Applied Pharmaceutical Science Inc. Announces FDA Approval of Investigational New Drug Application for APS03118, a Next generation RET Original New Drug for Unlimited Cancers

General News Monday January 24, 2022 12:40 —PRNewswire Press Releases

Applied 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.

Preclinical studies have shown that APS03118 is highly selective for RET kinases, and compared to the currently marketed first-generation selective RET inhibitors APS03118 showed significant nanomolar level potent antitumor activity in inhibition to various RET fusion and mutations including RET gatekeeper V804M/L/E and solvent frontier G810R/S/C mutations which lead to resistance to selective RET inhibitors. APS03118 also exhibited potent antitumor activity with a good safety profile in mouse models, and more significantly, in a brain tumor model, APS03118 completely eliminated brain tumors and all animals survived after dosing, demonstrating the therapeutic advantages of APS03118 for patients with brain metastases. It is potentially the best selective RET inhibitor of its kind globally.

Dr. Jun Zhong, Vice President of R&D at APS, said, "We are delighted that APS03118 has been clinically approved in the U.S. for a global unmet clinical need and that our self-developed innovative drug has been recognized by the FDA. APS has always adhered to its international development strategy to provide a new generation of precision therapeutic solutions for cancer patients worldwide."

About Applied Pharmaceutical Science, Inc.
Applied Pharmaceutical Science, Inc. is a biopharmaceutical high-tech company focused on innovative cancer precision therapy and tumor-driven gene drug development through in-depth exploration of cancer-causing driver genes, protein structure and function, and synthetic medicinal chemistry. APS aims to explore the life sciences, innovate precision cancer therapy, and seek new hope for cancer patients worldwide with breakthrough tumor precision therapies.

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