盟科药业(688373.SH)：获得药品补充申请及药物临床试验补充申请批准通知书

Group 1 - Company received approval from the National Medical Products Administration for the supplementary application of the drug "Kangti Zuoan Tablets" and the supplementary application for clinical trials of "MRX-5 Tablets" [1] - "Kangti Zuoan Tablets" is a new generation oxazolidinone antibiotic designed for treating complex skin and soft tissue infections, approved for marketing in China since June 2021 [1] - The approval allows Jiangsu Xuantai Pharmaceutical Co., Ltd. to act as a contract manufacturer, utilizing raw materials from Chongqing Boten Pharmaceutical Technology Co., Ltd., enhancing the product supply chain and ensuring stable supply [1] Group 2 - "MRX-5 Tablets" is a novel benzothiazole antibiotic aimed at treating infections caused by non-tuberculous mycobacteria (NTM), with increasing incidence and prevalence of NTM diseases [1] - The drug shows good antibacterial activity against common NTM, with favorable safety and pharmacokinetic properties demonstrated in animal and human trials [1] - The company has completed Phase I clinical trials in Australia, achieving expected goals, and received orphan drug designation from the US FDA for "MRX-5" [1][2] - The approval of a new 200mg specification for clinical trials will facilitate further clinical research [2]