Teropavimab

下面是2025年10月13日至2025年10月19日这一周国际头部药企（top30）的国际审批、合作授权、收并购、临床进展及财务业绩情况 国际审批方面：  强生：10月13日，强生MedTech宣布，在美国推出INHANCE INTACT，专门为肩胛下全肩关节置换术开发的专有仪器系统，使外科医生能够在保持肩部肌肉完整的情况下替换受损的肩关节。传统的全肩关节置换术三角胸肌入路虽然有效，但通常需要脱离肩胛下肌，肩胛下肌是肩胛前方的关键肌肉，与术后疼痛、不稳定和肌腱衰竭有关。患者往往面临长达6周的术后固定。INHANCE INTACT实现的组织保留入路允许外科医生在增强关节可视化的情况下进行肩关节置换术。可使患者在术后第一天就能活动肩部。INHANCE INTACT集成了无柄种植体，43个专用仪器和TRUMATCH个性化解决方案，通过患者特定的3D规划来支持解剖精度，骨保存和手术精度。  强生：10月16日，强生宣布，美国FDA同意优先审查其用于治疗BRCA突变转移性去势敏感前列腺癌患者的AKEEGA（尼拉帕尼和醋酸阿比特龙双作用片）联合泼尼松的补充新药申请。申请基于3期AMPLITUDE研究数据的支持，表明AKEEGA加泼尼松治疗可将放射学进展或死亡的风险降低48%，还显著延长了56%的症状进展时间，并显示出改善总生存期的趋势，死亡风险降低25%。AKEEGA是双作用片剂，结合了高选择性多聚ADP核糖聚合酶（PARP）抑制剂尼拉帕尼和CYP17抑制剂醋酸阿比特龙。2016年4月，杨森生物技术公司与TESARO公司（于2019年被葛兰素史克收购）就尼拉帕尼治疗前列腺癌的独家权利达成了全球（日本除外）合作和许可协议。  罗氏：10月17日，罗氏宣布，欧洲药品管理局人用药品委员会建议批准Gazyva/Gazyvaro（obinutuzumab）联合霉酚酸酯治疗活动性III类或IV类，伴或不伴V类狼疮性肾炎的成人患者。建议是基于II期NOBILITY和III期REGENCY研究的阳性结果。在REGENCY中，Gazyva/Gazyvaro加标准治疗（霉酚酸酯和糖皮质激素）的参与者中，46.4%达到了完全肾反应，而单独标准治疗为33.1%。还伴随着具有统计学和临床意义的皮质类固醇使用减少，以及蛋白尿反应的改善。Gazyva/Gazyvaro（obinutuzumab）是II型工程化人源单抗，设计用于附着CD20， CD20是某些B细胞上发现的蛋白质。在狼疮肾炎中，致病的B细胞驱动持续的炎症，损害肾脏并降低其正常工作的能力。Gazyva/Gazyvaro可消耗致病的B细胞，有助于限制对肾脏的进一步损害。  艾伯维：10月13日，艾伯维宣布，美国FDA批准了一项补充新药申请，更新了RINVOQ（upadacitinib）用于治疗中度至重度活动性溃疡性结肠炎和中度至重度活动性克罗恩病的适应症。此前，RINVOQ适用于对一种或多种肿瘤坏死因子（TNF）阻滞剂反应不足或不耐受的中度至重度活动性溃疡性结肠炎或克罗恩病成人。更新后的适应症还允许在临床不建议使用TNF阻滞剂的情况下，对接受过至少一种经批准的全身治疗的患者使用RINVOQ。RINVOQ是JAK抑制剂，抑制细胞因子诱导的由JAK1和JAK1/JAK3介导的STAT磷酸化。  葛兰素史克：10月14日，葛兰素史克宣布，中国国家药监局已批准Shingrix（重组带状疱疹疫苗）用于预防18岁及以上因已知疾病或治疗引起的免疫缺陷或免疫抑制而有带状疱疹风险增加的成年人。审批是基于6项临床试验结果，患者年龄在18岁及以上，近期接受过造血干细胞移植、肾移植或患有血癌、实体瘤或艾滋病毒感染。Shingrix为非活的重组亚单位疫苗，将抗原糖蛋白E与佐剂系统AS01B结合在一起，有助于克服与年龄相关的免疫反应自然下降，有助于保护50岁及以上的成年人免受带状疱疹的侵害。  阿斯利康：10月17日，阿斯利康宣布，其Saphnelo （anifrolumab）已被欧洲药品管理局人用药品委员会推荐批准，用于成人系统性红斑狼疮患者每周一次的自我给药。批准主要基于III期TULIP-SC试验的中期结果。与安慰剂相比，皮下给药与静脉临床特征一致。2004年，阿斯利康通过与Medarex, Inc.的独家许可和合作协议，获得了 Saphnelo 的全球权利。Medarex联合推广该产品的选择权于2009年被百时美施贵宝收购。阿斯利康将根据不同区域向百时美施贵宝支付约15%的特许权费。Saphnelo （anifrolumab）是与I型干扰素（IFN）受体亚基1结合的全人源单抗，可阻断I型IFN的活性。  阿斯利康：10月17日，阿斯利康宣布，其和安进的Tezspire（tezepelumab）已在美国获得批准，用于12岁及以上患有控制不充分的慢性鼻窦炎伴鼻息肉的成人和儿科患者的附加维持治疗，Tezspire是靶向胸腺基质淋巴生成素的生物制剂。美国FDA的批准是基于WAYPOINT III期试验的结果。结果显示，与安慰剂相比，几乎无需手术，全身皮质类固醇的使用也显著减少。对于Tezspire，阿斯利康向安进支付中等个位数的特许权费后，两家公司将继续平均分担成本和利润。  诺华：10月17日，诺华宣布，欧洲药品管理局人用药品委员会通过了积极意见，建议批准Scemblix（asciminib）在所有治疗线中用于治疗成年费城染色体阳性慢性粒细胞白血病慢性期的上市许可。积极意见是基于ASC4FIRST III期试验数据，比较Scemblix与研究人员选择的酪氨酸激酶抑制剂治疗效果。与所有酪氨酸激酶抑制剂（伊马替尼、尼罗替尼、达沙替尼和博舒替尼）以及与伊马替尼单独相比，Scemblix表现出优越的主要分子反应率。Scemblix在第48周的分子反应率为67.7%相比对照组49.0%。Scemblix相比单独使用伊马替尼，分子反应率为69.3%相比40.2%。与第2代酪氨酸激酶抑制剂相比，分子反应率为66%相比57.8%。在第96周，Scemblix与所有研究者选择的酪氨酸激酶抑制剂相比，为74.1%相比52%。Scemblix与伊马替尼相比，为76.2%相比47.1%。Scemblix是通过特异性靶向ABL Myristoyl Pocket（STAMP抑制剂）起作用。目前批准的其他慢性髓系白血病治疗方法是靶向ATP结合位点的酪氨酸激酶抑制剂。  赛诺菲：10月17日，赛诺菲宣布，欧洲药品管理局人用药品委员会对Rezurock （belumosudil）用于成人和儿童慢性移植物抗宿主病三线治疗的上市许可申请发表了负面意见。赛诺菲将寻求重新审查其意见。Rezurock（belumosudil）是选择性ROCK2（Rho相关卷曲螺旋蛋白激酶2）抑制剂。  赛诺菲：10月17日，赛诺菲宣布，欧洲药品管理局人用药品委员会通过了积极意见，建议批准Wayrilz（rilzabrutinib），布鲁顿激酶抑制剂，作为对其他治疗难治性成年患者的免疫性血小板减少症的新治疗方法。积极意见基于关键的LUNA 3的3期研究，Wayrilz达到了主要和次要终点，显示口服可逆布鲁顿酪氨酸激酶抑制剂对持续血小板计数、出血和其他血小板减小症症状有积极影响。  再生元：10月17日，再生元宣布，欧洲药品管理局人用药品委员会通过了Libtayo（cemiplimab）作为手术和放疗后复发风险高的成人皮肤鳞状细胞癌患者的辅助治疗的积极意见。