KELUN PHARMA(SZ:002422) Ge Long Hui·2026-01-05 12:59Core Insights - The pharmaceutical industry in 2025 experienced significant changes, particularly in the generic drug sector, marked by intense competition and regulatory challenges, with the race for first generic drugs becoming a central focus [1] Group 1: Market Dynamics - The 11th round of national drug procurement introduced optimized rules aimed at stabilizing clinical use, ensuring quality, and preventing price wars, marking a pivotal moment for the industry [2] - Over 277 first generic drugs were approved from 2022 to 2024, with a steady increase in numbers, indicating a resilient market despite challenging conditions [2] - In 2025, 959 generic drug varieties passed or were deemed to have passed consistency evaluations, with 207 being first approvals, accounting for over 20% of the total [2] Group 2: Leading Companies - In 2025, Kelun Pharmaceutical maintained its position as the leader in first generic drugs with 6 approvals, reinforcing its dominant market status [5] - Qilu Pharmaceutical followed closely with 5 first generic approvals, showcasing its strong R&D capabilities and market competitiveness [7] - Yichang Renfu Pharmaceutical and Hangzhou Muyuan Biopharmaceutical emerged as notable competitors, each achieving 3 first generic approvals, marking a significant rise in their market presence [8][9] Group 3: Regulatory Environment - A regulatory storm in December 2025 led to the rejection of 102 applications for chemical generics within a short span, highlighting the increased scrutiny on the authenticity and compliance of drug development [12] - This regulatory shift signals the end of a development model that prioritized speed over quality, emphasizing the need for stability and compliance in the race for first generics [12]