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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 - The company has received approval from the National Medical Products Administration for the clinical trial of VUM02 injection for the treatment of post-pneumonia progressive pulmonary fibrosis, marking a significant step in its drug development efforts [1][3]. Drug Information - Drug Name: VUM02 Injection - Dosage Form: Injection - Specification: 5E7 cells (10 mL) per bag - Registration Category: Class 1 therapeutic biological product - Application for: Domestic production drug registration clinical trial - Acceptance Number: CXSL2500651 - Notification Number: 2025LP02853 - Approval Conclusion: The VUM02 injection meets the requirements for drug registration and is approved to conduct clinical trials for post-pneumonia progressive pulmonary fibrosis [1]. Clinical Trial Details - The clinical trial plan submitted is a Phase IIa study evaluating the efficacy and safety of VUM02 injection in patients with post-pneumonia pulmonary fibrosis [2]. Drug Development Background - VUM02 injection is a cryopreserved cell preparation developed by the company, derived from umbilical cord mesenchymal stem cells (UC-MSCs) obtained from healthy newborns [3]. Disease Context - Progressive pulmonary fibrosis (PPF) is defined as a group of interstitial lung diseases characterized by progressive fibrosis and functional loss, with post-pneumonia progressive pulmonary fibrosis being a specific type that occurs after pneumonia [4]. - The condition is associated with various risk factors, including age, underlying diseases, immunosuppression, and smoking, and there is a significant need for effective treatment options [4]. Current Research Landscape - There is ongoing global clinical exploration of mesenchymal stem cell (MSC) therapies for various causes of pulmonary fibrosis, with existing data indicating good safety and tolerability [5]. - MSCs have the potential to address the core pathological processes of post-pneumonia progressive pulmonary fibrosis, offering a promising new treatment strategy [6]. - As of September 2025, the company has invested approximately RMB 23.52 million in related projects [6].