Clinical trials of Shanghai Ailes pharmaceutical methyl sulfonate vosumetini drugs have been approved

On January 12, Shanghai Allis Pharmaceuticals announced that it had recently received approval from the State Drug Administration to issue a "Notice of Approval for Clinical Trials of Drugs" on vosulphonate.
This time approved for clinical trials in patients with stage II-IIIA non-small cell lung cancer who are positive for the mutation of the skin growth factor (EGFR), the clinical trial is approved for postoperative ancillary therapy in patients with voxantinib (hereinafter referred to as "vomethine"), specifically: in the process of receiving root A randomized, double-blind, placebo-controlled, multi-center PHASE III study comparing the efficacy and safety of voxetinib and placebo in patients with stage II-IIIA non-small cell lung cancer after therapeutic excision or non-complementary chemotherapy.
Vomini is a skin growth factor subject tyrosine kinase inhibitor (EGFR-TKI), developed for the company's own class 1 small molecule targeting drug, is currently the company's core research products for the treatment of advanced non-small cell lung cancer.
November 2019, vomini developed disease progression during or after treatment of the previous skin growth factor subject tyrosine kinase inhibitor (EGFR-TKI) and tested positive for the EGFRT790M mutation The application for the listing of new drugs for the treatment (second-line treatment) of adult patients with local late stage or metastasis non-small cell lung cancer (NSCLC) has been accepted by the State Drug Administration, and has now completed clinical trial on-site inspection and production site inspection, is in the normal approval process, and is expected to be approved for market in the near future.
Vomedinib's treatment (first-line therapy) of adult patients with EGFR exon 19 missing or exon 21 (L858R) replacement mutations is in phase III clinical trials and was completed by the end of 2019.
ancillary treatment is a part of the comprehensive treatment of lung cancer based on surgery, which can consolidate the results of surgical treatment.
about 30% of NSCLC patients are diagnosed with phased I-IIIA, the main treatment is surgical excision.
Although patients treated with root-and-treat surgery have better prognosis than patients with advanced stages, the five-year survival rate for patients who undergo surgery alone remains low, from 57% (IB) to 23% (Phase IIIA).
options for postoperative complementary therapy are mainly complementary chemotherapy, but the benefits of complementary chemotherapy are limited, and there are more toxic side effects, seriously reducing the quality of life of patients.
currently, third-generation EGFR-TKI-assisted therapy has been shown to benefit disease-free lifetime (DFS) in EGFR mutation-positive NSCLC patients.
in order to improve the clinical application of Vomedinie, the Company will continue to promote the clinical study of Vossitinie's subsequent expansion of the certificate of adaptation, thereby further enhancing Vomediniry's competitiveness in the field of non-small cell lung cancer treatment.