此意见基于全球3期C-POST试验结果，与安慰剂相比，Libtayo降低了68%的疾病复发或死亡风险。接受Libtayo治疗的患者局部或远处复发较少（分别为4%相比对照组17%，5%相比对照组13%）。Libtayo是针对T细胞免疫检查点受体PD-1的全人源单抗，通过与PD-1结合，可以阻止癌细胞使用PD-1途径抑制T细胞的激活。 收并购方面：  强生：10月14日，强生宣布，拟将其骨科业务从集团分拆出来，以DePuy Synthes的名义单独运营。在2024财年，骨科业务的销售额约为92亿美元。  艾伯维：10月17日，艾伯维宣布，已完成对Gilgamesh Pharmaceuticals的在研药物bretisilocin的收购。Bretisilocin是新型的短效5-羟色胺5-HT2A受体激动剂和5-羟色胺释放剂，处于2期临床开发，用于治疗中重度抑郁症。收购价格高达12亿美元，包括预付款和开发里程碑付款。  默克：10月15日，默克宣布签署最终协议，收购JSR Life Sciences的色谱业务，JSR生命科学公司从事合同开发和生产、临床前和转化临床研究以及提供生物处理解决方案。JSR色谱业务总部位于比利时，拥有50多名员工，主要产品包括Amsphere A3和Amsphere A+ Protein A树脂，为各种单克隆抗体提供纯化支持。  晖致：10月15日，晖致宣布，完成收购Aculys Pharma，Inc.，Aculys是临床阶段的生物制药公司，专注于将神经疾病治疗。晖致获得了中枢神经系统治疗领域的两项资产pitolisant和Spydia（地西泮）的开发和商业化权利。晖致获得了pitolisant在日本的独家开发和商业化权利，pitolisant是组胺H3受体的选择性反向激动剂。基于最近在日本患者中进行的3期临床试验结果，晖致有望在2025年底前向日本监管部门申请上市批准，用于治疗成人发作性睡病患者的日间过度嗜睡或猝厥，以及与阻塞性睡眠呼吸暂停综合征相关的日间过度嗜睡。该交易还包括Spydia鼻喷雾剂在日本和亚太地区某些其他市场的专有权，该药物于2025年6月在日本获得批准，用于治疗癫痫持续状态。此次收购还包括用于治疗广泛性焦虑症的Effexor，用于治疗急性心肌梗死的selatogrel，用于治疗IgA肾病的Nefecon和用于治疗系统性红斑狼疮的cenerimod，所有这些产品目前都在进行关键的3期试验，Tyrvaya用于治疗干眼病，预计将于2026年开始进行3期试验。晖致已向Aculys Pharma股东支付了预付款，作为收购的对价，额外的对价取决于特定的监管和商业里程碑的实现，以及净销售额的特许权费。 合作授权方面：  诺和诺德：10月15日，诺和诺德和Omeros Corporation（Nasdaq：OMER）宣布，双方已就用于罕见血液和肾脏疾病临床开发的候选药物zaltenibart（原OMS906）达成最终资产购买和许可协议。诺和诺德将获得开发和商业化zaltenibart所有适应症的全球独家权利。Omeros有资格获得3.4亿美元的前期和近期里程碑付款，潜在开发和商业里程碑总额高达21亿美元付款，以及净销售额的分层特许权费。Zaltenibart是人源化单抗，旨在抑制甘露糖结合凝集素相关丝氨酸蛋白酶3（MASP-3）的抗体，MASP-3是补体系统替代途径的关键激活因子。补体系统是免疫系统的重要组成部分，其失调已被证明与许多罕见疾病的病理生理有关。MASP-3负责将补体前因子D转化为其活性形式，因子D。与其他替代途径蛋白相比，MASP-3的体循环低，循环清除缓慢。与C3或C5抑制剂不同，MASP-3抑制保留了经典通路功能，这对疫苗诱导的免疫和防御感染至关重要。此外，MASP-3被认为不是急性期反应物，这为MASP-3抑制剂提供另一优势。Omeros报告了zaltenibart治疗阵发性夜间血红蛋白尿的2期阳性数据。Omeros保留了与zaltenibart无关的临床前MASP-3项目的某些权利，包括开发和商业化具有有限适应症限制的小分子MASP-3抑制剂的能力。  勃林格殷格翰：10月15日，勃林格殷格翰和专门开发基于抗体疗法的生物技术公司AimedBio，宣布全球合作和许可协议，以开发用于多种癌症的新型抗体偶联药物疗法。AimedBio有权获得总计高达9.91亿美元的资金，包括预付款、开发和监管里程碑、商业里程碑，以及净销售额的特许权费。 临床进展方面：  强生：10月16日，强生宣布，3期MajesTEC-3研究的积极结果。评估了TECVAYLI（teclistamab）与DARZALEX FASPRO（daratumumab和透明质酸酶）联合治疗复发难治性多发性骨髓瘤患者，相比研究者选择的DARZALEX FASPRO、泊马度胺和地塞米松或DARZALEX FASPRO、硼替佐米和地塞米松的效果。在近三年的随访中，TECVAYLI和DARZALEX FASPRO的联合治疗达到了无进展生存期的主要终点，结果具有统计学意义，次要终点总生存期也具有统计学意义。TECVAYLI和DARZALEX FASPRO组合的2期MajesTEC-5研究结果显示，在新诊断为多发性骨髓瘤的符合移植条件的患者中，在诊断后首次接受治疗时，总有效率达到100%。此外，所有可评估的微小残留患者在诱导期结束时残留均转为阴性，96%的患者成功完成了干细胞动员。TECVAYLI（teclistamab）是双特异性T细胞接合抗体疗法，通过结合T细胞表面表达的CD3受体和多发性骨髓瘤细胞，以及B系细胞表面表达的B细胞成熟抗原（BCMA）来激活免疫系统。  罗氏：10月16日，罗氏宣布，在美国波士顿举行的美国人类遗传学学会2025年年会上，介绍了其创新扩增测序技术（SBX）的进展。SBX技术打破了迄今为止最快的DNA测序技术的吉尼斯世界纪录，使用人类基因组在不到四个小时的时间内从DNA样本处理到最终的基因组变异文件（VCF）。  罗氏：10月17日，罗氏公布了两项III期研究的结果，评估了两种剂量的vamikibart（0.25和1mg）相比模拟玻璃体内注射治疗葡萄膜性黄斑水肿患者的效果。主要和次要终点数据显示，vamikibart治疗可改善视力和减少黄斑厚度。在MEERKAT试验中，主要终点（在16周患者视力相比基线有15个或更多字母的改善），0.25mg剂量组有19.9%患者达到改善，1mg组有36.9%的患者达到改善，而对照组无改善。但在SANDCAT试验中未能达到。关键次要终点均显示最佳矫正视力的平均基线变化和黄斑中心凹平均厚度的平均基线变化具有临床意义的改善（在MEERKAT试验中，0.25mg组最佳矫正视力提高9.6，1mg组提高12.8，而对照组为3.5。SANDCAT试验中，0.25mg组为提高11.9，1mg组提高9.2，对照组提高5.0；MEERKAT试验中，0.25mg组黄斑中心凹平均厚度下降187.5，1mg组下降196.1，而对照组下降58.5.SANDCAT试验中，0.25mg组下降209.7，1mg组下降194.7，而对照组下降43.5）。Vamikibart是在研单抗，用于静脉注射给药，靶点是白细胞介素-6，葡萄膜性黄斑水肿炎症通路中的关键细胞因子。  罗氏：10月18日，罗氏宣布了evERA乳腺癌III期研究的阳性结果。