Core Points - The 2025 National Medical Insurance Directory negotiations have officially commenced, highlighting the importance of pharmaceutical innovation and patient access to medications [1] - The atmosphere at the negotiations is characterized by a cautious and low-key approach from pharmaceutical representatives, with an increased emphasis on confidentiality [3][4] - A total of 535 drugs are under review, with 311 outside the directory and 224 within it, alongside 121 high-value drugs reviewed under the commercial insurance innovation drug directory [9][10] Group 1: Negotiation Atmosphere - The entry process for pharmaceutical representatives was notably quieter and more orderly compared to previous years, reflecting a more subdued approach [3][4] - Representatives from both domestic and multinational pharmaceutical companies, including notable names like 恒瑞医药 and 阿斯利康, participated in the negotiations [4][9] Group 2: Key Drug Categories - Antibacterial drugs are expected to be a significant focus in the afternoon session of the negotiations, with specific products like 万古霉素 being highlighted [9][10] - Innovative drugs, including CAR-T products and new lipid-lowering medications, are also under consideration, with 恒瑞医药 presenting multiple products for initial review [10][12] Group 3: Market Insights - The PCSK9 inhibitor 瑞卡西单抗 has gained attention for its long-acting properties, with a market size of 1.32 billion yuan in 2023, representing 7.8% of the national lipid-lowering drug market [10][11] - The long-acting 阿立哌唑微球 from 丽珠集团 is another product of interest, potentially replacing oral formulations and capturing market share if included in the insurance directory [12]

Summary of the Conference Call for 恒瑞医药 (Hengrui Medicine) Company Overview - **Company**: 恒瑞医药 (Hengrui Medicine) - **Industry**: Pharmaceutical Key Financial Performance - **Revenue**: - Total revenue for the first three quarters of 2025 reached 231.9 billion CNY, a year-on-year increase of 14.9% - Q3 revenue was 74.3 billion CNY, up 12.7% year-on-year [2][5] - **Net Profit**: - Net profit attributable to shareholders for the first three quarters was 57.5 billion CNY, a 24.5% increase year-on-year - Q3 net profit was 13 billion CNY, up 9.5% year-on-year [2][5] - **Cash Flow**: - Operating cash flow for the first three quarters was 91.1 billion CNY, an increase of 45.2 billion CNY year-on-year - Q3 cash inflow was 48.1 billion CNY, up 15.5 billion CNY year-on-year [2][5] Product and Market Developments - **Innovative Drugs**: - Sales of innovative drugs accounted for 55% of total product sales, with rapid growth in products like 瑞维鲁胺 (Revelizumab), 达尔西利 (Darsylin), and 恒格列净 (Henggrelin) [2][5] - The company has launched 24 first-class innovative drugs and 5 second-class innovative drugs in China [3] - **Licensing Income**: - Significant increase in licensing income, with confirmed upfront payments totaling 290 million USD from collaborations with companies like艾迪尔 (Ediar), 默沙东 (Merck), and 默克 (Merck) [2][5] - **Clinical Research**: - Over 20 international clinical studies initiated, with 8 new drug applications accepted by CDE and 48 drugs receiving clinical approval [3][4] Strategic Initiatives - **Self-Immunity Field**: - Deepening layout in self-immunity with differentiated products like 洒露丝抗体 (Sarlutamab) and a focus on dual and triple antibody platforms [6][7] - **Metabolic Field**: - Progress in GLP-1, GIP peptide, and GLP-1 small molecule projects, with Clara securing 600 million USD in financing for further clinical development [8] - **Internationalization Strategy**: - Active internationalization through partnerships and collaborations, with a focus on global clinical research and regulatory compliance [11] Challenges and Adjustments - **Market Competition**: - Adjustments made to integrate non-oncology businesses into a biopharmaceutical division to enhance operational efficiency and manage the influx of new products [12] - **Cost Management**: - Increased management expenses due to talent acquisition and currency losses impacting net profit margins [23][24] Future Outlook - **Healthcare Negotiations**: - Preparing for upcoming healthcare negotiations, aiming to enhance accessibility and affordability of innovative drugs [16] - **Research and Development**: - Continued investment in R&D platforms, including AI technology, to improve drug discovery and development efficiency [22] - **Global Expansion**: - Plans to establish overseas commercial teams and production bases to strengthen international market presence by 2026 [21] Additional Insights - **Clinical Data Presentation**: - Significant data presented at ADA 2025, showing a 20% weight loss in a 48-week trial for the small molecule drug 9,531, indicating its potential in obesity management [9][10] - **BD Strategy**: - Strong focus on business development (BD) with over 15 licensing deals totaling more than 27 billion USD, showcasing the company's innovative capabilities [20] This summary encapsulates the key points from the conference call, highlighting the financial performance, product developments, strategic initiatives, challenges, and future outlook for 恒瑞医药.

