Hengrui Pharma(600276)
Search documents
中国首个自主研发的EZH2抑制剂获批上市
Zheng Quan Shi Bao Wang· 2025-09-01 12:35
Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its innovative drug, Zemeituosita Tablets, which is the first self-developed EZH2 inhibitor in China, providing a new treatment option for adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) [1][2] Company Summary - Heng Rui Medicine has developed Zemeituosita Tablets, a highly selective oral EZH2 inhibitor, which works by inhibiting histone methyltransferase EZH2, reversing abnormal epigenetic programming in tumor cells, and inducing cell cycle arrest and early apoptosis [2] - The company has successfully launched 24 first-class innovative drugs in China, with over half being anti-tumor drugs, and has more than 100 self-innovated products in clinical development, along with over 400 clinical trials ongoing domestically and internationally [2] Industry Summary - Peripheral T-cell lymphoma (PTCL) accounts for approximately 25-30% of non-Hodgkin lymphoma patients in China, significantly higher than in Western countries, with a median onset age of 52-57 years [2] - The clinical treatment of PTCL is challenging, as most patients experience relapse or become refractory after initial treatment, with a recent study showing a median progression-free survival of only 5.2 months for patients entering second-line treatment [2] - The approval of Zemeituosita Tablets highlights the need for innovative treatment options in the R/R PTCL patient population, which currently lacks standardized treatment protocols and effective therapeutic options [2]
A股公告精选 | 成都华微(688709.SH)发布新款ADC芯片 并已收到意向订单
智通财经网· 2025-09-01 12:10
Group 1: BYD Performance - BYD's August sales of new energy vehicles reached 373,600 units, nearly unchanged from 373,100 units in the same month last year [1] - Cumulative sales from January to August totaled 2.864 million units, representing a year-on-year growth of 23% [1] - BYD plans to export a total of 80,813 new energy vehicles by August 2025 [1] Group 2: Kweichow Moutai Shareholding - Kweichow Moutai's controlling shareholder, Moutai Group, increased its stake by 67,821 shares on September 1, 2025, accounting for 0.0054% of the total share capital [2] - The increase amounted to 100 million yuan and is part of a larger plan to buy back between 3 billion and 3.3 billion yuan worth of shares from September 1, 2025, to February 28, 2026 [2] Group 3: Chengdu Huamei Chip Development - Chengdu Huamei announced the successful launch of a 4-channel, 12-bit, 40G high-speed, high-precision RF direct sampling ADC chip [3] - The chip improves upon existing multi-channel high-speed ADCs, achieving international leading standards and filling a gap in similar products [3] - The company has received intention orders after sending samples to several clients [3] Group 4: Industrial Fulian Share Buyback - Industrial Fulian has repurchased a total of 7.6974 million shares, representing 0.04% of its total share capital, as of August 31, 2025 [6] - The highest repurchase price was 19.84 yuan per share, while the lowest was 18.40 yuan per share, with a total expenditure of 147 million yuan [6] Group 5: Innovative Drug Approval by Hengrui Medicine - Hengrui Medicine received conditional approval from the National Medical Products Administration for its innovative drug, SHR2554 tablets, aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma [7] - This drug is noted as China's first independently developed EZH2 inhibitor [7] Group 6: Yonghui Supermarket Fundraising Adjustment - Yonghui Supermarket announced adjustments to its plan for issuing A-shares to specific investors, reducing the total fundraising amount from a maximum of 3.992 billion yuan to 3.114 billion yuan [8] - The adjustments primarily affect the funding amounts for store upgrades and working capital or bank loan repayments [8] Group 7: Automotive Sales Performance - SAIC Motor's vehicle sales in August reached 363,400 units, reflecting a year-on-year increase of 41.04% [9] - Great Wall Motors reported August sales of 115,600 units, marking a year-on-year growth of 22.33% [12] - Dong'an Power's engine sales in August increased by 3.44% year-on-year [12]
9月1日重要公告一览
Xi Niu Cai Jing· 2025-09-01 10:19
Group 1 - Weisheng Information won four projects in August with a total amount of 85.5377 million yuan, accounting for 3.12% of the company's total revenue for 2024 [1] - Longqi Technology's shareholder plans to reduce its stake by up to 4.09%, equating to a maximum of 19.1916 million shares [1] - Guojin Modern's subsidiary received a drug registration certificate for injectable Nicardipine, used for treating unstable angina [3][4] Group 2 - SAIC Motor reported a total vehicle sales of 363,400 units in August, a year-on-year increase of 41.04%, with new energy vehicle sales reaching 129,800 units, up 49.89% [5] - Kuka Home plans to invest 1.124 billion yuan to build a self-owned base in Indonesia, aiming to enhance its international strategy [6] - Samsung Medical's subsidiary signed a contract for an intelligent meter project in Egypt worth 58.8 million USD, approximately 419 million yuan [8] Group 3 - North Vehicle Blue Valley's subsidiary reported a total production of 10,587 units in August, a year-on-year decrease of 15.13%, while sales increased by 3.47% [12] - Xianghe Industrial signed contracts worth 400 million yuan for railway fastener system components [13] - Hengrui Medicine's HRS9531 injection has received acceptance for its marketing authorization application [14] Group 4 - Hualu Hengsheng resumed normal production after completing maintenance on production facilities [16] - Shanghai Pharmaceuticals' hydrochloride verapamil injection passed the consistency evaluation for generic drugs [18] - Shanghai Construction received approval for debt financing tools with a registration period of two years [20] Group 5 - Kangli Elevator terminated the sale of its wholly-owned subsidiary due to the buyer's failure to obtain necessary approvals [21] - Times Wan Heng appointed Li Zhizhong as the new deputy general manager [22] - Hanma Technology reported a total truck sales of 1,051 units in August, a year-on-year increase of 58.05% [24] Group 6 - Wenzhou Hongfeng's subsidiary received a utility model patent certificate for a servo adjustment device [26] - Yibin Technology received a project designation from a domestic new energy vehicle company, with an estimated total sales of 243 million yuan over five years [28] - Star Ring Technology's H-share issuance application was accepted by the China Securities Regulatory Commission [30] Group 7 - Microchip Bio's vice president resigned for personal reasons [31] - Zhongxin Co. announced the resignation of a non-independent director due to personal reasons [32] - Changcheng Military Industry's vice chairman resigned due to retirement [35] Group 8 - Jiukang Bio received four invention patent certificates related to detection reagents [36] - Meino Bio's subsidiary changed its registered address [37] - Kuangda Technology announced a potential change in control due to a share transfer [38] Group 9 - China Rare Earth confirmed no undisclosed significant matters amid stock price fluctuations [72]
恒瑞医药泽美妥司他片获药品注册批准
Bei Jing Shang Bao· 2025-09-01 10:17
Core Insights - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its innovative drug, Ze Mei Tuo Si Ta Tablets (SHR2554), which is designed for adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) who have previously undergone at least one line of systemic therapy [2] Group 1 - Ze Mei Tuo Si Ta Tablets is a new, efficient, and selective oral EZH2 inhibitor developed by Heng Rui Medicine, marking it as China's first independently developed EZH2 inhibitor [1] - The drug is classified as a Class 1 innovative drug, indicating its novel therapeutic approach in the treatment of R/R PTCL [2]
速递|减重19.2%!恒瑞医药GLP-1R/GIPR激动剂申报上市
GLP1减重宝典· 2025-09-01 09:59
Core Viewpoint - The article discusses the recent acceptance of the HRS9531 injection application by the National Medical Products Administration of China, highlighting its potential for long-term weight management in adults with obesity or overweight conditions [2][3]. Group 1: Product Overview - HRS9531 is a dual receptor agonist for GLP-1 and GIP, developed by the company for the treatment of overweight/obesity and related comorbidities, as well as type 2 diabetes [3]. - The injection is intended for adults with a BMI of ≥28 kg/m² (obesity) or ≥24 kg/m² (overweight) with at least one weight-related comorbidity [2]. Group 2: Clinical Trial Results - The phase III clinical trial (HRS9531-301) showed positive topline results, with all dosage groups (2mg, 4mg, 6mg) achieving superior efficacy compared to the placebo [4]. - In the study involving 567 participants, the average baseline weight was 93 kg, and after 48 weeks of treatment, the maximum average weight reduction was 17.7% (adjusted for placebo) [4]. - The proportion of participants achieving a weight loss of ≥5% was 88.0%, with 44.4% of the high-dose group losing ≥20% of their weight [4]. Group 3: Safety and Tolerability - HRS9531 demonstrated good safety and tolerability, with most treatment-emergent adverse events being mild to moderate, primarily gastrointestinal in nature [6]. - Previous phase II trial results indicated an average weight reduction of 22.8% after 36 weeks of treatment with the 8mg dose, with no plateau effect observed [6]. Group 4: Future Developments - Complete results of the phase III clinical trial for HRS9531 will be presented at an upcoming academic conference [7].
恒瑞医药今日大宗交易平价成交17.6万股,成交额1202.96万元
Xin Lang Cai Jing· 2025-09-01 09:47
Group 1 - On September 1, 2025, Heng Rui Medicine conducted a block trade of 176,000 shares, with a transaction amount of 12.0296 million yuan, accounting for 0.2% of the total transaction amount for the day [1] - The transaction price was 68.35 yuan, which was flat compared to the market closing price of 68.35 yuan [1]
恒瑞医药(600276) - H股公告-证券变动月报表
2025-09-01 09:45
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 江蘇恒瑞醫藥股份有限公司 呈交日期: 2025年9月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01276 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 258,197,600 | RMB | | 1 RMB | | 258,197,600 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 258,197,600 | RMB | | 1 RMB | | 258,197,600 | | 2. 股份分類 | 普通股 | 股份類別 | A ...
恒瑞医药(01276):泽美妥司他片获药品注册批准
智通财经网· 2025-09-01 09:37
Group 1 - The company, Heng Rui Medicine, has received conditional approval from the National Medical Products Administration for its innovative drug, Zemeituosita Tablets (SHR2554), which is intended for adult patients with relapsed or refractory peripheral T-cell lymphoma (R/RPTCL) who have previously undergone at least one line of systemic therapy [1] - Zemeituosita Tablets is noted as the first independently developed EZH2 inhibitor in China [1]
恒瑞医药:泽美妥司他片获药品注册批准
Zhi Tong Cai Jing· 2025-09-01 09:35
Group 1 - The company Heng Rui Medicine (600276) has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, Zemeituosita Tablets (SHR2554), for adult patients with relapsed or refractory peripheral T-cell lymphoma (R/RPTCL) who have previously undergone at least one line of systemic therapy [1] - Zemeituosita Tablets is the first self-developed EZH2 inhibitor in China [1]
恒瑞医药(01276)子公司HRS9531注射液上市许可申请获受理
智通财经网· 2025-09-01 09:33
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 listing application of HRS9531 injection, indicating progress in the company's product pipeline [1] Group 1: Product Information - HRS9531 injection is intended for long-term weight management in adults with a body mass index (BMI) of ≥28 kg/m² (obesity) or ≥24 kg/m² (overweight) with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or fatty liver [1]