数据显示，对于雌激素受体阳性、人表皮生长因子受体2阴性、局部晚期或转移性，先前接受细胞周期蛋白依赖性激酶4/6抑制剂和内分泌治疗的乳腺癌患者中，在意向治疗和ESR1突变人群中，与标准护理内分泌治疗加依维莫司相比，giredestrant联合依维莫司显著降低了疾病进展或死亡风险，无进展生存期在两组人群中分别降低了44%和62%。在意向治疗人群中，中位无进展生存期为8.77个月，对照组为5.49个月。在ESR1突变人群中，中位无进展生存期为9.99个月，而对照组为5.45个月。总生存率数据尚不成熟，但观察到明显的阳性趋势。Giredestrant是在研口服下一代选择性雌激素受体降解剂和完全拮抗剂。用来阻止雌激素与雌激素受体结合，触发其分解，阻止或减缓癌细胞的生长。  辉瑞：10月14日，辉瑞宣布了HER2CLIMB-05 3期临床试验的阳性结果，评估采用酪氨酸激酶抑制剂TUKYSA（图卡替尼）的一线联合疗法用于人类表皮生长因子受体2阳性转移性乳腺癌患者的效果。HER2CLIMB-05评估TUKYSA相比安慰剂，在化疗诱导后联合一线标准疗法（曲妥珠单抗加帕妥珠单抗）维持治疗的疗效。该试验达到了其主要终点，TUKYSA组与安慰剂组相比，在无进展生存期方面具有统计学和临床意义的改善。TUKYSA是口服HER2酪氨酸激酶抑制剂。  辉瑞：10月18日，安斯泰来和辉瑞宣布，PADCEV（enfortumab vedotin）（靶向Nectin-4抗体偶联药物）与PD-1抑制剂KEYTRUDA（pembrolizumab）联合进行的关键3期临床试验（KEYNOTE-905）取得积极结果。评估了肌肉侵袭性膀胱癌不适合或拒绝顺铂化疗患者的联合治疗。PADCEV联合KEYTRUDA作为新辅助和辅助治疗时，与目前的标准治疗手术相比，显著提高了无事件生存期和总生存期。与单独手术相比，接受新辅助和辅助PADCEV+KEYTRUDA治疗的患者，肿瘤复发、进展或死亡风险降低了60%。联合组的估计中位无事件生存期尚未达到，而单独手术组为15.7个月。74.7%的联合治疗患者在两年内无事件发生，而仅接受手术治疗的患者为39.4%。联合疗法的死亡风险降低了50%。联合治疗的中位生存期尚未达到，而手术治疗组的中位生存期为41.7个月。估计79.7%的患者活到两年，而只接受手术的患者只有63.1%活到两年。对于病理完全缓解的次要终点，联合治疗的缓解率为57.1%，而仅接受手术的患者的为8.6%。PADCEV的抗癌活性是由于其与表达Nectin-4的细胞结合，将抗肿瘤药物monomethyl auristatin E（MMAE）内化并释放到细胞中，导致细胞周期阻滞和程序性细胞死亡。  艾伯维：10月13日，艾伯维宣布，将在10月17日至21日在德国柏林举行的2025年欧洲肿瘤医学学会大会上，公布其抗体偶联药物平台的新数据。包括telisotuzumab adizutecan (Temab-A)，ABBV-706和Emrelis（telisotuzumab vedotin）等。Temab-A是新型拓扑异构酶1抑制剂（Top1i）有效载荷的在研靶向c-Met的ADC。Temab-A单药和联合治疗晚期实体瘤的1期临床结果中，联合贝伐珠单抗用于结直肠癌的试验中，接受过3条或更多先前治疗的患者中，2.4 mg/kg剂量的Temab-A加贝伐珠单抗的客观缓解率为26.7%，而曲氟尿苷替匹嘧啶加贝伐珠单抗的客观缓解率为0%。用于MET扩增实体瘤的单药治疗中，在非小细胞肺癌、结直肠癌、胃食管腺癌和其他16种肿瘤类型里，在标准治疗后进展的患者中，Temab-A单药治疗在所有剂量水平和肿瘤类型中达到46%的客观缓解率，其中非小细胞肺癌客观缓解率达69%和胃食管腺癌为71%。单药治疗胰腺导管腺癌的试验中，接受或完成一线治疗后出现疾病进展的患者，Temab-A的总体客观缓解率为24%，在接受一线吉西他滨-单抗-紫杉醇治疗的患者中为40%。艾伯维还将公布针对复发难治性小细胞肺癌的ABBV-706的1期研究。ABBV-706是一种具有Top1i有效载荷的靶向SEZ6的ADC。患者在两线治疗后进展，比较ABBV-706单药治疗与铂基标准疗法的抗癌效果。患者均接受铂类标准治疗作为一线治疗。研究结果表明，ABBV-706可能有潜力取代铂基标准疗法作为小细胞肺癌的一线治疗方法。ABBV-706治疗也导致循环肿瘤DNA（ctDNA）和循环肿瘤细胞（CTC）的快速清除。  葛兰素史克：10月15日，葛兰素史克宣布，由其和辉瑞盐野义控股的全球HIV专科公司ViiV Healthcare，公布了来自I期CLARITY开放标签交叉研究的数据，69%的HIV阴性成人认为长效cabotegravir卡替拉韦注射剂“完全或非常可接受”，而lenacapavir来那帕韦注射剂为48%。90%的HIV阴性成年人和86%的医疗工作者在单次注射后更倾向于注射cabotegravir而不是lenacapavir。参与者首选cabotegravir的四个最常见原因是注射期间疼痛减轻，注射后疼痛或酸痛减轻，注射结节或肿胀持续时间，以及注射结节或肿胀的大小。卡替拉韦是整合酶抑制剂，来那帕韦是HIV-1衣壳抑制剂。  阿斯利康：10月17日，阿斯利康宣布，MATTERHORN III期试验的阳性结果显示对于可切除的早期和局部晚期（II期、III期、IVA期）胃癌和胃食管交界处癌患者，与单独化疗相比，采用Imfinzi（durvalumab）联合标准化疗FLOT（氟尿嘧啶、亚叶酸钙、奥沙利铂和多西他赛）围手术期治疗，相比单独化疗，在关键次要终点总生存期方面具有统计学和临床意义的改善。Imfinzi和标准化疗围手术期方案死亡风险降低22%。两组的中位总生存期均未达到。接受imfinzi方案治疗的患者中，69%的患者在3年时存活，而仅接受化疗方案的患者为62%。在无事件生存期主要终点的中期分析中，与单独化疗相比，试验组疾病进展、复发或死亡风险降低了29%。Imfinzi （durvalumab）是人源单抗，结合PD-L1蛋白并阻断PD-L1与PD-1和CD80蛋白的相互作用，对抗肿瘤的免疫逃避策略并释放对免疫反应的抑制。  阿斯利康：10月17日，阿斯利康宣布，POTOMAC III期试验的阳性结果显示，与单独BCG治疗相比，在BCG诱导和维持治疗中增加1年Imfinzi（durvalumab）治疗，对未经BCG治疗的高风险非肌肉浸润性膀胱癌患者的无病生存有统计学和临床意义的改善。中位随访时间为60.7个月，与对照组相比，Imfinzi显示高风险疾病复发或死亡风险降低32%。两组的估计中位无病生存期均未达到。接受Imfinzi的患者中有87%在两年后仍然存活且无病，而对照组为82%。  阿斯利康：10月18日，阿斯利康宣布，DESTINY-Breast11 III期临床试验的阳性结果显示，Enhertu（德曲妥珠单抗）和紫杉醇、曲妥珠单抗和帕妥珠单抗在新辅助治疗（术前）中显示出具有统计学和临床意义的病理完全缓解率的改善。试验比较了Enhertu联合紫杉醇、曲妥珠单抗和帕妥珠单抗，相比剂量密集的阿霉素和环磷酰胺联合紫杉醇、曲妥珠单抗和帕妥珠单抗，在高风险、局部晚期HER2阳性早期乳腺癌患者中的疗效。Enhertu加联合疗法的病理完全缓解率为67.3%，而对照组为56.3%。在激素受体阳性和阴性亚组中均观察到病理完全缓解率的改善（HR阳性：61.4%相比52.3%；HR阴性：83.1%相比67.1%）。