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新华制药:获得精氨酸布洛芬化学原料药上市申请批准
news flash· 2025-06-30 09:00
Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the market launch of arginine ibuprofen, which is primarily used for alleviating pain symptoms such as toothache and dysmenorrhea [1] Company Summary - The newly approved product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - The estimated sales revenue for arginine ibuprofen formulations in Chinese public medical institutions is approximately 114 million yuan in 2024 [1] - The approval of this product is expected to enhance the company's product line and improve its core competitiveness [1] Industry Summary - The approval of arginine ibuprofen aligns with the growing demand for pain relief medications in the healthcare sector [1] - The inclusion of this product in the national insurance catalog may increase its accessibility and market penetration [1]
21健讯Daily | 七部门:开展“人工智能赋能医药全产业链”应用试点;万泰生物第一季度净亏损5277.69万元
Policy Developments - Seven departments, including the Ministry of Industry and Information Technology, issued the "Implementation Plan for the Digital Transformation of the Pharmaceutical Industry (2025-2030)", emphasizing the integration of artificial intelligence across the pharmaceutical supply chain [1] Drug and Device Approvals - Kangtai Biological announced that its subsidiary Minhai Biological's application for the marketing authorization of an adsorbed tetanus vaccine has been accepted by the National Medical Products Administration [2] - Hendi Pharmaceutical received approval for the marketing application of arginine ibuprofen, a non-steroidal anti-inflammatory drug with superior solubility and faster absorption compared to regular ibuprofen [3] - Tianyao Pharmaceutical's subsidiary obtained a drug registration certificate for injectable hydrocortisone sodium succinate, used for critical conditions such as allergic shock and severe adrenal insufficiency [4] Financial Reports - Wantai Biological reported a net loss of 52.78 million yuan in Q1 2025, with revenue of 401 million yuan, a year-on-year decline of 46.76%, primarily due to market adjustments and government procurement impacts [5] - Heng Rui Pharmaceutical's Q1 2025 report showed a revenue of 7.206 billion yuan, a year-on-year increase of 20.14%, and a net profit of 1.874 billion yuan, up 36.9%, largely due to a licensing payment from IDEAYA [6] - Kingstone Pharma reported a revenue of 291 million yuan in Q1 2025, down 19.65%, with a net profit of 62.85 million yuan, a decrease of 30.02% [8] - Baijun Medical achieved a revenue of 100 million yuan in Q1 2025, a 31.3% increase, with a net profit of 32.50 million yuan, up 290.69%, driven by stable sales of existing products and successful new product launches [9] Capital Market Activities - Tonghe Pharmaceutical plans to invest 11 million yuan to increase its stake in Hangzhou Boya Biomedical Co., Ltd., raising its ownership from 16.34% to 24.93% [10] - Chengyuan Biotechnology announced the completion of several million yuan in equity financing, aimed at upgrading its gene synthesis technology platform [11] Industry Developments - Zhang Wenhong's team announced significant progress in developing a broad-spectrum antiviral drug for monkeypox, which is set to enter clinical approval stages [12] - Qianxin Biotechnology signed a licensing agreement with Caldera Therapeutics for its long-acting dual antibody QX030N, granting global exclusive rights for development and commercialization [13] Public Sentiment Alerts - Weiming Pharmaceutical announced that its important subsidiary, Tianjin Weiming, was suspended from production and sales, which could trigger further risk warnings if production does not resume within three months [14]
亨迪药业:公司获得化学原料药精氨酸布洛芬上市申请批准通知书
news flash· 2025-04-24 10:29
亨迪药业:公司获得化学原料药精氨酸布洛芬上市申请批准通知书 智通财经4月24日电,亨迪药业(301211.SZ)公告称,公司近日收到国家药品监督管理局核准签发的关于 精氨酸布洛芬的《化学原料药上市申请批准通知书》。精氨酸布洛芬是一种非甾体抗炎药,其水溶性优 于普通布洛芬,吸收更快,起效更迅速。该原料药的上市申请批准通知书丰富了公司产品种类,有利于 提升在化学原料药领域的市场竞争力。 ...