Sichuan Biokin Pharmaceutical Co., Ltd. voluntarily disclosed the announcement about the approval of izalontamab brengitecan (BL-B01D1/iza-bren)
Sichuan Biokin Pharmaceutical Co., Ltd. voluntarily disclosed the announcement about the approval of izalontamab brengitecan (BL-B01D1/iza-bren)
The Board of Directors and all directors of the Company 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 in accordance with the law.
Recently, Sichuan Biokin Pharmaceutical Co., Ltd. (the “Company”) received a Drug Registration Certificate from the National Medical Products Administration, approving the marketing of its independently developed izalontamab brengitecan (BL-B01D1/iza-bren), a first-in-class, novel-concept EGFR×HER3 bispecific ADC and the only one of its kind to have entered Phase III clinical development. The relevant information is announced below:
1. Basic information about drugs
Generic name of the drug: izalontamab brengitecan for injection
Drug product name: Yizekang
Dosage form: injection
Specifications: 120 mg/bottle
Registration Category: Biological Products for Therapeutic Use Class 1
Acceptance number: CXSS2500124
Prescription/Over-the-Counter Drugs: Prescription Drugs
Applicant: Chengdu Bailiduote Biopharmaceutical Co., Ltd.
Approved indications (or functional indications): This product is suitable for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least second-line systemic chemotherapy and PD-1/PD-L1 inhibitor treatment.
2. Other information about drugs
izalontamab brengitecan (BL-B01D1/iza-bren) is the world's first-in-class, new concept, and the only EGFR×HER3 bispecific ADC that has entered Phase III clinical stage. It is also the first EGFR×HER3 bispecific ADC approved for marketing in the world. China is also the first country to be approved for marketing of this drug.
izalontamab brengitecan has conducted more than 40 clinical trials targeting various tumor types in China and the United States, including 19 Phase III clinical studies (including Phase II/III). Up to now, 7 indications of izalontamab brengitecan have been included in the Breakthrough Therapy List by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, 2 indications have been included in the Priority Review List by CDE, and 1 indication has been included in the Breakthrough Therapy List by the U.S. Food and Drug Administration (FDA).
In addition to this drug registration approval, the drug marketing application (NDA) of izalontamab brengitecan for the treatment of recurrent or metastatic esophageal squamous cell carcinoma, locally advanced or metastatic triple-negative breast cancer has also been accepted by CDE.
3. Risk warning
The company's first independently developed Class 1 innovative therapeutic biological product, izalontamab brengitecan, has been successfully approved for marketing, which is of great significance to the company's business development. Drug sales may be affected by external factors such as policies and markets, and there is uncertainty. The company will promptly fulfill its information disclosure obligations based on subsequent progress. Investors are advised to make prudent decisions and pay attention to guarding against investment risks.
Announcement is hereby made.
Board of Directors of Sichuan Biokin Pharmaceutical Co., Ltd. June 23, 2026