Lutetium Dotatate LU-177

本期导读 本期为2026年9月25日生物医药行业日报，汇总9月23日至24日全球生物医药与创新药领域的重要动态。今日交易类消息密集：诺诚健华与礼来达成最高33.5亿美元研发合作；罗氏与Atavistik Bio达成最高20亿美元变构小分子合作；Merck KGaA 113亿美元收购Bio-Techne获股东批准；Zymeworks完成收购Theravance。创新药方面，FDA批准礼来每周一次基础胰岛素Onswik。AI制药方面，Basecamp Research完成1.4亿美元C轮融资，NVIDIA和Anthropic参投。今日十大动态01.诺诚健华与礼来达成最高33.5亿美元研发合作，共同开发至多5个创新靶点【管线买卖/创新药】 9月24日，诺诚健华（688428.SH/09969.HK）宣布全资子公司与礼来（Eli Lilly）签署研发合作及授权许可协议。诺诚健华将依托专有药物发现平台发现并开发至多5个创新靶点项目，礼来支付最高1亿美元首付款及近期里程碑，后续研发及商业化里程碑最高可达32.5亿美元，总交易额最高33.5亿美元。 涉及公司/机构：诺诚健华（InnoCare Pharma）、礼来（Eli Lilly） 信息来源：诺诚健华公告、上海证券报、财联社、新浪财经02.FDA批准礼来每周一次基础胰岛素Onswik（insulin efsitora alfa）用于2型糖尿病【创新药/多肽】 9月24日，FDA批准礼来Onswik（insulin efsitora alfa-gobe）作为成人2型糖尿病的每周一次基础胰岛素注射治疗。Onswik是全球第二个获批的每周一次基础胰岛素，较每日一次方案每年减少300余次注射。该批准基于礼来III期临床试验数据，此前已在欧洲、墨西哥和日本获批，美国为第四个获批市场，直接挑战诺和诺德的每周胰岛素产品。 涉及公司/机构：礼来（Eli Lilly）、FDA 信息来源：礼来IR官网、Medscape、HCPLive、Nasdaq03.Basecamp Research完成1.4亿美元C轮融资，NVIDIA和Anthropic参投，估值8亿美元【AI制药/融资】 9月23日，伦敦/波士顿AI制药公司Basecamp Research宣布完成1.4亿美元超额认购C轮融资，估值达8亿美元。本轮由S32（前Verily CEO Andy Conrad创立）领投，NVIDIA、Anthropic的Anthology Fund、Catalio Capital、NATO创新基金、洛克菲勒基金会等参投。Basecamp将用资金推进其280亿参数EDEN生物基础模型，以及基因插入、基因编辑和多肽设计六大管线向临床推进。 涉及公司/机构：Basecamp Research、S32、NVIDIA、Anthropic 信息来源：Basecamp官网、BioSpace、PR Newswire、Economic Times04.罗氏与Atavistik Bio达成最高20亿美元变构小分子合作，聚焦心脏代谢疾病【管线买卖/生物药新技术】 9月24日，Atavistik Bio宣布与罗氏（Roche）达成战略研究合作，利用Atavistik的AMPS代谢物-蛋白筛选平台发现新型变构小分子，用于心血管、肾脏和代谢（CVRM）疾病。Atavistik将获得7000万美元首付款，以及最高19亿美元研发和商业化里程碑付款及分级销售分成。这是罗氏在GLP-1之后布局心脏代谢领域的最新动作。 涉及公司/机构：罗氏（Roche）、Atavistik Bio 信息来源：Atavistik/GlobeNewswire、Fierce Biotech、BioSpace、Nasdaq05.Merck KGaA 113亿美元收购Bio-Techne获股东批准，生命科学工具行业整合加速【并购/生物药新技术】 9月23日，Bio-Techne（NASDAQ:TECH）股东投票批准德国Merck KGaA以每股73美元现金、总企业价值约113亿美元（约99亿欧元）收购公司的最终协议。该交易于6月25日宣布，美国反垄断等待期已于9月18日届满，预计2026年底或2027年初完成交割。合并将整合双方生命科学研究工具和诊断产品业务，强化Merck KGaA在生物制药上游供应链的地位。 涉及公司/机构：Merck KGaA（德国默克）、Bio-Techne 信息来源：Bio-Techne IR、American Pharmaceutical Review、亿欧06.Zymeworks完成收购Theravance Biopharma，扩展呼吸科产品组合【并购/创新药】 9月23日，Zymeworks（NASDAQ:ZYME）宣布完成对Theravance Biopharma的收购。交易于6月29日签署，每股17美元现金加或有价值权（CVR）。收购将Theravance的COPD维持治疗药物YUPELRI（revefenacin，首个也是唯一获批的雾化长效毒蕈碱拮抗剂LAMA）纳入Zymeworks产品组合。Zymeworks将于9月28日召开投资者电话会。 涉及公司/机构：Zymeworks、Theravance Biopharma 信息来源：Zymeworks IR、GlobeNewswire/Manila Times07.纽福斯生物获长江医投独家投资，加速眼科in vivo基因治疗商业化【细胞与基因治疗/融资】 据企查查9月24日披露，武汉纽福斯生物科技完成新一轮融资，由湖北省级国资平台长江医投独家投资，资金将用于加速核心管线商业化及新产品管线拓展。纽福斯是国内专注眼科疾病体内基因治疗的企业，其核心产品NR082眼用注射液（纽惟佳）用于治疗ND4基因突变导致的Leber遗传性视神经病变（LHON），国内III期临床即将完成。 涉及公司/机构：纽福斯生物、长江医投 信息来源：企查查、纽福斯公开报道08.欧洲投资银行向哥伦比亚VaxThera提供3500万欧元贷款，扩大拉美疫苗产能【疫苗/融资】 9月24日，欧洲投资银行（EIB）与欧盟委员会联合宣布，向哥伦比亚生物技术公司VaxThera提供3500万欧元（约4000万美元）融资，首批1500万欧元风险贷款已在联合国大会期间于纽约宣布。VaxThera专注于疫苗和生物药的开发与生产，贷款将用于扩大其在拉美的疫苗生产能力。 涉及公司/机构：欧洲投资银行（EIB）、VaxThera、欧盟委员会 信息来源：The Pharma Letter09.罗氏Gazyvaro（奥妥珠单抗）获英国MHRA批准用于系统性红斑狼疮【抗体药】 9月24日消息，英国药品和医疗产品监管局（MHRA）批准罗氏Gazyvaro（obinutuzumab，奥妥珠单抗）用于系统性红斑狼疮（SLE）治疗。Gazyvaro是一款抗CD20单抗，此前已获批用于滤泡性淋巴瘤和慢性淋巴细胞白血病等B细胞恶性肿瘤，此次拓展至自免疾病SLE，为B细胞清除疗法在SLE领域的又一进展。 涉及公司/机构：罗氏（Roche）、英国MHRA 信息来源：The Pharma Letter10.Lantheus Bravnetsa（Lu-177 dotatate）获FDA最终批准，为诺华Lutathera生物类似药【生物药新技术/核药】 9月24日，Lantheus Holdings宣布FDA最终批准Bravnetsa（lutetium Lu 177 dotatate），该药为诺华Lutathera的生物等效和治疗等效放射性配体疗法，用于治疗生长抑素受体阳性胃肠胰神经内分泌肿瘤（GEP-NETs）。这是核药生物类似药领域的重要进展，将降低GEP-NETs患者的治疗成本。 涉及公司/机构：Lantheus Holdings、FDA 信息来源：The Pharma Letter、Lantheus公告今日要点总结 中国Biotech出海大单： 诺诚健华与礼来达成最高33.5亿美元合作，5个靶点项目，首付款最高1亿美元。 FDA新批创新药： 礼来每周一次基础胰岛素Onswik获批，与诺和诺德在糖尿病领域正面竞争。 AI制药融资高热： Basecamp Research完成1.4亿美元C轮，NVIDIA和Anthropic同时下注，估值8亿美元。 MNC管线布局： 罗氏7000万美元首付款+最高19亿美元里程碑，与Atavistik合作变构小分子心脏代谢药物。 生命科学工具并购： Merck KGaA 113亿美元收购Bio-Techne获股东批准，上游供应链整合加速。 CGT国内融资： 纽福斯生物获长江医投独家投资，推进眼科in vivo基因治疗NR082商业化。 注：本文信息均来自公开渠道整理，每条均标注实际发布日期，仅供行业参考，不构成任何投资建议。完整原文链接可点击底部「阅读原文」查看。

