格隆汇12月24日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司子公司苏州盛迪亚生物 医药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局核准签发关于注射用SHR-A2102的《药 物临床试验批准通知书》，将于近期开展临床试验。 药物名称：注射用SHR-A2102 剂型：注射剂 申请事项：临床试验 受理号：CXSL2500879、CXSL2500881 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年10月13日和14日受理的注 射用SHR-A2102临床试验申请符合药品注册的有关要求，同意本品开展两项临床试验。分别为：本品联 合注射用维迪西妥单抗在晚期实体瘤中开展临床试验；本品联合阿得贝利单抗或其他PD-(L)1药物联合 或不联合其他抗肿瘤治疗在局部晚期或转移性食管癌受试者中的安全性、耐受性及有效性的多中心、开 放ⅠB/Ⅱ期临床研究。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate aimed at treating advanced solid tumors and esophageal cancer [1] Group 1: Clinical Trials - The company will conduct two clinical trials for SHR-A2102, one in combination with Vedolizumab for advanced solid tumors and another with Atezolizumab or other PD-(L)1 drugs for locally advanced or metastatic esophageal cancer [1] - The trials will assess the safety, tolerability, and efficacy of SHR-A2102 in a multicenter, open-label Phase I/II study [1] Group 2: Product Details - SHR-A2102 is an antibody-drug conjugate (ADC) targeting Nectin-4, with its active payload being a topoisomerase I inhibitor (TOP1i) [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its drug SHR-A2102, indicating progress in its oncology pipeline and potential market entry for a new targeted therapy [1] Group 1: Clinical Trials - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have been authorized to conduct two clinical trials for SHR-A2102 [1] - The first trial will evaluate SHR-A2102 in combination with Vedolizumab for advanced solid tumors [1] - The second trial will assess SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer in a multicenter, open-label Phase IB/II study [1] Group 2: Product Details - SHR-A2102 is a targeted antibody-drug conjugate (ADC) that targets Nectin-4, with an effective payload of topoisomerase I inhibitor (TOP1i) [1] - Currently, there is one similar product, Enfortumab vedotin (brand name: Padcev), which has been approved and is projected to generate global sales of approximately $1.949 billion in 2024 [1] Group 3: Investment and Development - The total investment in the SHR-A2102 development project has reached approximately 248.22 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, indicating progress in its drug development pipeline [1] Group 1: Drug Information - Drug Name: SHR-A2102 [1] - Dosage Form: Injectable [1] - Application Type: Clinical trial [1] Group 2: Approval Details - Acceptance Numbers: CXSL2500879, CXSL2500881 [1] - Approval Conclusion: The clinical trial applications for SHR-A2102, submitted on October 13 and 14, 2025, meet the requirements for drug registration and are approved for two clinical trials [1] Group 3: Clinical Trials - The first trial will investigate the combination of SHR-A2102 with Vedolizumab in patients with advanced solid tumors [1] - The second trial will assess the safety, tolerability, and efficacy of SHR-A2102 combined with Atezolizumab or other PD-(L)1 inhibitors, with or without other anti-tumor treatments, in patients with locally advanced or metastatic esophageal cancer [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., have received approval from the National Medical Products Administration for the clinical trial of SHR-A2102, which will commence shortly [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-A2102 was accepted on October 13 and 14, 2025, and meets the requirements for drug registration [1] - Two clinical trials will be conducted: one involving SHR-A2102 in combination with Vedolizumab for advanced solid tumors, and the other involving SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer [1]

Financial Performance - The company achieved a revenue of 1.72 billion yuan in the first three quarters, representing a year-on-year increase of 42.27% driven by strong sales of its core products, Taitasip and Vedisimab [2][5] - The net loss attributable to shareholders narrowed significantly to 551 million yuan from 1.071 billion yuan in the same period last year, indicating a substantial reduction in losses [2][5] - Operating cash flow turned positive with a net amount of 217 million yuan, compared to a negative 835 million yuan in the previous year, reflecting improved cash generation capabilities [2][5] Core Business Progress - Sales of the main products, Taitasip and Vedisimab, saw significant growth, contributing to the overall revenue increase [2][5] - The company signed an overseas licensing agreement with VorBio, which not only brought in cash flow but also reduced overseas R&D expenses [2][7] R&D and Cost Structure - R&D investment decreased to 891 million yuan, down 22.79% year-on-year, with its proportion of revenue falling to 51.78% from 86.4% in the previous year, indicating a focus on high-potential projects [2][6] - Sales expenses increased by 32.15% to 823 million yuan, reflecting a heightened marketing effort to capture market share, while management expenses slightly decreased to 216 million yuan [2][6] Asset and Liability Structure - As of the end of the third quarter, total assets stood at 5.977 billion yuan, with net assets attributable to shareholders at 2.32 billion yuan and a debt-to-asset ratio of 61.2% [2][8] - The cash balance at the end of the period was 1.067 billion yuan, a 40% increase from the beginning of the year, indicating strong liquidity [2][8] Future Focus - The company aims to focus on the commercialization of core products, optimize its R&D pipeline, and enhance operational efficiency through international licensing collaborations [3][10] - Key future considerations include the sustained growth of core products, progress in overseas licensing, R&D investments, and ongoing optimization of the cost structure [3][10]

