Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. has received acceptance for the drug listing application of HRS-5965 capsules from the National Medical Products Administration (NMPA) [1] - The drug HRS-5965 is intended for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1][2] - The clinical trial for HRS-5965 demonstrated significant improvements in hemoglobin levels, reduced need for blood transfusions, and enhanced quality of life compared to the existing treatment, eculizumab [2] Group 2 - PNH is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [3] - HRS-5965 is a complement factor B inhibitor that aims to improve hemoglobin levels in PNH patients [3] - Currently, the only approved drug for this indication is Novartis's eculizumab, which is projected to have global sales of approximately $129 million in 2024 [3] Group 3 - The company has also received clinical trial approval for several other drugs, including SHR-4394 for prostate cancer, HRS-5041 for prostate cancer, and Zemeituzumab for peripheral T-cell lymphoma [9][10][11] - SHR-4394 has a cumulative R&D investment of approximately 38.4 million yuan, while HRS-5041 has an investment of about 92.66 million yuan [9][10] - Zemeituzumab was approved in 2025 and has a cumulative R&D investment of around 216.82 million yuan, with a projected global sales of approximately $51 million in 2024 [10]

Core Viewpoint - The A-share and Hong Kong stock markets for the pharmaceutical sector have shown a strong recovery at the beginning of 2026, marked by a "five consecutive days of gains" trend, driven by supportive policies, payment innovations, and explosive growth in overseas markets [2][4][6]. Group 1: Market Performance - As of the latest close, the A-share innovative drug ETF (159992) closed at 0.897 CNY per share, up 1.7%, with a daily trading volume of 845 million CNY, and a year-to-date increase of 7.94% [2]. - The Hong Kong innovative drug ETF (159570) closed at 0.553 HKD per share, up 0.91%, with a trading volume of 572 million HKD, and a year-to-date increase of 11.04% [4]. - Notable stocks such as Weikang Pharmaceutical, Frontier Biologics-U, and Hongbo Pharmaceutical achieved daily price limits, indicating strong market sentiment [2][4]. Group 2: Policy Support - The turnaround in market sentiment is attributed to a combination of policy support, payment innovations, and explosive growth in overseas markets [6]. - The new medical insurance directory and the first commercial insurance innovative drug directory were launched simultaneously, further supporting the innovative drug sector [6]. - Local policies have also been strengthened, with the Guangzhou government announcing plans to accelerate the strategic layout of innovative drugs, focusing on monoclonal antibodies, vaccines, and blood products [8]. Group 3: Regulatory Improvements - The approval process for innovative drugs has entered a fast track, with the National Medical Products Administration (NMPA) enhancing support for innovative drugs with new mechanisms and targets [8]. - The NMPA has optimized the review and approval processes for urgently needed foreign drugs, aiming to shorten the listing cycle for innovative drugs [8]. - As of early 2026, several significant drugs have been approved, setting a positive tone for the industry's development [9]. Group 4: Supply Chain and Production - In 2025, a record 76 innovative drugs were approved for listing, with over one-third in the oncology treatment field, indicating a strong focus on cancer research [10]. - The majority of approved drugs were domestically developed, with a domestic rate of 85.53%, highlighting the strength of local innovation [12]. Group 5: Payment Innovations - A multi-tiered payment system has been established to address the "payment difficulty" that has historically hindered the development of innovative drugs in China [14]. - The new medical insurance directory includes 114 drugs, with an 88% success rate for inclusion, and 80% of innovative drugs entering the directory within two years of listing [16]. - The introduction of a commercial insurance directory for high-value innovative drugs enhances patient access and secures profitability for companies [16]. Group 6: International Expansion - The overseas market for Chinese innovative drugs has seen explosive growth, with total overseas authorization transaction amounts reaching 1356.55 billion USD in 2025, significantly up from 519 billion USD in 2024 [17]. - The focus on antibody drugs and ADCs has attracted attention from overseas pharmaceutical companies, with a shift towards later-stage clinical authorizations [17]. - The growth in overseas business not only provides substantial upfront payments but also benefits the entire industry chain, including contract research organizations (CROs) [17][18].

