Enzalutamide

蜕变中的核药未来有哪些趋势 全文摘要1、医药板块行情与投资策略·医药板块近期行情复盘：上周医药行业涨幅居全行业第二，整体指数出现较大幅度反弹，核心由创新药及CRO板块引领，此前周报总结的创新药引领反攻的逻辑当前依然成立。本轮创新药领涨的核心逻辑共四点：一是产业层面景气度持续向上，相关标的筹码已完成出清且未出现极端交易事件；二是当前市场整体存在高低切轮动的需求，低位的医药板块具备轮动上涨基础；三是美诺华、万邦德等高标标的打出可观涨幅空间，有效吸引市场活跃资金参与，提振板块整体交易情绪，多重因素共同推动创新药板块大小票形成上涨共振。近期CRO板块表现同样亮眼，一方面是部分CRO企业发布年报后，披露的订单情况及业绩指引超出市场预期；另一方面叠加礼来小分子减肥药供应链的相关催化形成共振，共同带动板块上行。当前2023年9月以来的创新药调整已处于筑底阶段，修复回补行情具备持续推进的基础，中长期对创新药板块较为看好。·医药板块投资方向梳理：医药板块投资方向可按时间维度分层梳理：a. 中短期投资主线：一是创新药回补，重点关注三类企业，即超跌的海外大药、近期有变化及催化的大药、创新平台输出型企业，核心标的包括新易泰、广生堂、诺思兰德、三生应恩、信达博泰、石药等；二是全市场映射主线，涵盖AI方向映射的九安医疗、战争导致资源品涨价逻辑下的手套标的英科医疗等；三是Q1业绩高增长标的，重点关注供应链及上游相关企业，如百奥赛图。b. 中长期投资方向：沿科技创新逻辑布局，一方面关注供应链上游，核心标的包括百奥赛图、森松、奥浦迈；CRO板块重点关注泰格、普蕊斯，CDMO关注药明系、凯莱英、皓元、维亚、博腾等。另一方面布局机器人、小核酸、脑机接口、AI四大从0到1赛道，其中AI创新药关注金泰控股、英西，小核酸关注前沿、悦康、必贝特、阳光诺和，机器人关注微创机器人、天智航。长期来看，创新与出海是医药产业的底层发展逻辑，2025年市场交易核心为创新及BD出海，2026年看好创新出海、困境反转三大产业脉络。药品板块建议关注已进入出海BD 2.0阶段的企业及供应链上游，器械板块深挖出海逻辑及机器人、脑机接口等主题，其余方向关注困境反转的脉冲性机会。2、核药市场规模与增长空间·全球及中国核药规模：全球核药市场处于快速增长阶段，从规模来看，2023年全球核医学市场规模近350亿美元，近年CAGR超10%；其中放射药市场增长态势明确，2026年全球放射药市场规模预计约80亿美元，2030年将增长至136亿美元，对应CAGR为13.5%。中国核药市场增速更为显著，预计2025年规模为93亿元，2030年达260亿元，CAGR超20%，显著高于全球平均水平，后续将迎来快速爆发期。拆分产品结构来看，诊断类核药当前占据市场主导地位，2025年占整体核药市场份额达77%，但市场增长核心引擎来自治疗端：目前治疗类核药占比偏小，但增速高于市场整体水平，2025年全球治疗类核药规模为21.9亿美元，2030年有望增长至40多亿美元，CAGR近15%，高于全球核医学市场及整体核药市场的平均增速。·核心产品商业化表现：治疗类核药快速增长的核心动力，来自于以RDC为代表的新型放射性核药陆续获批上市，以及其在肿瘤治疗领域临床价值的持续亮眼表现。目前RDC已经脱离早期实验室或概念阶段，逐步从技术验证跨越到商业兑现阶段。诺华旗下两款核心RDC产品是当前核药市场的标杆产品，印证了赛道的商业化潜力：第一款为普罗维特，用于治疗PSMA阳性转移性去势抵抗性前列腺癌，2025年销售额近20亿美元，同比增长42%，诺华在2025年JPM会议上预测该产品峰值销售额可达50亿美元；第二款为卢特萨拉，用于治疗胃肠胰神经内分泌肿瘤，2024年销售额超7亿美元，2024年5月获FDA或EUA扩展适应症至12岁及以上儿童患者，进一步扩大了市场空间，整体来看RDC市场天花板远未被触及。·研发管线布局情况：从研发管线布局来看，全球范围内肿瘤领域的RDC管线储备最多，超600个项目处于临床前及IND阶段，超500个项目已进入临床及NDA阶段，目前已上市RDC产品共22款；紧随其后的是诊断试剂类RDC，在研管线数量略少于肿瘤适应症RDC，目前已有20款产品实现上市。中国RDC管线整体呈快速赶超态势，国内在研肿瘤领域RDC管线占全球的1/3，诊断试剂类RDC管线占全球的40%，其中NDA阶段的品种数量处于全球领先地位：肿瘤领域目前全球共有4个处于NDA阶段的品种，全部为中国药企所有；诊断试剂类目前全球同期共有2个处于NDA阶段的品种，其中1个来自中国。未来3-5年，随着RDC在研管线的陆续上市，尤其是前列腺癌、神经内分泌肿瘤等适应症领域的产品落地，RDC市场规模极具增长潜力。3、国产核药发展驱动因素·政策支持驱动：近年核药行业相关政策呈现三大核心趋势：支持力度持续加大、监管框架体系化、审批流程持续优化。政策支持方面，2021年6月国家原子能机构、发改委发布《医用同位素中长期发展规划》，是国内首份核技术医疗领域应用的纲领性文件，规划周期至2035年，提出上游建立稳定自主的医用同位素供应保障体系，下游实现核医学科“一院一科”的建设目标。2024年10月发布的《核技术应用产业高质量发展三年行动方案》规划周期至2026年，明确2026年要具备3种以上放射性同位素自主供应能力，基本扭转关键同位素供应受制于人的局面，同时完成10个以上一类放射性新药临床试验申请，从顶层明确行业发展目标。监管体系化方面，国家药监局等多部门近年发布了覆盖生产、临床、运输全环节的专项指南与检查规范，为放射性药物申报上市提供规范化指引。审批提速方面，2025年1月起药监局取消医疗机构使用一二类放射性药物许可的审批事项，简化下游市场准入流程。·上游供应突破驱动：我国医用同位素生产高度依赖核反应堆、回旋加速器等大型设施，相关设施技术壁垒高、建设周期长、投资规模大，因此长期以来核心治疗用核素（镥-177、锕-225、LEI123等）高度依赖进口，是行业亟待解决的核心痛点。