Announcement on Receipt of Acceptance Notice for Drug Clinical Trial by Controlled Subsidiary
Securities code: 603858 Securities abbreviation: Buchang Pharmaceutical Announcement number: 2026-123
Shandong Buchang Pharmaceutical Co., Ltd.
Announcement on Obtaining the Acceptance Notice for Drug Clinical Trials of the Holding Subsidiary
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
Shandong Buchang Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") recently learned that the clinical trial application for a new indication of "BC008-1A Injection" from the company's holding subsidiary Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. was accepted by the State Food and Drug Administration and received an "Acceptance Notice". The relevant information is now announced as follows:
1. Basic information on drugs
Drug name: BC008-1A injection
Dosage form: Chinese Pharmacopoeia Dosage form: Injection
Specifications: 75mg/7.5ml/bottle
Registration Category: Biological Products for Therapeutic Use: Class 1
Application matters: Registration of clinical trials of domestically produced drugs
Applicant: Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Acceptance number: CXSL2600878
Acceptance conclusion: According to the provisions of Article 32 of the "Administrative Licensing Law of the People's Republic of China", after review, it is decided to accept the application.
2. Other conditions of drugs
- Drug description
BC008-1A injection (recombinant anti-PD-1/TIGIT humanized bispecific antibody injection) is a dual-antibody drug that specifically targets PD-1 and TIGIT. It can relieve the inhibition of T lymphocytes by directly blocking the PD-1 and TIGIT signaling pathways, thereby facilitating the activation of T cells and achieving the effect of enhancing immune surveillance, recognition and killing of tumor cells. It also blocks the potential synergy between PD-1 and TIGIT to enhance the anti-tumor effect.
This clinical trial application for new indications of BC008-1A injection has received the "Notice of Acceptance". The proposed new indications or functional indications are: combined with bevacizumab for the treatment of adult recurrent CNS WH0 grade 4 glioma.
- R&D investment
As of July 31, 2026, the company's research and development expenses on the BC008-1A injection project were approximately 114.5472 million yuan.
- Market situation of similar drugs
At present, no bifunctional specific antibody drug with the same target has been approved for marketing at home or abroad.
3. Risk warning
Because pharmaceutical products are high-tech, high-risk, and high-value-added, drug research and development is easily affected by factors such as technology, approval, and policies. There are many uncertainties and risks in the future product market competition. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks. The company will promptly fulfill its information disclosure obligations on the subsequent progress of the project in accordance with relevant regulations.
Announcement is hereby made.
Board of Directors of Shandong Buchang Pharmaceutical Co., Ltd.
August 20, 2026