Investment Rating - The report maintains an "Outperform" rating for the industry [1] Core Insights - ASCVD (Atherosclerotic Cardiovascular Disease) is a leading cause of death globally, with significant mortality rates in both the US and China. In 2022, approximately 370,000 deaths from coronary heart disease and 160,000 from stroke were reported in the US, while China saw around 1.96 million deaths from ischemic heart disease and 2.3 million from stroke in 2021 [2][5][26] - The report highlights the increasing focus of multinational pharmaceutical companies (MNCs) on cardiovascular treatments, particularly targeting PCSK9 and Lp(a). The global market for PCSK9 is projected to reach between $11 billion and $19 billion, while the Lp(a) inhibitor market is expected to reach $3 billion to $7 billion [2][3] - Upcoming Phase 3 clinical trials for cardiovascular endpoints are anticipated to yield significant data in the coming years, with several studies scheduled for completion between 2025 and 2029 [2][3] Summary by Sections ASCVD Disease Burden - ASCVD encompasses a range of conditions including coronary artery disease, cerebrovascular disease, and peripheral artery disease. It is associated with significant mortality and morbidity, with controllable risk factors such as dyslipidemia, diabetes, hypertension, and smoking [5][6] LDL-C: Unmet Needs Post-Statin Therapy - Despite the widespread use of statins, a substantial proportion of patients do not achieve target LDL-C levels, indicating a significant unmet need in the market for additional therapies [26] Lp(a): An Independent Risk Factor - Lp(a) is identified as an emerging risk factor for ASCVD, independent of LDL-C levels. Its levels are primarily genetically determined and show a skewed distribution in the population, with a notable percentage of individuals having elevated levels that correlate with increased cardiovascular risk [35][40] Investment Recommendations - The report identifies key companies involved in the development of Lp(a) inhibitors, including Hengrui Medicine and CSPC Pharmaceutical Group, which have entered into licensing agreements with major pharmaceutical companies for their respective Lp(a) small molecule inhibitors [2][3]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Views - The investment logic in the pharmaceutical sector is shifting from policy pressure to innovation-driven growth, with the "14th Five-Year Plan" directly supporting the development of innovative drugs and medical devices [8][26] - The industry is witnessing a transition from rapid following to original innovation, as demonstrated by Chinese companies showcasing their global competitiveness and pipeline value at the 2025 ESMO conference [8][26] - The recent approval of innovative drugs and the successful listing of companies on the STAR Market indicate a supportive capital market for innovative pharmaceutical enterprises [8][26] Industry Review - The pharmaceutical and biotechnology industry index increased by 1.89%, ranking 20th among 31 primary industries, underperforming the CSI 300 index which rose by 2.80% [5][16] - The sub-industries of medical research outsourcing and vaccines showed the highest gains, with increases of 5.26% and 4.19% respectively, while medical devices and traditional Chinese medicine experienced declines of 1.21% and 0.56% [5][16] - As of October 31, 2025, the industry’s PE (TTM, excluding negative values) was 30.67x, up from 30.08x in the previous period, indicating an upward valuation trend but still below the average [21] Company Dynamics - A total of 36 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 805 million yuan, with 4 companies increasing holdings by 120 million yuan and 32 companies reducing holdings by 925 million yuan [5][6] - Among the 501 tracked companies, 499 have disclosed their performance for the first three quarters of 2025, with 53 companies reporting a net profit growth of 100% or more, and 69 companies reporting growth between 30% and 100% [6] Investment Recommendations - Focus on companies with strong positions in innovative drugs and cutting-edge technology platforms, particularly those involved in ADC, bispecific/multispecific antibodies, and cell therapy, which can provide high potential for international market expansion [8] - Pay attention to the CXO industry, which is expected to see increased demand due to the recovery of innovative drug development and commercialization, especially for leading companies with strong service capabilities in new technology areas [8]

Core Points - The Investment Clock Index (399391) closed at 3364.41 points, up 0.23%, with a trading volume of 95.671 billion yuan and a turnover rate of 0.98% [1] - Among the index constituents, 66 stocks rose, with Xinghui Entertainment leading at a 9.29% increase, while 33 stocks fell, with Lingnan Holdings leading the decline at 5.24% [1] Index Constituents Summary - Major constituents include: - Kweichow Moutai (16.68% weight) at 1435.00 yuan, up 0.35%, with a market cap of 1797.008 billion yuan [1] - China Merchants Bank (15.74% weight) at 41.79 yuan, up 2.20%, with a market cap of 1053.937 billion yuan [1] - Zijin Mining (7.34% weight) at 30.00 yuan, down 1.64%, with a market cap of 797.327 billion yuan [1] - Wuliangye (5.26% weight) at 118.98 yuan, down 0.01%, with a market cap of 461.834 billion yuan [1] - Hengrui Medicine (4.84% weight) at 63.40 yuan, down 1.17%, with a market cap of 420.798 billion yuan [1] Capital Flow Summary - The index constituents experienced a net outflow of 2.407 billion yuan from institutional investors and 0.251 billion yuan from retail investors, while retail investors saw a net inflow of 2.658 billion yuan [3] - Notable capital flows include: - China Merchants Bank with a net inflow of 433.16 million yuan from institutional investors [3] - China Petroleum with a net inflow of 326 million yuan from institutional investors [3] - China Shipbuilding with a net inflow of 284 million yuan from institutional investors [3]

