Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2025-030

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure Regarding BL-M09D1 (ADC) for Injection in Advanced Solid Tumors

Announcement of the Notice of Approval for Drug 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-M09D1 (ADC) independently developed by the Company for injection 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-M09D1 for injection

Acceptance number: CXSL2500103

Notice No.: 2025LP01070

Application matters: registration and clinical trials of domestically produced drugs

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

Conclusion: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after review, BL-M09D1 for injection meets the relevant requirements of drug registration, and it is agreed that this product will be used as a single agent in patients with advanced solid tumors.

Second, other conditions of drugs

BL-M09D1 is based on the same small molecule technology platform as BL-B01D1 and shares the same platform as BL-B01D1

ADC drugs of the "linker + toxin" platform for the indication of advanced solid tumors.

3. Risk Warning

According to the requirements of laws and regulations related to drug registration in China, drugs need to complete relevant clinical trials and pass the review and approval of the State Drug Administration before they can be marketed.

Due to the characteristics of high-tech, high-risk and high value-added pharmaceutical products, drugs have a long cycle and many links from early research, clinical trial approval to production, and are easily affected by some uncertain factors

The relevant regulations actively promote the above-mentioned R&D projects, and strictly follow the relevant provisions to fulfill the information disclosure obligations on the follow-up progress of the project in a timely manner, please make prudent decisions and pay attention to preventing investment risks.

The announcement is hereby made.

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

April 17, 2025