Insilicon Smart (03696): ISM6331 is FDA Fast Track Qualified for Advanced Dermatoma Treatment

According to the Zhitong Finance App, Insili Intelligence (03696) announced that ISM6331, its self-developed AI-based potential best-in-class innovative pan-TEAD inhibitor, has obtained Fast Track Qualification (FTD) from the US Food and Drug Administration (FDA) to treat adult patients with unresectable malignant pleural mesothelioma who have previously received anti-PD-1 antibody treatment (whether or not in combination with anti-CTLA-4 antibody therapy) and platinum-containing chemotherapy.

According to relevant FDA policies, the “Fast Track” aims to promote the development and review process of new drugs used to treat serious or life-threatening diseases and address unmet medical needs. After receiving Fast Track eligibility, ISM6331 will enjoy a range of regulatory support aimed at accelerating clinical development, including establishing more frequent meetings and written communication mechanisms with the FDA to discuss clinical trial design, biomarker strategies, and overall development plans.

Furthermore, ISM6331 may be eligible for Accelerated Approval (Accelerated Approval) and Priority Review (Priority Review), and can use a rolling review (Rolling Review) process, provided that the relevant standards are met. Under the rolling review process, it is allowed to complete part of the biological product licensing application (BLA) or new drug application (NDA) and submit it to the FDA for review without having to wait for the full set of information to be ready.