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].

Group 1 - The core point of the article is that Zhongyuan Union has received approval for clinical trials of VUM02 injection for the treatment of severe/critical pneumonia from the National Medical Products Administration [2] Group 2 - The approval was granted to Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Zhongyuan Union [2] - The approval notification was issued on September 9, 2025 [2]

Group 1 - The core point of the article is that Zhongyuan Qihua has received approval from the National Medical Products Administration for its VUM02 injection to treat severe/critical pneumonia, which could enhance its market position and revenue potential [1] - Zhongyuan Qihua's revenue composition for the first half of 2025 shows that manufacturing accounts for 68.9%, services for 28.3%, and other businesses for 2.79% [1] - As of the report, Zhongyuan Qihua has a market capitalization of 11.6 billion yuan [1]

证券代码：600645 证券简称：中源协和 公告编号：2025-037 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大 遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 中源协和细胞基因工程股份有限公司（以下简称"公司"）全资子公司武汉 光谷中源药业有限公司于 2025 年 9 月 9 日收到国家药品监督管理局核准签发的 关于 VUM02 注射液用于治疗重型/危重型肺炎的《药物临床试验批准通知书》。 现对有关信息公告如下： 一、药品基本信息 药品名称：VUM02 注射液 剂型：注射剂 受理号：CXSL2500507 通知书编号：2025LP02332 审批结论： 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 6 月 23 日受理的 VUM02 注射液符合药品注册的有关要求，同意开展重型/危重型肺炎的 临床试验。 申请人提交的临床试验方案名称：一项以标准疗法为基础治疗评价 VUM02 注射液治疗重型/危重型肺炎患者的有效性和安全性的多中心、随机、双盲、安 慰剂对照的Ⅱ/Ⅲ期临 ...

Core Viewpoint - The company Zhongyuan Xiehe has received approval from the National Medical Products Administration for clinical trials of VUM02 injection for the treatment of severe/critical pneumonia, marking a significant step in the development of a novel cell therapy product [1] Company Summary - The full subsidiary Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd. has been granted a "Drug Clinical Trial Approval Notice" for VUM02 injection [1] - VUM02 injection is derived from umbilical cord mesenchymal stem cells (UC-MSC) obtained from selected healthy newborns, indicating a unique source for the new drug [1] - The total research and development investment for the related project amounts to RMB 16.5624 million [1] Industry Summary - Currently, there are no similar cell therapies approved for the treatment of severe/critical pneumonia globally, highlighting a potential market opportunity for VUM02 injection [1]

Core Viewpoint - Zhongyuan Union (600645.SH) announced that its wholly-owned subsidiary, Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of VUM02 injection for the treatment of severe/critical pneumonia, marking a significant advancement in the company's product pipeline [1] Company Summary - VUM02 injection is a cryopreserved cell preparation independently developed by Zhongyuan Union, with the clinical indication expanding to include the treatment of severe/critical pneumonia [1] - As of the announcement date, there are no similar cell drugs approved for the treatment of severe/critical pneumonia globally, with the fastest progressing similar drugs still in clinical trial stages [1]

Core Viewpoint - Zhongyuan Union (600645.SH) announced that its wholly-owned subsidiary, Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of VUM02 injection for the treatment of severe/critical pneumonia [1] Group 1 - VUM02 injection is an innovative drug developed by the company, derived from umbilical cord mesenchymal stem cells (UC-MSC) [1] - The drug is a cryopreserved cell preparation made from selected healthy newborn umbilical cord tissue, which undergoes in vitro separation, expansion, harvesting, and freezing [1] - The clinical trial aims to expand the indications for VUM02 injection to include the treatment of severe/critical pneumonia [1]

Core Viewpoint - Zhongyuan Union (600645.SH) announced that its wholly-owned subsidiary, Wuhan Guanggu Zhongyuan Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of VUM02 injection for the treatment of severe/critical pneumonia [1] Group 1 - VUM02 injection is an autologous developed cryopreserved cell preparation derived from selected healthy newborn umbilical cord tissue [1] - The clinical indication for VUM02 injection is being expanded to include the treatment of severe/critical pneumonia [1]

Core Viewpoint - Zhongyuan Union (600645.SH) announced that its wholly-owned subsidiary, Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of VUM02 injection for the treatment of severe/critical pneumonia [1] Group 1 - VUM02 injection is a cryopreserved cell preparation developed by the company, derived from selected healthy newborn umbilical cord tissue through in vitro separation, expansion, harvesting, and freezing [1] - The clinical indication for VUM02 injection is being expanded to include the treatment of severe/critical pneumonia [1]

Group 1 - The company will participate in the "2025 Tianjin Listed Companies Investor Online Collective Reception Day and Half-Year Performance Briefing" to enhance interaction with investors [1][2] - The event will be held online on September 11, 2025, from 15:00 to 17:00, allowing investors to join via the "Panjing Roadshow" website, WeChat public account, or the Panjing Roadshow APP [1][2] - Key company representatives attending the event include Vice Chairman and General Manager Wang Hongqi, independent directors Hou Xinyi and Luo Mingsheng, and CFO Chen Yiqing [2] Group 2 - The company will address investor concerns regarding its 2025 half-year performance, corporate governance, development strategy, and operational status during the event [2] - The company encourages widespread participation from investors in this interactive session [2]