太平洋医药日报(20260202):Lirafugratinib向FDA递交NDA
Tai Ping Yang Zheng Quan·2026-02-04 04:20

Investment Rating - The industry rating is neutral, indicating that the overall return is expected to be between -5% and 5% relative to the CSI 300 index over the next six months [9]. Core Insights - The pharmaceutical sector experienced a decline of 2.42% on February 2, 2025, underperforming the CSI 300 index by 0.29 percentage points, ranking 16th among 31 sub-industries [4]. - Key performers in the sector included hospitals (-0.99%), pharmaceutical distribution (-1.63%), and blood products (-1.65%), while other biopharmaceuticals (-3.69%) and offline pharmacies (-3.09%) lagged behind [4]. - Elevar has submitted a New Drug Application (NDA) to the FDA for Lirafugratinib, a selective oral FGFR2 inhibitor, showing a 46.5% objective response rate (ORR) in clinical trials for cholangiocarcinoma patients [5]. - The disease control rate for Lirafugratinib reached 96.5%, with a median progression-free survival (PFS) of 11.3 months and a median overall survival (OS) of 22.8 months [5]. - Jichuan Pharmaceutical has signed an exclusive commercialization agreement for a nasal spray in Greater China, with a payment of up to 100 million RMB [5]. - Heng Rui Pharmaceutical received FDA acceptance for its BLA submission for a combination therapy for liver cancer [6]. - Shanghai Yizhong reported a projected revenue of 317 million RMB for 2025, reflecting an 82.72% year-on-year growth [6]. Sub-industry Ratings - Chemical pharmaceuticals: No rating - Traditional Chinese medicine: No rating - Biopharmaceuticals II: Neutral - Other pharmaceuticals: Neutral [3].

太平洋医药日报(20260202):Lirafugratinib向FDA递交NDA - Reportify