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The innovative drug industry is entering a rapid growth phase, with significant investment opportunities expected in the next 6-12 months [3] - The pharmaceutical sector is experiencing a shift from generic drugs to innovative drugs, with major companies showing robust performance and growth driven by internationalization and commercialization capabilities [5][14] - The optimization of centralized procurement policies and the support of commercial insurance are expected to benefit the pharmaceutical industry in the long term [6][31] Summary by Sections 1. Performance Overview - The pharmaceutical sector's performance in the first half of 2025 shows steady growth, with a transition from generic to innovative drugs. Key companies like Hengrui Medicine reported a revenue of 15.76 billion yuan (up 15.88% year-on-year) and a net profit of 4.45 billion yuan (up 29.67% year-on-year) [5][14] - China National Pharmaceutical Group also achieved double-digit growth, with a revenue of 17.58 billion yuan (up 9.8% year-on-year) and a net profit of 3.39 billion yuan (up 13.10% year-on-year) [5][14] - The innovative drug revenue for Hengrui Medicine exceeded 60%, with significant contributions from newly approved drugs [16] 2. Market Dynamics - The National Healthcare Security Administration has initiated adjustments to the national basic medical insurance and commercial health insurance drug directories, which are expected to enhance the market for innovative drugs [6][29] - The recent centralized procurement policies have shifted from broad price reductions to more refined management, which is anticipated to stabilize the expectations for generic drug businesses [6][34] 3. Recommended Stocks - Recommended stocks in the pharmaceutical and biotechnology sector include Hengrui Medicine, CSPC Pharmaceutical Group, East China Pharmaceutical, and others, which are expected to benefit from the ongoing transformation and innovation in the industry [7][30] 4. Innovation and Internationalization - The report highlights that many traditional pharmaceutical companies are undergoing innovation transformations, with significant R&D investments expected to yield results in the near future. For instance, Hengrui Medicine and CSPC Pharmaceutical Group are projected to exceed 5 billion yuan in R&D expenses [36] - The total amount of license-out transactions for Chinese innovative drugs reached nearly 66 billion USD in the first half of 2025, indicating a strong internationalization trend [36]

Core Insights - The competitiveness of the biopharmaceutical industry ultimately reflects the cluster effect [1][11] - The biopharmaceutical industry is a core track of global technological revolution and industrial transformation, serving as a key indicator of regional economic high-quality development [2] Industry Development - The Yangtze River Delta region, centered around Shanghai Zhangjiang and Suzhou BioBAY, has established a first-mover advantage in the biopharmaceutical field due to early policy layouts, dense research resources, and a complete industrial chain [2] - Guangzhou Huangpu District has not lagged despite being a latecomer; it has optimized its policy system, built talent aggregation platforms, and focused on breakthroughs in niche markets, gradually compensating for industrial chain shortcomings [2][12] Key Companies and Innovations - Yunzhou Biotech, founded by Dr. Lan Tian in Huangpu District in 2014, focuses on gene delivery, a critical link between basic research and clinical application [3] - The company developed the world's first intelligent design and ordering platform for gene carriers, integrating over 120 carrier systems and more than 2 million carrier components, significantly lowering the barriers for researchers [4][5] - Yunzhou Biotech has become the world's largest custom gene carrier supplier, serving over 7,000 institutions in more than 130 countries, with a cumulative delivery of over 1 million carriers by September 2024 [5][6] Market Position and Achievements - In 2023, Yunzhou Biotech achieved a valuation of 7 billion, becoming a unicorn and the first biopharmaceutical company in Guangzhou to reach this status [6] - The company has established a full-service capability in the gene drug development chain, including CRO and CDMO services, with its products approved for clinical trials in the U.S. [6][7] Competitive Landscape - Innovation in drug development is a core competitive advantage in the biopharmaceutical industry, with companies like Kangfang Biopharma emerging as leaders in the field [8] - Kangfang Biopharma has developed over 50 innovative drug candidates, with 24 products undergoing clinical trials, and has successfully commercialized 7 first-class new drugs [10] Ecosystem and Collaboration - Huangpu District's "bending overtaking" is not merely the success of a single enterprise but a result of creating a quality industrial ecosystem that fosters collaboration between leading external companies and local enterprises [12] - The presence of major companies like Hengrui Medicine and Nuocheng Jianhua in Huangpu has attracted a network of supporting enterprises, enhancing the regional industrial chain [13][14]

