Zzcx.cs.com.cn report - Biokin Pharmaceutical (688506) announced in an evening statement on November 23 that the new drug application for its independently developed, globally innovative, novel-concept, and the only EGFR×HER3 bispecific antibody-drug conjugate (iza-bren) in Phase III
clinical trials has been officially accepted by the National Medical Products Administration (NMPA).

The acceptance is based on the interim analysis results of the BL-B01D1-303 study. Prior to this, the company had completed pre-NDA meetings and communications with the Center for Drug Evaluation (CDE) of the NMPA. Iza-bren, intended for the treatment of locally advanced or metastatic nasopharyngeal carcinoma, has been included in the list for priority review.

According to the announcement, BL-B01D1/iza-bren for injection is indicated for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously undergone PD-1/PD-L1 monoclonal antibody therapy and failed at least two lines of chemotherapy (including at least one platinum-based regimen).
The announcement highlights that iza-bren is the world's first, novel-concept, and only EGFR×HER3 bispecific ADC in Phase III clinical trials, as well as the first globally to have its new drug application accepted. The drug is currently undergoing over 40 clinical trials in China and the United States targeting various tumor types. To date, seven of its indications have been included in the breakthrough therapy designation list, one indication has been included in the priority review list, and one indication has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA).

Biokin Pharmaceutical's core business includes pharmaceutical products such as Propofol Emulsion Injection, Propofol Medium/Long-Chain Fat Emulsion Injection, and Sevoflurane for Inhalation.

Reference：https://finance.eastmoney.com/a/202511233572187514.html