Core Viewpoint - Shanghai Mengke Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the supplementary application of the drug "Kangti Zuoan Tablets" and the clinical trial of "MRX-5 Tablets," indicating significant progress in the company's product pipeline and supply chain management [1][4]. Group 1: Kangti Zuoan Tablets - The drug "Kangti Zuoan Tablets" is a new generation oxazolidinone antibiotic developed by the company, approved for treating complex skin and soft tissue infections, and was launched in China in June 2021 [2]. - The recent approval allows Jiangsu Xuantai Pharmaceutical Co., Ltd. to be added as a contracted manufacturing enterprise, and Chongqing Boteng Pharmaceutical Technology Co., Ltd. will supply the active pharmaceutical ingredient [1][3]. - This development is crucial for ensuring stable product supply and meeting market demand, although sales are subject to policy and market environment influences [3]. Group 2: MRX-5 Tablets - "MRX-5 Tablets" is a new type of benzoborazole antibiotic intended for treating infections caused by non-tuberculous mycobacteria (NTM), with an increasing incidence and prevalence of NTM infections [5][6]. - The company has received approval to conduct further clinical trials for a new 200mg specification of MRX-5, which has shown good antibacterial activity and safety in previous trials [4][6]. - MRX-5 has completed Phase I clinical trials in Australia and has been granted orphan drug designation by the US FDA, indicating its potential in the market [6][7].
上海盟科药业股份有限公司 自愿披露关于获得药品补充申请及药物临床试验补充申请批准通知书的公告