Investment Rating - The report maintains a "Buy" rating for the company [6] Core Insights - The company achieved a revenue of 15.76 billion yuan in H1 2025, representing a year-over-year growth of 15.88%, and a net profit attributable to shareholders of 4.45 billion yuan, up 29.67% year-over-year, slightly exceeding expectations due to a significant increase in licensing income [1][2] Summary by Sections Revenue and Profit Growth - The company's innovative drug sales and licensing income reached 9.56 billion yuan in H1 2025, accounting for 60.66% of total revenue, with innovative drug sales alone contributing 7.57 billion yuan. The clinical value of innovative drugs such as Rivoraxaban and Darsilene has been recognized by doctors, leading to rapid revenue growth [2] Business Development (BD) Achievements - In H1 2025, the company secured three external licensing agreements, including a 15 million euro upfront payment from Merck for an oral GnRH receptor antagonist, a 200 million USD upfront payment from MSD for an Lp(a) inhibitor, and a 500 million USD upfront payment from GSK for 12 new drugs. The total potential milestone payments and sales royalties from these agreements could reach up to 17.7 billion USD [3] Operational Efficiency - The company's management, sales, and R&D expense ratios were 8.15%, 27.85%, and 20.48% respectively, showing a year-over-year decrease of 0.48pp, 1.11pp, and 1.86pp, indicating effective cost control and improved operational efficiency. The net operating cash flow increased significantly by 41.80% to 4.30 billion yuan, reflecting strong cash generation capabilities [3] Profit Forecast and Valuation - The company is recognized as a leading player in China's innovative drug sector, with continuous investment in R&D. The net profit forecasts for 2025-2027 have been raised to 9.05 billion yuan, 9.48 billion yuan, and 10.60 billion yuan respectively, with corresponding P/E ratios of 48, 45, and 41 [4][5]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% in the next 6-12 months [5]. Core Insights - The company achieved a revenue of 15.76 billion RMB in H1 2025, representing a year-on-year growth of 15.88%, and a net profit attributable to shareholders of 4.45 billion RMB, up 29.67% year-on-year [2]. - The sales and licensing revenue from innovative drugs reached 9.56 billion RMB, accounting for 60.66% of total revenue, with significant contributions from new drugs such as Rivaroxaban and others [3]. - The company has successfully established multiple partnerships, generating substantial upfront payments, which have significantly enhanced its performance [3]. - R&D investment totaled 3.87 billion RMB in H1 2025, with a focus on over 100 innovative products undergoing more than 400 clinical trials [4]. - The company is expected to achieve revenues of 33.8 billion RMB, 38 billion RMB, and 42.6 billion RMB in 2025, 2026, and 2027 respectively, with net profits projected at 9 billion RMB, 10.5 billion RMB, and 12.1 billion RMB for the same years [5]. Summary by Sections Performance Review - In H1 2025, the company reported a revenue of 15.76 billion RMB, a 15.88% increase year-on-year, and a net profit of 4.45 billion RMB, reflecting a 29.67% growth [2]. Operational Analysis - The innovative drug sales and licensing revenue reached 9.56 billion RMB, with new drugs like Rivaroxaban and others showing strong growth [3]. - The company has successfully executed several high-value partnerships, including a 2 billion USD deal with MSD and a 750 million USD deal with IDEAYA, contributing to its revenue growth [3]. Research and Development - The company invested 3.87 billion RMB in R&D in H1 2025, with 6 new class 1 drugs approved, indicating a fruitful R&D phase [4]. - The company is conducting over 400 clinical trials for more than 100 innovative products, showcasing its commitment to innovation [4]. Profit Forecast and Valuation - The company is projected to achieve revenues of 33.8 billion RMB, 38 billion RMB, and 42.6 billion RMB in 2025, 2026, and 2027, respectively, with net profits expected to reach 9 billion RMB, 10.5 billion RMB, and 12.1 billion RMB [5].