此外，术后，在Enhertu联合疗法组接受新辅助治疗的患者中，81.3%的患者在切除的乳房或淋巴结组织中没有检测到或检测到极小的浸润性肿瘤残留，而在比较组中，这一比例为69.1%。无事件生存期的次要终点在分析时尚未成熟。Enhertu是靶向HER2的DXd抗体偶联药物，由第一三共发现，由第一三共和阿斯利康联合开发和商业化。第一三共保留其在日本的专有权。  百时美施贵宝：10月17日，SystImmune Inc.（百利天恒子公司）和百时美施贵宝在2025年欧洲肿瘤医学学会大会上宣布，披露了iza-bren（BL-B01D1）的全球I期US-Lung-101研究的数据。iza-bren是潜在的EGFR x HER3双特异性抗体偶联药物。Iza-bren由SystImmune和百时美施贵宝在中国大陆以外地区的合作和独家许可协议下联合开发。研究评估了iza-bren在术前转移性或不可切除的晚期非小细胞肺癌和其他实体肿瘤患者中的效果。接受2.5 mg/kg（每3周第1天和第8天）治疗的患者，55%显示出确诊的缓解，中位无进展生存期为5.4个月。在EGFR突变和未突变的非小细胞肺癌亚组中也观察到证实的应答。  第一三共：10月18日，第一三共宣布，DESTINY-Breast05 III期临床试验的阳性结果显示，Enhertu对疾病复发高风险乳腺患者的侵袭性无病生存期具有高度统计学和临床意义的改善。试验比较了Enhertu与trastuzumab emtansine(T-DM1)，作为新辅助治疗后（手术后）HER2阳性早期乳腺癌患者，乳腺和/或腋窝淋巴结残留侵袭性疾病的治疗效果。结果显示，与T-DM1相比，Enhertu降低53%的侵袭性疾病复发或死亡风险（无侵袭性疾病生存期）。3年时，Enhertu组中92.4%的患者存活且无侵袭性疾病，而T-DM1组中这一比例为83.7%。Enhertu降低了53%的疾病复发或死亡的风险（无病生存期指标）。此外，与T-DM1相比，Enhertu将远端疾病复发（远端无复发间期）的风险降低51%，脑转移的风险降低36%。  诺华：10月16日，诺华宣布，APPLAUSE-IgAN的阳性结果，评估Fabhalta（iptacopan）治疗成人IgA肾病的3期研究。口服补体途径抑制剂Fabhalta在减缓IgAN进展方面具有统计学意义，与安慰剂相比具有临床意义的优势，测量方法是估计超过两年的肾小球滤过率下降的年化总斜率。Fabhalta（iptacopan）是口服补体途径的因子B抑制剂。  诺华：10月17日，诺华公布了Kisqali（ribociclib）关键III期NATALEE试验的5年分析结果，在最广泛的高危II期和III期激素受体阳性/人表皮生长因子受体2阴性早期乳腺癌患者中，在Kisqali治疗3年后，持续获益的中位数为2年（中位数随访时间：58.4个月）。Kisqali联合内分泌治疗与单独接受内分泌治疗相比，复发风险降低28.4%。Kisqali联合内分泌组的5年无侵袭性疾病生存率为85.5%，而单独内分泌治疗组为81.0%。总生存期上，死亡风险降低了20%。Kisqali（ribociclib）是选择性细胞周期蛋白依赖性激酶抑制剂，通过抑制细胞周期蛋白依赖性激酶4和6（CDK4/6）的蛋白来帮助减缓癌症的进展。当这些蛋白质被过度激活时，会使癌细胞快速生长和分裂。Kisqali由诺华与Astex Pharmaceuticals合作开发。  礼来：10月15日，礼来宣布了3期ACHIEVE-2和ACHIEVE-5试验的积极结果。ACHIEVE-2是评估了orforglipron相比SGLT-2抑制剂dapagliflozin在二甲双胍控制不充分的成人2型糖尿病患者中的疗效。另外，ACHIEVE-5评估了orforglipron相比安慰剂对2型糖尿病患者的疗效，这些患者在使用或不使用二甲双胍和/或SGLT-2抑制剂时血糖控制不佳。在这两项试验中，orforglipron（3mg，12mg，36mg）在40周的疗效和治疗方案评估中都达到了主要和所有关键的次要终点，提供了显著的A1C降低和体重减轻，以及多种心血管危险因素的改善。ACHIEVE-2的主要终点，3mg，12mg和36mg剂量组在第40周，相比基线8.1%，糖化血红蛋白水平分别降低了1.3%，1.7%和1.7%，而10mg dapagliflozin组只降低了0.8%。在ACHIEVE-5的主要终点，3mg，12mg和36mg剂量组在第40周，相比基线8.5%，糖化血红蛋白分别降低了1.5%，2.1%和1.9%，而安慰剂组仅降低了0.8%。Orforglipron是每日一次的小分子（非肽）口服胰高血糖素样肽-1受体激动剂。由中外制药发现，并于2018年与礼来达成许可。  礼来：10月17日，礼来公布了3期monarchE试验的主要总生存期分析结果，显示在激素受体阳性、人表皮生长因子受体2阴性、淋巴结阳性的高危早期乳腺癌患者中，2年的辅助Verzenio加内分泌治疗相比单独内分泌治疗，可降低15.8%的死亡风险，并导致侵袭性无病生存期和远端无复发生存期的持续长期改善。中位随访时间为6.3年，超过75%的患者在完成两年Verzenio治疗期后至少随访了4年。Verzenio（阿贝西利，唯择），是口服靶向CDK4/6抑制剂，能选择性抑制周期蛋白依赖性激酶4/6，恢复细胞周期调控，并阻止肿瘤细胞增殖。  吉利德：10月13日，吉利德和旗下Kite公司将在欧洲肿瘤医学学会2025年大会上展示新进展。将展示Trodelvy（sacituzumab govitecan）作为转移性三阴性乳腺癌患者的一线治疗的3期ASCENT03研究的全部结果，这些患者无法接受PD-1/PD-L1抑制剂治疗。试验达到了主要终点，与化疗相比，在无进展生存期方面具有高度统计学和临床意义的改善。与Arcus Biosciences一起，吉利德还将分享来自EDGE-Gastric 2期研究的总生存期结果，评估了Fc抗体沉默抗TIGIT抗体domvanalimab加抗PD-1单抗zimberelimab和化疗在晚期胃癌或食管癌扩散或无法手术切除患者中的一线联合治疗。在研究的A1组中，50%的患者存活了两年以上，中位生存期为26.7个月。  吉利德：10月15日，吉利德宣布，将参加法国巴黎举行的第20届欧洲艾滋病大会，来自PURPOSE 2试验的进一步数据检查了同时服用他汀类药物以降低胆固醇和PDE-5抑制剂治疗勃起功能障碍的患者，同时使用lenacapavir。Lenacapavir是CYP3A4酶的中度抑制剂，可能会增加这类药物的水平。数据表明，lenacapavir与其他中度CYP3A4抑制剂一样，可以在适当的监测和剂量调整下与他汀类药物和PDE5抑制剂合用。BICSTaR研究的5年结果分析了来自加拿大、法国和德国的HIV感染者的长期真实数据。Biktarvy继续表现出持续的病毒抑制，良好的安全性和耐受性，以及高的耐药屏障。口服Islatravir和Lenacapavir联合治疗的第96周结果显示，切换到每周一次的Islatravir和Lenacapavir联合治疗方案，使艾滋病毒感染者能够维持2年的病毒抑制。在96周时，基于数据缺失=失败，以及缺失=排除两种分析方法，88.5%和100%接受新型研究组合治疗的成年人保持不可检测的病毒载量。