Keystone Pharmaceuticals RET Inhibitors To Submit Application for New Drug Listing

Guide: Keystone Pharmaceuticals RET Inhibitor China NSCLC Registration Study reached expectationsCornerstone Pharmaceuticals said in a statement today that it plans to submit a new drug application to NMPA in the near futureannounced the findings of the Chinese patient study of Keystone Pharmaceuticals' RET inhibitor Pralsetinib in a key global I/II ARROW trialThe study data showed that Pralsetinib had superior and long-lasting clinical anti-tumor activity and good tolerance in RET-positive NSCLC patients in ChinaPralsetinib is a powerful, highly selective targeted aggressive RET variant, including predictable drug-resistant mutations, developed by Blueprint Medicines, a strategic partner of Keystone PharmaceuticalsOverall data from the study showed that Pralsetinib's efficacy and safety in RET-positive NSCLC patients in China were consistent with those reported by the global patient population in previous ARROW studies"We are pleased to see that Pralsetinib has achieved the desired results in critical clinical studies of RET fusion-positive NSCLC patients in China after platinum chemotherapy," said DrJianxin Yang, Chief Medical Officer ofCornerstone PharmaceuticalsCurrently, no selective RET inhibitors have been approved in China, and Keystone Pharmaceuticals plans to submit a new application for Palsetinib to the State Drug Administration (NMPA) for the introduction of new drugs for the appoptionAt the same time, we will continue to make every effort to advance Pralsetinib's research and development in China, and to evaluate more broadly the efficacy of the product in patients with RET fusion-positive NSCLC, thyroid myelin cancer and other solid tumors without platinum-containing chemotherapy, so as to meet the clinical needs of this segment of Chinese cancer patientsCornerstone Pharmaceuticals plans to share specific data on the trial at future academic conferencesKey messages include:key efficacy data show that Pralsetinib showed superior and long-lasting antitumor activity in Chinese patients with RET fusion-positive non-small cell lung cancer (NSCLC) with platinum chemotherapy
pralsetinib's safety in the Chinese population of patients Well-toleratedCornerstone Pharmaceuticals plans to submit to the National Drug Administration (NMPA) Drug Review Center (CDE) in the near future a new drug listing application (NDA) for PRalsetinib for RET fusion-positive non-small cell lung cancer with platinum chemotherapy