On November 19, Beda Pharmaceuticals filed an application for the listing of the APK inhibitor Nsatinib hydrochloride (commodity name: Bemena) which was approved by the State Drug Administration.
Nsatinib is a new, powerful, highly selective next-generation ALK inhibitor developed by Beda Pharmaceuticals, and this declared adaptation is to provide new treatments for patients with localized late stage or metastasis non-small cell lung cancer who have progressed after treatment with clostrini or who are resistant to kerthionine.
the incidence and fatality rate of lung cancer in the global and Chinese malignant tumors, according to statistics, in 2015 there were 3.929 million new tumor patients in China, 2.338 million deaths, of which 787,000 new lung cancer patients and 631,000 deaths.
non-small cell lung cancer (NSCLC) accounted for 85% of all lung cancer patients, and most of the initial diagnosis was late.
the abnormal activity of the ALC path path is an important pathogenic mechanism of NSCLC.
currently, targeted therapeutic drugs for this category of patients in China are the first generation of ALK inhibitor clotinib, but most ALK-positive patients have progressed within 1 year of the use of ketamine.
, ensartinibs are more potent with ALK and exhibit strong inhibitory activity against clostrini drug-resistant mutants.
2019, clotinist's global sales are $530 million.
updated data on the efficacy and safety of phase II single-arm, multi-center clinical studies evaluating the efficacy and safety of patients with cytokine(X-396) capsules for the treatment of cytosterine-resistant mesolytic lymphoma kinase (ALK) Patients treated with ensartinib hydrochloric acid had ORR of 52.6%, disease control rate of 87.8%, medium PFS of 11.2 months, intracranial ORR of 71.4%, and intracranial lesions control rate of 95.2%.
Safety, patients have good tolerance, the most common adverse reactions are rash and ALT elevation, AST elevation, mostly mild moderate, after suspension of medication and/or treatment of symptoms, such as recovery or remission, suggesting that esadlinic hydrochloric acid has a good controlled safety.
Source: Professor Mao Li, Senior Vice President and Chief Medical Officer of Beida Pharmaceuticals, the official website of Beida Pharmaceuticals, said that clinical studies have fully demonstrated that Nsatephate has an advantage in efficacy over imported drugs, especially in intracranial transfer patients with higher response rates and better safety, providing a new and effective treatment option for ALK-positive NSCLC patients.
addition, Beda Pharmaceuticals plans to submit a new adaptive application for Nsatinib's first-line treatment of non-small cell lung cancer in China in 2021.
an interim analysis of a global multi-center Phase III clinical study in patients with ALK-positive non-small cell lung cancer showed a statistically significant difference between a medium non-progressive life (mPFS) of 25.8 months in patients receiving ensarinie treatment and 12.7 months in the treatment group of cyndini.
note: The original text has been modified