中源协和细胞基因工程股份有限公司关于全资子公司获得药物临床试验批准通知书的公告

Core Viewpoint - Zhongyuan Qihua Cell Gene Engineering Co., Ltd. announced that its wholly-owned subsidiary, Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., received the clinical trial approval notice for VUM02 injection for the treatment of severe/critical pneumonia from the National Medical Products Administration on September 9, 2025 [1]. Drug Information - Drug Name: VUM02 Injection - Dosage Form: Injection - Specification: 5E7 cells (10 mL) per bag - Registration Category: Class 1 therapeutic biological product - Application: Clinical trial registration for domestic drug production - Acceptance Number: CXSL2500507 - Notice Number: 2025LP02332 - Approval Conclusion: The VUM02 injection meets the requirements for drug registration and is approved to conduct clinical trials for severe/critical pneumonia [1]. Clinical Trial Details - The clinical trial plan is a multicenter, randomized, double-blind, placebo-controlled Phase II/III study to evaluate the efficacy and safety of VUM02 injection in treating patients with severe/critical pneumonia [2]. Drug Development Background - VUM02 injection is a cryopreserved cell preparation developed by the company, derived from selected healthy newborn umbilical cord tissue, aimed at treating severe/critical pneumonia [3]. - Severe/critical pneumonia is a common respiratory infectious disease with a high mortality rate of 30%-50%, ranking first in global infectious disease-related deaths [3][4]. - The incidence of community-acquired pneumonia in China is 7.13 per 1,000 person-years, with hospitalization rates increasing annually by 15.5% from 2009 to 2017 [3]. - The global burden of severe/critical pneumonia remains high due to factors such as antibiotic resistance and an aging population, necessitating effective treatment methods [4]. - Mesenchymal stem cells have been applied in various countries for the treatment of severe/critical pneumonia, showing good safety and efficacy [4]. - As of July 2025, the cumulative R&D investment for the related project is approximately RMB 16.56 million [5].