Core Viewpoint - The recent reforms in the Sci-Tech Innovation Board (STAR Market) have accelerated the review process for unprofitable companies, allowing them to be listed under specific conditions aimed at protecting investors while fostering innovation [1][2]. Group 1: Unprofitable Companies and Listing Standards - Several unprofitable companies have recently passed the review process, including He Yuan Bio and North Chip Life, indicating a shift in the regulatory environment [1]. - The new listing criteria categorize unprofitable companies into a "Sci-Tech Growth Layer," which requires them to achieve specific profit and revenue thresholds to move out of this category [1][2]. - Over the past six years, 54 unprofitable companies have been listed on the STAR Market, with 22 of them achieving profitability, resulting in a delisting rate of approximately 40% [1][2]. Group 2: Listing Standards and Performance - The STAR Market employs a multi-faceted listing standard system, with "Standard Five" allowing unprofitable companies to list without revenue requirements, raising questions about their commercialization capabilities [2][4]. - Among the 20 companies listed under Standard Five, three achieved profitability in the year prior to their listing, demonstrating that not all unprofitable companies are at equal risk [3][4]. - The probability of achieving profitability varies by listing standard, with Standard Four and Standard Five showing similar success rates in terms of companies becoming profitable post-listing [3][4]. Group 3: Risks and Market Perception - The perception that profitable companies inherently carry lower investment risks is challenged by data showing that some profitable companies have also faced delisting risks due to low revenue [5][6]. - Companies like Jindike, which achieved profitability, have recently reported significant revenue declines, highlighting that profitability does not guarantee stability [5][6]. - The market tends to focus more on long-term value and product competitiveness rather than short-term profitability, especially in sectors like pharmaceuticals and technology [7][9]. Group 4: Notable Companies and Market Trends - Companies like BeiGene and Cambricon have seen substantial market valuations despite being unprofitable, with BeiGene's market cap exceeding 200 billion yuan and significant revenue growth reported [7][8]. - Cambricon, as a leading AI chip company, has benefited from the surge in demand for AI technologies, leading to a significant increase in its market value [8][9]. - The overall trend indicates that investors are increasingly valuing long-term potential and innovation over immediate profitability, particularly in high-growth sectors [7][9].

Important News - The high-level economic and trade talks between China and the United States have made substantial progress, reaching important consensus [2] Company News - Ningde Times (810699.HK) will begin its IPO on May 12, with a maximum offer price of 263.00 HKD [3] - Li Auto (02015.HK) has achieved cumulative deliveries of over 300,000 units for the Li L7 [3] - Longfor Group (00960.HK) reported a contract sales amount of 5.13 billion RMB in April, with a cumulative contract sales amount of 22.08 billion RMB from January to April [3] - Rongchang Biopharmaceutical (09995.HK) received approval from the National Medical Products Administration for the injection of Vedicimab for treating HER2-positive late-stage breast cancer with liver metastasis in China [4] - GAC Group (02238.HK) reported April vehicle sales of 116,400 units, a year-on-year decrease of 12.66% [5] - China Overseas Development (00688.HK) achieved a cumulative contract property sales amount of 66.583 billion RMB from January to April [5] - China Jinmao (00817.HK) reported a signed sales amount of 7.001 billion RMB in April [5] - Shimao Group (00813.HK) had a cumulative contract sales total of 9.07 billion RMB in the first four months [5] - China Overseas Hongyang Group (00081.HK) realized a contract sales amount of 2.624 billion RMB in April, a year-on-year decline of 18.1% [5] - Q Technology (01478.HK) sold 31.783 million mobile camera modules in April, a month-on-month increase of 7.9% [5] - Stone Pharmaceutical Group (01093.HK) received approval for clinical trials in the U.S. for SYH2046 tablets [5]