细胞药物研发
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中源协和:VUM02注射液获临床试验批准
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-30 10:29
Core Viewpoint - Zhongyuan Union has received approval from the National Medical Products Administration for its VUM02 injection, which is intended for clinical trials to treat post-pneumonia progressive pulmonary fibrosis [1] Group 1: Product Development - The VUM02 injection is an autologous umbilical cord-derived mesenchymal stem cell injection, classified as a Class 1 therapeutic biological product [1] - The clinical trial aims to evaluate the efficacy and safety of VUM02 in patients with pulmonary fibrosis following pneumonia through a Phase IIa study [1] - As of September 2025, the company has invested a total of 23.5155 million yuan in the development of this project [1] Group 2: Market Context - Currently, there are no similar cell therapies approved for market globally, indicating a potential first-mover advantage for the company [1] - The therapy is expected to provide new treatment options through mechanisms such as immune modulation, anti-inflammation, and tissue repair promotion [1] Group 3: Future Considerations - The project will still need to undergo multiple stages, including clinical trials and market application, which introduces uncertainty regarding its future [1]
中源协和细胞基因工程股份有限公司关于全资子公司药品临床试验申请取得受理通知书的公告
Shang Hai Zheng Quan Bao· 2025-08-04 18:45
Group 1 - The core announcement is that the company's wholly-owned subsidiary, Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., has received a notice of acceptance for the clinical trial application of VUM02 injection from the National Medical Products Administration (NMPA) [1] - VUM02 injection is a cryopreserved cell preparation developed by the company, derived from umbilical cord mesenchymal stem cells (UC-MSC), aimed at treating post-pneumonia pulmonary fibrosis [2] - As of June 2025, the total R&D investment for the related project has reached RMB 22.33 million [2]
中源协和子公司VUM02注射液临床试验申请取得受理通知书
Zhi Tong Cai Jing· 2025-08-04 07:50
Core Viewpoint - Zhongyuan Union (600645.SH) announced that its wholly-owned subsidiary, Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., received the Clinical Trial Application Acceptance Notice from the National Medical Products Administration (NMPA) for VUM02 injection on August 1, 2025, marking a significant step in the development of a new treatment for post-pneumonia pulmonary fibrosis [1] Group 1 - VUM02 injection is an autologous cryopreserved cell preparation derived from umbilical cord mesenchymal stem cells (UC-MSC) obtained from healthy newborns [1] - The clinical application aims to treat post-pneumonia pulmonary fibrosis, a condition for which no similar cell therapies are currently available globally [1] - The development of VUM02 is supported by previous clinical research data from studies on COVID-19 and idiopathic pulmonary fibrosis [1]
中源协和(600645.SH)子公司VUM02注射液临床试验申请取得受理通知书
智通财经网· 2025-08-04 07:48
Core Viewpoint - Zhongyuan Union (600645.SH) announced that its wholly-owned subsidiary, Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., received the acceptance notice for the clinical trial application of VUM02 injection from the National Medical Products Administration (NMPA) on August 1, 2025, marking a significant step in the development of a new treatment for post-pneumonia pulmonary fibrosis [1] Group 1 - VUM02 injection is an autologous cryopreserved cell preparation derived from selected healthy newborn umbilical cord tissue, aimed at treating post-pneumonia pulmonary fibrosis [1] - There are currently no similar cell drugs approved globally for the treatment of post-pneumonia pulmonary fibrosis, with the fastest progressing similar drugs still in early research stages [1] - The application for this indication is supported by previous clinical research data from COVID-19 and idiopathic pulmonary fibrosis Phase I clinical trials [1]