Core Viewpoint - 恒瑞医药's subsidiary, 成都盛迪医药, has had its HRS-5965 capsule proposed for inclusion in the priority review list by the National Medical Products Administration, indicating a significant step in the drug's development process [1] Group 1: Product Development - HRS-5965 is a complement factor B inhibitor designed to treat Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] - The drug aims to inhibit complement-mediated hemolytic reactions and improve hemoglobin levels in patients [1] Group 2: Market Context - PNH has a low incidence/prevalence and is included in the national list of rare diseases, highlighting the potential market for treatments in this area [1] - Currently, the only drug targeting the same mechanism is Novartis's Iptacopan (Fabhalta), which is projected to generate global sales of approximately $129 million in 2024 according to EvaluatePharma [1] Group 3: R&D Investment - The cumulative research and development investment for HRS-5965 has reached approximately 209.94 million yuan [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of Rivoceranib tablets, a second-generation AR inhibitor, which is expected to enhance its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Group 1: Product Development - Rivoceranib tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] Group 2: Market Context - Rivoceranib tablets are entering a competitive market with other second-generation AR inhibitors such as Enzalutamide, Apalutamide, and Darolutamide already available [1] - According to EvaluatePharma, the global sales for similar products are projected to reach approximately $11.037 billion in 2024 [1] Group 3: Investment and R&D - The cumulative R&D investment for Rivoceranib tablets has reached approximately 693.09 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical's HRS-5965 capsules have been proposed for inclusion in the priority review list by the National Medical Products Administration [1] Group 1: Product Information - HRS-5965 capsules are a complement factor B inhibitor designed to suppress complement-mediated hemolytic reactions and improve hemoglobin levels [1] - The target indication is Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare acquired hemolytic disease characterized by the lack of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] Group 2: Market Context - PNH has been included in the national list of rare diseases due to its low incidence/prevalence [1] - Currently, the only drug approved for this indication is Novartis' Iptacopan (Fabhalta®), which is projected to have a global sales revenue of approximately $129 million in 2024 according to EvaluatePharma [1] Group 3: R&D Investment - The cumulative R&D investment for the HRS-5965 project has reached approximately 209.94 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Rivolumab tablets, a second-generation AR inhibitor, which is expected to enhance its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Company Summary - Rivolumab tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] - Cumulative R&D investment in Rivolumab tablets has reached approximately 693 million yuan [1] Industry Summary - The global sales of similar second-generation AR inhibitors, including Enzalutamide, Apalutamide, and Darolutamide, are projected to total approximately 11.037 billion USD in 2024 [1]

Core Viewpoint - Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, has announced that its HRS-5965 capsules are proposed to be included in the priority review list by the National Medical Products Administration (NMPA) of China, indicating a significant step towards potential market approval for a treatment targeting paroxysmal nocturnal hemoglobinuria in adults who have not previously received complement inhibitors [1] Drug Information - Drug Name: HRS-5965 Capsules [1] - Dosage Form: Capsule [1] - Applicant: Chengdu Shengdi Pharmaceutical Co., Ltd. [1] - Proposed Indication: Treatment for adult patients with paroxysmal nocturnal hemoglobinuria who have not previously received complement inhibitor therapy [1] Priority Review Justification - The application meets the requirements outlined in the "Drug Registration Management Measures" and the announcement regarding the "Review Procedures for Breakthrough Therapy Drugs" issued by the NMPA [1] - The drug is categorized under priority review for "clinically urgent shortage drugs, innovative drugs, and modified new drugs for the prevention and treatment of major infectious diseases and rare diseases" [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Ruvelamib tablets in combination with HS-20093 injection for prostate cancer treatment [1] Company Summary - Ruvelamib tablets are a second-generation AR inhibitor, demonstrating stronger AR inhibition compared to first-generation inhibitors, with no agonistic effects [1] - Ruvelamib tablets were approved for market launch in 2022 for the treatment of high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [1]

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) FF305 表格類別： 股票 狀態： 新提交 確認 根據《主板上市規則》第13.25C條 / 《GEM上市規則》第17.27C條，我們在此確認，據我們所知所信，第一章節所述的每項股份發行或庫存股份出售或轉讓已獲發行人董事會正式授權批准，並遵 照所有適用上市規則、法律及其他監管規定進行，並在適用的情況下： (註7) 公司名稱： 江蘇恒瑞醫藥股份有限公司 呈交日期： 2025年11月3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 | A | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) ...