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湖南方盛制药股份有限公司 关于洛索洛芬钠凝胶贴膏获得《药品注册证书》的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-01-25 23:17
Core Viewpoint - The company has received approval for the production of Loxoprofen Sodium Gel Patch, which is expected to enhance its product line in orthopedic medications and improve its competitive position in the market [1][3]. Group 1: Drug Registration and Details - The company's subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has obtained the Drug Registration Certificate for Loxoprofen Sodium Gel Patch from the National Medical Products Administration [1]. - Loxoprofen Sodium Gel Patch is indicated for the treatment of osteoarthritis, muscle pain, and swelling pain after injuries, with significant anti-inflammatory and analgesic effects [1]. - The total investment in this drug project, including research and development, has reached 7.0366 million yuan (approximately 1.01 million USD) as of the announcement date [1]. Group 2: Market Situation of Similar Drugs - A total of 15 companies in China have obtained drug registration certificates for Loxoprofen Sodium Gel Patch, including listed companies such as Jiutian Pharmaceutical, Darentang, and China Resources Sanjiu [2]. - According to Moen Pharmaceutical data, the total sales of Loxoprofen Sodium Gel Patch in hospitals for the first three quarters of 2025 reached 1.349 billion yuan (approximately 190 million USD), with retail sales in physical pharmacies amounting to 142 million yuan (approximately 20 million USD) in the first half of 2025 [2]. - Projected sales for 2024 are expected to be 1.709 billion yuan (approximately 240 million USD) in hospitals and 280 million yuan (approximately 40 million USD) in retail pharmacies [2]. Group 3: Impact on the Company - The approval of Loxoprofen Sodium Gel Patch will enrich the company's product line for orthopedic diseases, which already includes products like Xuanqi Jianguo Tablets and Tenghuang Jianguo Tablets [3]. - This new product is anticipated to enhance the company's competitiveness in the orthopedic medication market and improve overall profitability [3]. - The company emphasizes the importance of drug research and development while maintaining strict quality control in the manufacturing and sales processes [3].
湖南方盛制药股份有限公司关于洛索洛芬钠凝胶贴膏获得《药品注册证书》的公告
Shang Hai Zheng Quan Bao· 2026-01-25 19:08
Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Loxoprofen Sodium Gel Patch, allowing for production and sales, which enhances its product line in orthopedic medications and competitive position in the market [1][4]. Group 1: Drug Registration and Details - The Drug Registration Certificate for Loxoprofen Sodium Gel Patch was approved by the National Medical Products Administration on January 23, 2026 [1]. - Loxoprofen Sodium Gel Patch is indicated for osteoarthritis, muscle pain, and swelling pain after injuries, with significant anti-inflammatory and analgesic effects [1]. - The active ingredient, Loxoprofen Sodium, is a non-steroidal anti-inflammatory drug (NSAID) that works by inhibiting prostaglandin synthesis [1]. Group 2: Market Situation - As of the announcement date, 15 companies in China have obtained the Drug Registration Certificate for Loxoprofen Sodium Gel Patch, including listed companies such as Jiutian Pharmaceutical, Darentang, and China Resources Sanjiu [3]. - According to Moen Pharmaceutical data, the total hospital sales of Loxoprofen Sodium Gel Patch reached 1.349 billion yuan in the first three quarters of 2025, with retail sales in physical pharmacies amounting to 142 million yuan in the first half of 2025 [3]. Group 3: Impact on the Company - The approval of Loxoprofen Sodium Gel Patch enriches the company's product line for orthopedic diseases and enhances its competitiveness in the market, potentially improving overall profitability [4]. - The company has invested a total of 7.0366 million yuan in the drug project, including research and development and technology transfer [2]. - The company emphasizes the importance of drug research and development, maintaining strict quality control in the drug development, manufacturing, and sales processes [4].
湖南方盛制药股份有限公司关于公司《药品生产许可证》变更的公告
Shang Hai Zheng Quan Bao· 2025-10-21 18:38
Core Points - The company has completed the change registration of its "Drug Production License" and obtained the new license from the Hunan Provincial Drug Administration [1] - The validity of the "Drug Production License" has been extended to October 16, 2030 [1][3] - The company has made several changes to its production lines and added new products to its production scope [1][3] License Change Details - The license validity has been extended from December 3, 2025, to October 16, 2030 [1] - The production address for the raw material drug (Ibandronate) has been updated to "Raw Material Drug Workshop (Workshop 101) B Area and E Area" [1] - The company has added the production of "Raw Material Drug (Benidipine Hydrochloride)" at the same production address [1] - The company has commissioned Tian Di Heng Yi Pharmaceutical Co., Ltd. to produce "Yuan Qi Bone Pain Tincture" with a validity until October 16, 2030 [1] - Additional commissioned production information has been included for two products: "Flurbiprofen Gel Patch" and "Compound Glycyrrhizin Tablets" [1] Production Scope and Impact - The production scope includes various forms of drugs such as powder injections, tablets, hard capsules, and raw materials [3] - The changes in the "Drug Production License" will not affect the company's existing production structure and will maintain stable production capacity [3] - The new license is not expected to have a significant impact on the company's current performance [3]