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 ...

Investment Rating - The investment rating for the company is maintained at "Buy" with a target price of RMB 56.60 [1][5]. Core Insights - The company reported a steady performance in Q3 2025, with a year-on-year revenue increase of 3.8% to RMB 32.66 billion and a net profit increase of 7.2% to RMB 2.75 billion for the first nine months of 2025. The revenue for Q3 2025 was RMB 10.99 billion, up 4.5% year-on-year, and net profit was RMB 0.93 billion, up 7.7% year-on-year [1][5]. - The report highlights that the impact of industrial procurement is manageable, and the acceleration of domestic innovative drug approvals is expected to drive double-digit growth in industrial revenue for 2025 [2]. - The commercial segment showed stable growth with a revenue increase of 3.3% year-on-year, while the medical aesthetics segment faced short-term pressure with a revenue decline of 17.9% year-on-year [3]. - The research and development pipeline is diversified across endocrine, oncology, and autoimmune diseases, with several products in various stages of clinical trials [4]. Summary by Sections Financial Performance - For the first three quarters of 2025, the company achieved revenue of RMB 32.66 billion, a 3.8% increase year-on-year, and a net profit of RMB 2.75 billion, a 7.2% increase year-on-year. The Q3 revenue was RMB 10.99 billion, up 4.5% year-on-year, with net profit also increasing by 7.7% to RMB 0.93 billion [1][5]. Revenue Growth Drivers - The company’s revenue from innovative products and agency services reached RMB 1.68 billion, a significant increase of 62% year-on-year, driven by new drug approvals in the endocrine and oncology sectors [2][4]. R&D Pipeline - The R&D pipeline includes multiple products in various stages of development, focusing on endocrine disorders, oncology, and autoimmune diseases, indicating a robust future growth potential [4]. Profit Forecast and Valuation - The profit forecast for 2025-2027 has been slightly adjusted downwards due to the impact of the consumer environment on the medical aesthetics segment, with expected net profits of RMB 3.81 billion, RMB 4.30 billion, and RMB 4.78 billion respectively [5][11]. The overall valuation using the SOTP method is estimated at RMB 99.27 billion [11].

Core Viewpoint - Nanjing Inpai Pharmaceutical Co., Ltd. has submitted its application for a mainboard listing on the Hong Kong Stock Exchange, with Goldman Sachs and CICC as joint sponsors. The company focuses on precision cancer therapies based on synthetic lethality, with its only commercial product being the PARP1/2 inhibitor, Senaparib, for first-line maintenance therapy in ovarian cancer [1][2]. Financial Performance - The financial data of Inpai Pharmaceutical reflects the typical characteristics of innovative drug companies, showing high investment and slow output. The projected revenues for 2023, 2024, and the first half of 2025 are 235 million, 34 million, and 25 million yuan respectively, with a significant year-on-year decline of 85.47% in 2024 due to reliance on technology licensing rather than direct product sales [2][3]. - The net losses for the same periods are 20 million, 255 million, and 129 million yuan, indicating that losses have not narrowed post-approval of Senaparib, but rather expanded. As of June 30, 2025, the company has only 210 million yuan in cash and cash equivalents, which is insufficient to sustain operations for more than a year given its annual R&D expenditure of approximately 200 million yuan [2][3]. Product Overview - Senaparib is the only commercialized product of Inpai Pharmaceutical, approved in January 2025 for first-line maintenance treatment in ovarian cancer. Clinical data shows it has a competitive edge, with a risk ratio of 0.43, indicating a 57% reduction in the risk of disease progression or death [3][4]. - Despite promising clinical data, market performance has been underwhelming, with Senaparib only available in 27 provinces and around 200 pharmacies as of June 30, 2025. The competitive landscape includes established PARP inhibitors like Olaparib and Niraparib, which have already gained market traction [3][4]. Market Competition - The PARP inhibitor market is becoming increasingly competitive, with nearly 40 PARP inhibitors in clinical development and four in Phase III trials. The company faces challenges in converting its product advantages into market share due to established clinical practices and hospital access barriers [4][5]. Future Prospects - Senaparib has been recommended for inclusion in the National Medical Insurance Drug List, with negotiations expected in the fourth quarter. Successful inclusion could boost sales but may compress profit margins, raising questions about the company's ability to achieve breakeven [4][5]. - Other products in Inpai's pipeline are in early stages, with a new generation PARP1 selective inhibitor currently in Phase I/II trials, unlikely to reach the market before 2030. The company will continue to rely heavily on Senaparib for revenue in the near term [5][6]. Funding and Valuation - Inpai Pharmaceutical has completed seven rounds of financing since its establishment in 2009, attracting notable investors. However, post-D+ round, the company's diluted valuation decreased from approximately 3.138 billion yuan to 2.823 billion yuan [7][8]. - A redemption right was triggered for 24,089,597 shares, indicating potential issues related to the company's IPO timeline or other significant operational challenges, although specific reasons were not disclosed in the prospectus [7][8].