每年两次Lenacapavir联合广泛中和抗体方案的第52周结果显示，每年两次Lenacapavir联合广泛中和抗体（teropavimab和zinlirvimab），在易感HIV患者中维持了52周的病毒抑制，并且通常耐受性良好。Biktarvy（必妥维，比克恩丙诺片）为整合酶链转移抑制剂比克替拉韦、核苷类逆转录酶抑制剂恩曲他滨以及丙酚替诺福韦的三联制剂。  勃林格殷格翰：10月13日，勃林格殷格翰和Click Therapeutics公布了CT-155（BI 3972080）的关键III期CONVOKE研究数据，CT-155是处方数字治疗方案，用于精神分裂症体验性阴性症状的标准护理抗精神病治疗的辅助治疗。研究达到了主要终点，通过阴性症状、动机和愉悦量表（CAINS-MAP）的临床评估访谈，来测量相比基线，16周的经验阴性症状的变化。CT-155治疗显示Cohen's D效应值为-0.36，反映了16周时CAINS-MAP测量的阴性症状严重程度改善了6.8分（数字对照组为4.2分），相对改善了62%。数字资料方案是由医生开出的基于软件的干预措施，安装在智能手机上，以帮助解决疾病和病症的行为。可以提供以患者为中心的灵活护理，以满足患者在治疗过程中的需求。  勃林格殷格翰：10月17日，勃林格殷格翰报告了Beamion LUNG-1试验的阳性结果，评估了zongertinib在未经治疗的晚期非小细胞肺癌（酪氨酸激酶结构域有HER2 （ERBB2）激活突变）的阳性结果。zongertinib客观有效率为77%。在应答者中，8%的患者达到完全缓解，69%达到部分缓解，96%的患者达到疾病控制。缓解期和无进展生存期的中位数尚未成熟，47%的患者仍在接受治疗，6个月的反应持续时间和无进展生存期分别为80%和79%。zongertinib是不可逆酪氨酸激酶抑制剂，可选择性抑制HER2 (ERBB2)，同时保留野生型EGFR，最大限度地减少相关毒性。  默克：10月17日，默克宣布了全球3期试验的长期结果，评估了pimicotinib，由Abbisko Therapeutics Co.,Ltd.开发的在研集落刺激因子-1受体（CSF-1R）抑制剂，用于治疗腱鞘巨细胞瘤患者。中位随访14.3个月后，接受治疗的患者的客观缓解率从第25周的54%大幅增加到76.2%。与患者预后相关的关键次要终点（如疼痛和功能）持续有临床意义的改善。此3期MANEUVER试验包括63名患者，在第1部分接受了24周的pimicotinib治疗，然后在开放标签试验阶段继续使用pimicotinib。基于肿瘤体积评分的客观缓解率从第25周的61.9%增加到74.6%。在数据截止时，中位缓解持续时间尚未达到，在长期随访中，93.7%的患者肿瘤大小减少了。相比基线的活动范围平均变化为23.9%（基于第25周的15.6%增加），显示身体功能的改善以及僵硬度和疼痛度的减少64.5%。  安斯泰来：10月14日，安斯泰来宣布，zolbetuximab联合吉西他滨+白蛋白紫杉醇，相比吉西他滨+白蛋白紫杉醇治疗转移性胰腺癌患者的2期GLEAM试验，在最终分析中没有达到其主要终点总生存期。Zolbetuximab是单抗，针对表达CLDN18.2的肿瘤细胞。通过与CLDN18.2结合，zolbetuximab通过激活两种不同的免疫系统途径-抗体依赖性细胞毒性和补体依赖性细胞毒性，诱导癌细胞死亡和肿瘤生长抑制。  优时比：10月13日，优时比宣布，其在Neurology发表了针对胸苷激酶2缺乏症（TK2d）患者的嘧啶核苷和/或核苷酸治疗的研究结果。嘧啶核苷和/或核苷酸治疗可降低TK2d患者的死亡风险，并可影响功能结局。TK2d是极其罕见的、危及生命的遗传性线粒体疾病，其特征是进行性和严重的肌肉无力，可影响独立行走、进食和呼吸的能力。结果显示，治疗患者无死亡，而未治疗患者死亡率为58%。从TK2d症状出现的时间来看，治疗后死亡风险估计降低了85%至93%。从治疗开始的时间来看，死亡风险估计降低了75%至91%。回归分析显示，接受治疗的患者死亡风险降低95%。治疗前，约71%的患者失去≥1个运动里程碑，29%的患者失去≥4个运动里程碑。在治疗期间，没有患者失去运动里程碑，在开始治疗后，失去运动里程碑的患者中，65%至少恢复了一个运动里程碑。超过50%的患者在治疗前使用了呼吸支持。在接受治疗的患者中，29%的患者减少了对通气支持的需求。Doxecitine和doxribtimine的目的是将嘧啶核苷，脱氧胞苷和脱氧胸腺嘧啶纳入骨骼肌线粒体脱氧核糖核酸。临床前数据显示，这一作用可恢复TK2d突变小鼠的线粒体DNA拷贝数。  优时比：10月14日，优时比宣布，Fintepla (fenfluramine，芬氟拉明)治疗Lennox-Gastaut综合征的开放标签扩展研究的最终分析，发表在《癫痫与行为》杂志上。2-35岁的儿童和成人接受芬氟拉明治疗，与基线相比，从第2个月到研究结束，与跌倒相关的癫痫发作频率持续显著降低，整体功能有所改善。没有新的或意外的治疗不良事件。在社会交往和活动、耻辱感、总体健康、生活质量和焦虑方面有所改善。每月惊厥发作频率持续降低，有持续的长期耐受性。从第2个月到研究结束，与跌倒相关的癫痫发作频率的中位数百分比变化显著降低31.1%，其中儿科患者减少27.6%，成人患者减少40.0%。患者家属和医护人员分别报告了59.9%和57.0%的患者在临床总体印象改善（CGI-I）量表上的改善。从基线到第12个月，总体生活质量得分的平均变化为2.9分，表明改善。芬氟拉明能激活特定血清素受体（包括5-HT1D、5-HT2A 和 5-HT2C受体），另外可作用于sigma-1受体。 财务业绩及股息发放  强生：10月14日，强生宣布，2025年第3季度实现营业收入239.93亿美元，相比去年同期增长6.8%。强生宣布，在2025年第4季度派发每股1.30美元的普通股现金股利。将于2025年12月9日支付给2025年11月25日营业结束时登记在册的股东。  雅培：10月15日，雅培宣布，2025年第3季度实现营业收入113.69亿美元，相比去年同期增长6.9%。2025年前3个季度实现营业收入328.69亿美元，相比去年同期增长6.1%。

– New Data Showcase Safety Profile of Twice-Yearly Lenacapavir for Pre-Exposure Prophylaxis (PrEP) with Other Medications and Recruitment Strategies for PURPOSE 5 – – Five-Year BICSTaR Results Offer Insights into Long-Term Treatment with Biktarvy®, Helping Inform the Future of Coordinated, Person-Centered HIV Care – – Latest Results on Novel Long-Acting Combination Regimens, Including Once-Weekly and Twice-Yearly Treatment Options – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming participation in the 20th European AIDS