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科伦博泰1类新药仑博替尼上市申请获CDE受理,抗肿瘤研发与市场前景可期
Ge Long Hui· 2025-09-24 11:48
Core Viewpoint - Kolon Pharmaceutical's subsidiary, Kolon Biotech, has received acceptance for the marketing application of the new drug, Furmasan Lunbotin Capsules, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults [1][4]. Group 1: Drug Development and Clinical Trials - Lunbotin (A400/EP0031) is a second-generation small molecule selective RET inhibitor developed by Kolon Biotech, showing broad activity against common RET gene fusions and mutations, which may help overcome resistance seen with first-generation inhibitors [4]. - Kolon Biotech has conducted several key clinical studies for Lunbotin, including pivotal trials for first-line and second-line treatment of advanced RET fusion-positive NSCLC, as well as studies for RET fusion-positive medullary thyroid carcinoma (RET + MTC) and solid tumors [4]. Group 2: Market Trends and Company Performance - The anti-tumor drug market is experiencing robust growth, with sales in hospitals projected to exceed 120 billion yuan in 2024, reflecting a year-on-year increase of 6.15% [7]. - Kolon Biotech has successfully developed and commercialized several anti-tumor and immune modulators, including the first-class new drug, Tagolizumab Injection (PD-L1), and the antibody-drug conjugate, Lukanosatuzumab Injection [9]. - In the first half of 2025, Kolon Biotech reported revenues of 950 million yuan, with self-commercial sales amounting to 310 million yuan, representing 32.6% of total revenue [12].