Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2024-064

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure of Access to Medicines for the BL-M08D1 (ADC) Program for the Treatment of Relapsed or Refractory Hematologic Malignancies and Locally Advanced or Metastatic Solid Tumors

Announcement of the Notice of Approval for Clinical Trials

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Sichuan Baili Tianheng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") recently received the "Drug Clinical Trial Approval Notice" officially approved and issued by the National Medical Products Administration (NMPA), and the clinical trial of the innovative biological drug BL-M08D1 (ADC) independently developed by the Company was approved. The relevant information is hereby announced as follows:

1. Basic information of the Notice of Approval of Drug Clinical Trials

Product name: BL-M08D1 for injection

Acceptance number: CXSL2400613

Notice No.: 2024LP02657

Application matters: registration and clinical trials of domestically produced drugs

Applicant: Sichuan Baili Pharmaceutical Co., Ltd.; Chengdu Bailidote Biopharmaceutical Co., Ltd

Conclusion: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after review, the clinical trial application for BL-M08D1 for injection accepted on September 12, 2024 meets the relevant requirements of drug registration, and it is agreed that this product will be used as a single agent to carry out clinical trials in relapsed or refractory hematologic malignancies and locally advanced or metastatic solid tumors.

Second, other conditions of drugs

BL-M08D1 is based on the same small molecule technology platform as BL-B01D1 and shares the same platform as BL-B01D1

An ADC drug of a "linker + toxin" platform for the indications of relapsed or refractory hematologic malignancies and locally advanced or metastatic solid tumors.

3. Risk Warning

According to the requirements of laws and regulations related to national drug registration, the drug is in the process of obtaining the approval notice of drug clinical trial

After the book, clinical trials are still to be carried out and approved by the NMPA before they can be produced and marketed.

Due to the characteristics of high-tech, high-risk and high value-added pharmaceutical products, drugs from early research, clinical trial approval to production cycle is long and linked, and is easily affected by some uncertain factors, the company will actively promote the above-mentioned research and development projects in accordance with relevant national regulations, and strictly follow the relevant regulations to timely fulfill the information disclosure obligations on the follow-up progress of the project, please make careful decisions and pay attention to preventing investment risks.

The announcement is hereby made.

Board of Directors of Sichuan Baili Tianheng Pharmaceutical Co., Ltd

November 29, 2024