Core Viewpoint - Nanjing Inpai Pharmaceutical Co., Ltd. has submitted an application for listing on the Hong Kong Stock Exchange, marking its entry into the innovative drug sector focused on synthetic lethality mechanisms for cancer treatment [1] Company Overview - Established in 2009, Inpai Pharmaceutical is a commercial-stage biotechnology company specializing in precision cancer therapies based on synthetic lethality [1] - The company is one of only three globally that possesses both commercial-stage PARP1/2 inhibitors and clinical-stage next-generation PARP1 selective inhibitors [1][7] Financial Performance - In 2023, 2024, and the first half of 2025, the company recorded losses of approximately RMB 199 million, RMB 255 million, and RMB 129 million, respectively, primarily due to high R&D expenditures [2][3] - As of June 30, 2025, the company had cash and cash equivalents of RMB 21 million, indicating a tightening cash flow situation [2] Product Development and Commercialization - The core product, Senaparib, received approval in January 2025 for first-line maintenance treatment of ovarian cancer in China, showing the largest progression-free survival benefit among its peers [3][4] - As of June 30, 2025, Senaparib has been launched in 27 provinces in China and is available in over 200 direct-to-patient pharmacies and more than 600 medical institutions [4] - The product is expected to be included in the National Medical Insurance Drug List in early 2026, enhancing its market penetration [4] Market Potential and Competitive Landscape - The synthetic lethality mechanism is gaining recognition in clinical settings, with significant potential for market expansion due to its targeted approach and ability to overcome drug resistance [6][9] - The global market for synthetic lethality drugs is projected to reach USD 8.7 billion by 2029, while the small molecule targeted tumor drug market is expected to reach USD 105.8 billion in the same period [9] - Inpai Pharmaceutical has established a leading position in the synthetic lethality space, with a diverse pipeline that includes one commercial-stage drug, four clinical-stage drugs, and seven pre-IND drugs [7][9] Challenges and Future Outlook - The competitive landscape is intensifying, with nearly 40 PARP inhibitors in clinical development, highlighting the need for Inpai to maintain its competitive edge [7][9] - Despite the challenges, the rapid commercialization of Senaparib and its clinical advantages position the company for potential revenue growth and market success [10]

Group 1: Market Overview - The Hang Seng Healthcare Index (HSCICH) decreased by 2.76% during the week, while the Hong Kong Innovation Drug ETF (513120) fell by 1.60% [4] - The pharmaceutical and biotechnology index dropped by 1.69%, underperforming the Shanghai Composite Index by 1.04 percentage points [4] Group 2: Company Developments - Nanjing Inpai Pharmaceutical Co., Ltd. submitted a listing application to the Hong Kong Stock Exchange, reporting a net loss of 129 million yuan in the first half of the year [5][6] - Inpai's core product, Senapali, was approved for marketing in China as a first-line maintenance therapy for ovarian cancer, applicable to all populations [6] - Inpai's revenue projections for 2023, 2024, and the first half of 2025 are 235 million yuan, 34 million yuan, and 25 million yuan respectively, with net losses of 20 million yuan, 255 million yuan, and 129 million yuan [6][7] Group 3: Clinical Trials and Innovations - The first subcutaneous antibody-drug conjugate (ADC) for advanced non-small cell lung cancer has entered Phase II clinical trials [8][16] - JSKN033, a subcutaneous ADC, aims to simplify administration time and reduce risks associated with intravenous delivery [18] - The National Medical Products Administration disclosed 117 new clinical trial registrations, with 29 in Phase II or higher, focusing on oncology and autoimmune diseases [8] Group 4: Stock Performance and Market Sentiment - Yimeng Bio-B experienced a significant decline, attributed to overall adjustments in the innovation drug sector and the upcoming lock-up expiration for cornerstone investors [12][13] - Yimeng Bio-B's stock price has seen a 30% drop from its peak, despite being up approximately 279% since its IPO [13] - Analysts from GF Securities and Morgan Stanley have set target prices for Yimeng Bio-B at 574.28 HKD and 766 HKD per share, respectively, citing its leading ADC platform and partnerships with global firms [13][15]

