Announcement of Zhongyuan Xiehe Cell Gene Engineering Co., Ltd. on the postponement of the fundraising project
Securities code: 600645 Securities abbreviation: Zhongyuan Xiehe Announcement number: 2025-055
Zhongyuan Xiehe Cell Gene Engineering Co., Ltd.
Announcement on the postponement of fundraising projects
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
1. Basic situation of raised funds
According to the China Securities Regulatory Commission’s “Reply on Approving the Issuance of Shares by Zhongyuan Concord Genetic Engineering Co., Ltd. to Wang Xiaoge and Others to Purchase Assets and Raise Supporting Funds” (CSRC License [2018] No. 1180), the company actually non-publicly issued 27,815,801 RMB ordinary shares at an issue price of 16.07 yuan, raising total funds of 446,999,922.07 After deducting relevant issuance fees (including underwriting fees, audit and capital verification fees, legal fees, etc.) of 2,550,000.00 yuan, the company’s actual net raised funds were 444,449,922.07 yuan. All the funds raised were received on July 22, 2019. Ruihua Accounting Firm (Special General Partnership) issued a "Capital Verification Report" (Ruihua Yanzi [2019] No. 12010004) on the actual receipt of the company's new registered capital.
The company adopts a special account storage system for raised funds. After the raised funds are in place, they have all been stored in a special account for raised funds. The company has signed a tripartite supervision agreement for raised funds with the sponsor institution and the commercial bank where the raised funds are stored.
2. Raised investment projects and use of raised funds
As of June 30, 2025, the use of supporting funds raised this time is as follows:
Unit: 10,000 yuan
The original planned project has reached the pre-serial number. Project name. Planned investment amount. Cumulative investment.
The state-time investment project "National Stem Cell Engineering Products" can be used
1 30,000.00 101.80
The third phase construction project of the industrialization base in October 2026"
Fundraising project “Tumor Marker Diagnostic Test”
2 6,000.00 5,200.00
“December 2025 Dosage Development Project”
3 Raised investment project “Permanent replenishment of working capital” 4,444.99 4,444.99
Not applicable
4 Pay the fees related to this transaction 4,000.00 4,000.00
Not applicable
Total 44,444.99 13,746.79 -
3. Details of the postponement of this fundraising project
(1) Extension situation
The company's investment project with raised funds this time is the "Tumor Marker Diagnostic Reagent Development Project". Based on the actual implementation progress of the company's current investment project with raised funds, and under the condition that the implementation entity, implementation method, investment amount, etc. of the raised investment project do not change, the time for the project to reach the scheduled usable state will be extended.
(2) Reasons for postponement
The company held the 2020 Annual General Meeting of Shareholders on May 14, 2021 to review and approve matters related to changes in the implementation method of the fundraising project "Tumor Marker Diagnostic Reagent Development Project", and entrusted Beijing Zhongyuan Weikang Gene Technology Co., Ltd. (hereinafter referred to as "Beijing Zhongyuan Weikang") to be responsible." Research and development of "human EGFR/KRAS/BRAF/NRAS/ERBB2/PIK3CA gene mutation detection kit (time-of-flight mass spectrometry)" (hereinafter referred to as the "tissue kit") and "human circulating tumor DNA multi-gene mutation combined detection kit" (hereinafter referred to as the "blood kit"). During this period, due to the impact of public health events, the overall progress of the project's clinical trials was greatly affected.
Beijing Zhongyuan Weikang submitted the tissue kit registration documents to the National Medical Products Administration on March 1, 2024. Later, clinical replenishment trials were carried out in accordance with the replenishment notice of the State Food and Drug Administration. So far, the clinical replenishment trials of the tissue kit have been completed. Beijing Zhongyuan Weikang has submitted the final registration document to the State Food and Drug Administration on October 24, 2025, and is currently awaiting final review.
The blood kit has completed all clinical trials according to the original work plan. Later, the State Food and Drug Administration newly promulgated the "Guiding Principles for Clinical Trial Registration Review of Non-Original Companion Diagnostic Reagents for Anti-tumor Drugs", which put forward higher requirements for the design and evaluation of clinical trials, including clinical trial institutions, enrollment groups, comparison methods, etc., especially An evaluation method for comparative studies with original companion diagnostic reagents was proposed; Beijing Zhongyuan Weikang conducted repeated communication and adjustments to the clinical trial protocol of the blood kit with relevant departments of the State Food and Drug Administration and four hospital clinical centers according to the new requirements. The revised protocol added new test requirements and re-applied for national ethics approval, which also affected the progress of clinical trials. The new test requirements for the revised blood kit clinical trial protocol have passed national ethics approval. The new trial requirements in the revised protocol include the addition of original controlled comparative trials. Since the clinical trial of the blood kit is a prospective sample collection and contains rare mutations in some detection site data, the clinical enrollment progress is slower than expected. Beijing Zhongyuan Weikang is actively promoting clinical trials in accordance with the new trial requirements in the revised protocol and will submit registration documents to the National Medical Products Administration as soon as possible after the clinical trials are completed.
Therefore, according to the current implementation progress of the project, the time for the project to reach the scheduled usable state has been extended to December 2026.
(3) Measures to ensure on-schedule completion after extension
i Strengthen close communication with clinical centers to promptly solve problems that arise during the enrollment of clinical trial samples; improve enrollment efficiency by publishing clinical research recruitment plans online or offline.
ii. Hire third-party review experts to conduct a pre-assessment of the quality management system, and rectify the issues raised by the experts in advance to ensure smooth passing of the formal system examination and accelerate the progress of kit approval.
iii The company will strengthen the management of fundraising projects, closely follow up the implementation progress of fundraising projects, conduct supervision, inspection and evaluation of projects to ensure the quality and progress of fundraising projects.
4. Impact on the company and follow-up arrangements
The company's postponement adjustment for this fundraising project is a prudent decision based on the actual implementation progress of the project. This postponement of the raised investment project does not involve changes in the implementation entity, implementation method, investment amount, etc. of the raised investment project. The feasibility of project implementation has not changed significantly, and there is no change or disguised change in the investment direction of the raised funds or damage to the interests of the company and all shareholders. This postponement of the investment project will not have a substantial impact on the company's normal operations.
5. Review procedures for the extension of this fundraising project
The company held the 24th extraordinary meeting of the 11th Board of Directors on December 25, 2025, and reviewed and approved the "Proposal on the Extension of Fund-raising Projects". This proposal does not need to be submitted to the company's shareholders' meeting for review.
6. Verification opinions of the independent financial consultant on the extension of the investment project
After verification, the independent financial consultant Dongxing Securities Co., Ltd. believes that:
The postponement of the investment project with raised funds is a prudent decision based on the actual implementation progress of the project. This postponement of the raised investment project does not involve changes in the implementation entity, implementation method, investment amount, etc. of the raised investment project. The feasibility of project implementation has not changed significantly, and there is no change or disguised change in the investment direction of the raised funds or damage to the interests of the company and all shareholders. This postponement of the investment project will not have a substantial impact on the company's normal operations.
This matter has been reviewed and approved by the company’s board of directors, and is in compliance with the provisions of the "Regulations on the Supervision of Funds Raised by Listed Companies ([2025] No. 10)", "Shanghai Stock Exchange Self-Discipline Supervision Guidelines for Listed Companies No. 1 - Standardized Operations (Revised in May 2025)" and other relevant laws, regulations and normative documents.
In summary, the independent financial consultant has no objection to the postponement of the company's investment project with funds raised this time. Announcement is hereby made.
Board of Directors of Zhongyuan Xiehe Cell Gene Engineering Co., Ltd.
December 26, 2025