion, and Hang Seng China Enterprises (02828) with 1.566 billion [2] - Other notable stocks in the net inflow list are Meituan-W (03690) with 0.670 billion and Southern Hang Seng Technology (03033) with 0.620 billion [2] Net Outflow Rankings - The top ten stocks by net outflow include Xiaomi Group-W (01810) with -0.721 billion, Innovent Biologics (01801) with -0.466 billion, and Pop Mart (09992) with -0.458 billion [2] - Other significant stocks in the net outflow list are Li Auto-W (02015) with -0.298 billion and China Construction Bank (00939) with -0.254 billion [2] Net Inflow Ratio Rankings - The top three stocks by net inflow ratio are Yuexiu Transportation Infrastructure (01052) at 63.76%, Crystal International (02232) at 56.34%, and China Resources Gas (01193) at 53.63% [3] - Additional stocks with high net inflow ratios include China Ship Leasing (03877) at 49.13% and Jiangsu Ninghu Expressway at 45.49% [3] Net Outflow Ratio Rankings - The stocks with the highest net outflow ratios include QuanFeng Holdings (02285) at -59.36%, Yadea Group (01585) at -54.53%, and TCL Electronics (01070) at -54.28% [3] - Other notable stocks with significant net outflow ratios are Kangji Medical (09997) at -53.77% and QiuTai Technology (01478) at -47.17% [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) due to rapid performance growth and accelerated internationalization [5]. Core Views - The company achieved a significant revenue increase of 50.6% year-on-year in the first half of 2025, reaching 5.95 billion RMB, and turned a profit with a net profit of 834 million RMB [7]. - The product revenue was 5.23 billion RMB, reflecting a year-on-year growth of 37.3%, driven by strong performance in oncology and a diverse product pipeline [7]. - The company has 16 commercialized products and is well-positioned for future growth with a robust commercialization team [7]. - IBI363, a dual-target antibody, is expected to become a cornerstone of immuno-oncology therapy, with multiple clinical trials ongoing [7]. - The company has a strong pipeline in metabolic, autoimmune, and ophthalmic areas, with several catalysts expected in the near future [7]. - Revenue forecasts for 2025-2027 are 11.49 billion RMB, 15.37 billion RMB, and 20.60 billion RMB respectively, indicating a strong growth trajectory [8]. Financial Summary - The company is projected to achieve a net profit of 1.27 billion RMB in 2025, with a staggering growth rate of 1443.7% compared to the previous year [8]. - The earnings per share (EPS) is expected to be 0.74 RMB in 2025, increasing to 1.90 RMB by 2027 [8]. - The return on equity (ROE) is forecasted to improve from -0.7% in 2024 to 16.7% in 2027, indicating a strong recovery and profitability [8].