Core Viewpoint - Inpai Pharmaceuticals has submitted a listing application to the Hong Kong Stock Exchange, with Goldman Sachs and CICC as joint sponsors [1] Group 1: Company Overview - Inpai Pharmaceuticals is a commercial-stage biotechnology company focused on precision cancer therapies based on synthetic lethality mechanisms [1] - The company's core product, Senaparib (PARP1/2 inhibitor), was approved in China for first-line maintenance treatment of ovarian cancer in January 2025 and is now commercialized [1] - Senaparib has been accepted by the European Medicines Agency (EMA) and is expected to receive approval in the second half of 2026, with plans to participate in negotiations for inclusion in China's National Medical Insurance Drug List in Q4 2025 [1] Group 2: Product Pipeline - Inpai Pharmaceuticals has multiple clinical-stage assets, including IMP1734 (selective PARP1 inhibitor), IMP9064 (selective ATR inhibitor), and IMP1707 (selective PARP1 inhibitor) [1] - The company's pipeline also includes preclinical candidates targeting WEE1, PKMYT1/WEE1, DHX9, ATM, USP1, and CHK1/2 [1] Group 3: Fundraising Purpose - The funds raised will be used for the development and commercialization of the core product Senaparib, clinical development of key products IMP1734 and IMP9064, and research and development of other pipeline assets [1]

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]

Investment Rating - The investment rating for the company is "Buy" with a target price of RMB 57.07 [1][5]. Core Views - The company reported a steady revenue growth in 1H25, achieving revenue of RMB 21.67 billion (up 3.4% YoY) and a net profit of RMB 1.81 billion (up 7.0% YoY) [1]. - The report highlights the gradual improvement of the company's self-developed innovative drug pipeline and the limited impact of the 2025 centralized procurement [1][2]. - The domestic innovative drugs are expected to see rapid growth, with several products already gaining market traction [2][4]. Summary by Sections Financial Performance - In 1H25, the company achieved revenue of RMB 21.67 billion, with a net profit of RMB 1.81 billion and a non-GAAP net profit of RMB 1.76 billion [1]. - For 2Q25, revenue was RMB 10.94 billion (up 3.6% YoY) and net profit was RMB 0.90 billion (up 8.0% YoY) [1]. Industrial Growth - The company’s industrial revenue in East China reached RMB 7.32 billion in 1H25, up 9.2% YoY, with a net profit of RMB 1.58 billion, up 14.1% YoY [2]. - The report anticipates double-digit growth in industrial revenue for 2025, driven by limited impact from generic drug procurement and the rapid approval of domestic innovative drugs [2]. Innovative Drug Pipeline - The company has a comprehensive GLP-1 innovative drug portfolio, with several products in various stages of clinical trials [4]. - Notable products include BCMA CAR-T, which received approval in March 2024, and is expected to reach a peak domestic revenue of over RMB 1 billion [2][4]. Business Segments - The commercial segment reported revenue of RMB 13.95 billion in 1H25, up 2.9% YoY, while the medical aesthetics segment faced challenges with a revenue decline of 17.5% YoY [3]. - The medical aesthetics segment is expected to see a slight decline in revenue due to increased competition [3]. Profit Forecast and Valuation - The company’s net profit forecasts for 2025-2027 have been slightly adjusted downwards to RMB 3.88 billion, RMB 4.49 billion, and RMB 4.95 billion respectively [5]. - The overall valuation using the SOTP method is estimated at RMB 100.1 billion, with a target price of RMB 57.07 [5][12].