Lutetium Dotatate LU-177

Novartis ends a radiopharma trial with PeptiDream : The Swiss drug giant terminated a Phase 1 trial of [177Lu]Lu-FF58 in patients with selected advanced solid tumors, a spokesperson confirmed to Endpoints News . The spokesperson cited “careful evaluation of available clinical data” as the reason and noted it “was not based on safety concerns.” All patients have either discontinued treatment or completed safety follow-up, the spokesperson added. The asset is part of Novartis’ collaboration with PeptiDream . A PeptiDream spokesperson didn’t respond to a request for comment. The Novartis spokesperson didn’t comment on the future of the candidate. Radiopharma has become a key focus for Novartis, which markets Pluvicto and Lutathera and has inked multiple deals in the space . — Kyle LaHucik Solve Therapeutics eyes $75 million funding round: The Belmont, CA-based ADC biotech, led by former VelosBio CEO Dave Johnson, has raised $50 million so far in a $75 million equity round, according to an SEC filing on Thursday. Johnson declined to comment. He sold VelosBio to Merck for $2.75 billion in cash in 2020. About a year later, Solve raised a $126 million Series A from Matrix, Decheng Capital, General Atlantic and Surveyor Capital, according to Johnson’s LinkedIn page . The company acquired Cereius, a radiodiagnostics and radiotherapeutics spinout from Duke University, in 2023. — Kyle LaHucik Veru sold off some non-essential assets: The company announced Tuesday that it’s selling its FC2 Female Condom business to a New York investment firm called Riva Ridge Capital Management for $18 million. The deal lets Veru focus on its obesity program called enobosarm, which is expected to read out topline Phase 2b data in January. — Max Gelman Ideaya Biosciences makes an ADC deal with Hengrui Pharma : The South San Francisco biotech will pay $75 million upfront and up to $1.04 billion in total, for ex-China access to Hengrui’s DLL3-targeting ADC called SHR-4849. The candidate, with a Topo-I payload, could be combined with Ideaya’s PARG inhibitor, which is called IDE161 . The drug is in Phase 1 in solid tumors in China, and Ideaya plans to ask for FDA trial clearance in the first half of next year. — Kyle LaHucik Amylyx expands GLP-1 work with a new Gubra collaboration: The neurodegenerative biotech said Monday it is paying a “small upfront fee” plus research payments, with more than $50 million in milestones available to Gubra to identify a novel long-acting GLP-1 drug. Amylyx will have the option to lead future development if a candidate is found. — Max Bayer Good news for Novartis ’ intrathecal Zolgensma: The treatment succeeded in a Phase 3 trial in patients with spinal muscular atrophy (SMA) type 2 between the ages of 2 and 18 who can sit but have never walked independently. Patients given the gene therapy had increased scores on a rating scale of motor ability and disease progression compared with sham control. Further data and regulatory submissions are expected to come in 2025. An approval would extend Zolgensma’s reach; it is currently only approved in SMA patients aged younger than 2. — Elizabeth Cairns Immedica Pharma announces plans to buy Marinus Pharmaceuticals : The Swedish rare disease company agreed to acquire Marinus for an enterprise value of about $151 million . Marinus’ shares $MRNS were up about 42% to 52 cents apiece in early trading on Monday, nearly matching the offer of 55 cents per share. Marinus markets the rare seizure drug Ztalmy. The medicine, also known as ganaxolone, recently failed a late-stage trial, leading the company to again lay off employees . Also on Monday, Orion and Marinus mutually terminated a marketing and distribution pact for ganaxolone in Europe. — Kyle LaHucik Johnson & Johnson is partnering with the Japanese company Kaken on a STAT6 program. J&J will get the rights to KP-723, an oral STAT6 inhibitor still in preclinical testing, and take over development after Kaken completes Phase 1 studies. Kaken gets $30 million upfront and up to $1.2 billion. — Max Gelman Kronos Bio and Roche ended their R&D alliance following Kronos’ significant downsizing, according to SEC documents. The biotech elected to end development on a CDK9 inhibitor called istisociclib last month, resulting in layoffs of about 83% and the departure of CEO Norbert Bischofberger. Kronos and Roche had partnered in 2023 on a different program for $20 million upfront and $554 million in milestones. — Max Gelman AusperBio raised a $73 million Series B round led by HanKang Capital, the proceeds of which will fund mid-stage development of its lead candidate AHB-137. The antisense oligonucleotide, intended as a functional cure for hepatitis B, is in a Phase 2 trial in China that could be reported next year. The company said the new financing will also enable global trials of AHB-137, as well as expansion of its therapeutic pipeline, manufacturing and operational capabilities. — Elizabeth Cairns A few months after announcing a strategic review , London-based Achilles Therapeutics is offloading data and samples from its non-small cell lung cancer study to AstraZeneca for $12 million. The UK pharma will also get access to a platform and network of tumor samples from nearly 300 cancer patients. — Kyle LaHucik AstraZeneca and Daiichi Sankyo have withdrawn their European Medicines Agency application for the ADC datopotamab deruxtecan in lung cancer. While AstraZeneca has positioned the drug as a successor to Enhertu, the company said in May that a lung cancer trial failed to reach its overall survival goal. — Max Gelman China’s CASI Pharmaceuticals said in a securities filing that its experimental drug CID-103 has been put on a clinical hold by the FDA. The drug is an anti-CD38 antibody that’s being studied to prevent the rejection of transplanted kidneys. The company said it plans to respond to the FDA. — Drew Armstrong Assembly Biosciences reported interim Phase 1b data for its hepatitis B antiviral program ABI-4334. In patients who were predominantly hepatitis B e antigen (HBeAg) negative, ABI-4334 induced a 99.9% average decline of hepatitis B virus DNA (a 2.9 log10 reduction). Among those with detectable virus RNA at baseline, there was an average decline of 99.7% (2.5 log10). Assembly said there were “limited changes in viral antigens” due to the nature of the 28-day study. The company is partnered with Gilead on a trio of antivirals, including ABI-4334. — Max Gelman

随着全球核药技术的不断发展，治疗型核药快速发展全球 RDC 药物加速开发与商业化落地。目前全球已有11款RDC 药物获批上市，其中9款药物用于诊断，2款药物用于治疗，上市的RDC 药物靶点集中于前列腺特异性膜抗原(PSMA)和生长抑素受体(SSTR)。 特别是 2018 年和 2022 年诺华的两款重磅 RDC 产品(Lutathera、Pluvicto)获批上市后展现的优异疗效以及快速的商业化放量，吸引全球更多的MNC将资源投入治疗用核药的开发上。2023年Pluvicto的销售额约为9.21亿美元，2024 上半年该药销售额已超过5亿美元，预计全年销售额将超过 10 亿美元。 从长远来看，2026年全球核药市场规模有望超百亿美元目前诊断类核药占比近七成。自2013年起全球核药市场规模快速扩容，十年间的 CAGR 约为6%，据Nature(自然杂志)披露 2026 年全球核药市场规模有望达120 亿美元，而据Evaluate 预测，到2028 年全球治疗型放射性药物的年销售额预计将超过 60 亿美元，治疗用核药市场规模占核药整体市场比重有望快速提升。而据中国核安全局数据显示，预计2025 年，国内放射性药物市场规模将达到93 亿元人民币，到 2030年，市场规模将进一步增加至260 亿元人民币。 那么，在RDC核药当前形势下，我们该如何把握和抓住RDC 核药的发展机遇和前景趋势呢? 识别二维码▼查看完整版报告 《2024-2030 年 RDC 核药行业深度调研及发展战略咨询报告》正是在这一背景下应运而生，旨在通过全面、深入的分析，为业界提供一份关于 RDC 核药行业未来发展趋势的权威指南。本报告基于广泛的市场调研、专家访谈、政策解读以及技术创新追踪，力求从多角度、多层次揭示 RDC 核药行业的现状、挑战与机遇。 识别二维码进群▼了解更多报告 一审| 黄佳 二审| 李芳晨 三审| 李静芝