Core Viewpoint - Zhongyuan Xiehe announced that its affiliated company, Beijing Sanyouli, in collaboration with Capital Medical University, is progressing with the clinical trials of "human dental pulp mesenchymal stem cell injection" for the treatment of chronic periodontitis, with all participants for Phase II expected to be enrolled by 2024 [1] Group 1 - The company is conducting regular follow-up work for the chronic periodontitis treatment trial [1] - The treatment for idiopathic pulmonary fibrosis has completed all participant dosing in Phase I, and the company is currently organizing clinical safety and efficacy data [1]

证券代码：600645 证券简称：中源协和 公告编号：2025-038 中源协和细胞基因工程股份有限公司 关于用于现金管理的闲置募集资金归还至募集资金 专户的公告 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。 公司于 2024 年 12 月 18 日召开十一届十五次临时董事会和十一届七次临时 监事会，会议审议通过了《关于使用暂时闲置募集资金及自有资金进行现金管理 的议案》。在不影响正常经营、不影响募集资金项目建设和募集资金使用计划的 前提下，同意公司及控股子公司使用不超过人民币 1.2 亿元的闲置募集资金及不 超过人民币 6 亿元的闲置自有资金进行现金管理，自公司董事会、监事会审议通 过之日起 12 个月内有效。具体详见公司公告：2024-051、052、053。 后公司使用 1.2 亿闲置募集资金购买了华夏银行股份有限公司上海分行人 民币单位结构性存款 DWJGX2510630，产品期限 90 天，成立日 2025 年 6 月 27 日， 到期日 2025 年 9 月 25 日（具体详见公司公告：2025-026）。该产品 ...

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]