Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2024-053

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure of GNC-077 Multi-Specific Antibody Injection Project

Announcement of approval of phase I clinical trial for the treatment of advanced solid tumors

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 GNC-077, an innovative biologic drug independently developed by the Company, was approved. The relevant information is hereby announced as follows:

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

Product name: GNC-077 Multi-specific Antibody Injection

Acceptance number: CXSL2400460

Notice No.: 2024LP02145

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 application for GNC-077 multi-specific antibody injection accepted on July 16, 2024 meets the relevant requirements of drug registration, and it is agreed to carry out clinical trials of advanced solid tumors.

Second, other conditions of drugs

GNC-077 is an innovative multi-specific antibody molecule independently developed by the company based on the world's leading innovative multi-specific antibody drug discovery platform (GNC platform), and its molecular structure includes antibody domains targeting T cell CD3 and T cell immune checkpoints, as well as antibody domains targeting tumor antigens. GNC-077 can effectively induce the activation, differentiation, and proliferation of T cells, and mediate the specific targeting of activated T cells to kill tumor antigen-positive tumor cells.

In in vivo studies, GNC-077 has demonstrated potent anti-tumor efficacy in a variety of solid tumors.

3. Risk Warning

According to the requirements of laws and regulations related to national drug registration, after obtaining the approval notice of drug clinical trial, the drug still needs to carry out clinical trials and be approved by the NMPA before it can be produced and 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 is easily affected by some uncertain factors, the company will actively promote the above-mentioned research and development projects in accordance with relevant national regulations, and strictly follow the relevant regulations to timely fulfill the information disclosure obligations on the follow-up progress of the project, please make careful decisions and pay attention to preventing investment risks.

The announcement is hereby made.

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

September 23, 2024