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]

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received a notice of acceptance from the National Medical Products Administration for the market approval application of HRS-5965 capsules, a treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) [1][2] Group 1: Product Development - The application for HRS-5965 is based on a pivotal study involving PNH patients who had not previously received complement inhibitor treatment [1] - The study, HRS-5965-301, is a Phase III clinical trial comparing HRS-5965 capsules with Eculizumab in treating PNH patients, involving 76 patients across 13 centers in China [1] - Results indicate that HRS-5965 significantly improves hemoglobin levels, reduces the need for blood transfusions, and alleviates fatigue compared to Eculizumab, enhancing patients' quality of life [1] Group 2: Market Context - PNH is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [2] - HRS-5965 is a complement factor B inhibitor that can suppress complement-mediated hemolytic reactions and improve hemoglobin levels [2] - Currently, the only approved drug targeting this indication is Novartis's Iptacopan (Fabhalta), with projected global sales of approximately $129 million in 2024 [2] - The cumulative R&D investment for HRS-5965 has reached approximately 218 million yuan [2]

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, indicating progress in the drug approval process for treating Paroxysmal Nocturnal Hemoglobinuria (PNH) in adult patients [1]. Group 1 - The drug name is Fumaric Acid Likanopam Capsules [1] - The dosage form is capsule [1] - The acceptance number for the application is CXHS2600014 [1] - The application is currently in the marketing phase [1] - The applicant is Chengdu Shengdi Pharmaceutical Co., Ltd. [1] - The intended indication is for the treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1]

Core Insights - 恒瑞医药 has received approval from the National Medical Products Administration for clinical trials of several new drugs, including SHR-4394, HRS-5041, Zemeituzumab, and Rivolumab [1][2] Group 1: Drug Approvals and Clinical Trials - The company has been granted approval to conduct clinical trials for SHR-4394, a self-developed biopharmaceutical aimed at treating prostate cancer, with a total R&D investment of approximately 38.4 million yuan [1] - HRS-5041 is a new, efficient, and selective AR PROTAC small molecule also targeting prostate cancer, with a total R&D investment of about 92.66 million yuan [1] - Zemeituzumab is a novel oral EZH2 inhibitor approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in adults, with a total R&D investment of around 217 million yuan [2] - Rivolumab is a second-generation AR inhibitor approved for treating high-burden metastatic hormone-sensitive prostate cancer, with a total R&D investment of approximately 697 million yuan [2] Group 2: Market Context and Competitors - Currently, there are no approved products in the market for SHR-4394 and HRS-5041, indicating a potential first-mover advantage for the company [1] - Zemeituzumab faces competition from Tazemetostat and Valemetostat, which are already approved in the market, with Tazemetostat projected to generate global sales of about 51 million dollars in 2024 [2] - Rivolumab competes with several second-generation AR inhibitors, including Enzalutamide, Apalutamide, and Darolutamide, with projected global sales of similar products reaching approximately 11.037 billion dollars in 2024 [2]

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 2026年1月9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。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-006 ...

Core Insights - The company has received approval from the National Medical Products Administration for clinical trials of several new drugs, including SHR-4394, HRS-5041 tablets, Zemeituzumab tablets, and Rivolumab tablets [1][2] Group 1: SHR-4394 - SHR-4394 is a self-developed biopharmaceutical intended for the treatment of prostate cancer, with no similar products approved for sale domestically or internationally [1] - The total R&D investment for SHR-4394 has reached approximately 38.4 million yuan [1] Group 2: HRS-5041 Tablets - HRS-5041 is a new, efficient, and selective AR PROTAC small molecule aimed at treating prostate cancer, showing significant degradation effects on wild-type and most mutant AR proteins [1] - There are currently no similar products approved for sale domestically or internationally, with a total R&D investment of about 92.66 million yuan [1] Group 3: Zemeituzumab Tablets - Zemeituzumab is a new, efficient, and selective oral EZH2 inhibitor approved for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) who have received at least one line of systemic therapy [2] - Similar products include Tazemetostat and Valemetostat, with Tazverik's global sales projected to be approximately 51 million dollars in 2024 [2] - The total R&D investment for Zemeituzumab has reached about 217 million yuan [2] Group 4: Rivolumab Tablets - Rivolumab is a second-generation AR inhibitor with stronger AR inhibition and no agonistic effects, approved for the treatment of high-burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [2] - Competing products include Enzalutamide, Apalutamide, and Darolutamide, with global sales of similar products projected to be around 11.037 billion dollars in 2024 [2] - The total R&D investment for Rivolumab has reached approximately 697 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of multiple drugs, indicating progress in its oncology treatment pipeline [1] Group 1: Drug Approvals - Jiangsu Heng Rui Medicine Co., Ltd. and its subsidiaries have been granted clinical trial approval for SHR-4394, HRS-5041 tablets, Zemeituo Sita tablets (SHR-2554), and Ruvelamine tablets [1] - The approval is based on compliance with the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] Group 2: Clinical Trials - The clinical trials will focus on the safety, tolerability, and efficacy of SHR-4394 or HRS-5041 in combination with anti-tumor treatment in participants with prostate cancer [1] - The trials are categorized as multi-center and open-label Phase II studies [1]