New research proposes using an effectively stable gadolinium precursor to overcome a decades-old isotope supply bottleneck and enable Tb-149 production on widely available medical cyclotrons. SAN FRANCISCO, Sept. 24, 2026 /PRNewswire/ -- Marathon Fusion today announced a novel approach for large-scale production of terbium-149 (Tb-149), a radioactive isotope that researchers have studied for decades as a promising candidate for targeted cancer therapy, but have never been able to produce in quantities sufficient for clinical use. "[Tb-149] is the radionuclide of choice in all aspects except production," wrote researchers affiliated with the University Hospital of Geneva and CERN in a 1996 paper examining the isotope's potential for targeted cancer therapy. Tb-149 was discovered in 1950 and has been considered for targeted alpha therapy for more than three decades. Marathon's new paper, Scalable Terbium-149 Production from Highly Enriched Gadolinium-150 Targets, introduces a novel approach to break this supply constraint and enable the full potential of Tb-149-based cancer therapies. The challenge of Tb-149 production Highlighting both the isotope's desirability and limited production, researchers in a 2025 European multidisciplinary review of targeted alpha therapy wrote: "Due to the valuable combination of physical characteristics… Terbium-149 is one of the most promising radionuclides. [However,] the radionuclide's restricted availability has prevented the start of clinical trials… The unconventional production of Terbium-149 was the main reason why Terbium-149 had not yet reached clinical trials." Tb-149 has a rare combination of properties for targeted radiotherapy. It emits an alpha particle capable of destroying nearby cancer cells while traveling only a short distance through tissue. Unlike other alpha emitters under development, Tb-149 also produces a positron signal that could allow physicians to image the tumor while treating it. Despite promising preclinical work with targeting agents including PSMA, rituximab and somatostatin-receptor ligands, Tb-149 has not previously progressed to human trials. Only a handful of specialized facilities have produced Tb-149 with current facilities achieving far less production than is necessary to complete a clinical trial. Because Tb-149 has a half-life of only 4.1 hours, conventional centralized production faces extreme logistical challenges. This is contrasted with the 66-hour half-life of Mo-99, or the 6.6-day half-life of Lu-177, radioisotopes which are successfully produced centrally. Marathon's scalable production method Inspired by the fluorine-18 production pathway used to enable millions of PET scans each year in the United States alone, Marathon proposes focusing on the production of a rare precursor isotope to unlock onsite production of Tb-149, mitigating challenges associated with its short half-life. In fluorine-18 production, a precursor isotope called oxygen-18 is irradiated to produce fluorine-18, an isotope with a half life of less than 2 hours. This is made possible by the centralized offsite enrichment of oxygen-18, a rare isotope which makes up just 0.2% of naturally occurring oxygen. By producing a stockpile of a rare precursor isotope, oxygen enrichment enables the decentralized, onsite production of the short-lived fluorine-18. In Marathon's proposed production pathway, the precursor gadolinium-150 (Gd-150) is produced centrally. Unlike oxygen-18, Gd-150 is not technically stable, but its 1.8-million-year half-life enables stockpiling and shipment without meaningful losses. Gd-150 could then be