A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor (SSTR)-positive tumors.

开始日期2025-01-01

申办/合作机构

ITM Solucin GmbH

NCT05918302

/ Recruiting临床3期IIT

Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy with 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.

开始日期2023-10-27

申办/合作机构

Itm Isotope Technologies Munich SE

100 项与镥[177Lu]依多曲肽相关的临床结果

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100 项与镥[177Lu]依多曲肽相关的转化医学

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100 项与镥[177Lu]依多曲肽相关的专利（医药）

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项与镥[177Lu]依多曲肽相关的文献（医药）

2024-06-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Safety and Efficacy ofPara-Aminohippurate Coinfusion for Renal Protection During Peptide Receptor Radiotherapy in Patients with Neuroendocrine Tumors

Article

作者: Jentzen, Walter ; van Echteld, Cees J A ; Meckel, Marian ; Fendler, Wolfgang P ; Himmen, Stephan ; Coelho, Marta ; Fragoso Costa, Pedro ; Sraieb, Miriam ; Herrmann, Ken ; Moraitis, Alexandros ; Kersting, David

Para-aminohippurate, also known as p-aminohippuric acid (PAH), is used clinically to measure effective renal plasma flow. Preclinically, it was shown to reduce ¹⁷⁷Lu-DOTATOC uptake in the kidneys while improving bioavailability compared with amino acid (AA) coinfusion. We report the safety and efficacy of PAH coinfusion during peptide receptor radiotherapy in patients with neuroendocrine tumors. Methods: Twelve patients with metastatic or unresectable gastroenteropancreatic neuroendocrine tumors received ¹⁷⁷Lu-DOTATOC in 33 treatment cycles. Either 8 g of PAH or a mixture of 25 g of arginine and 25 g of lysine were coinfused. Safety was assessed by monitoring laboratory data, including hematologic and renal data, as well as electrolytes obtained before and 24 h after treatment. For radiation dosimetry, whole-body scans were performed at 1, 24, and 48 h and a SPECT/CT scan was performed at 48 h, along with blood sampling at 5 min and 0.5, 2, 4, 24, and 48 h after administration. Absorbed dose estimations for the kidneys and bone marrow were performed according to the MIRD concept. Results: In 15 treatment cycles, PAH was coinfused. No changes in mean creatinine level, glomerular filtration rate, and serum electrolytes were observed before or 24 h after treatment when using PAH protection (P ≥ 0.20), whereas serum chloride and serum phosphate increased significantly under AA (both P < 0.01). Kidney-absorbed dose coefficients were 0.60 ± 0.14 Gy/GBq with PAH and 0.53 ± 0.16 Gy/GBq with AA. Based on extrapolated cumulative kidney-absorbed doses for 4 cycles, 1 patient with PAH protection and 1 patient with AA protection in our patient group would exceed the 23-Gy conservative threshold. The bone marrow-absorbed dose coefficient was 0.012 ± 0.004 Gy/GBq with PAH and 0.012 ± 0.003 Gy/GBq with AA. Conclusion: PAH is a promising alternative to AA for renal protection during peptide receptor radiotherapy. Further research is required to systematically investigate the safety profile and radiation dosimetry at varying PAH plasma concentrations.

2024-01-01·Theranostics

Long-term Nephrotoxicity after PRRT: Myth or Reality

Article

作者: Yu, Fei ; Zhang, Jingjing ; Baum, Richard P ; Schuchardt, Christiane ; Fan, Xin ; Jakobsson, Vivianne ; Chen, Xiaoyuan

Rationale: The kidneys are commonly considered as the potential dose-limiting organ for peptide receptor radionuclide therapy (PRRT), making the risk of nephrotoxicity a primary concern. This retrospective analysis with prospective documentation and long-term follow-up aims to assess the risk of nephrotoxicity after PRRT in a large cohort of patients with neuroendocrine neoplasms (NENs) treated at our institution over the past 18 years. Methods: A total of 1361 NEN patients treated with 1-10 cycles of ¹⁷⁷Lu-DOTA-TOC/-NOC/-TATE, ⁹⁰Y-DOTA-TOC/-NOC/-TATE, DUO-PRRT (sequential administration of ⁹⁰Y- and ¹⁷⁷Lu-), or TANDEM-PRRT (combination of ⁹⁰Y- and ¹⁷⁷Lu- on the same day concomitantly) were included in this analysis. All parameters were prospectively documented in a structured database comprising over 250 items per patient and retrospectively analyzed. Kidney function, including serum creatinine, blood urea nitrogen, cGFR, and electrolytes, was evaluated before each PRRT cycle and during follow-up. Restaging was regularly performed at 6-month intervals until death. Treatment-related adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). Results: Between 2000 and 2018, a total of 5409 cycles of PRRT were administered to 1361 NEN patients. Follow-up after complete treatment was available for 1281 patients receiving 4709 cycles of PRRT, with a median follow-up time of 69.2 months (interquartile range, 32.8-110.5 months) and a maximum follow-up time of 175 months. Baseline creatinine levels were normal in 1039/1281 (81.1%) subjects, while grade 1 (G1) renal insufficiency was present in 221/1281 (17.3%) prior to PRRT. G2 was present in 19/1281 (1.5%), and G3 in 2/1281 (0.2%). After treatment, the proportion of G3/G4 grade patients only increased from 0.2% to 0.7%. Mean creatinine levels increased from a baseline of 0.90 ± 0.30 to 1.01 ± 0.57 mg/L (80.0 ± 26.7 to 89.4 ± 50.8 μmol/L) after treatment. In our main analysis cohort of 1244 patients (4576 cycles), 200 patients experienced an increase in CTCAE creatinine grade. Age, number of treatment cycles, type of radionuclides, and length of follow-up time were the main factors affecting CTCAE creatinine grading after treatment. When comparing the subgroups treated with different radionuclides, the risk of nephrotoxicity after ⁹⁰Y treatment alone and the ⁹⁰Y/¹⁷⁷Lu combination group was higher than after ¹⁷⁷Lu treatment alone. In the ⁹⁰Y treatment subgroup, the two significant risk factors for an increased CTCAE creatinine grade were identified to be age (≥60) and a long follow-up time. Conclusions: This retrospective analysis with prospective documentation in a large cohort of 1281 NEN patients receiving 4709 cycles of PRRT co-administered with renal protection, treated through the individualized approach at a single institution over 18 years, did not reveal any evidence of long-term PRRT-related renal toxicity. The results of our study suggest that with the use of proper renal protection, nephrotoxicity due to PRRT is more likely a myth than a reality.