目前国内上游同位素供应正逐步实现突破：中国科学院高能物理研究所联合散裂中子源首次实现医用级α同位素居里级量产，覆盖锕-225等核心治疗用核素；国内核药龙头也在加速向上游供应环节延伸，东诚药业布局“一堆两器”可覆盖钼99、铜67等多种同位素制备，远大医药比利时IBA加速器将于2025年6月正式投产，可覆盖10余种医用同位素制备。医用同位素自主供应实现从0到1的突破，除解决进口依赖外还有三层深层意义：一是成本价格优势，α核素居里级量产将推动核药价格下降，原本高额的治疗将进入可及范围，有望加速医保纳入进程；二是保障供应链安全与研发自由度，企业无需再受进口配额、地缘政治、国际物流中断影响，研发进度可自主可控，能够更自由地开展RDC等前沿方向的早期探索与临床试验；三是加深全产业链壁垒，龙头企业布局上游工业化能力将成为未来核药公司综合竞争力的重要组成部分。·管线差异化布局驱动：国内核药研发管线的赶超是行业发展的重要驱动，主要体现在数量赶超与靶点差异化布局两个层面。数量层面，国内核药研发在管线成熟度、靶点原创性、临床后期品种数量上正逐步缩小与全球领先水平的差距；截至目前全球核肿瘤相关核药在研管线（含临床前至1b期）超2000个，中国肿瘤核药管线占比达40%，其中临床前和临床早期项目增长迅速，未来3-5年将有大量国产核药从早期研发进入临床验证阶段，为后续NDA申报储备充足后备力量。靶点布局层面，全球研发最集中的两大靶点为PSMA、FAP，其中PSMA已进入成熟期，全球已有8款产品上市、22款处于临床后期，竞争格局拥挤；ICP泛癌种靶点管线大多处于临床前及早期阶段，全球暂未有产品获批，仍属蓝海市场。国内核药靶点布局与全球存在明显差异：FAP靶点管线数量超过PSMA位列第一，PD-L1、αβ3等靶点布局占比高于全球；RDC领域同样存在差异化特征，FAP等靶点管线占比高于全球水平。这种差异化布局有望帮助国产核药避免与全球巨头在成熟靶点（更多实时纪要加微信：jiyao19）的正面竞争，更有机会在ICP等泛癌种靶点上实现局部领先。4、核药行业趋势与投资标的·诊疗一体化趋势：随着RDC兴起，核药行业整体朝着诊疗一体化方向演进，国内外核药企业均在诊疗配对核药方向积极布局：海外诺华已有成熟诊疗配对产品落地；国内企业中，远大医药针对前列腺癌的RDC产品2024年1月递交IND，配套诊疗产品已获批加入国际多中心III期临床，未来有望在前列腺癌治疗领域形成一体化闭环；东诚药业子公司蓝纳成搭建了诊疗一体化完整技术平台，已开发PCMA、FAP、阿尔法贝塔3等靶点的13款候选药物，临床阶段诊疗一体化药物数量居全国第一。诊疗一体化成为核药核心趋势主要有三大原因：a. 精准筛选患者，提升治疗成功率与药物经济学价值：通过诊断试剂先筛选出靶点阳性患者，确保治疗药物精准投放，避免无效治疗的资金浪费，在医保谈判中赋予产品更强议价能力；b. 同一靶向分子降低二次研发风险：诊疗配体验证安全有效后，治疗版本仅需更换合作标的即可快速推进，大幅降低研发失败风险，拥有诊疗对组合的企业可更低边际成本扩张管线；c. 延长产品整体生命周期：产品可覆盖患者诊断、治疗、随访全流程，单个患者贡献价值显著提升，药企估值逻辑将从销售一次性诊断试剂向提供全病程精准诊疗解决方案转变。·α核素应用趋势：当前已商业化的治疗性核药以β核素为主，代表产品如诺华的普维妥、卢瑟拉均采用β核素作为标记。β核素通过发射β射线杀伤肿瘤细胞，射程为1-2毫米，适合治疗中等大小实体瘤，但存在能量相对较低、射程较长的缺陷，杀伤肿瘤细胞的同时易损伤周围正常组织。与β核素相比，α核素（如225、碘-211、镭-223等）具备三大核心优势：一是能量更高，杀伤性更强；二是射程极短、精度更高，可精准清除微小转移灶，最大程度保护周围正常组织；三是适配微转移灶、术后微小残留病灶清除场景，在血液肿瘤、微转移灶治疗等领域具备不可替代的优势。近年全球药企核药板块并购焦点已明确从β核素向α核素转移，礼来、BMS、阿斯利康、诺华等企业均在过去两三年通过收购丰富核药管线，重点布局α核素标记的RDC产品。·核药房布局趋势：核药房网络布局是核药赛道商业化的核心竞争壁垒，核药物理半衰期极短，最短仅为数小时，行业通用模式为生产商根据医院预约按需生产，且需在极短时间内完成包装、运输并送达医院，因此核药房的布局密度、覆盖广度及高效配送体系，是核药产品成功商业化的关键因素。目前中国同辐、东诚药业已建成全国性核药房布局，具备明显先发优势。核药房行业壁垒较高，一方面建设周期长、单个项目投资额大，另一方面生产许可、环保相关审批要求严格，后续无自有配送网络的研发型药企需与拥有核药房网络的企业合作才能实现商业化落地，平台型企业在合作谈判中具备较强议价能力，可从创新核药销售中获得稳定分成收益。未来随着国产创新核药密集上市，高效配送网络需求将持续上升，拥有全国性核药网络的平台型企业有望迎来价值重估。·核药投资标的推荐：未来随着RDC药物崛起，叠加国内政策端大力支持、上游同位素自主供应突破、在研管线快速扩充、靶点差异化布局等因素驱动，中国核药行业有望迎来蓬勃发展的黄金窗口，未来3-5年国产创新诊疗一体化核药将密集上市，α核素等下一代技术也有望实现弯道超车，产业链各环节均值得关注。标的选择方面建议关注三类企业：a. 创新管线积累丰富、全产业链布局的龙头企业：东诚药业、中国同辐、远大医药；b. 在RDC治疗端进行差异化布局的传统大型药企：恒瑞、百利天恒、科伦博泰；c. 港股相关标的：先通医疗、蓝纳成。5、CRPC治疗框架梳理·ABEV治疗框架拆解：围绕去势抵抗性前列腺癌（CRPC）的治疗框架、临床需求及创新药发展趋势展开分析，分析基础为2024年ASCO GU会后斯隆凯特琳医学纪念中心前列腺癌PI梳理的ABEV治疗框架，核心聚焦CRPC领域未满足的临床需求、具备突围潜力的创新药方向及相关上市公司的竞争格局。