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，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年8月20日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 江苏恒瑞医药股份有限公司 2025 年半年度报告 公司代码：600276 ...

Core Insights - Sanofi has confirmed the cessation of the promotion of its PCSK9 inhibitor, Alirocumab, in the Chinese market due to global supply issues and a strategic upgrade in its cardiovascular product line [2][3] - The exit of Alirocumab from the market has opened opportunities for domestic pharmaceutical companies to enter the PCSK9 inhibitor space [1][3] Industry Overview - PCSK9 inhibitors are considered a milestone in lipid-lowering therapies, with significant implications for managing high LDL cholesterol levels, which are primarily influenced by genetic factors [1][3] - The understanding of lipoprotein(a) [Lp(a)] in cardiovascular diseases has led to increased interest in developing new lipid-lowering drugs targeting this specific marker [1][7] Market Dynamics - The market for lipid-lowering medications is competitive, with established statin drugs and newer PCSK9 inhibitors being used in combination for optimal patient outcomes [4][5] - There are currently seven approved PCSK9 inhibitors in China, including both imported and domestic products, with ongoing developments from various companies [5][6] Emerging Opportunities - Companies are actively pursuing the development of alternative medications in light of Alirocumab's market exit, indicating a robust interest in the PCSK9 inhibitor segment [3][6] - The market is also seeing advancements in therapies targeting Lp(a), with several multinational corporations engaged in clinical trials for new drugs aimed at lowering Lp(a) levels [7]

Core Viewpoint - Eli Lilly announced the acquisition of Verve Therapeutics for up to $1.3 billion, including nearly $1 billion upfront payment, which significantly boosted Verve's stock price by over 80% on the announcement day [1][3]. Group 1: Acquisition Details - Eli Lilly's acquisition of Verve Therapeutics aims to enhance its portfolio in the cardiovascular disease treatment sector, alongside its existing GLP-1 weight loss drug, expected to generate over $30 billion in total sales this year [3]. - Verve Therapeutics is developing a gene-editing therapy, Verve-102, targeting the PCSK9 protein to lower cholesterol levels, potentially transforming chronic cardiovascular disease treatment into a one-time therapy [1][3]. Group 2: Market Potential and Clinical Trials - Verve-102 is currently undergoing a Phase 1b clinical trial and has received Fast Track designation from the FDA, indicating its potential for significant market impact if proven effective [3]. - The gene therapy market for cardiovascular diseases may face skepticism regarding demand, as existing PCSK9-targeting drugs already meet a substantial portion of market needs [4]. Group 3: Competitive Landscape - The PCSK9 monoclonal antibodies have shown to reduce LDL cholesterol levels by over 50% compared to statins, with several products already available in the market, including a long-acting PCSK9 monoclonal antibody recently launched in China [4][5]. - Oral PCSK9 inhibitors from major pharmaceutical companies like Merck and AstraZeneca are expected to drive sales from approximately $4 billion to $12 billion by 2034, indicating a growing competitive landscape [6].

Core Viewpoint - Heng Rui Medicine reported record high revenue and net profit for Q1 2025, but the market reaction was lukewarm, with a slight decline in stock price despite strong financial performance [1][2]. Financial Performance - For Q1 2025, Heng Rui Medicine achieved revenue of 7.206 billion yuan, a year-on-year increase of 20.14% [1] - The net profit attributable to shareholders was 1.874 billion yuan, up 36.90% year-on-year [1] - The net profit excluding non-recurring items was 1.863 billion yuan, reflecting a 29.35% increase year-on-year [1] Licensing and R&D Investments - The company recognized a $75 million upfront payment from IDEAYA Biosciences as revenue, contributing to profit growth [2] - Heng Rui Medicine licensed the global development rights (excluding Greater China) for the antibody-drug conjugate SHR-4849 to IDEAYA Biosciences [2] - Cumulative R&D investment reached 46 billion yuan, with R&D expenses for Q1 2025 amounting to 1.533 billion yuan [2] New Drug Approvals and Management Changes - Six innovative products have been approved in 2025, including a new generation JAK1 inhibitor and the first PCSK9 inhibitor in the cardiovascular field [3] - In Q1 2025, the company received 28 clinical trial approval notices [3] - A significant management change occurred with the appointment of Feng Ji as the new president and COO, seen as a move towards accelerating innovation and transformation [3]