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力生制药:子公司药品阿普米司特片通过上市许可申请
Xin Lang Cai Jing· 2025-12-12 08:07
力生制药公告称,其子公司中央药业收到国家药监局颁发的阿普米司特片10mg、20mg、30mg规格的 《药品注册证书》,该药品通过上市许可申请。该药品为化学药品4类,用于治疗中度至重度斑块状银 屑病的成人患者。此次获批将丰富公司治疗银屑病药物产品线,扩大产品市场销售,对未来业绩产生积 极影响,但药品销售受市场环境等因素影响,存在不确定性。 ...
上海医药:氨磺必利口崩片纳入国家医保目录 该药品境内暂无其他企业上市
Xin Lang Cai Jing· 2025-12-08 07:56
上海医药(601607.SH)公告称,公司下属上海上药中西制药有限公司的氨磺必利口崩片通过国家医保谈 判,成功纳入《国家医保目录》,协议有效期为自2026年1月1日至2027年12月31日。氨磺必利口崩片是 赛诺菲(Sanofi)公司于1986年在法国上市的氨磺必利片的改良剂型,用于治疗成人精神分裂症。2025 年10月,经国家药品监督管理局批准,上药中西成为氨磺必利口崩片的上市许可持有人。截至本公告 日,中国境内氨磺必利口崩片暂无其他企业上市。IQVIA数据库显示,2024年氨磺必利口服制剂的医院 采购金额为1.68亿元。 ...
华东医药(000963.SZ):瑞玛比嗪注射液上市许可申请获批准
智通财经网· 2025-10-17 10:36
Core Viewpoint - The company has received approval for the marketing license of Remabizine Injection, a drug that requires specific equipment for assessing kidney function [1] Company Summary - East China Pharmaceutical (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd. (referred to as "Sino-American East China"), has received the drug registration certificate issued by the National Medical Products Administration (NMPA) [1] - The approved drug, Remabizine Injection, is an exogenous fluorescent tracer used in conjunction with MediBeacon Inc's transcutaneous glomerular filtration rate measurement device (TGFR) to evaluate patients' glomerular filtration rate (GFR) [1]
人福医药:咪达唑仑注射液获法国上市许可
news flash· 2025-06-30 09:42
Core Viewpoint - The company Yichang Renfu Pharmaceutical, a subsidiary of Renfu Pharmaceutical (600079), has received approval from the French National Agency for the Safety of Medicines and Health Products for the marketing authorization of midazolam injection, which is indicated for sedation, pre-anesthesia in adults and children, and sedation in intensive care units [1] Group 1 - The approved indications for midazolam injection include sedation, pre-anesthesia in adults and children, and sedation in intensive care units [1] - The marketing authorization application was submitted in December 2023 and has now been approved, with a validity period of five years [1] - The total R&D investment for this project is approximately 8 million RMB [1] Group 2 - According to IQVIA data, the estimated annual sales for midazolam injection in the French market in 2024 is approximately 33 million USD [1]
力生制药:替格瑞洛分散片通过上市许可申请
news flash· 2025-06-06 07:48
Core Viewpoint - The announcement indicates that the company has received a drug registration certificate from the National Medical Products Administration for Ticagrelor dispersible tablets (90mg), which has been approved for market licensing. This drug is intended for use in patients with acute coronary syndrome or a history of myocardial infarction, along with at least one high-risk factor for atherosclerotic thrombotic events, to reduce the incidence of cardiovascular death, myocardial infarction, and stroke [1] Company Impact - The launch of Ticagrelor dispersible tablets will enhance the company's product line for treating circulatory system diseases, thereby increasing its market competitiveness [1] - The introduction of this drug is expected to have a positive impact on the company's future operating performance [1]
新天地:硫酸氢氯吡格雷原料药获准上市
news flash· 2025-05-07 08:08
Core Viewpoint - The company has received approval from the National Medical Products Administration for the raw material drug Sulfhydryl Clopidogrel, indicating compliance with Chinese drug review standards and enhancing the company's product portfolio [1] Group 1: Regulatory Approval - The company received the approval notice for Sulfhydryl Clopidogrel on May 6, 2025 [1] - The approval allows the raw material to be used in domestic formulations, expanding the company's product offerings [1] - The approval notice is valid until May 5, 2030 [1] Group 2: Product Information - Sulfhydryl Clopidogrel is a commonly used antiplatelet drug [1] - It is primarily used for the prevention and treatment of cardiovascular diseases related to atherosclerotic thrombosis [1] - The drug works by inhibiting platelet aggregation to reduce the risk of thrombosis [1]
兆科眼科、恒瑞医药争夺第二张“入场券” 阿托品的故事还动听吗
Mei Ri Jing Ji Xin Wen· 2025-04-03 03:32
Core Viewpoint - The recent performance of Zhaoke Ophthalmology shows significant revenue growth and a narrowing net loss, while investors are particularly interested in the approval timeline for its key product, low-concentration atropine eye drops [1][4]. Financial Performance - Zhaoke Ophthalmology reported a revenue of 69.32 million HKD for 2024, representing a year-on-year increase of 268.6% [1]. - The company's net loss decreased by 38.3% compared to the previous year [1]. - Cash reserves reached 1.12 billion HKD [1]. Product Approval and Market Potential - Zhaoke Ophthalmology's low-concentration atropine eye drops (NVK002) have been accepted for a simplified new drug application by the National Medical Products Administration [1]. - The target patient group for NVK002 includes children and adolescents aged 3 to 17 [1]. - The market demand for atropine eye drops is believed to be larger than that for PD-1 treatments, indicating significant growth potential [5]. Competitive Landscape - Currently, the only approved low-concentration atropine eye drops are held by Xingqi Eye Medicine, which has faced challenges in meeting sales expectations [2][3]. - Xingqi Eye Medicine's total revenue from eye drops, including atropine, was reported at 512 million CNY, suggesting that the sales of atropine may not reach the previously forecasted 1.5 billion CNY [3]. - Zhaoke Ophthalmology is preparing to scale operations rapidly upon the approval of NVK002, indicating a proactive approach to market entry [5]. Future Outlook - Zhaoke Ophthalmology is targeting three major indications: childhood myopia, dry eye syndrome, and wet age-related macular degeneration, with several products expected to enter the market within the next 1 to 2 years [5].