PR94206

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

BEIJING and PHILADELPHIA, Jan. 24, 2022 /PRNewswire=KYODO JBN/ --

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.

Please visit the official website at www.apspharm.com

SOURCE  Applied Pharmaceutical Science, Inc.