中源协和细胞基因工程股份有限公司 2025年第一次临时股东大会 会议资料 2025 年第一次临时股东大会会议议程 现场会议时间：2025 年 11 月 14 日 14:00。 网络投票时间：采用上海证券交易所网络投票系统，通过交易系统投票平台的投 票时间为股东大会召开当日的交易时间9:15-9:25,9:30-11:30， 13:00-15:00；通过互联网投票平台的投票时间为股东大会召开 当日 9:15-15:00。 会议地点：天津市滨海高新区华苑产业区梅苑路 12 号公司会议室。 会议出席人： 1、2025 年 11 月 7 日下午 3:00 收市后在中国证券登记结算有限责任公司上 海分公司登记在册的公司股东及股东代理人； 2、本公司董事、监事及高级管理人员； 2025 年 11 月 14 日 中源协和细胞基因工程股份有限公司 3、本公司聘请的股东大会见证律师。 会议议程： 四、审议各项议案，股东提问与解答； | 编号 | 议案内容 | | --- | --- | | 1 | 《关于续聘天健会计师事务所为公司 2025 年度审计机构的议案》 | | | 五、股东对上述议案进行投票表决； | | | 六、宣 ...

Market Overview - The precision medicine sector experienced a decline of 1.77% on November 4, with TuoJing Life leading the drop [1][2] - The Shanghai Composite Index closed at 3960.19, down 0.41%, while the Shenzhen Component Index closed at 13175.22, down 1.71% [1] Stock Performance - Notable stock performances in the precision medicine sector included: - RenDu Bio (688193) closed at 52.90, up 1.05% with a trading volume of 7076.23 hands and a transaction value exceeding 36.99 million yuan [1] - TuoJing Life (300642) closed at 22.73, down 2.86% with a trading volume of 78,200 hands and a transaction value of 178 million yuan [2] - Other companies like DaAn Gene (002030) and Anke Bio (300009) showed minimal changes, with DaAn Gene remaining flat at 6.57 and Anke Bio down 0.55% to 10.84 [1][2] Capital Flow - The precision medicine sector saw a net outflow of 979 million yuan from institutional investors, while retail investors contributed a net inflow of 642 million yuan [2][3] - Specific stock capital flows indicated: - GuoMai Technology (002093) had a net inflow of 8.61 million yuan from institutional investors, while retail investors saw a net outflow of 15.98 million yuan [3] - TuoJing Life experienced minimal net inflow from institutional investors at 25,000 yuan, with retail investors also showing a slight outflow [3]

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].

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]

Core Insights - The recombinant protein industry in China, despite its late start, has rapidly developed due to continuous support from national industrial policies, leading to significant breakthroughs in technology, production processes, and quality control [1][15] - The market for recombinant proteins is expected to grow steadily, driven by increased investment in innovative drug research, rising demand for precision medicine, and the expansion of downstream application scenarios [1][15] Industry Overview - Recombinant proteins are proteins obtained through genetic engineering and cell engineering, essential for the development and production of biopharmaceuticals, cell immunotherapy, and diagnostic reagents [4] - The industry has experienced three stages: the initial stage (1970-1990), rapid development (1990-2000), and transformation and upgrading (2000-present) [8][9] Market Growth - The market size of China's recombinant protein industry is projected to grow from 5.1 billion yuan in 2015 to 27 billion yuan in 2024, with a compound annual growth rate (CAGR) of 20.34% [1][15] - The global recombinant protein market is expected to increase from $7 billion in 2015 to $18.5 billion in 2024, with a CAGR of 11.4% [13][14] Policy Support - The Chinese government has implemented various policies to encourage technological innovation and market expansion in the biopharmaceutical sector, including funding support for research and expedited drug approval processes [9][10] Industry Chain - The upstream of the recombinant protein industry includes raw materials and equipment, while the midstream consists of recombinant protein products, and the downstream includes customers such as research institutions and pharmaceutical companies [10] Competitive Landscape - The recombinant protein market is characterized by a diverse and dynamic competitive landscape, with major multinational pharmaceutical companies like Pfizer, Roche, and Novartis leading the market, while numerous small and medium-sized enterprises focus on innovative technologies [16][17] Development Trends - The industry is moving towards high-end products, focusing on complex structures and high-value proteins, with an emphasis on product activity, purity, and consistency [18] - Intelligent technologies, including AI and machine learning, are expected to enhance research and production processes, improving efficiency and product quality [19][20] - Chinese recombinant protein companies are increasingly participating in global competition, aiming to meet international standards and establish a strong global presence [21]

