The first domestic ALK inhibitor! Betta Pharmaceuticals "Ensatinib" was approved for listing

On November 19th Beda Pharmaceuticals filed an application for the listing of the ALK inhibitor ensatinib hydrochloride (commodity name: Bemena), which was approved by the State Drug Administration.
Ensatinib is a new, powerful, highly selective next-generation ALK inhibitor developed by Beda Pharmaceuticals, and the 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 clostridium or who are resistant to kerthionine.
the incidence and fatality rate of lung cancer in the global and Chinese malignancies, 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.
, Ensatini and ALK are more binding and exhibit strong inhibitory activity against clostrini drug-resistant mutants.
2019, clotinist's global sales are $530 million.
updated data from a Phase II single-arm, multi-center clinical study evaluating the efficacy and safety of patients with cytokine (ALK)-resistant mesolytic lymphoma kinase (ALK) in the treatment of esadientine (X-396) capsules. Patients treated with ensatinib 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 the disease can be restored or alleviated, suggesting that ensatita hydrochloride has 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 ensatinib hydrochloride has an advantage over imported drugs in terms of efficacy, 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 in China in 2021 for Ensatini's first-line treatment of non-small cell lung cancer.
A mid-term analysis of a global multi-center Phase III clinical study of patients with ALK-positive non-small cell lung cancer showed a statistically significant difference between the medium non-progressive lifetime (mPFS) of patients receiving ensatinie treatment group at 25.8 months and the 12.7 months in the treatment group with ketamine.
pharmaceutical industry has more than 30 innovative drugs, covering lung cancer, kidney cancer, breast cancer and other tumor adaptations.
its own research and development of the first domestic small molecule-targeted anti-cancer drug ektinib hydrochloric acid has been included in the 2017 National Health Insurance Category B directory, 2019 sales exceeded 1.5 billion yuan.
we congratulate Ensatini hydrochloric acid on its official approval to benefit more lung cancer patients.