NKF(SH:603707) Shang Hai Zheng Quan Bao·2025-11-10 18:17Core Viewpoint - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., announced that its subsidiary, Meitheal Pharmaceuticals, Inc., received approval from the U.S. FDA to increase the production site for injectable vecuronium bromide, which is expected to positively impact the company's operating performance [1][4]. Group 1: Drug Information - The drug approved is injectable vecuronium bromide, indicated as an adjunct for general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation [1]. - The approved specifications for the drug are 10 mg/vial and 20 mg/vial, with ANDA number 074688 [1][5]. - The reference formulation of injectable vecuronium bromide is held by ORGANON USA INC under the brand name NORCURON, which was approved by the FDA in 1984 and 1992 [2]. Group 2: Financial and Developmental Aspects - The company has invested approximately RMB 2.4238 million in the research and development of injectable vecuronium bromide [3]. - The newly approved product is expected to be launched in the U.S. market soon, which may have a positive effect on the company's financial performance [4]. Group 3: Market Context - Currently, besides the original manufacturer, there are eight other companies in the U.S. that have received approval to market injectable vecuronium bromide in the same specifications [2].