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].

Core Viewpoint - The adjustment of the national medical insurance and commercial health insurance drug directories is a significant event for the innovative drug investment landscape in the second half of the year, with over 650 drugs entering the basic medical insurance directory and commercial insurance innovative drug directory [1][2]. Group 1: Medical Insurance Directory Adjustments - A total of 534 drug generic names passed the initial review for the basic medical insurance directory, with 310 drugs being added to the directory, a significant increase from 249 in 2024 [2]. - The directory adjustments allow newly approved innovative drugs to have the opportunity to enter the insurance directory, including several notable drugs such as the lung cancer drug Gorailis and the autoimmune drug Fuanqi [2]. Group 2: Commercial Health Insurance Directory - The commercial health insurance innovative drug directory has approved 121 drugs, including five CAR-T therapies and a domestic vaccine, marking a new approach for market access for preventive biological products [3]. - Notable CAR-T therapies that made it into the directory include products from Fosun Kite, Huyuan Bio, and WuXi AppTec, with the latter's product achieving $808 million in revenue in the first half of the year, reflecting a doubling in growth [3]. Group 3: Future Outlook for Innovative Drugs - The upcoming months will see significant overseas pharmaceutical conferences and further developments in the medical insurance directories, providing ample opportunities for speculation and investment in innovative drugs [4]. - The domestic innovative drug sector is expected to benefit from increased clinical data catalysts and a rebound in funding and secondary market activity, enhancing the demand for new drug development [4].