医药：中药新药申报加速，国谈助力新药快速放量

Investment Rating - The investment rating for the sector is "Strongly Outperform" [1] Core Insights - The number of new Chinese medicine applications accepted by CDE has significantly increased, with 1.1 category new drugs rapidly entering the market through medical insurance negotiations [3][5] - The report highlights that the number of accepted new Chinese medicine applications has been on a continuous rise since 2021, with 124 new drug varieties accepted by CDE as of December 16, 2024, of which over 50% are 1.1 category innovative drugs [3][9] - The report identifies key companies benefiting from this trend, including Kangyuan Pharmaceutical, Tian Shi Li, Yi Ling Pharmaceutical, Jian Min Group, Yue Kang Pharmaceutical, and Fang Sheng Pharmaceutical [5][68] Summary by Sections 1.1 Increase in New Drug Applications - The number of new Chinese medicine applications accepted by CDE has shown a clear upward trend since 2021, with 1.1 category new drugs consistently exceeding 40 applications annually [3][9] - As of December 16, 2024, 124 new Chinese medicine varieties have been accepted, with 1.1 category accounting for over 50% and 3.1 category for 20% [3][9] 1.2 Clinical Trials and Approvals - Tian Shi Li has the highest number of ongoing clinical III phase trials, with 9 products, while Kangyuan Pharmaceutical has 5, and Yi Ling Pharmaceutical has 4 [4][57] - The report notes that the number of IND applications has been increasing year by year, reaching 53 by December 5, 2024, with Kangyuan Pharmaceutical leading with 10 applications [60][62] 1.3 Characteristics of Approved Drugs - The report outlines that approved 1.1 category innovative drugs have high initial daily usage costs, rapid entry into the medical insurance directory, and significant price reductions during negotiations, averaging around 70% [66][68] - The initial daily usage amounts for these drugs are generally above 50 yuan, with some nearing 200 yuan [66][68] 1.4 Sales Growth Post-Insurance Entry - Medical insurance negotiations are crucial for accelerating sales post-launch, with successful negotiations leading to significant revenue growth in the following years [5][68] - For instance, Fang Sheng Pharmaceutical's Xuan Qi Jian Gu Pian achieved sales exceeding 30 million yuan in its second full year post-launch [68][70] 1.5 Recommended and Benefiting Companies - The report recommends Kangyuan Pharmaceutical as a key investment target, with Tian Shi Li, Yi Ling Pharmaceutical, Jian Min Group, Yue Kang Pharmaceutical, and Fang Sheng Pharmaceutical identified as benefiting companies [5][68]