ABEV治疗框架各部分核心内涵如下：a. A为雄激素受体通路抑制剂（ARPI），代表药物包括阿比特龙、恩扎卢胺、阿帕鲁胺等，是CRPC治疗的基石，贯穿多数患者的治疗全程，目前该类药物无直接替代逻辑，行业多探索其与PARP联用的方案，以冲击现有一线治疗格局。b. B为生物标志物，涵盖针对同源重组修复突变患者的PARP、前列腺特异性膜抗原PSMA等，其中PSMA靶点已有较多核药、放射性配体治疗相关产品布局。c. C为化疗，代表药物为多西他赛、卡巴他赛，分别作为ARPI一线治疗后的化疗一线、二线用药，该类药物毒副作用较强，患者整体停药率偏高，是当前创新药重点替代的方向。当前前列腺癌耐药机制的复杂性日益凸显，一线ARPI治疗后可能出现AR通路再激活，约10%-20%的患者会出现谱系转化，叠加DNA修复功能恢复等多因素交织，现有治疗仍存在较大未满足的临床需求。在ABC基础上，多种可药物化的新兴通路（即D类）正在涌现，主要分为两大方向：a. 细胞表面靶向策略：包含T细胞衔接器（TCE，如安进StepOne TCE、强生KOK two TCE）、抗体偶联药物（ADC，如港股英诺生物、翰森制药的相关ADC）、PDC等；b. 雄激素受体通路相关新兴疗法：包含AR降解剂（AR PROTAC）、CYP11抑制剂、RIPTAC等。对于上述新兴可药物化通路，不能因部分通路在未经过筛选的患者人群中展现出有限疗效就放弃研究，只要相关通路具备明确的生物学原理，就需要持续推进相关研究。未来前列腺癌领域需对各个通路开展细致研究，针对不同精细分层的患者匹配最优治疗药物，同时搭配明确的生物标志物预判患者预后，搭建多维度治疗平台。6、CRPC创新药赛道进展·ADC药物研发进展：前列腺癌血管丰富度较低，且多数存在骨转移问题，致密性骨转移会阻碍ADC的分布与渗透，对临床应用形成挑战。当前应对策略主要包括两类：一是借助毒素的旁观者效应，使药物到达靶抗原阳性细胞后，可通过喜树碱、MMAE等毒素扩散至邻近靶抗原低表达或阴性的细胞；二是配合重复给药策略。核心在研B7-H3 ADC进展如下：一是英恩生物的相关产品，在2024年ASCO GU公布的二期临床数据显示，单药用于经多线化疗、核药治疗的末线患者，影像学PFS超过11个月，OS达到22个月，是目前末线单药治疗的顶尖二期临床数据，目前该产品已启动注册临床。二是默沙东与第一三共合作的DS-7300，目前已启动针对前列腺癌的III期注册临床，试验方案针对转移部位（早期骨转移/晚期内脏转移尤其是肝转移）、B7-H3表达水平（高表达/低表达/无法评估）进行精细分层，未来其临床数据有望验证B7-H3是否可作为有效的生物标志物，区分患者对该类治疗的响应。·TCE药物研发进展：TCE赛道核心在研产品包括安进PSMA TCE与强生KLK2 TCE两类：a. 安进PSMA TCE是安进在2024年5月全球首个实体瘤TCE产品获批后，计划推进的全球第二个治疗实体瘤的TCE产品。临床数据显示，该产品末线单药治疗的OS达到17个月，优于同类产品15个月的OS数据。安全性层面，由于靶点在骨骼、肌肉正常组织中广泛分布，给药初期会出现骨骼肌肉炎症问题，安进通过调整给药方案，从0.75毫克每周一次优化为1.5毫克每两周一次，可有效管理相关毒性，目前该产品已推进至1.5线及一线化疗替代的注册临床，分别于2024年年底、2025年年底启动两项注册临床，试验中采用联用阿比特龙替代阿比特龙单药、替代一线化疗多西他赛的方案。b. 强生KLK2 TCE针对的KLK2靶点此前因被误认为是可溶性抗原未受到关注，后续发现其存在细胞膜表达，成为前列腺癌领域的潜力靶点。强生的KLK2 TCE临床数据表现优异，单药治疗的影像学中位无进展生存期超过8个月，安全性优势突出，单药治疗欧美人群的CRS（细胞因子风暴）整体发生率仅9%，无3级以上CRS事件，联用多西他赛用于末线治疗时未出现CRS事件，被临床研究者认可可作为耐受性良好的门诊治疗方案。该靶点特异性极强，仅在前列腺及前列腺癌组织表达，表达丰度远高于PSMA等现有靶点，且在局限性前列腺癌、激素敏感性前列腺癌（HSPC）阶段表达丰度更高、更均一，仅在晚期存在内脏转移的CRPC阶段表达阳性率下降至40%左右；同时该靶点与PSMA存在互补性，约20%的患者为PSMA阴性、KLK2阳性，适合与PSMA靶向药物联用。目前强生已在2023年年底启动两项注册临床，分别作为一线化疗多西他赛的替代方案、末线单药治疗方案，未来该产品有望向HSPC等更早线治疗阶段拓展，国内已有多家企业布局该靶点管线。7、CRPC创新药格局展望·创新药格局与趋势：当前CRPC一线治疗仍以恩扎卢胺、阿比特龙等ARPI为标准方案，目前已出现一线强化治疗趋势，辉瑞ECH2已启动与恩扎卢胺联用的相关临床。1.5线API互换领域，诺华ProFect 6177已获批，另有安进STEP ONE TCE联用阿比特龙、辉瑞ECH2联用恩扎卢胺、默沙东CYP P11抑制剂、BMS AR配体定向降解剂（PROTAC）等产品已进入三期注册临床。一线化疗所用的多西他赛毒性较高，目前有较多药物组合在推进替代方案，相关在研产品包括英诺生物B73 ADC（已启动注册临床）、安进STEP ONE TC10联用阿比特龙、强生KOK2 TC10联用多西他赛、辉瑞ECH2联合加鲁安、AR PROTAC、CYP11A1抑制剂等，该赛道是当前布局最拥挤的领域，1.5线、二线及一线化疗领域合计已有5~6款相关产品处于已获批或进入三期注册临床阶段。未来CRPC创新药领域并非只有单一产品能留存，各类靶向药将通过配合基因测序实现患者精细分层，针对特定bar market阳性人群发挥更好的治疗效果。