智通财经APP获悉，11月14日，中国证监会公布《境外发行上市备案补充材料要求((2025年11月10日— 2025年11月14日)》。中国证监会国际司公示10家企业补充材料要求，其中，公示提到要求英派药业补 充说明历次增资及股权转让定价依据、设立以来是否存在股份代持的情形等事项。据港交所9月26日披 露，南京英派药业股份有限公司向港交所主板递交上市申请，高盛、中金为联席保荐人。 中国证监会请英派药业补充说明以下事项，请律师核查并出具明确的法律意见： 四、关于本次发行上市及"全流通"：（1）请公司对照《监管规则适用指引——境外发行上市类第2号》 要求说明本次发行方案；（2）请说明本次拟参与"全流通"股东所持股份是否存在被质押、冻结或其他 权利瑕疵的情形。 英派药业成立于2009年，是一家处于商业化阶段的生物技术公司，专注于基于合成致死机制的精准抗癌 疗法的全球开发。公司建立了全面且先进的合成致死产品组合，是全球仅有三家同时拥有商业化阶段 PARP1/2抑制剂和临床阶段新一代PARP1选择性抑制剂的公司之一。 公司的核心产品塞纳帕利是一种PARP1/2抑制剂，已于2025年1月在中国获批用于卵巢癌"全人群"一线 ...

四、关于本次发行上市及"全流通"：(1)请公司对照《监管规则适用指引——境外发行上市类第2号》要 求说明本次发行方案；(2)请说明本次拟参与"全流通"股东所持股份是否存在被质押、冻结或其他权利 瑕疵的情形。 一、关于股权变动：(1)请说明公司历次增资及股权转让定价依据，是否实缴出资，是否存在未履行出 资义务、抽逃出资、出资方式存在瑕疵的情形，并就历次股权变动是否合法合规出具明确结论性意见； (2)请说明公司3家境外子公司涉及的境外投资、外汇登记等监管程序具体履行情况，并就合规性出具结 论性意见；(3)请说明公司设立以来是否存在股份代持的情形。 二、请说明公司持股5%以上的股东向上穿透后的境内主体是否存在法律法规规定禁止持股的主体。 三、请公司结合药物研发技术路线等情况说明公司及下属公司经营范围、实际业务经营是否涉及"人体 干细胞、基因诊断与治疗技术开发和应用"或其他外商投资准入限制或禁止领域及相关判断依据，本次 发行上市前后是否持续符合外商投资准入政策要求。 11月14日，中国证监会公布《境外发行上市备案补充材料要求((2025年11月10日—2025年11月14日)》。 中国证监会国际司公示10家企业补充材 ...

Core Viewpoint - The pharmaceutical industry is experiencing a surge in IPO activities in the Hong Kong stock market, with companies like Nanjing Inpai Pharmaceutical, Guangdong Runtai Pharmaceutical, and A-share listed Borui Pharmaceutical all submitting their listing applications simultaneously, reflecting a recovery in the capital market for biopharmaceuticals and the attractiveness of Hong Kong as a financing platform [1][7]. Group 1: Company Developments - Nanjing Inpai Pharmaceutical focuses on developing precision cancer drugs based on synthetic lethality mechanisms and has a robust pipeline of DNA damage repair products [3]. - Guangdong Runtai Pharmaceutical is the fourth largest provider of marketing and supply chain solutions in China's outpatient pharmaceutical market and aims to enhance its digital marketing and supply chain through IPO funding [4][6]. - Borui Pharmaceutical is transitioning from raw material production to innovative drug development, with plans to use IPO proceeds for research and international expansion [2][8]. Group 2: Financial Highlights - Borui Pharmaceutical's revenue from raw materials reached 885 million yuan in 2023, with a 170% year-on-year increase in antiviral product sales [2]. - The company has invested 380 million yuan in its core product BGM0504, which is in the clinical trial phase for type 2 diabetes and weight loss indications, representing 60% of its total R&D investment [2]. - Runtai Pharmaceutical's business model involves purchasing products from upstream pharmaceutical companies and selling them through various e-commerce platforms, indicating a clear revenue generation strategy [6]. Group 3: Market Trends and Challenges - The current environment of improving overseas liquidity and a favorable financing climate for the biopharmaceutical sector has led to increased IPO activities [7]. - The Hong Kong market's regulatory framework allows unprofitable biotech companies to list, providing early capital access for firms like Inpai Pharmaceutical [9]. - Despite the positive trends, liquidity issues in the Hong Kong market remain a concern, with analysts noting that the enthusiasm for biopharmaceuticals in the primary market is still not sufficiently high [10][11].

