BIOKIN, trading as Sichuan Biokin Pharmaceutical Co.,Ltd. (ASX: 688506), has announced that its wholly-owned subsidiary, SystImmune, Inc., recently received notification from the U.S. Food and Drug Administration (FDA). The application for a Phase III clinical trial of BL-M14D1 (DLL3 ADC) in combination with immunotherapy for first-line treatment of patients with extensive-stage small cell lung cancer has been granted permission by the FDA.

BL-M14D1 (DLL3 ADC) shares the same small molecule technology platform as iza-bren, and the company holds full global rights to it. At the ASCO meeting in June 2024, the company disclosed early clinical research data for this ADC: in second-line patients with extensive-stage small cell lung cancer, the median progression-free survival (mPFS) was 8.1 months, the objective response rate (ORR) was 78.6%, and the confirmed objective response rate (cORR) was 71.4%.

This FDA-approved Phase III clinical study is the world's first Phase III study of an ADC combined with immunotherapy for first-line extensive-stage small cell lung cancer. It also marks the company's first independently conducted global Phase III clinical trial.

The granting of the IND permission for this BL-M14D1 Phase III study by the FDA is expected to further advance the company's business and product internationalization strategy. This development is not anticipated to have a significant impact on the company's near-term financial performance.