Workflow
生物医药Ⅱ
icon
Search documents
ARS吸入式过敏疗法Neffy获FDA批准
Tai Ping Yang· 2025-03-09 00:25
Investment Rating - The industry investment rating is "Positive," indicating an expected overall return exceeding the CSI 300 Index by more than 5% over the next six months [9]. Core Insights - The pharmaceutical sector experienced a decline of 0.96% on March 7, 2025, underperforming the CSI 300 Index by 0.65 percentage points, ranking 22nd among 31 sub-industries [4]. - The approval of ARS's Neffy (1 mg epinephrine nasal spray) by the FDA marks a significant innovation in the delivery method for treating type I allergic reactions in children aged 4 and above, representing the first major advancement in 35 years for this patient group [5][9]. - Notable stock performances included Aosaikang (+9.99%), Yipinhong (+9.77%), and Rejing Biology (+8.84%) on the gainers' list, while Aopumai (-6.26%), Puri Eye (-5.97%), and BGI (-4.86%) led the decliners [4]. Summary by Sections Market Performance - As of March 7, 2025, the pharmaceutical sector's performance was -0.96%, with sub-sectors like in vitro diagnostics (-0.43%) and blood products (-0.72%) performing better, while hospitals (-2.11%) and medical devices (-1.67%) lagged [4]. Industry News - The FDA's approval of Neffy is a pivotal development for the treatment of severe allergic reactions in children, highlighting the ongoing innovation in the pharmaceutical industry [5]. - Companies such as Jingxin Pharmaceutical announced an increase in their share repurchase plan, raising the total amount from a minimum of 200 million RMB to 350 million RMB [5]. - Nouvegen and BGI have entered a strategic cooperation agreement to leverage their respective expertise in reproductive genetics, tumor prevention, chronic disease management, and infection control [5]. Company News - Heng Rui Pharmaceutical received approval for clinical trials of several new drugs, indicating ongoing research and development efforts [6]. - Kanglong Chemical reported the completion of a share reduction plan, with a total of 10,666,716 shares reduced, representing 0.60% of the company's total share capital [6].
医药行业周报:罗氏创新疗法TNKase获FDA批准,用于治疗AIS
Tai Ping Yang· 2025-03-05 03:47
Investment Rating - The industry investment rating is "Positive," indicating an expected overall return exceeding 5% above the CSI 300 index in the next six months [6]. Core Insights - Roche's innovative therapy TNKase has received FDA approval for the treatment of acute ischemic stroke (AIS), marking it as the first stroke medication approved in nearly 30 years [2][6]. - The pharmaceutical sector showed a performance increase of +0.54% on March 4, 2025, outperforming the CSI 300 index by 0.62 percentage points, ranking 19th among 31 sub-industries [1][6]. - Among sub-industries, in vitro diagnostics (+2.26%), medical devices (+1.17%), and hospitals (+0.85%) performed well, while other bioproducts (-0.06%), medical research outsourcing (+0.07%), and offline pharmacies (+0.17%) lagged [1]. Summary by Sections Market Performance - The pharmaceutical sector's performance on March 4, 2025, was +0.54%, outperforming the CSI 300 index by 0.62 percentage points, with in vitro diagnostics leading at +2.26% [1]. - Notable individual stock performances included BGI Genomics (+20.00%), Shengxiang Biology (+15.24%), and Aidi Pharmaceutical (+11.31%), while Jiangsu Wuzhong (-8.80%), Zhixiang Jintai (-6.22%), and Sihuan Bio (-6.01%) faced declines [1]. Company News - Yinos announced that its clinical immunohistochemistry laboratory received CAP certification, enhancing its clinical testing business prospects [2]. - Tiantan Biological reported that its human coagulation factor IX has completed clinical ethical review and is set to begin Phase III clinical trials, with cumulative R&D investment reaching 25.5766 million yuan [2]. - Sunshine Novo has repurchased 2.716789 million shares, accounting for 2.43% of its total share capital, with a total expenditure of approximately 99.75 million yuan [3]. - Tigermed has repurchased 9.8063 million shares, representing 1.1337% of its total share capital, with a total expenditure of approximately 500.12 million yuan [3].
医药行业周报:礼来与Magnet达成近13亿美元分子胶合作
Tai Ping Yang· 2025-03-04 05:17
2025 年 03 月 03 日 行业周报 看好/维持 医药 医药 礼来与 Magnet 达成近 13 亿美元分子胶合作 科伦药业(002422):公司发布公告,公司 5%以上持股股东雅安国资 拟通过集中竞价的方式增持公司股份,拟增持金额为 5000-9900 万元,增 持价格不超过 37.60 元/股,资金来源为自有资金和股票回购专项贷款。 鱼跃医疗(002223):公司发布公告,公司申请的自动体外除颤器(AED) 获得符合欧盟《医疗器械第 2017/745 号法规》(MDR)要求的 III 类医疗 器械 CE 认证证书,此次获批表明该产品具备欧盟市场的最新准入条件, 进一步提升了公司急救类产品在相应领域的综合竞争力。 昭衍新药(603127):公司发布公告,公司累计通过集中竞价交易方 式回购 A 股股份 3,269,820 股,占公司总股份的 0.4363%,回购价格区间 为 13.20-18.15 元/股,使用资金总额为人民币 52,991,757.40 元(不含 交易费用)。 ◼ 走势比较 报告摘要 市场表现: 2025年3月3日,医药板块涨跌幅+0.66%,跑赢沪深300指数0.70pct, 涨跌幅 ...
医药行业周报:Sobi在研Gamifant获FDA授予优先审评资格
Tai Ping Yang· 2025-03-02 05:44
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 ...
Sobi在研Gamifant获FDA授予优先审评资格
Tai Ping Yang· 2025-03-02 00:25
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].