目前多款在研产品已向更早线治疗拓展，其中ECH2、诺华Provigo 6177、KOL two的TCE、英诺生物B细胞ADC等均已布局HSPC阶段治疗，若能成功切入CRPC一线或HSPC更早线治疗将获得更大市场空间。当前多款在研产品已在后线CRPC治疗中展现出良好数据，英诺生物、艾斯科、恒瑞等布局相关管线的企业，未来有望推出优于海外大药企的产品。Q&AQ: 上周申万医药指数的表现及领涨板块是什么？A: 上周申万医药指数上涨2.26%，跑赢创业板指数与沪深300指数，涨幅位居全行业第二，反弹由创新药与CRO板块引领。CRO板块因年报业绩与订单指引超预期，叠加礼来小分子减肥药供应链催化，表现亮眼。 Q: 医药板块中短期与中长期的核心投资方向有哪些？A: 中短期聚焦三方面：创新药回补；全市场映射主线；Q1业绩高增长。中长期看好科技创新逻辑蔓延，包括上游供应链、四大从0到1赛道，CRO关注泰格医药、普蕊斯，CDMO关注药明系、凯莱英、皓元医药等，小核酸领域关注前沿生物、悦康药业等。 Q: 2025至2026年医药板块的产业主线与配置建议是什么？A: 2025年市场交易核心为创新，重点通过BD实现出海；2026年延续创新出海与困境反转双主线。药品领域建议配置已进入BD 2.0阶段的出海企业及供应链上游标的；器械领域深挖出海机会，关注机器人、脑机接口等主题；其他方向侧重困境反转的脉冲逻辑。全年底层逻辑仍为创新+出海。 Q: 全球与中国核药市场的规模、增速及结构特点如何？A: 2023年全球核医学市场规模预计近350亿美元，CAGR超10%；放射性药物市场2026年预计80余亿美元，2030年达136亿美元，CAGR为13.5%。中国市场增速更高，2025年规模93亿元人民币，2030年预计260亿元，CAGR超20%。结构上，诊断类核药2025年占77%，但治疗类核药为增长引擎，2025年全球规模21.9亿美元，2030年有望超40亿美元，CAGR约15%，高于整体增速。 Q: 驱动国产核药发展的三大核心因素是什么？A: 一是政策支持持续强化，包括2021年《医用同位素中长期发展规划》提出建立自主供应体系与一县一科目标，2024年《核技术应用产业高质量发展三年行动方案》要求实现关键同位素自主供应并完成10个以上一类放射性新药临床申请，叠加监管体系完善与审批流程优化。二是上游同位素自主供应突破，中科院高能物理研究院联合散裂中子源实现医用级α核素居里级量产，东诚药业一堆两器、远大医药比利时IBA加速器等加速布局，提升供应链安全与研发自由度。三是研发管线快速赶超与靶点差异化，中国肿瘤核药管线占全球40%，FAP靶点占比全球领先，ICP等泛癌种靶点布局有望实现局部领先。 Q: 核药行业未来三大发展趋势及商业价值如何？A: 一是诊疗一体化加速落地，通过诊断筛选靶点阳性患者提升治疗精准度与药物经济学价值，降低研发风险并延长产品生命周期。二是α核素成为新一代疗法方向，相比β核素具备能量高、射程短、对微小转移灶杀伤力强等优势，礼来、BMS、阿斯利康等跨国药企并购焦点已转向α核素RDC。三是核药房网络构建商业化壁垒，因核药半衰期短，中国同辐、东诚药业已建立全国性配送网络，平台型企业凭借先发优势与高准入壁垒，在创新核药商业化中具备强议价能力与稳定分成收益。 Q: 核药领域重点推荐的投资标的有哪些？A: 建议关注创新管线丰富且具备全产业链布局的龙头企业，在RDC治疗端进行差异化靶点布局的传统大型药企，以及港股已上市标的先通医药、东诚药业子公司蓝纳成。 Q: 前列腺癌ABEV治疗框架的核心内容及当前治疗格局如何？A: A指雄激素受体通路抑制剂，为治疗基石贯穿全程；B指生物标志物；C指化疗；D指新兴可药物化通路。当前一线标准为ARPI，1.5线已有诺华Pluvicto获批，多西他赛因毒性高、停药率高成为创新药重点替代方向。 Q: KLK2靶点在前列腺癌治疗中的独特优势与临床潜力是什么？A: KLK2靶点表达高度特异，表达丰度显著高于PSMA等靶点；在激素敏感性前列腺癌与局限性前列腺癌阶段表达均一，无需生物标志物筛选；与PSMA存在互补性，适合联合用药；在AR通路再激活患者中持续阳性表达。强生KLK2 TCE在末线治疗中展现8个月以上中位rPFS，CRS发生率仅9%且无3级以上，安全性优异，已启动一线化疗替代与HSPC阶段注册临床。 Q: 前列腺癌1.5线与二线治疗领域的主要在研药物进展如何？A: 1.5线领域：安进StepOne TCE联用阿比特龙、辉瑞EZH2抑制剂联用恩扎卢胺、默沙东CYP11A1抑（更多实时纪要加微信：jiyao19）制剂、BMS AR PROTAC均进入注册三期临床。化疗一线替代方向：英诺生物B7-H3 ADC、强生KLK2 TCE联用多西他赛、辉瑞EZH2抑制剂联用阿比特龙等积极推进。多个靶向方案通过生物标志物分层实现精准治疗，避免同质化竞争。 Q: 前列腺癌治疗领域的未来趋势与国内企业机会在哪里？A: 未来趋势为精细化患者分层实现精准治疗，并向更早治疗线推进以扩大市场空间。国内企业在KLK2靶点TCE、B7-H3 ADC、AR PROTAC、CYP11A1抑制剂等领域布局积极，凭借靶点差异化与临床数据潜力，有望在细分赛道实现突破并参与全球竞争。 不可获缺的投资利器，如下知识星球，每日实时更新（调研纪要、会议录音）等实时资讯。年度5万篇以上。 如果想成为一名合格的投资者，一款辅助工具特别重要，本星球将会是您一个优质的选择，现开放运营以来，已受到部分朋友的关注，需要了解更多投资资讯，调研纪要，会议纪要、行业分析报告关注上方星球二维码，每日最新推送，专业投研工具，让您选股无忧。基本面爱好者的集合地，如果您是基本面的爱好者以及想掌握各行业实时资讯那么这里或许比较合适您                              点“赞”“在看”，转发，优质资讯与您一起分享

