Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2025-007

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure of BL-B01D1 (EGFR×HER3 Bispecific Antibody ADC) in Combination With Osimertinib in First-Line EGFR-Mutant Locally Advanced or Metastatic Non-Small Cell Lumon

Announcement of the completion of the enrollment of the first subject in the phase III clinical trial for cancer

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") independently developed innovative organisms

Medicatal BL-B01D1 (EGFR×HER3 bispecific antibody ADC) plus osimertinib for first-line EGFR spikes

The first patient has recently been enrolled in a phase III clinical trial in metamorphic locally advanced or metastatic non-small cell lung cancer. The relevant information is hereby announced as follows:

First, the basic situation of drugs

BL-B01D1 is the world's only independent research and development in the phase III registration clinical trial stage

Bispecific antibody ADC drugs targeting EGFR and HER3. Recently, BL-B01D1 combined with osimertinib was used in the first line

The clinical study of EGFR-mutant locally advanced or metastatic non-small cell lung cancer has entered the phase III clinical trial phase and completed the enrollment of the first subject.

To date, BL-B01D1 is undergoing about 30 clinical trials in China and the U.S. for multiple tumor types

In addition to the newly enrolled clinical trials, 7 domestic phase III registration clinical trials of BL-B01D1 in lung cancer, breast cancer, nasopharyngeal cancer, esophageal squamous cell carcinoma, etc., are also in the stage of subject enrollment.

2. 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

March 3, 2025