On August 1, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage US-China oncology drug development company, reported that Xynomic has received approval from China’s National Medical Products Administration ("NMPA") to start two pivotal clinical trials in China (Press release, Xynomic Pharmaceuticals, AUG 1, 2019, View Source [SID1234537980]). In these two trials, Xynomic will test its lead drug candidate abexinostat (as a single agent) as a third-line treatment of diffuse large B-cell lymphoma ("DLBCL") and as a third-line treatment of follicular lymphoma ("FL"), respectively.
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According to China’s National Cancer Center and China’s National Health Commission, DLBCL is the most common aggressive non-Hodgkin’s lymphoma (NHL) subtype with an estimated 50,000 new cases per year in China and FL is the most common indolent NHL subtype with an estimated 10,000 new cases per year in China. DLBCL and FL combined represent approximately 45-60% of China’s NHL market.
According to China’s Center for Drug Evaluation’s database, Xynomic’s abexinostat is the only drug candidate currently under clinical development as third-line treatment of DLBCL in China. Xynomic plans to complete patient enrollment for these two trials in 12 months or sooner. These trials will be conducted in about 24 leading hematological cancer hospitals across China.
"We are truly excited to receive the approval from NMPA of China, world’s second largest market for oncology drugs. Currently in China there are virtually no approved treatment options for DLBCL and FL patients once the patients’ disease progress after R-CHOP treatment. Our abexinostat has demonstrated both safety and efficacy in these settings in prior Phase 1/2 trials. We look forward to completing these trials expeditiously and have also started preparation for commercial launch," said Y. Mark Xu, Xynomic’s Chairman and CEO.