Sobi在研Gamifant获FDA授予优先审评资格

Investment Rating - The industry investment rating is "Positive," indicating an expected overall return exceeding 5% above the CSI 300 index within the next six months [6]. Core Views - The pharmaceutical sector experienced a decline of 2.22% on February 28, 2025, underperforming the CSI 300 index by 0.25 percentage points, ranking 19th among 31 sub-industries [1]. - Sobi's investigational drug Gamifant has received priority review status from the FDA, with a decision expected by June 27, 2025. Gamifant is a monoclonal antibody used for treating primary HLH patients resistant to standard treatments [2][6]. - Notable stock performances included Blue Sail Medical (+9.98%), Hotgen Biotech (+6.32%), and BeiGene (+5.49%), while Jiangsu Wu Zhong (-10.05%), Saint Noble Bio (-9.67%), and Kangtuo Medical (-9.34%) faced significant declines [1]. Summary by Sections Market Performance - The pharmaceutical sector's performance on February 28, 2025, was -2.22%, with blood products (-1.42%), medical consumables (-1.59%), and offline pharmacies (-1.64%) showing relatively better performance compared to hospitals (-3.79%), medical R&D outsourcing (-3.65%), and other biological products (-2.67%) [1]. Company News - Notable company updates include: - Novartis' subsidiary successfully passed the FDA's cGMP inspection, confirming compliance [2]. - Tianyu Co. also received confirmation of passing the FDA's cGMP inspection [2]. - Mingde Bio announced a share buyback of 13,034,741 shares, representing 5.61% of its total share capital, with a total transaction amount of approximately 248 million yuan [3].