On December 6, Impair Pharmaceuticals announced that its PARP inhibitor senaparib (IMP4297) for the treatment of prostate cancer clinical trial application has been approved by the National Medical Products Administration (NMPA) of China. The press release pointed out that this is a global multi-center clinical study. Its clinical trial application in the United States was approved by the FDA in July this year. At present, the study has initiated recruitment of subjects in many countries and regions around the world.

Impair Pharmaceutical focuses on the "synthetic lethal" mechanism of action, and the company's president and chief executive officer is Dr. Bao Jun. "Synthetic lethality" refers to the phenomenon that two non-lethal genes are inhibited at the same time, leading to cell death. Using this mechanism to find specific mutations in tumors, and then find its "synthetic lethal partner", will hopefully kill cancer cells specifically. Public information shows that PARP inhibitors are the first drugs to use the concept of "synthetic lethality" to achieve clinical success. Currently, many products have been approved worldwide.

Senaparib, independently developed by Impair Pharmaceuticals, is also an oral small molecule PARP inhibitor. Clinical and preclinical data show that senaparib has a wider treatment window and better safety, is more suitable for long-term medication and combination medication, and has the potential to become a "best-in-class".

According to the information on the official website of Impair Pharmaceuticals, senaparib is currently undergoing a number of clinical studies worldwide, including phase 3 clinical studies for the first-line maintenance treatment of ovarian cancer, phase 2 clinical studies for ovarian cancer third-line and above BRCA mutant populations, and senaparib Combined with temozolomide (TMZ) for phase 1/2 clinical studies of advanced solid tumors and small cell lung cancer. In addition, the phase 1/2 study of the single-agent therapy of IMP9064, the ATR inhibitor IMP9064, and the combination therapy with senaparib for dose escalation and dose expansion will also be launched in the United States in the near future.

According to the press release, the approval of senaparib is a randomized, double-blind, multi-center, placebo-controlled, global multi-center clinical study aimed at obtaining partial or complete response to docetaxel treatment or homologous recombination with stable disease In subjects with metastatic castration-resistant prostate cancer (mCRPC) with a mutation in the repair (HRR) gene, the efficacy and safety of senaparib as a single-agent maintenance treatment for the above patients were evaluated.

Public information shows that prostate cancer is the second most common cancer among men. mCRPC is a serious type of prostate cancer. The patient's cancer has spread to other parts of the body, and even though the androgen in the body has been reduced to a very low level, the tumor continues to proliferate. Although the available treatments for men with mCRPC have increased, the five-year survival rate remains low. In mCRPC patients, about 20-30% will have HRR gene mutations.

It is worth mentioning that Impair Pharmaceuticals has reached a strategic cooperation agreement with Junshi Biologics in August 2020. The two parties will cooperate on the senaparib project in the joint venture area (Mainland China, Hong Kong, Macau) for multiple indications. Clinical trials, production, commercial preparation, etc.