苹果酸司妥吉仑片(信妥安)
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上海又一款创新药获批上市
Xin Lang Cai Jing· 2025-12-19 12:48
Core Insights - The National Medical Products Administration has approved the listing of a new innovative drug, Suojirolin Tablets (brand name "Xintuoan"), developed by Shanghai Shiyin Pharmaceutical Co., Ltd., for the treatment of primary hypertension, marking the ninth domestically developed innovative drug approved in Shanghai this year [1][3] Group 1: Product Details - Suojirolin is a new generation oral non-peptide small molecule renin inhibitor aimed at addressing unmet clinical needs in hypertension treatment, providing a new therapeutic option for over 300 million patients with primary hypertension in China [1][4] - Compared to traditional antihypertensive drugs, Suojirolin directly inhibits renin activity, targeting the core issues in hypertension treatment and enhancing safety through optimized molecular structure [4] Group 2: Clinical Efficacy - Clinical trial results indicate that a daily dose of 100mg Suojirolin taken for 12 weeks can safely and effectively lower blood pressure in patients with primary hypertension, providing solid evidence for a significant reduction in average sitting diastolic blood pressure [4] Group 3: Production and Commercialization - Shanghai Shiyin Pharmaceutical has designed a new production line for Suojirolin and is currently testing core equipment for tablet compression, with plans to commence commercial production by the first quarter of 2026 [2][4]
上海医药1类创新药司妥吉仑正式获批上市 攻坚破局高血压治疗
Zheng Quan Shi Bao Wang· 2025-12-15 12:25
Core Viewpoint - Shanghai Pharmaceuticals has received approval for its innovative drug, Suojirolin, aimed at treating primary hypertension, marking a significant achievement in its commitment to independent innovation in the pharmaceutical industry [1][2]. Group 1: Product Approval and Clinical Significance - The National Medical Products Administration (NMPA) has officially approved Suojirolin (brand name: Xintuoan), a first-class innovative drug for the treatment of primary hypertension [1]. - Suojirolin is a new generation of oral non-peptide small molecule renin inhibitors, designed to meet unmet clinical needs, providing a new treatment option for over 300 million patients with primary hypertension in China [1]. - Clinical trials have shown that Suojirolin demonstrates good efficacy and safety, with its Phase II trial results published in the authoritative journal "Hypertension Research," indicating growing global academic interest in Chinese innovative drugs [1]. Group 2: Research and Development Strategy - Shanghai Pharmaceuticals has positioned research and development (R&D) innovation at its strategic core, with a planned R&D investment of 2.818 billion yuan for 2024, leading the industry in investment intensity [2]. - As of the end of Q3 2025, the company has submitted 57 new drug applications for clinical trials, including 45 innovative drug pipelines, establishing a comprehensive and tiered R&D team [2]. - The company has several innovative drugs in advanced clinical stages, including a CD20 injection for neuromyelitis optica and a traditional Chinese medicine for cervical spondylosis, indicating a robust pipeline [2]. Group 3: Collaborative Innovation and Market Strategy - Shanghai Pharmaceuticals has established the Shanghai Frontier Biomedical Innovation Center to foster an open innovation ecosystem by collaborating with top universities and research institutions [3]. - The company has created a comprehensive distribution network covering over 80,000 medical institutions across 25 provinces and municipalities in China, ensuring effective market access for Suojirolin [3]. - The integration of online and offline pharmaceutical services enhances the company's ability to reach patients quickly and efficiently [3].
金城医药实控人收到行政处罚决定书;新诺威递交H股上市申请
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-12 00:10
Group 1: Industry Developments - Jiangsu Province has officially released its 15th Five-Year Plan, emphasizing the enhancement of industries such as biomedicine, new generation information technology, and high-end equipment, aiming to cultivate strategic emerging industry clusters with international competitiveness [1] - The global first CDK2/4/6 inhibitor, Kimosir, developed by China National Pharmaceutical Group's subsidiary, has been approved for marketing, marking a significant advancement in targeted therapy for breast cancer in China [1] - The innovative drug, Simoziran, developed by Shanghai Pharmaceuticals, has been approved for the treatment of primary hypertension, representing a new addition to the hypertension treatment market [2] Group 2: Company Announcements - Health元 has received a drug registration certificate for its innovative anti-influenza drug, Marpacisavir, which is effective for treating influenza A and B in adolescents and adults, showcasing significant advantages in efficacy and safety [3] - Baijun Medical's subsidiary has received approval for its collagen implant product, the first of its kind in China for improving facial smoothness, highlighting the company's innovation in the collagen field [4] - Innovent Biologics has announced the approval of its next-generation TRK inhibitor, Zoltritinib, for treating adult and adolescent patients with NTRK fusion gene solid tumors, marking a milestone in China's oncology market [5] Group 3: Market Movements - Saili Medical has reported a reduction in shareholding by Shanghai Anze Private Equity Fund to 5.00%, indicating a strategic shift in investment [6][7] - Newnow has submitted an application for H-share listing on the Hong Kong Stock Exchange, reflecting the trend of innovative pharmaceutical companies seeking dual listings [8] - Yunding New Medicine has entered into strategic cooperation with Haishen Biopharmaceuticals, enhancing its commercialization capabilities in the cardiovascular field through service and licensing agreements [9]
上海医药1类创新药信妥安获批上市
Zhong Zheng Wang· 2025-12-11 10:37
Core Viewpoint - Shanghai Pharmaceuticals has received approval for its innovative drug, Sitojilun, aimed at treating primary hypertension, marking a significant achievement in its commitment to independent innovation in the pharmaceutical industry [1][2]. Group 1: Product Approval and Market Strategy - The innovative drug Sitojilun (SPH3127), a new generation oral non-peptide small molecule renin inhibitor, has been approved for market launch, addressing unmet clinical needs in hypertension treatment [1]. - Shanghai Pharmaceuticals has established a comprehensive distribution network covering over 80,000 medical institutions across 25 provinces, municipalities, and autonomous regions in China, ensuring effective market access for Sitojilun [1]. Group 2: Research and Development Investment - In 2024, Shanghai Pharmaceuticals plans to invest 2.818 billion yuan in R&D, positioning itself among the industry leaders in investment intensity [2]. - As of the end of Q3 2025, the company has submitted 57 new drug applications for clinical trials, with 45 of these being innovative drugs, demonstrating a robust pipeline and commitment to long-term innovation [2]. Group 3: Collaborative Innovation Ecosystem - The company has established the Shanghai Frontier Life Science Innovation Center to foster collaboration with top universities and research institutions, creating an open innovation ecosystem [3]. - Since its launch in September of last year, the center has attracted numerous renowned research institutions and pharmaceutical companies, enhancing the innovation landscape [3]. - Shanghai Pharmaceuticals aims to continue investing in R&D focused on urgent clinical needs in areas such as oncology, immunology, cardiovascular health, and infectious diseases, with the goal of transforming innovative results into marketable products [3].