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received a notice from the National Medical Products Administration regarding the acceptance of its drug application for HRS-5965 capsules, aimed at treating adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1] Group 1: Drug Development and Clinical Trials - The application for HRS-5965 is based on a key study (HRS-5965-301) evaluating the efficacy of HRS-5965 capsules compared to eculizumab in PNH patients who have not previously received complement inhibitor therapy [1] - The phase III clinical trial involved 76 patients and was conducted across 13 centers in China, led by prominent researchers from the Chinese Academy of Medical Sciences [1] - The total research and development investment for HRS-5965 capsules has reached approximately 218 million yuan [1]

Group 1 - The company, Heng Rui Medicine, stated that it regularly discloses the number of shareholders as required [1] - Investors are advised to pay attention to the relevant content in the periodic reports [1]

Group 1 - JPMorgan increased its stake in Heng Rui Medicine (01276) by 1,127,828 shares at a price of HKD 74.6126 per share, totaling approximately HKD 84.15 million [1] - After the increase, JPMorgan's total shareholding in Heng Rui Medicine is approximately 19.194 million shares, representing a holding percentage of 7.43% [1]

Group 1 - The core point of the article is that JPMorgan has increased its stake in Heng Rui Medicine (600276) by purchasing 112,782.8 shares at a price of 74.6126 HKD per share, totaling approximately 84.15 million HKD [1] - After the purchase, JPMorgan's total holdings in Heng Rui Medicine amount to approximately 19.194 million shares, representing a holding percentage of 7.43% [1]

（编辑 丛可心） 证券日报网讯 1月9日，恒瑞医药在互动平台回答投资者提问时表示，公司坚持科技创新与国际化两大 发展战略，创新成果转化高效赋能，创新药销售引领业绩增长。2025年上半年，公司创新药销售及许可 收入95.61亿元，占公司营业收入比重60.66%。此外，公司自2023年以来达成12笔创新成果对外授权， 潜在总交易额超270亿美元。公司将继续大力推进"科技创新"和"国际化"两大发展战略，稳步推进研发 创新和制剂产品的国际化。同时，也将着力于产品结构的优化提升，通过产品创新升级和多元化产品管 线的拓展推动公司的持续发展，促进公司业绩可持续增长，以更好的发展回馈股东。 ...

证券日报网讯1月9日，恒瑞医药（600276）在互动平台回答投资者提问时表示，二级市场股价受宏观经 济、市场情绪等多重因素影响。公司将继续大力推进"科技创新"和"国际化"两大发展战略，稳步推进研 发创新和制剂产品的国际化。同时，也将着力于产品结构的优化提升，通过产品创新升级和多元化产品 管线的拓展推动公司的持续发展，促进公司业绩可持续增长，以更好地发展回馈股东。 ...

Core Viewpoint - Heng Rui Medicine (600276) is strategically expanding its presence across multiple therapeutic areas, focusing on long-term diversified growth through a robust R&D pipeline in oncology and other fields [1] Group 1: Strategic Development - The company has a comprehensive layout in various treatment areas, including oncology, metabolic and cardiovascular diseases, immunology, respiratory diseases, and neuroscience [1] - Heng Rui Medicine is committed to a differentiated R&D strategy that is guided by clinical needs, utilizing advanced technology platforms to develop a highly differentiated innovative product matrix [1] Group 2: Global Expansion and Collaboration - The company plans to accelerate its global expansion steadily and deepen external collaborations to enhance its overseas R&D capabilities [1] - There is a focus on strengthening commercialization capabilities in both domestic and international markets to maximize the global market potential of high-quality innovative products [1]

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received a notice of acceptance from the National Medical Products Administration for the marketing authorization application of HRS-5965 capsules, a treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) [1][2] Group 1: Company Developments - The application for HRS-5965's market approval is based on a pivotal study involving PNH patients who had not previously received complement inhibitor treatment [1] - The clinical study (HRS-5965-301) was a Phase III trial comparing HRS-5965 capsules with Eculizumab in treating PNH patients, led by prominent researchers from the Chinese Academy of Medical Sciences [1] - The study included 76 patients across 13 centers nationwide, showing that HRS-5965 significantly improved hemoglobin levels, reduced the need for blood transfusions, and enhanced quality of life compared to Eculizumab [1] Group 2: Industry Context - PNH is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis, and has been included in the national rare disease directory due to its low incidence/prevalence [2] - HRS-5965 capsules act as a complement factor B inhibitor, which can suppress complement-mediated hemolysis and improve hemoglobin levels [2] - Currently, the only other drug targeting this indication is Novartis's Iptacopan (Fabhalta), which is projected to generate global sales of approximately $129 million in 2024 [2] - The cumulative R&D investment for HRS-5965 capsules has reached approximately 218 million yuan [2]