Workflow
VUM02注射液
icon
Search documents
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].
中源协和:干细胞药物临床试验再获批 用于治疗肺炎后进展性肺纤维化
Zhong Zheng Wang· 2025-10-31 11:31
Core Insights - Zhongyuan Xiehe has received approval from the National Medical Products Administration for its VUM02 injection to conduct Phase IIa clinical trials for treating post-pneumonia progressive pulmonary fibrosis [1] - The company has a total of 10 indications approved for IND for VUM02, including severe COVID-19 and pneumonia, with some already in Phase II/III trials [1][2] Clinical Research Progress - VUM02 injection has completed all subject dosing in Phase I trials for idiopathic pulmonary fibrosis (IPF) and is currently organizing clinical safety and efficacy data [1] - The company’s equity stake in Beijing Sanyouli and Ze Biotechnology has led to the completion of subject enrollment for Phase II clinical trials of a human dental pulp mesenchymal stem cell injection [1] Product Development - VUM02 and VUM03 injections have collectively received approval for 11 INDs, reinforcing the company's competitive edge in the stem cell field and serving as a foundation for sustainable development [2]
中源协和:VUM02注射液获临床试验批准
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]
上证早知道|事关基础研究,上海大动作!智元机器人预告,8月21日将“上新”!公募“新基”,持续升温
Group 1 - Shanghai Municipal Government issued measures to support enterprises in enhancing basic research and high-quality development [4][5] - Hainan Provincial Government released a three-year action plan to accelerate the construction of a modern industrial system with distinctive advantages [4] - Shanghai Science and Technology Committee introduced management measures for the "Explorer Program" to encourage enterprises to invest in basic research [4] Group 2 - AI agent concept gained traction with several companies experiencing significant stock price increases following the certification of an AI customer service agent [9] - The global first organic solvent testing standard for footwear was officially released, addressing a critical global issue [6] - The electric vehicle industry is witnessing advancements with the announcement of the world's first mass-produced semi-solid battery vehicle [14][15] Group 3 - The innovative drug sector remains active, with several companies experiencing stock price surges due to strategic partnerships and clinical trial advancements [12][13] - Public fund issuance continues to rise, with 36 new funds launched this week, marking a 5.88% increase from the previous week [26] - Foreign investment in A-shares is increasing, with four stocks having over 24% of their shares held by foreign investors [27]
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
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: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
Core Viewpoint - Zhongyuan Union 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 [1] Group 1 - The clinical trial application for VUM02 injection has been officially accepted by the NMPA [1]
8月4日晚间重要公告一览
Xi Niu Cai Jing· 2025-08-04 10:11
Group 1 - Weihai Guangtai reported a net profit of 83.32 million yuan for the first half of 2025, a year-on-year decrease of 22.41%, while total revenue reached 1.425 billion yuan, an increase of 10.91% [1] - Haowei Group expects a net profit increase of 39.43% to 49.67% for the first half of 2025, estimating a profit range of 1.906 billion to 2.046 billion yuan [1] - Tengda Construction won a bid for a project worth 118 million yuan, with a construction period of 500 calendar days [1] Group 2 - Shanda Power plans to use up to 520 million yuan of idle raised funds for cash management, investing in safe and liquid products with a term not exceeding 12 months [3] - Rundu Co., Ltd. received approval for the listing application of its chemical raw material drug, which is suitable for surgical treatment in adults and children over one month old [4] - Zhongyuan Qihua's subsidiary's clinical trial application for a drug aimed at treating pulmonary fibrosis has been accepted [4] Group 3 - Shanghai Xiba plans to establish a joint venture with Yuyuan Rare Earth, focusing on advanced materials for lithium-ion solid-state batteries, with a registered capital of 200 million yuan [6] - Aorite's senior management plans to reduce their holdings by up to 62,500 shares, accounting for 0.02% of the company's total equity [7] - Yipin Hong's subsidiary's clinical trial application for a new oral drug for endometriosis has been accepted [8] Group 4 - Haya Pharmaceutical plans to lease idle assets covering 22,671.39 square meters for a period of 10 years [9] - Southern Precision Engineering applied for a credit limit of 50 million yuan from a bank for operational purposes [11] - Jindawei's subsidiary established a joint venture with a registered capital of 5 million yuan, focusing on the sale of food additives and health products [12] Group 5 - Gaode Infrared signed a product order contract worth 307 million yuan, expected to account for 11.46% of the company's audited revenue for 2024 [13] - Xichang Electric will implement a low valley electricity price policy starting September 1, 2025, which is expected to reduce net profit by approximately 5.55 million yuan [14] - Huyou Pharmaceutical's first subject has been dosed in a Phase I clinical trial for a drug targeting advanced solid tumors [16] Group 6 - Chuanheng Co., Ltd. received a patent for a dust removal system in mining operations [17] - Spring Wind Power's application for issuing convertible bonds has been accepted by the Shanghai Stock Exchange [18] - Liuyao Group plans to repurchase shares worth between 100 million and 200 million yuan [19] Group 7 - Baiyun Electric has obtained a commitment letter for a stock repurchase loan of up to 18 million yuan [20] - Tonghe Pharmaceutical received a patent for a method of preparing an intermediate for a migraine treatment drug [21] - Tainkang's subsidiary's Phase II clinical trial for a drug for vitiligo has shown significant efficacy and safety [23] Group 8 - Yuhua Tian's secretary and deputy general manager resigned for personal reasons [24] - Heizhima's controlling shareholder is planning a change in control, leading to a temporary suspension of stock trading [25] - Keda Li's subsidiary completed a capital increase, raising its registered capital to 700 million yuan [26] Group 9 - Fangda Special Steel's shareholder plans to reduce holdings by up to 1% of the company's shares [28] - ST Pava's director is under investigation for alleged embezzlement, but the company's operations remain normal [29] - Jiachuan Video's controlling shareholder is planning a change in control, resulting in a temporary stock suspension [32] Group 10 - Danhua Technology will change its stock name to Jinmei Technology starting August 7, 2025, due to a relocation of its registered office [33] - Morning Wind Technology's shareholder plans to reduce holdings by up to 1% of the company's shares [34] - Leshan Electric will adjust residential gas prices starting September 1, 2025, which is expected to increase gross profit by approximately 2.7 million yuan [35] Group 11 - SAIC Motor reported a total vehicle sales of 337,500 units in July 2025, a year-on-year increase of 34.22%, with significant growth in new energy vehicle sales [36] - LIGONG Navigation's shareholders plan to reduce holdings by up to 3% of the company's shares [37] - United Imaging's employee stock ownership platform plans to reduce holdings by up to 1.62% of the company's shares [38] Group 12 - Beiqi Blue Valley's subsidiary reported a 6.38% decline in sales in July 2025 [39] - Watson Bio's clinical research application for an mRNA vaccine has been accepted [40]
中源协和(600645.SH):VUM02注射液药品临床试验申请取得受理通知书
Ge Long Hui A P P· 2025-08-04 07:52
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, indicating progress in the development of this new drug [1] Group 1 - The VUM02 injection is a cryopreserved cell preparation developed independently by the company, derived from selected healthy newborn umbilical cord tissue [1] - The clinical trial aims to expand the indications for VUM02 injection to include the treatment of pulmonary fibrosis following pneumonia [1]
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]