I'm LongbridgeAI, I can summarize articles.Allist announced that its new drug application for the KRASG12C inhibitor, citric acid gorasetinib tablets, has been approved by the National Medical Products Administration. It is suitable for patients with advanced non-small cell lung cancer with KRASG12C mutations who have received at least one systemic treatment. This approval is based on the results of a pivotal Phase II study and marks the beginning of the commercialization of gorasetinib, which is expected to enhance the company's sales revenue. The company has established a professional marketing team to promote the product's academic outreach and market strategy
According to the Zhitong Finance APP, Allist (688578.SH) announced that the company's KRASG12C inhibitor, citric acid goraisan tablets (trade name "Airikai®") (hereinafter referred to as "goraisan"), has recently received approval from the National Medical Products Administration for its new drug marketing application, intended for the treatment of adult patients with advanced non-small cell lung cancer carrying the KRASG12C mutation who have received at least one systemic treatment.
This approval is based on the results of a pivotal Phase II single-arm study aimed at evaluating the safety, tolerability, and efficacy of goraisan as a monotherapy in subjects with advanced non-small cell lung cancer carrying the KRASG12C mutation who have failed or are intolerant to standard treatment.
The completion of the marketing application approval for goraisan's indication as a second-line treatment for non-small cell lung cancer marks the official start of goraisan's commercialization, which is beneficial for enriching the company's commercialization pipeline and enhancing its sales revenue. The company has established a specialized marketing team that will fully leverage goraisan's clinical treatment advantages, continuously improve the academic promotion and marketing strategies of the product, expand the patient population coverage for the approved indications of goraisan, increase goraisan's product sales revenue, and actively promote the inclusion of goraisan's indication for second-line treatment of non-small cell lung cancer into the national medical insurance catalog to benefit more lung cancer patients