2025 年 02 月 28 日 行业周报 看好/维持 医药 医药 Sobi 在研 Gamifant 获 FDA 授予优先审评资格 ◼ 走势比较 报告摘要 市场表现： 公司要闻： 诺泰生物（688076）：公司发布公告，子公司诺泰诺和于 2024 年 10 月 28 日至 2024 年 11 月 1 日接受了美国 FDA 的 cGMP 现场检查。近日， 诺泰诺和收到了美国 FDA 签发的现场检查报告（EIR），确认顺利通过本次 cGMP 现场检查。 天宇股份（300702）：公司发布公告，公司于 2024 年 11 月 21 日至 11 月 29 日接受了美国 FDA 的 cGMP 现场检查。近日，公司收到了美国 FDA 签发的现场检查报告（EIR），确认顺利通过本次 cGMP 现场检查。 明德生物（002932）：公司发布公告，公司以集中竞价方式回购公司 股份 13,034,741 股，占公司总股本的 5.61%，回购价格区间为 15.33- 20.98 元/股，总成交金额为 247,957,339.20 元。截至目前，本次回购方 案中维护公司价值及股东权益部分的股份回购已实施完毕。 风险提示：新药研发及上 ...

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].