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首仿药获批热潮:2024年896款过评,齐鲁制药霸榜,技术门槛提升成趋势
Ge Long Hui· 2025-05-26 01:18
Core Insights - The balance between innovation and generics is crucial for the healthy development of the pharmaceutical industry. Recently, the first generic drugs have become a focus for domestic pharmaceutical companies, with over 170 first generics approved from 2022 to 2023, and the number of approvals increasing year by year. In 2024, despite fierce competition from ten rounds of centralized procurement, 896 drugs have passed or are deemed to have passed consistency evaluations, with 254 being first approvals and 107 being significant first generics. Qilu Pharmaceutical topped the annual list with 7 first generics [1][2][4]. Industry Overview - The domestic generic drug market has become increasingly competitive due to market opening and reform of drug approval systems. The tenth round of national centralized procurement has intensified competition, leading to extreme pricing situations, with some injectable drugs priced lower than bottled water. This has put significant pressure on B-class enterprises, with some industry insiders claiming that generic drug projects are becoming unsustainable [2][4]. Company Performance - Leading companies in the domestic generic drug sector, such as Qilu Pharmaceutical, Kelun Pharmaceutical, and Heng Rui Medicine, have maintained strong competitive positions. In 2022, Heng Rui and Kelun each achieved 7 first generics, while in 2023, Kelun led with 6 first generics. In 2024, Qilu Pharmaceutical excelled with 7 first generics, solidifying its leading position in the generic drug field [4][5][6]. Market Dynamics - In 2024, a total of 896 generic drugs passed or were deemed to have passed consistency evaluations, with 254 being first approvals, accounting for 28.34%. The competition for first generics remains fierce, with Qilu Pharmaceutical achieving the highest number of first generics [2][4][5]. Emerging Competitors - Other companies, such as Zhengda Tianqing, also demonstrated strong R&D capabilities, achieving 5 first generics in both 2023 and 2024, maintaining a solid position in the market. Companies like Shanghai Xuantai and Wuhu Daorun have made significant gains, with Xuantai achieving 4 first generics in 2024, marking a notable improvement from 2023 [5][9][12]. Future Outlook - The generic drug market in China is expected to continue evolving, with a focus on high-quality first generics and innovative drugs. The success of first generics is concentrated in high-tech niche areas, highlighting the progress made by pharmaceutical companies in overcoming technical challenges. The competitive landscape will likely shift further as policies and market conditions change [14].