Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2024-055

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure of BL-B01D1 for Injection for EGFR-Sensitive Mutations

and 2 indications for patients with EGFR wild-type non-small cell lung cancer

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 innovative biological drugs

BL-B01D1 for injection for locally advanced or metastatic EGFR-sensitive mutations that have failed treatment with EGFR-TKIs

Patients with non-squamous non-small cell lung cancer and 2 indications for the treatment of patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer who have previously been treated with anti-PD-1/PD-L1 monoclonal antibodies and failed platinum-based chemotherapy have been included in the Breakthrough Therapy Variety List by the Center for Drug Evaluation ("CDDE") of the National Medical Products Administration (NMPA).

First, the basic situation of drugs

Name of drug: BL-B01D1 for injection

Application No. CXSL2101249

Type of drug: Therapeutic biologics

Register Category 1

Application deadline is August 9, 2024

(1) Locally advanced OR EGFR-sensitive mutations that have failed treatment with EGFR-TKIs

Proposed indications: Patients with metastatic non-squamous non-small cell lung cancer;

(or functional indications) (2) Prior treatment with anti-PD-1/PD-L1 monoclonal antibody and failure of platinum-containing chemotherapy

of patients with locally advanced or metastatic EGFR wild-type non-small cell 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, 3 indications of BL-B01D1 have been included in the Breakthrough Therapy Variety List by the Drug Evaluation Center.

In addition to the 2 new inclusions, the other 1 indication is 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 first-line platinum-contained) therapy have been included in the Breakthrough Therapy List by the Center for Drug Evaluation 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 undergoing more than 20 clinical trials in China and United States across multiple tumor types

Trial. Includes (i) 7 Phase III clinical trials evaluating BL-B01D1 monotherapy for the post-line treatment of cancer, including 2

non-small cell lung cancer indications, 1 small cell lung cancer indication, 2 breast cancer indications, 1 esophageal squamous cell carcinoma

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

Symptoms (small cell lung cancer, non-small cell lung cancer, nasopharyngeal cancer, head and neck squamous cell carcinoma, esophageal cancer, gastric cancer, colorectal cancer,

breast cancer and urothelial carcinoma) and (iii) evaluating it in combination with TKIs in the first-line lung cancer

2 phase II trials of treatment.

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

October 8, 2024