药品上市

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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].