The first domestically produced APK inhibitor Nsatini was approved

According to the official website of the State Drug Administration on November 19 drug approval documents to be received information shows that Beda Pharmaceuticals' ALK inhibitor Nsatinib hydrochloric acid (commodity name: Bemena) was approved for the market, indications for the treatment of ketinib progression treatment of patients with local late stage or metastasis non-small cell lung cancer who are resistant to alkydinib, which is also the second commercialized self-research product of Beida Pharmaceuticals after the ektinib hydrochloric acid tablet (commodity name: Kemina).
Nsatini is a new powerful, highly selective new generation of ALK inhibitors independently developed by Beda Pharmaceuticals, and it is understood that mesozoic lymphoma kinase (ALK) is one of the important carcinogenic drivers of non-small cell lung cancer.
the activation of ALK can lead to the activation of downstream signaling path, which in turn can lead to the occurrence and survival of tumors, ALK inhibitors can effectively inhibit the activity of ALK, thereby playing a role in inhibiting tumor growth.
currently, the domestic targeted treatment for non-small cell lung cancer is the first generation of ALK inhibitor ketinib, but most ALK-positive patients within 1 year of the use of ketamine progress.
, Ensartini is more potent with ALK and exhibits strong inhibitory activity on clostridium-resistant mutants.
October last year, a domestic Phase II registered clinical study on nsatini was published in full in The Lancet Respiratory Medicine, and clinical data show that ensarinium treats the overall ORR of patients with kerthionine resistance at 52. 6%, disease control rate of 87.8%, the medium PFS of 11.2 months, especially for intracranial lesions treatment effect is very obvious, intracranial ORR of 71.4%, intracranial disease control rate of 95.2%.
studies have shown that Nsatini is more effective than similar imported drugs.
The listing of Nsatini broke the domestic APK-positive non-small cell lung cancer targeted treatment drugs are imported drugs monopoly situation, there are industry analysis, it may be after Kemina, another 1 billion varieties.
Ektinistinib was approved for advanced non-small cell lung cancer in 2011, which is the first small molecule-targeted anti-tumor drug approved in China with fully independent intellectual property rights, which holds Chinese, U.S. and international patents, similar to giftoninib, erlotinib in chemical structure, molecular action, efficacy, etc., but has better safety, and as a conventional drug access varieties were included in the 2019 health insurance list.
According to Beda Pharmaceuticals' 2020 semi-annual report, by the end of the reporting period, Ektinib had been used in more than 250,000 patients with advanced lung cancer, of whom 1,600 had taken ecstasy for more than five years, with cumulative sales exceeding 8 billion yuan.
Photo Source: Beda Pharmaceuticals' 2019 Annual Report According to Beda Pharmaceuticals Announcement, Ektinib's postoperative complementary treatment for non-small cell lung cancer patients with skin growth factor (EGFR) gene-sensitive mutations has been included in the priority review and is expected to be approved shortly.
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