k8凯发(中国)天生赢家·一触即发

Shanghai, China, September 1, 2023—IMPACT Therapeutics, Inc. (“IMPACT Therapeutics”) announced that the National Medical Products Administration (NMPA) has recently accepted the New Drug Application (NDA) for Senaparib (product code: IMP4297),  which was developed by IMPACT Therapeutics, as a first-line maintenance treatment of adult patients with ovarian epithelial carcinoma, fallopian tube cancer or primary peritoneal cancer following a response to platinum-based chemotherapy.

This application is based on a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (FLAMES Study). The study results demonstrate that Senaparib maintenance therapy significantly prolongs progression-free survival (PFS) of advanced ovarian cancer patients. All patients could benefit from this therapy, whether they have breast cancer susceptibility gene (BRCA) mutations or not. Additionally, Senaparib exhibits a well-tolerated and manageable safety profile.

“We are delighted that NMPA has accepted our NDA for Senaparib. I sincerely appreciate our team for their long-term dedication, and would like to thank the healthcare institutions, professional medical staff and patients who participated in this study. We are looking forward to bringing this medicine to patients in need, and enhancing their quality of life”, said Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT Therapeutics.

About Ovarian Cancer

Ovarian cancer is one of the most commonly fatal malignant tumors affecting the female genital tract. According to published data, around 310,000 new cases of ovarian cancer are diagnosed across the world annually, resulting in roughly 210,000 ¹ deaths every year. As the early symptoms of ovarian cancer are hidden and non-specific, around 80% of patients with ovarian cancer are diagnosed at an advanced stage, with a five-year survival rate of only 40% ². Although primary platinum-based chemotherapy can help alleviate ovarian cancer, most patients inevitably experience cancer relapse ³. Over the years, PARP inhibitor has revolutionized the treatment of ovarian cancer. In particular, PARP inhibitor maintenance treatment can extend the response time following first-line platinum-based chemotherapy and delay cancer relapse ⁴.

【References】

1. Sung H, et al. CA Cancer J Clin. 2021; 71(3):209-49 

2. Morgan RJ Jr, et al. J Natl Compr Canc Netw. 2016; 14:1134-63.  

3. Jayson GC, et al. Lancet. 2014;384(9951):1376–88. 

4. Khalique S, et al. Curr Opin Oncol. 2014;26(5):521–8. 

About FLAMES Study

The FLAMES Study is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evalsuate the efficacy and safety of Senaparib as monotherapy maintenance treatment following first-line platinum-based chemotherapy in patients with FIGO stage III/IV ovarian cancer who have achieved complete response (CR) or partial response (PR).

About Senaparib

Senaparib is a novel PARP inhibitor, which has completed phase I clinical study in Australia and China, and has met its primary endpoint for advanced ovarian cancer maintenance treatment following first-line therapy. In August 2022, the fixed dose combination capsules of Senaparib and temozolomide for the treatment of adult patients with small cell lung cancer was granted orphan-drug designation by the U.S. Food and Drug Administration.

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 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), PARP1 selective inhibitor (IMP1734，in collaboration with Eikon Therapeutics) and other novel DDR pathway inhibitors.

IMPACT Therapeutics Contact Information:

http://www.getunderline.com

Email: info@getunderline.com