Core Viewpoint - The Hong Kong IPO market experienced a strong resurgence in 2025, with 114 companies completing listings and raising a total of 285.3 billion HKD, a 224% increase from 88.1 billion HKD in 2024, making it the largest IPO fundraising exchange globally [1][9]. Industry Analysis - The fundraising distribution in the Hong Kong IPO market shows a clear structural characteristic, with significant differences in financing vitality and capital preferences across different sectors, highlighting the importance of understanding the market ecology [1][9]. - The top five industries—Industrial, Information Technology, Consumer Discretionary, Materials, and Healthcare—accounted for 90% of the total fundraising, raising a combined 260.2 billion HKD, demonstrating the strong appeal of core sectors to investors [1][9]. Major Fundraising Projects - Notably, the largest IPO projects in these five industries came from well-known companies, including CATL, which raised 41.0 billion HKD, and SANY Heavy Industry, which raised 15.3 billion HKD through A to H listings [3][11]. - The fundraising landscape changes significantly when excluding established companies, revealing that the top three industries for new entrants are Consumer Discretionary, Information Technology, and Healthcare, which collectively raised 72.5 billion HKD, representing 81% of the total for new entrants [4][12]. Sector Highlights - The Consumer Discretionary sector led the new entrants with a total fundraising of 30.2 billion HKD, driven by key players like Chery Automobile, which raised 10.4 billion HKD [6][14]. - The Information Technology sector also performed well, with 20 new entrants raising a total of 21.8 billion HKD, benefiting from the rise of robotics and artificial intelligence [6][14]. - The Healthcare sector raised 20.5 billion HKD, with 16 unprofitable biotech companies completing IPOs, accounting for 65% of the sector's total fundraising, showcasing the sector's potential as a financing platform for innovative medical enterprises [6][14]. Market Preferences - The distribution of industry fundraising aligns with market capital preferences, where established industries attract long-term capital due to stable profitability, while new sectors like Consumer Discretionary, Information Technology, and Healthcare are favored for their high growth potential [7][15].

江蘇恒瑞醫藥股份有限公司 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。 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） Jiangsu Hengrui Pharmaceuticals Co., Ltd. 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-005 江苏恒瑞医药股份有限公司 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 2026年1月9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。 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。 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 ...

Core Viewpoint - The Hong Kong IPO market experienced a strong resurgence in 2025, with 114 companies completing listings and raising a total of HKD 285.3 billion, a 224% increase from HKD 88.1 billion in 2024, making it the largest IPO fundraising exchange globally [1][3]. Group 1: IPO Market Performance - The significant rebound in the IPO market is attributed to both the global liquidity environment and the concentrated demand from mainland companies seeking to raise funds in Hong Kong [1][3]. - The fundraising landscape in 2025 is characterized by a dominance of familiar types of listings, including A to H, spin-offs, and returning Chinese companies, which collectively contributed over 70% of the total fundraising [1][3]. Group 2: A to H Listings - A to H listings emerged as the absolute mainstay of fundraising in 2025, with 19 A-share companies successfully listing in Hong Kong, raising a total of HKD 140 billion, accounting for 49% of the total IPO fundraising [3]. - Notable A to H IPOs include CATL, which raised HKD 41 billion, followed by SANY Heavy Industry (HKD 15.3 billion), Seres (HKD 14.3 billion), and others, all contributing significantly to the overall fundraising [3]. Group 3: Spin-offs and Related Listings - In 2025, four companies completed spin-off listings, raising a total of HKD 34.9 billion, with Zijin Mining International leading at HKD 28.7 billion [3]. - Related companies, such as Innovation Industry and Conch Materials Technology, raised a combined HKD 6.8 billion, leveraging their parent company resources [3]. Group 4: Returning Chinese Companies - Three Chinese companies returned to Hong Kong for secondary listings, focusing on advanced sectors like smart driving and lidar, raising a total of HKD 13.9 billion [4]. - The trend of returning Chinese companies is expected to encourage more firms to consider dual listings in Hong Kong, enhancing market dynamics [4]. Group 5: Market Structure Changes - The fundraising structure has shifted significantly over the years, with familiar faces dominating the market in 2025, contrasting with the balanced new face listings seen in 2021-2022 [4]. - The proportion of familiar face listings surged in 2025, marking a reversal from the previous year's decline, driven by the resurgence of A to H listings [4]. Group 6: Market Outlook - The Hong Kong market serves as a crucial bridge between mainland and global capital, requiring both established players and new entrants to enhance market vitality [6]. - The expectation is for more high-quality unlisted entities, like Chery Automobile, to enter the market, bringing innovation and growth potential [6].