此外，防城港市持续强化食品、药品、工业产品和特种设备等"三品一特"安全监管，食品安全评价性抽检合格率 稳定在99.55%以上，监督抽检不合格样品核查处置按时完成率连续5年保持100%。"十四五"期间，全市查处药品 领域违法违规案件733起，为医药产业健康发展营造公平有序的市场环境。药品检验能力显著提升，相关资质项目 较"十三五"末增长13.22倍，并顺利通过中国合格评定国家认可委员会实验室认可。创新药物滥用监测机制相关经 验获国家药监局肯定。(刘子寒) 据介绍，"十四五"期间，防城港全市医疗器械备案注册量由全区末位跃升至第四位，二类医疗器械生产企业由3家 增至40家，产业规模加快壮大。3款一、二类生物创新药获药物临床试验批件，实现历史性突破；负离子磁疗仓、 心理诊疗数据管理软件等6个医药产品实现全区首产。通过精准帮扶，企业成功获批辖区首张三类医疗器械注册 证，实现防城港市三类医疗器械注册"零的突破"。 防城港市市场监管部门相关负责人表示，围绕医药产业发展需求，市场监管部门坚持"监管提质、服务赋能"，在 审评审批、检验检测等关键环节组建专业服务团队，形成前后联动、上下协同的服务机制，助力医药产品在医学 试验区提 ...

Regulatory Developments - The National Health Commission and other departments have released the 2025 National Random Supervision and Inspection Plan, which includes new regulatory areas such as internet diagnosis and treatment, and mental health, while explicitly targeting online medical fraud [1] - The regulatory focus on combating online medical fraud represents a significant upgrade in medical supervision, aiming to purify the medical online space [1] Pharmaceutical Approvals - Innovent Biologics announced that its third-generation EGFR TKI drug, Olitinib (Leratinib), has received approval from the National Medical Products Administration (NMPA) for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [2] - Olitinib is the only approved third-generation EGFR TKI based on a naphthalene structure, expanding treatment options for EGFR mutation-positive NSCLC patients [2] Market Regulation and Antitrust Issues - Xianju Pharmaceutical is facing a potential fine of approximately 195 million yuan for alleged monopolistic practices related to the pricing of dexamethasone phosphate raw materials, with the case still under review by the Tianjin Market Supervision Administration [3] - This incident highlights the regulatory authorities' emphasis on antitrust measures within the pharmaceutical industry, which could disrupt normal market operations [3] Combination Therapy Approvals - Pfizer announced that its oral targeted drug, Axi-cabtagene ciloleucel (Axitinib), has been approved for first-line treatment in combination with Toripalimab for high-risk, unresectable, or metastatic renal cell carcinoma (RCC) patients [4] - This approval marks the first and only approved first-line targeted and immune combination therapy for advanced kidney cancer in China, indicating a shift towards combination therapies in the treatment landscape [4]