Conference (EACS) to be held in Paris, France from October 15-18. As the leader in HIV innovation, Gilead will provide an update on its strategic initiatives, key collaborations, and share new scientific data from its HIV research and development programs. The research that will be presented at EACS 2025, along with the Gilead-led symposia and supported community forums, reflect the company’s person-centered approach to advancing scientific discovery and underscores its focus on community partnership to help end the HIV epidemic. “It is fitting that thousands of scientists and community stakeholders will gather in Paris for EACS 2025,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “The first Declaration on Fast-Track Cities to end the HIV epidemic was signed in Paris on World AIDS Day in 2014. Fueled by Gilead’s longstanding commitment to develop and deliver HIV prevention and treatment options tailored to the individual’s needs, my colleagues and I continue to strive for a future without HIV, in Europe and around the world.” Gilead’s EACS 2025 program highlights include: HIV Prevention Research Expanding reach to populations in Europe not currently using PrEP: Researchers will present the strategies that supported the recruitment of people in high-priority populations across France and the UK for the Phase 2 PURPOSE 5 trial (N06513CT312), which is evaluating the persistence of twice-yearly lenacapavir among people who need or want PrEP but who have not previously engaged with existing HIV prevention options. Through collaboration with community advisory groups, thoughtful site selection and targeted recruitment goals for understudied populations, the study team achieved its enrollment goals and established a model for future HIV prevention studies. Safety data build understanding around concomitant use of lenacapavir: Further data from the PURPOSE 2 trial examined the concomitant use of lenacapavir by people also taking statins administered to lower cholesterol and PDE-5 inhibitors to treat erectile dysfunction. Lenacapavir is a moderate inhibitor of the enzyme CYP3A4 and could potentially increase levels of these classes of drugs. The accumulated data suggests that lenacapavir, like other moderate CYP3A4 inhibitors, can be co-administered with statins and PDE5 inhibitors with appropriate monitoring and dose adjustment. HIV Treatment Research Five-year outcomes from the BICSTaR (NCT03580668) Study: Long-term, real-world data were analyzed from individuals with HIV who were enrolled in Canada, France and Germany. The five-year outcomes are consistent with the results observed from multiple Phase 3 clinical trials evaluating the treatment responses of people with HIV on Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. These benefits were seen in both treatment-naïve and treatment-experienced people with HIV who have a high burden of co-morbidities. The results underscore the importance of patient-reported outcomes as a person-centered approach to HIV research and can help us to better understand the impact on health-related quality of life and specifically, mental