BIOKIN Pharmaceutical has announced the receipt of a Drug Registration Certificate from China's National Medical Products Administration.

This approval grants marketing authorization for the company's novel, first-in-class, EGFR×HER3 bispecific antibody-drug conjugate, 伦康依隆妥单抗/宜泽康 (BL-B01D1/iza-bren), for the treatment of advanced second-line esophageal cancer.

The drug candidate is the first and only globally approved therapy of its kind for this indication.

伦康依隆妥单抗 has been the subject of over 40 clinical trials in China and the United States, targeting various tumor types, including 20 Phase III studies.

To date, seven of its indications have been included in the Breakthrough Therapy Designation list by China's Center for Drug Evaluation, with two more on the Priority Review list.

One of its indications has also received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.

In addition to this new approval, the drug has previously received marketing approval in China for recurrent or metastatic nasopharyngeal carcinoma.

A New Drug Application for treating locally advanced or metastatic triple-negative breast cancer has also been accepted for review by the CDE.