irradiated locally by a distributed network of cyclotrons, using existing equipment, to generate Tb-149 onsite. "Terbium-149 has been clinically interesting for a long time, we just haven't had enough of it to get drugs through clinical trials, or to feel like there will be a meaningful market even after approval," said Adam Rutkowski, CTO and Co-founder of Marathon Fusion. "Our work shows that there's a practical solution leveraging existing infrastructure to not only get Tb-149-based drugs through clinical trials, but to reach patients all over the world." To produce the Gd-150 precursor, an abundant isotope called Europium-151 is irradiated and transmuted. Marathon's analysis finds that existing technology could produce enough Gd-150 to support tens of thousands of Tb-149 doses per year. "We've seen a recent confluence of factors: progress in targeting driven by years of clinical research, evidence for the efficacy of alpha therapy demonstrated through dozens of clinical trials, and a vibrant ecosystem capable of bringing new treatments to market," said Kyle Schiller, CEO and Co-founder of Marathon Fusion. "If we can show that there's a scalable production pathway for terbium-149, an isotope clinicians have wanted to use for decades, that'll bring all the pieces together to take a leap forward in cancer treatment options." At a large scale, Marathon's researchers calculate that small fusion reactors could irradiate enough europium-151 to produce the precursor stockpile necessary for millions of annual doses of Tb-149, creating a promising connection between the emerging fusion industry and the supply chain for next-generation cancer medicines. Radiotherapy: driving the early market for nuclear fusion While several fusion startups are targeting power-plant demonstrations in the 2030s, fusion reactors could be used to produce isotopes for radiotherapy even earlier, and without needing to hit the size or performance requirements necessary for power production. "Fusion reactors produce an extraordinary number of high-energy neutrons," said Dr. Jason Parisi, Principal Research Scientist at Marathon Fusion who previously worked as a Staff Research Scientist at the Princeton Plasma Physics Lab. "Electricity is the application everyone associates with fusion, but those neutrons can also be used to mass-manufacture medical isotopes, creating a new supply chain for this critical industry." A scientific hypothesis now moving toward experiment Models predict a reaction rate based on decades of nuclear data and advances in computational tools, but there has not been a direct experimental measurement of the nuclear cross section at the heart of Marathon's production method. Marathon's methods rely on established nuclear-reaction models, benchmarked experimentally against neighboring isotopes. "With the model in place, it's now critical to move forward with experimental confirmation," said Dr. Jason Parisi. "If demonstrated, this would validate a previously overlooked route with all the right characteristics to solve Tb-149 supply. The important thing now is to test it." About Marathon Fusion Marathon Fusion is an isotope production company, enabling an abundant supply of radioisotopes for the radiopharma industry, and developing isotope technology to deliver clean fusion energy more quickly with better economics. Marathon is supported by leading institutions including the U.S. Department of Energy's ARPA-E, Breakthrough Energy Fellows, 1517 Fund and Übermorgen Ventures. For more information, visit . CONTACT: Kyle Schiller; [email protected] SOURCE Marathon Fusion, Inc. 21% more press release views with Request a Demo