Fusion Pharmaceuticals, Inc.

iStock, Andrii Dodonov Nuclidium’s radiopharmaceutical platform is unique in its use of copper-based payloads, which the biotech claims can deliver higher doses while also being safer. Nuclidium’s coin purse is approximately $99 million heavier after the Swiss biotech closed its series B round on Thursday. Unlike other players in the radiopharma space, which mostly use actinium- or lutetium-based payloads, Nuclidium is seeking to differentiate by using copper as its isotope of choice. As per the biotech’s website , a copper-based radiopharmaceutical agent can deliver higher therapeutic doses per tumor volume, also carrying a lower radiation burden overall, thereby being safer. Importantly, Nuclidium also contends that copper-based agents are easier to manufacture, with affordable and accessible raw materials, a lower burden of radioactive waste and no need for a nuclear reactor. Thursday’s raise will help Nuclidium deepen its pipeline of copper-based radiopharmaceutical agents, which the company is proposing for various theranostic purposes across oncology indications. According to its website , Nuclidium has three programs running, the most mature of which is dubbed NuriPro, for metastatic castration-resistant prostate cancer. The diagnostic application of NuriPro has completed Phase I development, while its therapeutic application is just about to enter early-stage studies. Last month, Phase I data showed that NuriPro, when used as an imaging agent for positron emission tomography, detected additional lesions in 50% of patients that were not seen on an 18 F-piflufolastat-based scan. Nuclidium’s copper-based tracer was also able to visualize more lesions than the standard agent up to four hours after administration, according to the company. Nuclidium also has a breast cancer program, dubbed TraceNET, in mid-stage development for diagnostic applications and about to enter Phase I for therapeutic applications. In its news release Thursday, Nuclidium touted promising early therapeutic findings for both NuriPro and TraceNET, with “strong” tumor-to-background ratios. Thursday’s series B was led by Kurma Growth Opportunities Fund and Angelini Ventures, alongside Wellington Partners and Neva SGR. Other institutional investors, such as DeepTech & Climate Fonds, Bayern Kapital and HighLight Capital, participated in the fundraising push. Nuclidium’s series B is the second big radiopharma raise this week, after Massachusetts-based Actithera brought in $75.5 million in series A proceeds on Wednesday. The influx of money in the space comes amid growing interest from Big Pharma. Novartis is currently the clear leader in the field , with two approved therapies in Pluvicto and Lutathera. Fellow powerhouses are playing catch up. Bristol Myers Squibb acquired RayzeBio for $4.1 billion in December 2023, while AstraZeneca in March 2024 bought Fusion Pharmaceuticals for $2.4 billion .

iStock, Andrii Yalanskyi Actithera’s radiopharma assets irreversibly bind to their targets, allowing for longer retention of the drug inside tumors. Massachusetts startup Actithera closed an oversubscribed series A financing Wednesday, beefing up its capital by $75.5 million to advance next-generation radiopharmaceuticals. The money will help support the development of the company’s lead asset, a radioligand therapy that targets the fibroblast activation protein (FAP), for which it plans to initiate clinical studies in “multiple indications,” as per Wednesday’s release. Actithera did not reveal its priority indications nor did it specify a timeline for the asset’s early-stage development. The series A round was co-led by M Ventures, Actithera’s founding investor, alongside new lead investors Sofinnova Partners, 4BIO Capital and Hadean Ventures. Other participating investors include second founding investor Arkin Bio Ventures II as well as Surveyor Capital and Bioqube Ventures. Aside from advancing its lead FAP-targeting asset, Actithera will also use its series A proceeds to further develop its discovery engine, which allows the startup to produce radiotherapies that can form covalent and irreversible bonds with its targets to maximize treatment specificity. Actithera’s assets are also isotope-agnostic, meaning they can be designed to carry alpha- or beta-emitting payloads. The use of covalent chemistry also leads to the “extended retention” of Actithera’s radioconjugates inside tumors, CEO and founder Andreas Goutopoulos said in a prepared statement on Wednesday. Ultimately, Actithera expects its covalent technology to provide patients with “more convenient dosing schedules and enhanced efficacy and safety,” Goutopoulos added. With its series A round closed, Actithera enters the burgeoning radiopharma space, currently dominated by a handful of Big Pharma players. Leading the pack is Novartis, which owns two commercial radiotherapies: Lutathera, for gastroenteropancreatic neuroendocrine tumors, and Pluvicto, approved for metastatic castration-resistant prostate cancer. Last year, both drugs together earned more than $2.1 billion . In building out their radiopharma pipelines, many of these industry powerhouses have turned to smaller players, licensing their assets or acquiring them outright. Eli Lilly is a prime example, signing a flurry of deals to beef up its radiopharma presence. In October 2023, for instance, the pharma bought Point Biopharma for $1.4 billion , following this up a few months later with a collaboration with Aktis Oncology worth a potential $1.1 billion and an up-to $1.14 billion deal with Radionetics Oncology. AstraZeneca and Bristol Myers Squibb have also signed high-ticket acquisitions in the radiopharma space, with the former’s $2.4 billion buyout of Fusion Pharmaceuticals in March 2024 and the latter’s $4.1 billion takeover of RayzeBio in December 2023.

