Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its drug candidate, BL-B01D1. This in-house developed antibody-drug conjugate (ADC) targets EGFR and HER3, key drivers in various solid tumors.
BL-B01D1’s Clinical Development in China
The product candidate, BL-B01D1, is currently the subject of five different Phase Ia/Ib clinical studies in China, encompassing 16 solid tumor types. These studies are part of a broad development program aimed at evaluating the safety and efficacy of BL-B01D1 across a range of oncological indications. In addition, communication filings for two single-arm Phase III regulatory studies and two single-arm pivotal regulatory studies for the drug as monotherapies have been carried out in China.
Efficacy Data and Combination Trials
Preliminary data available to date show that BL-B01D1 as a monotherapy has produced strong signs of efficacy in non-small cell lung cancer and nasopharyngeal carcinoma, two aggressive forms of cancer with significant unmet medical needs. Building on these promising results, the drug has also been approved to start Phase II clinical trials in China in combination with SI-B003, chemotherapy, or osimertinib (Tagrisso), offering potential new treatment options for patients.-Fineline Info & Tech
