Applied Pharmaceutical Science Inc. Announces FDA Approval of Investigational  New Drug Application for APS03118, a Next generation RET Original New Drug  for Unlimited Cancers - DKODINGApplied Pharmaceutical Science, Inc. (“APS” or “the Company”), has recently announced the Investigational New Drug (IND) application for its self-developed breakthrough new drug APS03118, a next generation selective RET inhibitor, has been approved by the U.S. Food and Drug Administration (FDA).

The clinical application is also in the process of being submitted to the National Medical Products Administration (NMPA) in China, and a global multi-center clinical trial is in the pipeline for initiation in the second quarter of 2022 in the U.S., China and Australia etc.

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types, targeting patients with non-small cell lung cancer, thyroid cancer, pancreatic cancer, breast cancer, ovarian cancer, colorectal cancer and other advanced solid tumors caused by rearranged during transfection (RET) gene alterations, as well as patients with resistance to first-generation selective RET inhibitors.

The currently marketed first-generation selective RET inhibitors have both been granted priority review, breakthrough therapy, orphan drug status, accelerated approval and other review incentives by the FDA for their impressive efficacy.

readmore…