同写意年度巨献！！大会特设“核药全产业链开发”分会，7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！近日，BMS子公司RayzeBio豪掷13.5亿美元引进前列腺癌核药OncoACP3，诺华同步在华启动SSTR2靶向药Lutathera治疗晚期胃肠胰神经内分泌瘤的III期临床。两大巨头重金加码与关键进展齐发，标志着全球核药行业进入加速发展的新阶段，全球核药浪潮来袭。TONACEA01核药的全球浪潮全球医疗产业正迎来治疗性核药的爆发性增长，这一领域凭借其精准靶向和诊疗一体化的独特优势，重塑肿瘤等重大疾病的治疗范式。据Precedence Research数据，2024年全球放射性药物市场规模达67.4亿美元，并以8.2%的复合年增长率加速扩张，预计2034年将突破144.4亿美元。这一增长主要源于放射性核素偶联药物（RDC）的技术突破与商业化落地。RDC的结构与抗体偶联药物（ADC）类似，但作用机理截然不同，其通过靶向配体引导放射性核素（如镥-177、锕-225）精准定位病灶，实“体内精准放疗”，而非ADC的细胞毒性杀伤。2024年-2034年放射性药物市场规模/图片来源：Precedence Research其中，诺华的两款RDC药物Pluvicto和Lutathera成为行业标杆。2024年，靶向PSMA的前列腺癌疗法Pluvicto销售额达13.92亿美元，同比增长42%，成为核药领域首个“重磅炸弹”。为了巩固Pluvicto地位，诺华正在进行Pluvicto的适应证拓展。2025年3月，Pluvicto获批用于更早期的前列腺癌治疗的新适应证，根据诺华在2025 JPM大会上预测，其销售峰值预计超50亿美元；而另一款靶向SSTR的神经内分泌肿瘤药物Lutathera在2024年收入7.24亿美元，同比增长20%。两者合计贡献21.16亿美元，验证了治疗性核药的商业潜力。另外，诊断性核药增长势头同样喜人，2024年两款PSMA-PET显影剂Plarify和Illuccix销售额合计16亿美元，同比增长33%，美国医保支付改革将进一步推动诊断核药的市场扩容，据Lantheus预测，2025年PSMA PET诊断规模有望超25亿美元，预计到2030年其市场规模有望超过35亿美元。2025年-2030年美国PSMA PET诊断市场预测/图片来源：LantheusTONACEA02MNC争相入局随着诺华旗下Pluvicto和Lutathera的商业化成功，核药赛道已成为MNC战略布局的新焦点。2024年至2025年初，礼来、BMS、阿斯利康等巨头通过高溢价收购和战略合作加速布局。礼来成为最活跃的投资者，2023年10月以14亿美元收购Point Biopharma，获得其PSMA靶向疗法PNT2002；2024年先后与Aktis Oncology、Radionetics Oncology达成合作；2025年2月又与AdvanCell扩大合作，整合后者领先的Pb212生产技术，共同开发靶向α核素疗法。BMS以41亿美元收购RayzeBio，创下核药领域最高交易纪录，核心资产为225Ac靶向药物RYZ101，意图挑战诺华的Lutathera。2025年6月10日，BMS全资子公司RayzeBio又以13.5亿美元的潜在总金额引进一款临床在研前列腺癌治疗和诊断药物OncoACP3，其野心可见一斑。主要MNC布局核药情况汇总/图片来源：平安证券研报阿斯利康从试水转向全面投入，2020年与Fusion Pharmaceuticals合作后，2024年3月以24亿美元直接收购该公司，获得其FastClear linker技术平台及4款在研核药，包括靶向PSMA的225Ac疗法FPI2265，同年还投资CDMO企业Nucleus RadioPharma完善产业链。诺华在巩固先发优势的同时，2024年5月以17.5亿美元收购礼来曾投资的Mariana Oncology，加码放射性配体疗法（RLT）管线，并加速推进225AcPSMA617等新一代药物。近些年，拜耳也持续布局核药领域。2021年，拜耳收购Noria Therapeutics和PSMA Therapeutics，扩展了基于Ac-225的核药产品研发管线。2023年5月，拜耳与Bicycle Therapeutics达成战略合作，开发RDC。截至2024年末，其研发管线中已拥有7款处于临床前研究阶段、2个进入早期临床开发的RDC项目。TONACEA03国内商业化征程已然开启近年来，国内核药产业同样迎来实质性突破，从研发阶段迈入商业化价值兑现期。2020年2025年初，国内共获批5种新型核药，其中远大医药的钇[90Y]微球注射液表现最为亮眼，2024年实现收入近5亿港元，同比增长140%。后续伴随着2025年商保推出及落地，钇[90Y]微球注射液有望放量。此外，2025年成为国内核药商业化进程的关键节点。其中，安迪科的氟[18F]化钠已于5月底获NMPA批准上市。同时，诺华围绕PSMA靶点的前列腺癌治疗药镓[68Ga]戈泽肽及配套诊断药镥[177Lu]特昔维匹肽于2024年11月获CDE优先审评，2025年有望双双获批。值得一提的是，2025年6月10日，诺华还在中国启动了SSTR2靶向核药Lutathera在1级和2级晚期胃肠胰神经内分泌瘤（GEP-NET）患者III期临床研究。与此同时，国内企业的研发与管线布局同样进入收获期。远大医药核药抗肿瘤诊疗板块目前已储备12款创新产品，3款RDC产品处于III期临床阶段，其中前列腺癌诊断药物TLX591-CDx计划2025年递交上市申请。远大医药还提出“自研核药出海”战略，目标是自2025年起每年向FDA递交一个产品申请，2028年-2029年首个产品完成临床试验并向FDA递交上市申请。远大医药介入治疗和RDC管线/图片来源：远大医药2024年财报东诚药业则聚焦诊断核药商业化，旗下产品氟[18F]化钠已于2025年5月底获批上市，锝[99mTc]-GSA等产品有望年内提交新药申请；治疗性核药中，其FAP靶点药物177Lu-LNC1004获FDA快速通道资格，全球进度领先。结语：随着国内外企业加速布局与商业化破局，核药必将引爆下一个百亿美元级的蓝海市场。精准“核爆”，未来已来！