Tasly Bioharma (hereinafter referred to as the "Company") has received a Notice of Approval for Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the "SDA") for the project of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as the "B2278 Injection"), agreeing to carry out the project of Coronary Artery Bypass Grafting (Coronary Artery Bypass Grafting). The Company has received a Notice of Approval for Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as "B2278 Injection") from the State Drug Administration (hereinafter referred to as the "SDA"), agreeing to carry out a clinical trial on chronic heart failure caused by chronic ischemic cardiomyopathy with indications of Coronary artery bypass graft ("CABG"). The relevant information is announced as follows:

I. Basic information of the drug
Drug name: human umbilical cord mesenchymal stem cell injection
Dosage form: Injection
Specification: 5×107
cells/1 ml/vial
Acceptance No.: CXSL2300728
Notification No.: 2024LP00162
Registered Classification: Therapeutic biological products, Class 1
Applicant：Tianshili Pharmaceutical Group Co.
Conclusion of Approval: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after examination, Human Umbilical Cord Mesenchymal Stem Cell Injection accepted on October 25, 2023 meets the relevant requirements for drug registration, and it is agreed to carry out the clinical trial of chronic ischemic cardiomyopathy resulting in chronic heart failure accompanied with coronary artery bypass grafting indications.

II. Drug Development and Other Relevant Information
B2278 Injection was developed by Shanghai Dongfang Hospital (Dongfang Hospital Affiliated to Tongji University) ("Dongfang Hospital"). In August 2022, the Company and Dongfang Hospital signed the Technology Transfer (Cooperation) Contract, pursuant to which the Company will be granted the relevant technology and results of B2278 Injection, and will prioritize the registration of the drug and subsequent clinical trials in China on a global scale. China to carry out drug registration filing and subsequent clinical trial development. Preclinical studies have proved that B2278 injection can regulate the microenvironment of myocardial tissue through paracrine action, and has obvious inhibitory effect on myocardial cell tissue damage in ischemic cardiomyopathy, increase cardiac function, promote vascular regeneration and reduce myocardial apoptosis in animals.The application for clinical trial of B2278 injection was accepted by the State Administration of Pharmaceutical Affairs of the PRC (SAFPARC) on 25th October 2023, and the notification of approval of drug clinical trial was obtained recently. The notification of approval will be followed by the research work related to the clinical trial of the product in accordance with the requirements of the notification. As at the date of this announcement, the Company's cumulative investment in research and development of B2278 Injection amounted to RMB11,621,100 (including the paid license fee).
(including the license fee paid).

Heart failure is a group of clinical syndromes in which ventricular filling and/or ejection capacity is impaired due to structural and/or functional abnormalities of the heart, and it is the final stage in the development of most cardiovascular diseases, and the prevalence and incidence of heart failure increase significantly with age. Current treatments for heart failure mainly include drug therapy, hemodialysis, cell and gene therapy, of which coronary artery bypass grafting (CABG) is a commonly used hemodialysis treatment modality, and the "White Paper on Cardiovascular Surgery and Extracorporeal Circulation Data in China, 2022" shows that CABG will account for 21.1% of the total number of cardiac surgical procedures in 2022. The above treatments can delay the progression of heart failure to some extent, but they cannot regenerate dead myocardium. Local injection of stem cells into the myocardium accompanying CABG surgery is expected to play a therapeutic role in heart failure by stimulating cardiac cell proliferation and differentiation, inhibiting cardiomyocyte damage and immunomodulation, and repairing cardiomyocytes so that myocardial contraction is enhanced. At present, there are more than ten kinds of stem cells approved internationally, but there is no stem cell product on the market for the treatment of heart failure.

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