Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2025-029

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure: Obtained 4 Phase II IND approvals for BL-B01D1 (EGFR×HER3 bispecific antibody ADC) in combination with multiple advanced solid tumors

of the announcement

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 4 "Drug Clinical Trial Approval Notices" officially approved and issued by the National Medical Products Administration (NMPA), which were independently developed by the company

Phase II of 4 combinations of innovative biologics BL-B01D1 for injection (EGFR×HER3 bispecific antibody ADC).

Clinical trials are approved. The relevant information is hereby announced as follows:

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

Product name: BL-B01D1 for injection

Acceptance number: CXSL2500115, CXSL2500116, CXSL2500118, CXSL2500120

Notice Nos: 2025LP01063, 2025LP01064, 2025LP01065, 2025LP01066

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 of BL-B01D1 for injection meets the relevant requirements of drug registration, and it is agreed that this product will be used for clinical trials in combination with lenvatinib for advanced liver cancer, axitinib in combination with axitinib± pembrolizumab for advanced renal cancer, bevacizumab ± chemotherapy for advanced colorectal cancer, and pembrolizumab ± chemotherapy for advanced biliary tract malignant tumors.

Second, other conditions of drugs

BL-B01D1 is a first-in-class, new concept and the only one to enter III

Phase clinical EGFR×HER3 bispecific antibody ADC. In addition to the 4 newly approved clinical trials,

BL-B01D1 is undergoing more than 30 clinical trials in China and the U.S. for more than a dozen tumor types.

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 from early research, clinical trial approval to production cycle is long and linked, and are easily affected by some uncertain factors, the company will actively promote the above-mentioned research and development projects in accordance with relevant regulations, and strictly follow the relevant regulations 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 16, 2025