MELBOURNE, Australia and INDIANAPOLIS, April 07, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) provides a market update on its commercial and operational performance for the quarter ended March 31, 2026 (Q1 2026). Q1 2026 Highlights Q1 2026 unaudited Group revenue of US$230 million, up 11% quarter-over-quarter. FY 2026 revenue guidance of US$950 million to US$970 million is reaffirmed. Precision Medicine Q1 2026 unaudited revenue of US$186 million, up 16% quarter-over-quarter. Strong revenue growth in both Illuccix® and Gozellix® segments. ProstACT® Global Phase 3 study of TLX591-Tx prostate cancer therapy candidate: Part 1 lead-in met safety and dosimetry objectives, with no new safety signals observed 1 . TLX101-Px (brain cancer imaging candidate): New Drug Application (NDA) resubmitted to the United States (U.S.) Food and Drug Administration (FDA) 2 for Pixclara® 3 . Marketing Authorization Application (MAA) filed in Europe 4 for Pixlumi® 3 . TLX591-Px 5 : NDA accepted in China by the National Medical Products Administration (NMPA) 6 . Q1 2026 Revenue (Unaudited) Revenue (US$M) Q1 2026 Q1 2025 Variation Q4 2025 Variation Group revenue 230 186 24% 208 11% Precision Medicine revenue 7 186 151 23% 161 16% TMS third-party revenue 8 44 34 29% 44 —% Executive Commentary Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, “Growth accelerated across our Precision Medicine business in the first quarter, with U.S. dose volumes increasing 5% quarter-over-quarter. This performance reflects the growing uptake of Gozellix alongside Illuccix, contributing to market share gains underpinned by disciplined sales execution and pricing, and high-quality service delivery despite extreme North American weather conditions, an advantage of the pharmacy distribution model. With our two‑product PSMA 9 imaging strategy, differentiated clinical positioning and expanding commercial presence globally, we are seeing a solid foundation for continued growth through 2026. Importantly, we are delivering on our strategic priorities to advance our high-value clinical programs, demonstrated by the momentum in our therapeutics pipeline this quarter.” Therapeutics Business Unit Telix continues to progress its industry-leading Therapeutics pipeline, which spans multiple product candidates and disease areas. Q1 2026 highlights include: TLX591-Tx (lutetium ( 177 Lu) rosopatamab tetraxetan): Part 1 of ProstACT Global, the Phase 3 trial of its lead prostate