Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of HR20013, an injectable drug for preventing nausea and vomiting caused by moderately emetogenic chemotherapy in adult patients [1][2]. Drug Basic Information - Drug Name: Injectable Phosphor-Rolapitant Palonosetron - Dosage Form: Injectable - Acceptance Number: CXHS2600019 - Application Stage: Marketing - Applicant: Fujian Shengdi Pharmaceutical Co., Ltd. - Indication: Prevention of acute and delayed nausea and vomiting induced by moderately emetogenic anticancer drugs in adult patients [1]. Clinical Trial Information - The application for the new indication is based on a Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of the drug. The trial was led by Sun Yat-sen University Cancer Center and involved 96 clinical research centers across the country, enrolling 706 participants [2]. - The primary and key secondary endpoints were the proportion of patients achieving complete response during the delayed and overall phases after administration of moderately emetogenic anticancer drugs. Results showed that the trial group had significantly higher complete response rates compared to the control group, with consistent advantages in symptom control, quality of life improvement, and time to treatment failure [2]. Other Drug Information - Nausea and vomiting induced by anticancer drugs are common adverse reactions in cancer treatment, potentially leading to dehydration, electrolyte imbalance, nutritional deficiencies, and esophageal mucosal tears, significantly affecting patients' quality of life and treatment adherence [3]. - Current guidelines recommend using NK1 receptor antagonists and 5-HT3 receptor antagonists in combination for preventing nausea and vomiting from highly emetogenic chemotherapy, while a dual regimen is suggested for moderately emetogenic drugs. However, adherence to these guidelines is often suboptimal due to various clinical factors [3]. Drug Characteristics - Injectable Phosphor-Rolapitant Palonosetron is a combination formulation that activates both NK-1 and 5-HT3 receptors to inhibit the vomiting reflex. It has a long half-life and high central nervous system penetration, providing advantages in preventing delayed and ultra-delayed vomiting [4]. - The product was approved for marketing in May 2025 for preventing acute and delayed nausea and vomiting caused by highly emetogenic chemotherapy in adults. Similar products available internationally include Helsinn Healthcare's AKYNZEO [4]. Research and Development Investment - Cumulative R&D investment for Injectable Phosphor-Rolapitant Palonosetron is approximately 247 million yuan (unaudited) [5].

Investment Rating - The report maintains a neutral rating for the biopharmaceutical industry, specifically focusing on the ADC (Antibody-Drug Conjugate) sector [1]. Core Insights - The global ADC market is experiencing rapid growth, with the total market size reaching approximately $10.4 billion in 2023 and projected to grow to $66.2 billion by 2030, reflecting a compound annual growth rate (CAGR) of over 30% [11]. - Domestic Chinese companies are catching up in ADC drug development, with the number of research pipelines expected to surpass that of the United States by 2024, positioning China as the leader in ADC research pipelines [11][16]. - Several domestic companies are optimizing ADC drugs by leveraging existing technologies and platforms developed by international firms, leading to the development of more effective and stable ADC products [7][9]. - Key targets for ADC drugs include HER2, TROP2, EGFR, and HER3, with multiple domestic companies showing promising clinical data for their pipelines in these areas [7][9]. Summary by Sections Section 1: Introduction to ADC Drugs - ADCs are a class of targeted cancer therapies that combine monoclonal antibodies with cytotoxic drugs, allowing for precise delivery of treatment to cancer cells while minimizing damage to normal cells [19]. Section 2: Domestic and International ADC Platforms - The report highlights the advancements made by domestic companies in establishing ADC platforms, with firms like Hengrui Medicine and Kolon Biotech leading the way in developing innovative ADC technologies [70][62]. Section 3: Popular Targets and Key Pipelines for ADC Drugs - Notable companies such as Hengrui Medicine and Kolon Biotech have developed ADCs targeting HER2 and TROP2, showing strong clinical efficacy in treating breast and lung cancers [7][9]. Section 4: Business Development (BD) Situations for Domestic ADC Drugs - The report notes an increasing trend of domestic ADC drugs being sought after by international firms, with the number of BD transactions for ADCs accounting for 12%-13% of total drug transactions from 2022 to 2024 [9]. Section 5: Related Companies and Investment Opportunities - The report suggests focusing on companies with established ADC platforms and promising product pipelines, including Hengrui Medicine, Kolon Biotech, BaiLi Tianheng, and China National Pharmaceutical Group [9].

