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恒瑞医药(600276.SH):1类创新药泽美妥司他片获附条件批准上市
Ge Long Hui· 2025-09-03 10:22
Core Viewpoint - Heng Rui Medicine (600276.SH) has received conditional approval from the National Medical Products Administration for its independently developed 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] Company Summary - Zemeituosita Tablets is the first EZH2 inhibitor independently developed in China [1]
“医药一哥”重磅消息!恒瑞医药公布两款药品新进展
Zhong Guo Ji Jin Bao· 2025-09-02 00:27
Group 1 - Company received conditional approval from the National Medical Products Administration for its innovative drug, SHR2554, which is the first EZH2 inhibitor developed in China, aimed at treating adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) [1][5] - The development cost for SHR2554 has reached approximately 213 million yuan [5] - Peripheral T-cell lymphoma (PTCL) accounts for about 25% to 30% of non-Hodgkin lymphoma cases in China, with a median onset age of 52 years, indicating a younger patient demographic [5] Group 2 - The company’s subsidiary, Fujian Shengdi Pharmaceutical, received a notice of acceptance for the drug application of HRS9531 injection, which is intended for long-term weight management in adults [3][5] - HRS9531 aims to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [5] - Cumulative R&D investment for HRS9531 has reached approximately 45.235 million yuan [6] Group 3 - In the first half of 2025, the company achieved a revenue of 15.761 billion yuan, representing a year-on-year growth of 15.88%, with a net profit of 4.450 billion yuan, up 29.67% [7] - Innovative drug sales and licensing revenue accounted for 60.66% of total revenue, with innovative drug sales reaching 7.570 billion yuan [8] - The company is focused on developing first-in-class and best-in-class molecules, supported by 14 global R&D centers [7][8]
机构持续看好,A股药企密集发布利好
Zheng Quan Shi Bao· 2025-09-01 22:43
Group 1 - The pharmaceutical sector is experiencing positive momentum, with increasing interest from international institutions in domestic drug companies, exemplified by BlackRock's significant stake increase in 3SBio [1][3] - A number of A-share pharmaceutical companies have announced favorable news, including drug approvals, contributing to a strong rally in the sector, particularly in innovative drugs, which saw an index increase of over 2% [2][9] - 3SBio's stock price has surged nearly 400% this year, reflecting strong market confidence and performance [4] Group 2 - BlackRock purchased approximately 47.6 million shares of 3SBio at a price of HKD 30.1096 per share, totaling around HKD 14.33 billion, increasing its stake to 5.1% [3] - 3SBio has over 100 national invention patents and 40 marketed products across various therapeutic areas, with a robust pipeline of 30 products under development [3] - The company reported a revenue of CNY 4.36 billion for the first half of 2025, a slight decrease of 0.8% year-on-year, while net profit increased by 24.6% to CNY 1.36 billion [3] Group 3 - Several international institutions have continued to increase their holdings in Chinese innovative pharmaceutical companies, with Barclays, Goldman Sachs, and BNP Paribas among those buying shares in Innovation Medical [6] - Lianhuan Pharmaceutical and Hasun Pharmaceutical also saw significant purchases from international institutions in the second quarter, indicating growing foreign interest in the sector [7][8] Group 4 - The outlook for the pharmaceutical sector remains optimistic, with reports highlighting the benefits of ongoing business development, strong clinical data, and supportive policies for innovative drugs [11] - The innovative drug sector is entering a phase of rapid sales growth, with several key products receiving approvals and being included in medical insurance, driving domestic sales [11] - Chinese innovative drugs are increasingly gaining recognition on global platforms, with more products entering late-stage clinical trials and demonstrating potential as Best-in-Class therapies [11]
A股9月“开门红” 贵金属、创新药板块涨势突出
Market Performance - On the first trading day of September, the A-share market continued its strong performance, with all three major indices achieving gains, and the Shanghai Composite Index reaching a high of 3879.05 points, close to the late August high of 3888.60 points [1] - The Shanghai Composite Index closed at 3875.53 points, up 0.46%; the Shenzhen Component Index closed at 12828.95 points, up 1.05%; and the ChiNext Index closed at 2956.37 points, up 2.29% [1] - The total trading volume of the Shanghai and Shenzhen markets was 2.75 trillion yuan, a decrease of approximately 50 billion yuan compared to the previous Friday [1] Precious Metals Sector - The precious metals sector collectively rose, driven by new highs in international gold prices, with the Shenwan Precious Metals Index closing up 8.44% [2] - Major companies such as Zhongjin Gold, Hunan Gold, and Western Gold reached their daily limit, while Xiaocheng Technology surged over 13% [2] - COMEX gold futures reached $3557 per ounce, with a daily increase of over 1%, marking a cumulative increase of approximately 35% for the year [2] - Geopolitical risks and expectations of a Federal Reserve interest rate cut have supported the rise in precious metals [2] Innovative Pharmaceuticals - The pharmaceutical sector saw a significant rise, particularly in innovative drugs, brain-computer interfaces, and ophthalmic medical fields, contributing to the strength of the ChiNext Index [3] - Recent breakthroughs in medical innovation in China include the launch of the world's first "5G Brain-Heart Mobile" for Alzheimer's disease detection [3] - Heng Rui Pharmaceutical announced the conditional approval of its innovative drug, SHR2554, marking it as China's first self-developed EZH2 inhibitor [3] Growth Sectors - The technology growth sector has been highly active since July, with a focus on AI leading the gains [5] - Analysts suggest that investors should pay attention to growth sectors that have lagged behind but possess potential catalysts for future performance [5] - The shift from growth to value styles is also under discussion, with potential opportunities in sectors like agriculture and chemicals due to improving inflation expectations [6]
“医药一哥”,重磅消息!