cancer therapy candidate, achieved its study objectives, demonstrating an acceptable safety and tolerability pro no new safety signals observed 1 . No adverse drug-drug interactions were observed in TLX591-Tx combinations, demonstrating the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC 10 , including ARPIs 11 (enzalutamide or abiraterone) and docetaxel. Telix has commenced engagement with the FDA to present data from Part 1 and ascertain eligibility for U.S. patients to participate in Part 2 (randomized treatment expansion). Part 2 is open for enrollment in Australia, New Zealand and Canada, with site activation underway in preparation to open enrollment in China, Singapore, South Korea, Türkiye, the United Kingdom and Japan, where regulatory approvals have already been granted. TLX250-Tx (lutetium ( 177 Lu) girentuximab tetraxetan): Telix has opened its first clinical site and is recruiting patients for Part 1 of LUTEON 12 , a pivotal trial of TLX250-Tx as a monotherapy in advanced ccRCC 13 . Trial recruitment will initially focus ex-U.S. TLX101-Tx ( 131 I-iodofalan): Telix has enrolled the first patient in IPAX-BrIGHT, an international, multi-center pivotal trial of TLX101-Tx in patients with recurrent glioblastoma 14 . The trial is now open for enrollment in Australia, Austria and the Netherlands and has received regulatory approval to commence in Belgium. TLX090-Tx ( 153 Sm-DOTMP): Telix continues to dose patients in SOLACE 15 , a Phase 1 study of a drug candidate for treating pain in patients with osteoblastic bone metastases from prostate and breast cancers. The study was expanded this quarter to include additional U.S. sites to accelerate recruitment. TLX597-Tx ( 177 Lu-DOTA-HYNIC-panPSMA): TLX597-Tx is a "next generation" PSMA-targeting prostate cancer therapy candidate being developed to facilitate patient access in select geographies, where routine clinical availability to approved therapies is limited or not available. Early clinical data suggests a favorable asset biodistribution with limited uptake in healthy organs of concern (e.g., salivary glands, kidneys) relative to available 177 Lu-PSMA therapies. Interim data from OPTIMAL-PSMA 16 , an investigator-led, randomized, dose intensification study of TLX597-Tx in mCRPC, will be presented at the International Prostate Cancer Symposium in April 2026. Precision Medicine Business Unit PSMA imaging portfolio: Telix continues to expand its commercial footprint