2023年中国创新药研发报告

Investment Rating - The report indicates a positive investment outlook for the innovative drug sector in China, highlighting significant growth in the number of IND applications and new drug approvals. Core Insights - Since 2017, the number of IND applications for Class 1 new drugs has been steadily increasing, with a notable 31.7% year-on-year growth in 2023, reaching 1241 applications [5][22] - The number of Class 1 new drugs approved for market in China nearly doubled from 2022 to 2023, increasing from 9 to 35, representing a growth rate of 289% [7][10] - The focus of innovative drug development is primarily on oncology and immunotherapy, with these areas accounting for 64.4% of the total new drug sales [70] Summary by Sections Section 1: Current Status of Pharmaceutical Innovation in China - The report notes a significant increase in IND applications for Class 1 new drugs, attributed to supportive government policies and a recovering economic environment [5][22] - The proportion of biological products in IND applications has stabilized at around 48.3%, while innovative chemical drugs have seen a slight decline [15][22] Section 2: Growth of Marketed Innovative Drugs - The number of marketed Class 1 innovative drugs has shown a consistent upward trend, with a substantial increase in 2023 [7][10] - The distribution of therapeutic areas for new drugs shows a strong emphasis on oncology and immunology, which are currently the hottest research fields [10][70] Section 3: IND Application Trends - The report highlights a 16.4% increase in the number of first-time IND applications in 2023, with a compound annual growth rate (CAGR) of 25.1% over the past four years [22][25] - The report identifies a growing interest in small molecule drugs and antibody therapies, with CGT (cell and gene therapy) and ADC (antibody-drug conjugates) showing significant growth rates [25][51] Section 4: Internationalization of Domestic Innovative Drugs - The report discusses the increasing number of Chinese companies successfully bringing their innovative drugs to international markets, with 33 license-in and 78 license-out transactions in 2023 [58][67] - Notable approvals by the FDA for Chinese-developed drugs indicate a growing recognition of domestic innovation capabilities [68][70]