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securities code: 688506 securities abbreviation: Baili Tianheng announcement number: 2024-024

the company's board of directors and all directors to ensure that the contents of this announcement does not exist any false records, misleading statements or major omissions, and the authenticity, accuracy and completeness of the contents of the legal responsibility.

The innovative biopharmaceutical BL-B16D1 (dual anti-ADC) independently developed by 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 State Drug Administration (NMPA). The relevant information is hereby announced as follows:

Basic information on the 1. of the Notice of Approval for Clinical Trials of Drugs

Product Name: BL-B16D1 for Injection

Accept number: CXSL2400159

Notification No.: 2024LP01118

Application: Domestic drug registration clinical trials

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

Conclusion: According to the the People's Republic of China Drug Administration Law and relevant regulations, the clinical trial application for BL-B16D1 for injection accepted on February 26, 2024 meets the relevant requirements of drug registration, and it is agreed to carry out clinical trials in patients with advanced solid tumors.

Other conditions of 2. drugs

BL-B16D1 is the company's self-developed dual-anti-ADC drug coupled to a new generation of toxins, and its indication is advanced solid tumors.

3. risk warning

According to the requirements of national laws and regulations related to drug registration, after obtaining the drug clinical trial approval notice, clinical trials need to be carried out and approved by the NMPA before production and marketing.

As pharmaceutical products have the characteristics of high technology, high risk and high added value, the drug has a long cycle and many links from early research and clinical trial approval to production, and is easily affected by some uncertain factors. The company will actively promote the above-mentioned R & D projects in accordance with the relevant national regulations, and fulfill the obligation of information disclosure on the follow-up progress of the project in a timely manner in strict accordance with the relevant regulations. Investors are invited to make cautious decisions and pay attention to prevent investment risks.

It is hereby announced.

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

10 May 2024