with Illuccix now launched in 21 countries globally, which includes 16 countries in Europe. This growing international presence enhances access to PSMA-PET/CT imaging 17 while establishing a scalable commercial and operational platform to support future product launches, including follow-on therapeutic products. Telix's broad proposed label for TLX591-Px (Illuccix) is under review by the NMPA Centre for Drug Evaluation as part of the NDA submission 18 . TLX101-Px, (Floretyrosine F 18 or 18 F-FET): Telix has resubmitted its NDA in the U.S. with the additional clinical data and analysis as agreed with the FDA. Telix has submitted a MAA in Europe covering commercially significant markets, seeking to expand patient access to advanced brain imaging. Zircaix® 3 (TLX250-Px, 89 Zr-DFO-girentuximab): Based on two successful Type A meetings with the FDA, Telix believes it has aligned on key outstanding issues for the Biologics License Application (BLA) resubmission, including demonstration of drug product comparability between clinical trial material and scale-up commercial production. The Company is now completing the agreed deliverables and documentation required, targeting a H1 2026 submission. Corporate Updates Telix has announced the appointment of David Gill as Non-Executive Director (NED), effective May 11, 2026, as part of its Board renewal process 19 . Mr. Gill is expected to be appointed as Chair in due course, succeeding Dr. Mark Nelson who will remain on the Board as NED. The Board believes Mr. Gill's appointment will enhance the Board’s capability, with extensive experience in U.S. public company governance, financial oversight and senior leadership across commercial and clinical-stage biopharmaceutical companies. FY 2026 guidance Telix reaffirms FY 2026 revenue guidance of US$950 million to US$970 million 20 . Guidance reflects revenue from product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS. Telix reaffirms research and development (R&D) expenditure guidance of US$200 million to US$240 million, subject to achieving ongoing global commercial milestones. About Telix Pharmaceuticals Limited Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Illuccix (kit for the preparation of gallium-68 ( 68 Ga) gozetotide injection) has been approved by the FDA 21 , and in multiple markets globally. Gozellix (kit for the preparation of gallium-68 ( 68 Ga) gozetotide injection) has been approved by the FDA 22 . No other Telix