Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2025-001

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure of BL-B01D1 for Injection in Prior Platinum-Containing Chemotherapy and Anti-Therapy

Patients with recurrent small cell lung cancer who have failed PD-1/PD-L1 monoclonal antibody therapy

Announcement of inclusion in the Breakthrough Therapy List

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 BL-B01D1 for injection for patients with recurrent small cell lung cancer who have failed to be treated with platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibody has been included in the list of breakthrough therapy varieties by the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the "Drug Evaluation Center").

First, the basic situation of drugs

Name of drug: BL-B01D1 for injection

Application No. CXSL2101249

Type of drug: Therapeutic biologics

Register Category 1

The application deadline is November 19, 2024

Proposed indications Recurrent minor relapse of previous treatment with platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibodies

(or functionally indicated) patients with lung cancer

After review, this application is in compliance with the "Measures for the Administration of Drug Registration" and the "State Food and Drug Administration".

Rationale and Basis for the release of the Breakthrough Therapy Drug Evaluation Working Procedures (Trial) and other three documents

Notice (No. 82 of 2020), which agreed to be included in the Breakthrough Therapy Program.

2. Other relevant conditions of drugs

Up to now, 5 indications of BL-B01D1 have been included in the Breakthrough Therapy Variety List by the Drug Evaluation Center.

In addition to this new inclusion, the other 4 indications are as follows:

In April 2024, BL-B01D1 for injection was used for at least two prior treatment with PD-1/PD-L1 monoclonal antibodies

Patients with recurrent or metastatic nasopharyngeal carcinoma who have failed first-line chemotherapy (at least one line of platinum-contained) therapy were included in the drug review center

The list of disruptive treatment varieties has been completed and publicized.

In September 2024, BL-B01D1 for injection was used for EGFR-sensitive mutations that have failed treatment with EGFR-TKIs

Patients with locally advanced or metastatic non-squamous non-small cell lung cancer and patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer who have been previously treated with anti-PD-1/PD-L1 monoclonal antibodies and have failed platinum-based chemotherapy have been included in the Breakthrough Therapy List by the Drug Evaluation Center and have been publicized.

In October 2024, BL-B01D1 for injection was administered for prior treatment with PD-1/PD-L1 monoclonal antibody in combination with platinum-containing chemotherapy

Patients with recurrent or metastatic esophageal squamous cell carcinoma who have failed treatment have been included in the Breakthrough Therapy List by the Drug Evaluation Center and have been publicized.

BL-B01D1 is the world's first-in-house developed EGFR × and the only one to enter the clinical stage

Bispecific antibody ADC for HER3. BL-B01D1 is being conducted in China and the United States for more than 20 projects targeting multiple tumor types

Clinical trial. Includes (i) 7 Phase III clinical trials evaluating BL-B01D1 monotherapy for the post-line treatment of cancer, package

Including 2 indications for non-small cell lung cancer, 1 indication for small cell lung cancer, 2 indications for breast cancer, and 1 esophagus

Squamous cell carcinoma indication, 1 indication for nasopharyngeal carcinoma, (ii) evaluated in combination with PD-(L)1 therapy for the first-line treatment of 9 cancers

Indications (small cell lung cancer, non-small cell lung cancer, nasopharyngeal cancer, head and neck squamous cell carcinoma, esophageal cancer, gastric cancer, straightening.)

Bowel cancer, breast cancer, and urothelial carcinoma) and (iii) evaluated in combination with TKIs in the lungs

2 phase II trials of first-line treatment for cancer.

3. Risk Warning

According to the Announcement of the NMPA on Issuing the Working Procedures for the Evaluation of Breakthrough Therapy Drugs (Trial) and Other Three Documents (No. 82 of 2020), the Center for Drug Evaluation (CRC) will prioritize the allocation of resources for drugs included in the Breakthrough Therapy Program, strengthen guidance and promote drug research and development.

Drug R&D is susceptible to the influence of technology, approval, policy and other factors, and there are many uncertain risks in the review policy and the future competition situation in the drug market. The company will actively promote the above-mentioned R&D projects in accordance with relevant 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.

The announcement is hereby made.

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

January 3, 2025