Core Viewpoint - Zhongyuan Union is a leading enterprise in the domestic cell industry, focusing on cell detection, preparation, storage, and in vitro diagnostics, with a comprehensive and differentiated advantage across the entire industry chain [1] Group 1: Business Performance - In Q3 2025, Zhongyuan Union achieved a revenue of 1.092 billion yuan, ranking 9th among 39 companies in the industry [2] - The company's main business composition includes testing reagents (410 million yuan, 58.46%), cell detection preparation and storage (186 million yuan, 26.49%), scientific research reagents (83.27 million yuan, 11.86%), gene testing (16.87 million yuan, 2.40%), and others (5.53 million yuan, 0.79%) [2] - The net profit for the same period was 99.86 million yuan, ranking 12th in the industry [2] Group 2: Financial Ratios - As of Q3 2025, Zhongyuan Union's asset-liability ratio was 29.26%, down from 30.31% year-on-year, which is higher than the industry average of 18.29% [3] - The company's gross profit margin in Q3 2025 was 69.22%, slightly down from 69.82% year-on-year, but still above the industry average of 56.20% [3] Group 3: Management and Shareholder Structure - The total compensation for General Manager Wang Hongqi was 2.3881 million yuan in 2024, an increase of 1.9688 million yuan compared to 2023 [4] - The controlling shareholder is Shenzhen Jiadao Successful Investment Enterprise (Limited Partnership), with actual controllers Chen Chunmei and Gong Hongjia [4] Group 4: Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 4.06% to 34,700 [5] - The average number of circulating A-shares held per shareholder decreased by 3.91% to 13,500 [5]

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]

证券代码：600645 证券简称：中源协和 公告编号：2025-043 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 10 月 30 日收到国家药品监督管理局核准签发 的关于 VUM02 注射液用于治疗肺炎后进展性肺纤维化的《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 当前，全球范围内已广泛开展间充质基质细胞（MSCs）治疗各类病因所致 肺纤维化的临床探索，现有数据表明该疗法具有良好的安全性和耐受性。MSCs 凭借其独特的免疫调节、抗炎、抗纤维化以及促进组织修复与再生的能力，有望 同时干预肺炎后进展性肺纤维化的三大核心病理过程——持续炎症损伤、组织修 复失调和病理性纤维过度沉积，从而为这类患者提供一种潜在的有效治疗新策略。 剂型：注射剂 受理号：CXSL2500651 通知书编号：2 ...

Core Viewpoint - Zhongyuan Xiehe (600645.SH) reported a decline in operating revenue for Q3 2025, while net profit showed a slight increase, indicating mixed financial performance [1] Financial Performance - Operating revenue for Q3 2025 was 376 million yuan, a year-on-year decrease of 6.82% [1] - Net profit attributable to shareholders was 50.14 million yuan, reflecting a year-on-year increase of 3.74% [1] - Net profit attributable to shareholders after deducting non-recurring gains and losses was 44.03 million yuan, a year-on-year decrease of 5.10% [1]

Core Viewpoint - Zhongyuan Xiehe (600645.SH) reported a decline in operating revenue for Q3 2025, while net profit showed a slight increase, indicating mixed financial performance [1] Financial Performance - Operating revenue for Q3 2025 was 376 million yuan, a year-on-year decrease of 6.82% [1] - Net profit attributable to shareholders was 50.14 million yuan, reflecting a year-on-year increase of 3.74% [1] - Net profit attributable to shareholders after deducting non-recurring gains and losses was 44.03 million yuan, a year-on-year decrease of 5.10% [1]