product mentioned in this announcement has received a marketing authorization in any jurisdiction. Visit for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn , X and Facebook . Telix Investor Relations (Global) Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com Telix Investor Relations (U.S.) Ms. Annie Kasparian Director Investor Relations and Corporate Communications annie.kasparian@telixpharma.com Telix Investor Relations (Australia) Ms. Charlene Jaw Associate Director Investor Relations charlene.jaw@telixpharma.com This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Guidance Disclaimer The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation, regulation, or policy that affects product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix’s ability to protect its patents and other intellectual property. See the Legal Notices section below for additional information, risks and assumptions. Legal Notices Cautionary Statement Regarding Forward-Looking Statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including TLX101-Px and TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 1 Telix media release March 9, 2026. ClinicalTrials.gov ID: NCT06520345 . 2 Telix ASX disclosure March 16, 2026. 3 Brand name subject to final regulatory approval. 4 Telix ASX disclosure February 18, 2026. 5 Branded as Illuccix in commercial jurisdictions outside of China. 6 Telix ASX disclosure January 20, 2026. 7 Primarily sales of Illuccix and Gozellix in our Precision Medicine business. 8 Telix Manufacturing Solutions (TMS) third-party revenue predominantly driven by RLS Radiopharmacies (RLS), excludes Illuccix and Gozellix sales and TMS inter-segment revenue. Q1 2025 includes RLS revenue contribution since acquisition close on January 28, 2025. 9 Prostate-specific membrane antigen. 10 Metastatic castration-resistant prostate cancer. 11 Androgen receptor pathway inhibitor. 12 ClinicalTrials.gov ID: NCT07197580 . 13 Clear cell renal cell carcinoma. 14 ClinicalTrials.gov ID: NCT07100730 . 15 ClinicalTrials.gov ID: NCT07197645 . 16 ANZCTR.org.au ID: ACTRN12625000971437. 17 Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography. 18 Telix media release January 20, 2026. 19 Telix ASX disclosure April 2, 2026. Appointment subject to grant of Australian Director Identification number. 20 Refer to Telix ASX disclosures February 20, 2026. 21 Telix ASX disclosure December 20, 2021. 22 Telix ASX disclosure March 21, 2025.