k8凯发(中国)天生赢家·一触即发

IMPACT Therapeutics (IMPACT) announced that its PARP inhibitor Senaparib (IMP4297) targeting prostate cancer has been approved by the National Medical Products Administration (NMPA) for clinical trials in China soon. In July this year, the clinical study was approved by the FDA, and IMPACT already began to recruit volunteers in many countries and regions around the world for the study.

Senaparib (IMP4297) is an oral small-molecule PARP inhibitor internally developed by IMPACT, with worldwide intellectual property rights. Data from the early clinical study shows that Senaparib has a better safety profile and a wider therapeutic window.

This is a randomized, double-blind, multicenter, and placebo-controlled multi-country and multi-center clinical study. The purpose of this study is to evalsuate the efficacy and safety of senaparib in the maintenance treatment of metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations, who have obtained a complete or partial response to docetaxel treatment.

Dr. Jun Bao, President & CEO of IMPACT, said: "IMPACT always adopts a strategy of developing new drugs globally. I'm very excited to see that Senaparib targeting prostate cancer has been approved by the NMPA for clinical trials in China following its approval by the FDA. This will further accelerate the development pace of our synthetic lethality pipeline. Senaparib has a unique chemical structure, and I hope that its differentiated property will enable it to fill a gap of first-line maintenance treatment for advanced prostate cancer, so that patients around the world can benefit from it as soon as possible."

PARP inhibitor (Senaparib/ IMP4297), is in Phase II/III studies for ovarian cancer, prostate cancer, small cell lung cancer and other indications worldwide, including China. Senaparib’s preliminary clinical data demonstrated superior tolerability and wider therapeutic window compared with other PARPi. In October, IMPACT Therapeutics announced that its ATR inhibitor IMP9064 has received the IND clearance from the FDA for the Phase I/II clinical study including IMP9064 as monotherapy and in combination with PARP inhibitor Senaparib in patients with advanced solid tumors.

About IMPACT Therapeutics

IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage response (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT pipeline products include PARP inhibitor (senaparib/ IMP4297), Wee1 inhibitor (IMP7068), ATR inhibitor (IMP9064) and other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (senaparib/ IMP4297), is in Phase II/III studies for ovarian cancer, prostate cancer, small cell lung cancer and other indications worldwide, including China. Senaparib’s preliminary clinical data demonstrated superior tolerability and wider therapeutic window compared with other PARPi. Phase I study of Wee1 inhibitor (IMP7068) is conducted globally. ATR Inhibitor IMP9064 has received IND Clearance by FDA to start clinical studies in the U.S. and submitted clinical application in China. Hedgehog pathway inhibitor (IMP5471) has received IND approval from NMPA to initiate clinical studies in China.