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the drug listing application of HR20013, an injectable formulation of fosaprepitant dimeglumine, indicating progress in its regulatory approval process [1] Group 1: Drug Development and Clinical Trials - The new indication application is based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of HR20013 for preventing nausea and vomiting induced by moderately emetogenic anticancer drugs [1] - The study was led by Sun Yat-sen University Cancer Prevention and Treatment Center, with Professors Zhang Li and Li Yuhong as principal investigators, and involved 96 clinical research centers nationwide, enrolling a total of 706 subjects [1] - The primary and key secondary endpoints of the study were the proportion of subjects achieving complete response during the delayed phase and overall phase after administration of moderately emetogenic anticancer drugs [1] Group 2: Study Results - The results indicated that the complete response rates during the delayed phase and overall phase in the trial group were significantly superior to those in the control group [1] - The trial group demonstrated consistent advantages over the control group in multiple dimensions, including symptom control, quality of life improvement, time to treatment failure, and various subgroup characteristics [1] - Regarding safety, the trial group exhibited good safety and tolerability, with no new safety signals identified [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the drug application of HR20013, an injectable formulation of fosaprepitant for a new indication [1] Group 1: Drug Application and Clinical Trials - The application for the new indication is based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of HR20013 in preventing nausea and vomiting induced by moderately emetogenic chemotherapy [1] - The study was led by Sun Yat-sen University Cancer Prevention Center, with Professors Zhang Li and Li Yuhong as principal investigators, and involved 96 clinical research centers nationwide, enrolling a total of 706 subjects [1] Group 2: Study Results - The primary and key secondary endpoints of the study were the proportion of subjects achieving complete response during the delayed phase and overall phase after the administration of moderately emetogenic chemotherapy [1] - Results indicated that the complete response rates in the delayed phase and overall phase for the trial group were significantly better than those of the control group, with consistent advantages in symptom control, quality of life improvement, time to treatment failure, and various subgroup analyses [1] - The trial group demonstrated good safety and tolerability, with no new safety signals identified [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for its drug application, indicating progress in the drug approval process [1] Group 1: Drug Information - The drug in question is Phosphorapitant Palonosetron Injection (HR20013) [1] - The dosage form is an injection [1] - The acceptance number for the application is CXHS2600019 [1] - The application is currently in the listing phase [1] Group 2: Indication - The proposed indication for the drug is to prevent acute and delayed nausea and vomiting in adult patients caused by moderately emetogenic anticancer drugs [1]

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30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。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the marketing authorization application of injectable fosnetupitant palonosetron, which is intended for the prevention of acute and delayed nausea and vomiting induced by moderately emetogenic anticancer chemotherapy in adult patients [1] Group 1 - The drug is a compound formulation that can simultaneously activate NK-1 and 5-HT3 receptors to inhibit the vomiting reflex [1] - Currently, there are no similar injectable products approved for marketing in China [1] - The total research and development investment for this project is approximately 247 million yuan [1]

Core Viewpoint - Heng Rui Medicine (600276) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the drug application of HR20013, which is intended for the prevention of acute and delayed nausea and vomiting caused by moderately emetogenic anticancer drugs in adult patients [1] Group 1 - The drug HR20013 is specifically designed to address nausea and vomiting associated with cancer treatment [1] - The acceptance of the drug application marks a significant step towards potential market entry for Heng Rui Medicine [1] - This development highlights the company's ongoing commitment to expanding its oncology product portfolio [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-017 申请人：福建盛迪医药有限公司 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司福建盛迪医 药有限公司收到国家药品监督管理局（以下简称"国家药监局"）下发的《受理 通知书》，公司注射用磷罗拉匹坦帕洛诺司琼（HR20013）的药品上市许可申请 获国家药监局受理。现将相关情况公告如下： 一、药品的基本情况 药品名称：注射用磷罗拉匹坦帕洛诺司琼 剂型：注射剂 受理号：CXHS2600019 申报阶段：上市 特此公告。 江苏恒瑞医药股份有限公司董事会 拟定适应症（或功能主治）：本品用于成年患者预防中度致吐性抗肿瘤药物 引起的急性和迟发性恶心和呕吐。 二、药品的临床试验情况 此次申报新适应症，是基于一项评价注射用磷罗拉匹坦帕洛诺司琼用于预防 中度致吐性抗肿瘤药物引起恶心呕吐的有效性和安全性的多中心、随机、双盲、 阳性对照的Ⅲ期临床试验（HR20 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 江蘇恒瑞醫藥股份有限公司 呈交日期： 2026年1月30日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 A | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | A股（於上海證券交易所上市） | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | 佔有關事件 ...