政策动向 软骨发育不全等86个罕见病病种诊疗指南发布 近期，国家卫生健康委办公厅公布《86个罕见病病种诊疗指南（2025年版）》。2023年9月，国家卫生 健康委等部门联合发布《第二批罕见病目录》，纳入包括软骨发育不全、获得性血友病等86种罕见病。 为进一步提高罕见病诊疗规范化水平，保障医疗质量安全，国家卫生健康委组织对《第二批罕见病目 录》中的86个病种分别制定了诊疗指南。 广东全面上线人工智能辅助影像阅片系统 21点评：在影像诊断领域，传统方式依赖医生经验和大量时间，AI辅助影像阅片系统能快速精准分析 影像，辅助医生诊断，极大提高诊断质量和效率，降低漏诊误诊风险，为患者争取宝贵治疗时间。这种 省级统筹的推广模式，也为医疗AI产品的标准化、规范化应用提供了重要参考，有望加速医疗AI产品 审批和收费目录制定进程。 药械审批 FDA受理默沙东HIV双药疗法上市申请 近期，默沙东（MSD）宣布，美国FDA已受理其为所开发的在研复方口服药物doravirine/islatravir （DOR/ISL）所提交的新药申请（NDA）。这是一款每日一次的双药方案，用于治疗病毒学抑制的 HIV-1感染成人患者。该申请的PDU ...

Core Insights - The report maintains a positive outlook on the HIV sector, highlighting Gilead's long-acting therapy, Lenacapavir, as a potential game-changer in HIV treatment and prevention [1][3]. Group 1: HIV Mechanism and Treatment - HIV is a retrovirus that selectively targets CD4+ cells, integrating its genetic material into the host's genome, leading to viral replication [5][7]. - The primary treatment for AIDS is the "cocktail therapy," which combines multiple antiviral drugs to minimize resistance and maximize viral suppression [5][7]. Group 2: Lenacapavir's Impact - Lenacapavir is Gilead's first long-acting HIV capsid inhibitor, showing promising results in clinical trials for treating multi-drug resistant HIV in adults [9][11]. - In the CAPELLA study, 83% of participants using Lenacapavir achieved a viral load of less than 50 copies/mL after 52 weeks, compared to only 11% in the placebo group [13][14]. - Lenacapavir has significant potential in post-exposure prophylaxis (PrEP), with studies indicating a 100% reduction in HIV infection risk among participants receiving biannual injections [20][21]. Group 3: Market Potential and Future Developments - The global HIV infection rate in 2023 was approximately 39.9 million, with a significant portion of the population being women [15][18]. - Lenacapavir's approval for PrEP is anticipated to set a new standard in HIV prevention, potentially generating substantial revenue for Gilead [23]. - Other recent advancements in HIV treatments include Merck's dual-drug therapy achieving positive results in Phase III trials and ViiV Healthcare's long-acting antibody therapy showing good efficacy [24][26].