医药产品国际化
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汇宇制药:注射用帕瑞昔布钠、注射用培美曲塞二钠获境外上市许可
Zhi Tong Cai Jing· 2025-08-13 08:01
Core Viewpoint - The company has received marketing approvals for its injectable products, Parecoxib Sodium and Pemetrexed Disodium, from regulatory authorities in the Netherlands and Saudi Arabia, enhancing its international market presence and brand image [1] Group 1 - The company's subsidiary, Seacross Pharma (Europe) Ltd., and Seacross Pharmaceuticals Ltd. have obtained marketing licenses for injectable Parecoxib Sodium and Pemetrexed Disodium [1] - The approvals from the Dutch Medicines and Health Products Regulatory Authority and the Saudi Health Products Regulatory Authority signify a strategic expansion into international markets [1] - The successful launch of these products is expected to enrich the company's product pipeline and support sustainable development in international markets [1]
步长制药: 山东步长制药股份有限公司关于控股子公司泸州步长与GOODFELLOW签署《独家供应协议》的公告
Zheng Quan Zhi Xing· 2025-08-07 10:14
Core Viewpoint - The company aims to enhance its internationalization strategy and brand influence by signing an exclusive supply agreement with GOODFELLOW PHARMA CORPORATION for the product Efparepoetin alfa in the Philippines [1][6]. Summary by Sections Agreement Overview - The board of directors approved the exclusive supply agreement with GOODFELLOW for the product Efparepoetin alfa, which is currently under registration [2]. - The agreement does not involve related party transactions or constitute a major asset restructuring [2][3]. Product Information - Efparepoetin alfa is a new biological drug intended for treating anemia in adult dialysis patients due to chronic kidney disease (CKD) and has submitted a listing application [2]. - As of June 30, 2025, the cumulative R&D investment in Efparepoetin alfa is approximately 498.92 million yuan [2]. Partner Information - GOODFELLOW PHARMA CORPORATION, established in 2004, is based in Metro Manila, Philippines, and specializes in the import and export of medical products [3][4]. - There is no related party relationship between GOODFELLOW and the company [4]. Agreement Details - GOODFELLOW is authorized as the exclusive agent in the Philippines for the registration, clinical trials, promotion, distribution, and sales of Efparepoetin alfa [4][5]. - The agreement includes provisions for product registration, with the company responsible for preparing necessary documentation and providing product samples for clinical research [5]. - The agreement is effective for five years from the date of obtaining the import drug license, with a potential five-year extension [5][6]. Impact on the Company - This transaction represents a significant step in the company's internationalization strategy, expected to generate economic benefits and enhance brand value [6][7]. - The collaboration aims to expedite the commercialization of R&D results and expand the overseas market for Efparepoetin alfa, thereby improving the company's performance [7].
汇宇制药:子公司产品获得德国和沙特阿拉伯上市许可
news flash· 2025-07-25 07:49
Core Insights - The company’s subsidiary, Seacross Pharma Ltd., has recently obtained marketing approvals from the German Federal Institute for Drugs and Medical Devices and the Saudi Food and Drug Authority for several products, including Zoledronic Acid Injection, Injection for Cetuximab, Sodium Valproate Injection Concentrate, and Bendamustine Hydrochloride Injection [1] Group 1 - The approvals will help the company enhance its international product pipeline, improve brand image, and expand the breadth and depth of its international business [1] - The company has prepared for the market launch and sales of these products [1] - Future revenue generation remains uncertain due to market competition and other factors [1]