(November 25, 2020, Hong Kong) Kintor Pharmaceutical Limited (stock code: 9939.HK, hereinafter referred to as “Kintor Pharmaceutical” or the “Company”) announced that its SMO antagonist GT1708F was approved by the US Food and Drug Administration (FDA) for clinical trials, and the treatment of basal cell carcinoma (BCC) will be commenced. It is also the fifth clinical trial approval obtained by Kintor Pharmaceutical in the US. Prior to that, GT1708F was approved for clinical trial by China National Medical Products Administration on 17 February 2020, and is currently undergoing phase I clinical trial research for hematoma.

Basal cell carcinoma (BCC) is the most common skin malignant tumor in human beings. According to data from the American Cancer Society, the annual incidence in the US exceeds 3.3 million people. The pathogenesis of BCC is closely related to the signaling pathway of hedgehog. The signaling pathway of hedgehog plays an important role in the variety of solid tumors and hematological malignancies. Inhibition of signaling pathway of hedgehog is an important and effective anti-cancer strategy.

GT1708F is a smooth transmembrane protein (SMO) antagonist in the signaling pathway of hedgehog. At the moment, there are a total of three SMO antagonists approved for marketing worldwide. Vismodegib, developed by Roche together with Genentech, and Sonidegib from Novartis were approved by FDA for treatment of BCC in 2012 and 2015, respectively. In 2018, Glasdegib developed by Pfizer was approved in combination with cytarabine for acute myeloid leukemia, representing the first SMO antagonist approved for use in myeloid leukemia.

Dr. Tong Youzhi, founder, chairman and CEO of Kintor Pharmaceutical, said, “there are no SMO antagonists in the market of China, and the research field has relatively large unmet clinical need. The Company will actively advance the clinical study of the SMO antagonist program and explore the combination of drugs and extension of possible indications in the hope of benefiting more cancer patients.”