Stock code: 688506 Stock abbreviation: Baili Tianheng Announcement No.: 2023-021

Sichuan Baili Tianheng Pharmaceutical Co., Ltd.

Regarding the voluntary disclosure of "BL-B01D1 + chemotherapy" and "BL-B01D1 SI-B003 ±

Chemotherapy "Notice of Approval for Phase II Clinical Trials

the company's board of directors and all directors to ensure that the contents of this announcement does not exist any false records, misleading statements or major omissions, and the authenticity, accuracy and completeness of the contents of the legal responsibility.

Sichuan Baili Tianheng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") independently developed innovative biological drug BL-B01D1, SI-B003-related combination drugs "BL-B01D1 chemotherapy" and "BL-B01D1 SI-B003 ± chemotherapy", and recently received the National Drug Administration (NMPA) officially approved the issuance of the "Drug Clinical Trial Approval Notice". The relevant information is hereby announced as follows:

Basic Information of 1. Drug Clinical Trial Approval Notice

1. Product name: SI-B003 bispecific antibody injection

Acceptance number: CXSL2300028

Notice No.: 2023LP00385

Application: Domestic production of drug registration clinical trials

Applicant: Chengdu Bailidot Biopharmaceutical Co., Ltd.; Sichuan Baili Pharmaceutical Co., Ltd.

Conclusion: According to the "the People's Republic of China Drug Administration Law" and relevant regulations, after examination, the SI-B003 bispecific antibody injection accepted on January 10, 2023 meets the relevant requirements of drug registration, and it is agreed to carry out clinical trials of this product, specifically: to evaluate the therapeutic effect of BL-B01D1 combined chemotherapy (BL-B01D1 chemotherapy) and BL-B01D1 SI-B003 combined chemotherapy (BL-B01D1 SI-B003 plus chemotherapy).

A Phase II Clinical Study of Efficacy and Safety in Patients with Body Tumors (Protocol No:

BL-B01D1-SI-B003-201).

2. Product Name: BL-B01D1 for Injection

Acceptance number: CXSL2300029

Notice No.: 2023LP00386

Application: Domestic production of drug registration clinical trials

Applicant: Chengdu Bailidot Biopharmaceutical Co., Ltd.; Sichuan Baili Pharmaceutical Co., Ltd.

Conclusion: According to the the People's Republic of China Drug Administration Law and relevant regulations, after examination, the BL-B01D1 for injection accepted on January 10, 2023 meets the relevant requirements of drug registration, and it is agreed to carry out clinical trials, specifically: Phase II clinical studies to evaluate the effectiveness and safety of BL-B01D1 combined chemotherapy (BL-B01D1 chemotherapy) and BL-B01D1 SI-B003 combined chemotherapy (BL-B01D1 SI-B003 plus chemotherapy) in the treatment of solid tumor patients (protocol number: BL-B01D1-SI-B003-201).

Other 2. of medicines

BL-B01D1 is the company's own research and development of the world's exclusive targeting EGFR × HER3 dual anti-ADC drug.

5 Phase Ia/Ib clinical studies have been conducted in BL-B01D1 single drug, covering 16 tumors. at present,

BL-B01D1 single drug has 12 tumors of more than 200 subjects into the group, tumor assessment data show that,

BL-B01D1 single agent has strong efficacy signals in all 12 tumors, and the recommended dose in phase II

(RP2D) has good security. Among them, BL-B01D1 monotherapy has shown breakthrough efficacy in patients with non-small cell lung cancer and nasopharyngeal carcinoma at the end of the line.

SI-B003 is the company's self-developed bispecific antibody targeting PD-1 x CTLA-4, which has been developed.

The Phase I clinical trial of SI-B003 single drug has seen clear efficacy signals and good safety in patients with a variety of solid tumors, and has begun to carry out phase Ib/II clinical trials in combination with SI-B001(EGFR x HER3 double resistance) in patients with head and neck squamous cell carcinoma.

Based on the aforementioned BL-B01D1 monotherapy and SI-B003 monotherapy in patients with clear efficacy signals and good

Good safety, the company submitted "BL-B01D1 chemotherapy" in December 2022 ",

IND application of "BL-B01D1 SI-B003 ± chemotherapy" to explore the efficacy and safety of the aforementioned combination regimen in first-line patients with a variety of solid tumors.

For BL-B01D1 single drug, the company will explore and promote key registration clinical studies in patients with a variety of solid tumors, and for combination drug regimens such as "BL-B01D1 chemotherapy" and "BL-B01D1 SI-B003 ± chemotherapy", the company will explore and promote key registration clinical studies in patients with a variety of solid tumors.

3. Risk Alert

According to the requirements of national laws and regulations related to drug registration, after obtaining the drug clinical trial approval notice, clinical trials need to be carried out and approved by NMPA before production and marketing.

As pharmaceutical products have the characteristics of high technology, high risk and high added value, the drug has a long cycle and many links from early research and clinical trial approval to production, and is easily affected by some uncertain factors.

Actively promote the above-mentioned research and development projects in accordance with relevant national regulations, and perform information disclosure obligations on the follow-up progress of the project in a timely manner in strict accordance with relevant regulations. Investors are kindly requested to make cautious decisions and pay attention to preventing investment risks.

It is hereby announced.

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

22 March 2023