玛硒洛沙韦片(济可舒)

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诺和泰新增适应症;康华生物控股股东变更
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-21 02:13
Policy Developments - The National Medical Products Administration (NMPA) reported five cases of illegal online sales of medical devices, including companies selling products without proper licenses and failing to meet regulatory requirements [2] Drug and Device Approvals - East China Pharmaceutical's subsidiary received approval for clinical trials of HDM2012, a novel antibody-drug conjugate targeting mucin-17, marking it as a global first-class biological product [3] - Novo Nordisk announced that the NMPA approved the new indication for Ozempic (semaglutide injection) for chronic kidney disease, making it the first GLP-1 receptor agonist approved for this use in China [4] - Wanfu Bio received a medical device registration certificate for its MSI detection kit, which is significant for various solid tumor patients [5] Financial Reports - Fuan Pharmaceutical projected a net profit decline of 39.95% to 53.81% for the first half of 2025, primarily due to price reductions from national procurement policies [6] Capital Market Activities - Kanghua Bio announced a transfer of shares that will change its controlling shareholder to Wanke Xin Bio, with a total transfer price of approximately 1.85 billion yuan [8] - Jichuan Pharmaceutical's stock will resume trading after a tender offer by Cao Fei, who will control 56.07% of the company post-offer [9] Industry Developments - A new oral antiviral drug for influenza, Marselevosavir, developed by Zhengxiang Pharmaceutical, has been approved for use in treating uncomplicated influenza in previously healthy adults [10] Public Opinion Alerts - Notai Bio is facing other risk warnings due to a prior administrative penalty for false reporting, which included inflating revenue and profits [11]
医药行业周报:本周医药上涨4.0%,第十一批国采启动报量,禾元重组人白蛋白获批上市-20250720
Shenwan Hongyuan Securities· 2025-07-20 13:36
Investment Rating - The report rates the pharmaceutical industry as "Overweight," indicating an expectation for the industry to outperform the overall market [1][21][29]. Core Insights - The pharmaceutical sector saw a weekly increase of 4.0%, outperforming the Shanghai Composite Index, which rose by 0.7% [3][5]. - The overall valuation of the pharmaceutical sector stands at 31.7 times PE (2025E), ranking 6th among 31 primary industries [5][8]. - The 11th batch of national drug procurement has been initiated, with 55 products selected, establishing a sales threshold of 100 million yuan for participation [10]. - Recent approvals include the launch of recombinant human albumin injection by He Yuan Biotech and a new flu drug by Jichuan Pharmaceutical and Zhengxiang [10][11]. - Noteworthy IPO approval for Beixin Life, marking a significant milestone in the FFR measurement system in China [11]. - Financial misconduct has led to a penalty for Nuotai Bio, resulting in a stock warning and a halt in trading [11]. Market Performance - The pharmaceutical sector's performance is highlighted with a 4.0% increase, ranking second among 31 sub-industries [3][5]. - Detailed performance across sub-sectors includes raw materials (+7.0%), chemical preparations (+6.8%), and others, with offline pharmacies showing a decline of -2.7% [5][6]. Key Events - The report emphasizes significant events such as the initiation of the 11th national drug procurement and the approval of new drugs, which are expected to impact market dynamics positively [10][11]. - The report also notes the financial penalties faced by Nuotai Bio, which may affect investor sentiment and market stability [11]. Investment Analysis - The report suggests focusing on innovative drug companies and related CXO companies that are expected to benefit from upcoming product launches and business development opportunities [10]. - Companies highlighted for potential growth include Heng Rui Pharmaceutical, Bei Da Pharmaceutical, and WuXi AppTec among others [10].
新一代国产流感抗病毒口服药上市
第一财经· 2025-07-18 05:32
Core Viewpoint - The approval of the antiviral oral drug Marcilosavir (brand name: Jikeshou) by the National Medical Products Administration marks a significant advancement in the treatment of influenza, specifically for healthy adult patients with uncomplicated influenza A and B [1] Group 1: Product Approval - Marcilosavir is developed by Zhengxiang Pharmaceutical and is a new generation polymerase acidic protein (PA) endonuclease inhibitor [1] - The drug exhibits broad-spectrum antiviral properties against influenza viruses, including both A and B types, as well as highly pathogenic avian influenza viruses [1]
据国家药监局官网7月18日消息,流感抗病毒口服药物玛硒洛沙韦片(商品名:济可舒)获批上市,用于治疗既往健康的成人单纯性甲型和乙型流感患者,不包括存在流感相关并发症高风险的患者。
news flash· 2025-07-18 04:55
据国家药监局官网7月18日消息,流感抗病毒口服药物玛硒洛沙韦片(商品名:济可舒)获批上市,用 于治疗既往健康的成人单纯性甲型和乙型流感患者,不包括存在流感相关并发症高风险的患者。 (国 家药监局) ...