Core Insights - The company, established in 2009, is a biotechnology firm focused on the global development of precision cancer therapies based on synthetic lethality mechanisms, possessing a comprehensive and advanced product portfolio [1] Product Highlights - The core product, Senaparib, is a PARP1/2 inhibitor approved for first-line maintenance treatment of ovarian cancer in China as of January 2025, demonstrating the largest progression-free survival benefit among approved PARP inhibitors for this indication [2] - Senaparib's marketing authorization application has been accepted by the European Medicines Agency, with an expected approval in the second half of 2026 [2] - The company has signed a commercial agreement with a subsidiary of Huadong Medicine for the commercialization of Senaparib in China, aiming to establish the largest gynecological oncology platform in the country [2] Pipeline Overview - The company has a diverse pipeline including several clinical-stage and preclinical assets targeting PARP and other key synthetic lethality pathways [3] - IMP1734, a next-generation selective PARP1 inhibitor, is currently in global Phase I/II trials, with plans to initiate Phase II in the second half of 2025 [3] - IMP9064, a potential first-in-class selective ATR inhibitor in China, is also in global Phase I/II trials and has received approval for combination studies with Senaparib [4] - IMP1707, a selective PARP1 inhibitor capable of penetrating the central nervous system, is undergoing Phase I clinical evaluation [5] - Other assets include preclinical candidates targeting WEE1, PKMYT1/WEE1, DHX9, ATM, USP1, and CHK1/2, as well as next-generation ADCs and protein degraders [6] Financial Performance - The company reported losses of approximately RMB 199.9 million, RMB 255.5 million, and RMB 129 million for the years ending December 31, 2023, December 31, 2024, and the six months ending June 30, 2025, respectively, primarily due to ongoing R&D investments [7] - Revenue sources include licensing income and pharmaceutical product sales, with total revenues of RMB 235.2 million for 2023 and RMB 33.5 million for the first half of 2024 [8] - The funds raised from the IPO are intended for the clinical development, regulatory approval, and commercialization of Senaparib, as well as the clinical development of key products IMP1734 and IMP9064, and other pipeline assets [8]

Core Viewpoint - Nanjing Inpai Pharmaceutical Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Goldman Sachs and CICC as joint sponsors [1] Company Overview - Established in 2009, Inpai Pharmaceutical is a biotechnology company focused on the global development of precision cancer therapies based on synthetic lethality mechanisms [4] - It is one of only three companies globally that possess both commercial-stage PARP1/2 inhibitors and clinical-stage next-generation PARP1 selective inhibitors [4] Key Product - The core product, Senaparib, is a PARP1/2 inhibitor that has been approved and commercialized in China for first-line maintenance treatment of ovarian cancer as of January 2025 [5] - Senaparib demonstrated the greatest progression-free survival benefit among approved PARP inhibitors for this indication, with good tolerability [5] - The marketing authorization application for Senaparib has been accepted by the European Medicines Agency, with approval expected in the second half of 2026 [5] - The product has been recommended for inclusion in China's National Medical Insurance Drug List, with negotiations planned for the fourth quarter of 2025 [5] - A sales service agreement has been signed with a subsidiary of Huadong Medicine to commercialize Senaparib in China, aiming to create the largest gynecological oncology platform in the country [5] - As of August 20, 2025, Senaparib has entered over 200 DTP pharmacies and covers more than 600 medical institutions [5] Product Pipeline - The company has a rich and differentiated product pipeline, including several clinical-stage and preclinical assets targeting PARP and other key synthetic lethality pathways [6] - IMP1734 is a next-generation PARP1 selective inhibitor currently in global I/II trials, with plans to initiate Phase II in the second half of 2025 [6] - IMP9064 is a potential first-in-class ATR selective inhibitor in China, also in global I/II trials, approved for combination studies with Senaparib [6] - IMP1707 is a PARP1 selective inhibitor capable of penetrating the central nervous system, currently undergoing Phase I clinical evaluation [6] - Other assets include clinical candidates targeting WEE1, PKMYT1/WEE1, DHX9, ATM, USP1, and CHK1/2, as well as next-generation ADCs and protein degraders [6] Financial Performance and Fund Utilization - The company reported losses of approximately RMB 199.9 million, RMB 255.5 million, and RMB 129 million for the years ending December 31, 2023, December 31, 2024, and the six months ending June 30, 2025, respectively, primarily due to ongoing R&D investments [7] - Revenue sources include licensing income and pharmaceutical product sales, with total revenues of RMB 235.2 million for 2023 [9] - The funds raised from the listing are planned for clinical development, regulatory approval, and commercialization of Senaparib, as well as the clinical development of key products IMP1734 and IMP9064, and other pipeline assets [9]