Securities code: 688506 Securities abbreviation: Baili Tianheng Announcement No.: 2025-004

Sichuan Baili Tianheng Pharmaceutical Co., Ltd

Voluntary Disclosure of BL-M07D1 for Injection (HER2-ADC) for the Postoperative Adjuvant Treatment of HER2-Positive Breast Cancer With Residual Invasive Carcinoma Following Neoadjuvant Therapy

Announcement of the approval of the Phase III clinical trial

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 phase III clinical trial of the company's self-developed innovative biological drug BL-M07D1 for injection (HER2-ADC) was approved. The relevant information is hereby announced as follows:

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

Product name: BL-M07D1 for injection

Acceptance number: CXSL2400792

Notice No.: 2025LP00269

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 of BL-M07D1 for injection meets the relevant requirements of drug registration, and it is agreed that this product will be used to carry out clinical trials CXSB2400033 with samples of the approved process version, specifically: BL-M07D1 for injection versus enmetuzumab for injection (T-DM1) in the postoperative adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy Phase clinical study (protocol number: BL-M07D1-302).

Second, other conditions of drugs

BL-M07D1 is an innovative HER2-targeting ADC with best-in-class potential

Significant anti-tumor efficacy has been demonstrated in bed trials. As of the disclosure date of this announcement, except for the newly approved pro

In addition to the bed trial, BL-M07D1 is being used as a single agent or in combination with nine Phase I/II/III clinical trials in China and the United States

to evaluate. Various clinical studies include a variety of solid tumors (including non-small cell) with HER2 expression/mutations

lung cancer, breast cancer, urothelial cancer, gynecological tumors and gastrointestinal 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

February 8, 2025