health status of people with HIV. This could help inform treatment strategies for these groups. Demographic profile of ARTISTRY-1 participants: Baseline characteristics from the Phase 3 portion of an ongoing study (NCT05502341) investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily oral regimen of bictegravir and lenacapavir. The results contextualize the unmet need for people living with HIV on complex regimens who may benefit from a single-tablet regimen. In September, the last patient completed their Week 48 visit in the Phase 3 portion of ARTISTRY-1. A topline data readout for the primary endpoint is anticipated to be announced before the end of the year. Late-breaking: Week 96 outcomes of an oral combination of Islatravir and Lenacapavir: Data from an ongoing, randomized, open-label Phase 2 study (NCT05052996) demonstrate that switching to an investigational once-weekly combination regimen of islatravir and lenacapavir enabled people living with HIV to maintain viral suppression to two years. At 96 weeks, based on the Missing = Failure and Missing = Excluded analyses, respectively, 88.5% (46/52) and 100% (n=46/46) of adults treated with the novel investigation combination maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) demonstrating the potential of the combination, which could become the first weekly oral HIV treatment option. Two Phase 3 studies - ISLEND-1 and ISLEND-2 are ongoing. Week 52 results of twice-yearly regimen of Lenacapavir and broadly neutralizing antibodies (bNAbs): The Phase 2 (NCT05729568) open-label study from Gilead’s long-acting treatment pipeline demonstrated that twice-yearly lenacapavir in combination with bNAbs (teropavimab [GS-5423, TAB] and zinlirvimab [GS-2872, ZAB]) maintained viral suppression in people with HIV with susceptible viruses out to 52 weeks and was generally well tolerated. The investigational combination has the potential to be the first twice-yearly complete regimen. The novel treatment combination is now progressing to Phase 3 clinical development. Gilead’s symposia at EACS are focused on exploring the treatment needs of women with HIV throughout life, plus long-acting PrEP options and opportunities to address unmet HIV prevention needs: Overview of Scientific Presentations HIV PREVENTION RESEARCH Recruitment of Disproportionately Affected Populations in the PURPOSE 5 Study Evaluating Lenacapavir for PrEP in France and the UK Analysis of Barriers to Testing for HIV Prevention and Linkage to Care Among Migrants in Europe Commonly Prescribed Concomitant Medications and Clinical Safety Findings with Lenacapavir for PrEP in PURPOSE 2 Annual Persistence to Twice-Yearly Lenacapavir vs Daily Oral F/TDF for PrEP in the PURPOSE 2 Trial HIV TREATMENT RESEARCH Efficacy and Safety of a Twice-Yearly Regimen of Lenacapavir, Teropavimab, and Zinlirvimab: Phase 2 Week 52 Results Oral Weekly ISL/LEN in VS PWH: 96 Week Outcomes from a Phase 2 Study Five-Year Extended Follow-Up of the Observational BICSTaR Cohort: Final Analysis in PWH Receiving B/F/TAF in Routine Clinical Practice Demographics and Clinical Characteristics of Phase 3 Participants in ARTISTRY-1, An Open- Label Study Comparing a BIC/LEN STR With Complex ART Regimens For more information about Gilead at EACS 2025, including a complete list of abstracts and their corresponding oral and poster sessions, please visit: https://eacs-conference.com Lenacapavir for PrEP is not approved by any regulatory authority outside of the U.S. and the EU. Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established in combination. The combination of islatravir and lenacapavir is investigational. Use in combination for the treatment of HIV has not been approved by any regulatory authority. Teropavimab and zinlirvimab are investigational compounds. The use of these compounds in combination with lenacapavir are investigational, are not approved by any regulatory authority, and their safety and efficacy has not been established. The use of lenacapavir in virologically suppressed people with HIV is investigational and the safety and efficacy of this use have not been established. There is currently no cure for HIV or AIDS. Please see below for U.S. and E.U. Indications and Important Safety Information, including Boxed Warning, for Yeztugo and Yeytuo. Please see below for U.S. Indications and Important Safety Information, including Boxed Warning, for Biktarvy. About Lenacapavir Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.” EU Indication for Yeytuo® Yeytuo® injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV-1 acquisition risk weighing at least 35kg. U.S. Indication for Yeztugo® Yeztugo® (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Adverse reactions Most common adverse reactions(≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. About Biktarvy Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. U.S. Indication for Biktarvy Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg with no antiretroviral treatment history; or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir; or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration: Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment: Not recommended in patients with severe hepatic impairment. Prior to or when initiating: Test patients for HBV infection. Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population. Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy, lenacapavir, teropavimab and zinlirvimab (such as ARTISTRY-1, BICsTaR, EMPOWER, PURPOSE 2 and PURPOSE 5); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of the programs for the indications currently under evaluation and, as a result, the programs may never be successfully commercialized for such indications; Gilead’s ability to effectively manage its global health equity access strategy; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. Full Prescribing Information for Truvada, Yeztugo, and Biktarvy including Boxed Warning, are available at www.gilead.com. Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Biktarvy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs. Blair Baumwell, Media public_affairs@gilead.com Jacquie Ross, Investors Investor_relations@gilead.com