中国基金报· 2025-09-01 16:03
Core Viewpoint - Heng Rui Medicine's first self-developed EZH2 inhibitor, Ze Mei Tuo Si Ta Pian (SHR2554), has received conditional approval for market launch from the National Medical Products Administration (NMPA) in China, marking a significant milestone for the company as it is the first EZH2 inhibitor developed in China [2][7]. Group 1: Drug Development Progress - The conditional approval for Ze Mei Tuo Si Ta Pian is aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) who have received at least one line of systemic therapy [7]. - Peripheral T-cell lymphoma (PTCL) accounts for approximately 25% to 30% of non-Hodgkin lymphoma cases in China, with a median onset age of 52 years, indicating a relatively younger patient demographic [7]. - The total R&D investment for SHR2554 has reached approximately 21.3 million yuan [7]. Group 2: Additional Drug Approvals - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., has received a notice from the NMPA regarding the acceptance of the drug listing application for HRS9531 injection, which is intended for long-term weight management in adults [4][7]. - HRS9531 is designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [7]. Group 3: Financial Performance - In the first half of 2025, Heng Rui Medicine reported a revenue of 15.761 billion yuan, representing a year-on-year growth of 15.88%, with a net profit of 4.450 billion yuan, up 29.67% [10]. - The company has maintained a high level of R&D investment, totaling 3.871 billion yuan during the same period, with 3.228 billion yuan classified as expensed R&D [10]. - Revenue from innovative drugs accounted for 60.66% of total revenue, with sales and licensing income from innovative drugs reaching 9.561 billion yuan [11]. Group 4: Market Position and Future Plans - Heng Rui Medicine is committed to developing innovative products and has established a strong and differentiated technology platform supported by 14 global R&D centers [11]. - The company is exploring both self-developed and potential acquisitions to enhance its product pipeline, particularly in oncology and metabolic disease areas [11]. - As of September 1, the stock price of Heng Rui Medicine was 68.65 yuan per share, reflecting a year-to-date increase of over 49% [11].
“医药一哥”,重磅消息!
Zhong Guo Ji Jin Bao· 2025-09-01 15:54
Core Viewpoint - Heng Rui Medicine has made significant progress with two new drug approvals, including the first domestically developed EZH2 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma and a new injection for long-term weight management [2][7][10]. Group 1: Drug Approvals - Heng Rui Medicine received conditional approval from the National Medical Products Administration for its innovative drug SHR2554 (Zemaitoside), which is the first domestically developed EZH2 inhibitor in China [2][7]. - SHR2554 is intended 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 [7]. - The company’s subsidiary, Fujian Shengdi Pharmaceutical, has had its application for HRS9531 injection accepted, which is aimed at adult long-term weight management [4][7]. Group 2: Market Context and Financials - Peripheral T-cell lymphoma (PTCL) accounts for approximately 25% to 30% of non-Hodgkin lymphoma cases in China, with a median onset age of 52 years, indicating a younger patient demographic [7]. - The total R&D investment for SHR2554 has reached approximately 213 million yuan [7]. - HRS9531 is designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [4][8]. Group 3: Financial Performance - In the first half of 2025, Heng Rui Medicine reported revenue of 15.76 billion yuan, a year-on-year increase of 15.88%, with a net profit of 4.45 billion yuan, up 29.67% [10][11]. - The revenue from innovative drug sales and licensing reached 9.56 billion yuan, accounting for 60.66% of total revenue, with innovative drug sales alone amounting to 7.57 billion yuan [11]. - The company continues to invest heavily in R&D, with total R&D expenditures of 3.87 billion yuan in the reporting period [10].
恒瑞医药:关于获得药品注册批准的公告
Zheng Quan Ri Bao· 2025-09-01 13:36
Core Viewpoint - 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 [2] Group 1 - The drug Zemeituosita Tablets is classified as a Class 1 innovative drug [2] - The approval is specifically for adult patients with R/RPTCL [2] - The drug is aimed at patients who have received at least one line of systemic treatment prior to this therapy [2]
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]
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(600276.SH):泽美妥司他片获得药品注册批准
智通财经网· 2025-09-01 09:17
Core Viewpoint - Heng Rui Medicine (600276.SH) has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, which is the first EZH2 inhibitor developed in China, aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma who have previously undergone at least one line of systemic therapy [1] Company Summary - The company has developed SHR2554 tablets, marking a significant milestone as it is the first EZH2 inhibitor independently developed in China [1] - The approval is specifically for adult patients with relapsed or refractory peripheral T-cell lymphoma, indicating a targeted therapeutic application [1] Industry Summary - The approval of SHR2554 tablets highlights advancements in the oncology sector, particularly in the development of innovative treatments for complex hematological malignancies [1] - The introduction of the first EZH2 inhibitor in the Chinese market may enhance competition and innovation within the pharmaceutical industry, particularly in the field of cancer treatment [1]