2023-07-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of ¹⁶¹Tb into the Clinic.

Article

作者: Landolt, Stefan ; van der Meulen, Nicholas P ; Grundler, Pascal V ; Talip, Zeynep ; Köster, Ulli ; Sepini, Lebogang ; Schibli, Roger ; Favaretto, Chiara ; Müller, Cristina ; Geistlich, Susanne

¹⁶¹Tb is an interesting radionuclide for application in the treatment of neuroendocrine neoplasms' small metastases and single cancer cells because of its conversion and Auger-electron emission. Tb has coordination chemistry similar to that of Lu; therefore, like ¹⁷⁷Lu, it can stably radiolabel DOTATOC, one of the leading peptides used for the treatment of neuroendocrine neoplasms. However, ¹⁶¹Tb is a recently developed radionuclide that has not yet been specified for clinical use. Therefore, the aim of the current work was to characterize and specify ¹⁶¹Tb and to develop a protocol for the synthesis and quality control of ¹⁶¹Tb-DOTATOC with a fully automated process conforming to good-manufacturing-practice guidelines, in view of its clinical use. Methods: ¹⁶¹Tb, produced by neutron irradiation of ¹⁶⁰Gd in high-flux reactors followed by radiochemical separation from its target material, was characterized regarding its radionuclidic purity, chemical purity, endotoxin level, and radiochemical purity (RCP) in analogy to what is described in the European Pharmacopoeia for no-carrier-added ¹⁷⁷Lu. In addition, ¹⁶¹Tb was introduced into a fully automated cassette-module synthesis to produce ¹⁶¹Tb-DOTATOC, as used for ¹⁷⁷Lu-DOTATOC. The quality and stability of the produced radiopharmaceutical in terms of identity, RCP, and ethanol and endotoxin content were assessed by means of high-performance liquid chromatography, gas chromatography, and an endotoxin test, respectively. Results: ¹⁶¹Tb produced under the described conditions showed, as the no-carrier-added ¹⁷⁷Lu, a pH of 1-2, radionuclidic purity and RCP of more than 99.9%, and an endotoxin level below the permitted range (175 IU/mL), indicating its appropriate quality for clinical use. In addition, an efficient and robust procedure for the automated production and quality control of ¹⁶¹Tb-DOTATOC with clinically applicable specifications and activity levels, that is, 1.0-7.4 GBq in 20 mL, was developed. The radiopharmaceutical's quality control was also developed using chromatographic methods, which confirmed the product's stability (RCP ≥ 95%) over 24 h. Conclusion: The current study demonstrated that ¹⁶¹Tb has appropriate features for clinical use. The developed synthesis protocol guarantees high yields and safe preparation of injectable ¹⁶¹Tb-DOTATOC. The investigated approach could be translated to other DOTA-derivatized peptides; thus, ¹⁶¹Tb could be successfully applied in clinical practice for radionuclide therapy.

项与镥[177Lu]依多曲肽相关的新闻（医药）

2025-04-10

·远大医药官微

远大医药经桡动脉远端通路导管获批上市

近日，远大医药(0512.HK)经桡动脉远端通路导管获批上市。这是公司在心脑血管精准介入诊疗领域血管介入方向的又一次里程碑式进展。在介入治疗中，经股动脉和经桡动脉是两种常用的入路方式。由于经股动脉入路具有快速、操作方便等优点，其仍然是目前脑血管介入的主要入路方式。但是由于股动脉解剖部位较深，术后压迫止血较为困难，易发生穿刺点血肿等并发症。而相比之下，经桡动脉路径可以显著降低穿刺部位血肿、神经损伤等并发症，并且术后恢复快、患者舒适度高等优势。但目前市场上缺乏专门用于经桡动脉入路的产品，大大限制了经桡动脉入路的选择。基于以上，远大医药为更好满足患者的需求，创新性地开发了经桡动脉远端通路导管，该产品专门为经桡动脉入路介入治疗而设计，为临床提供了更多的选择性。随着技术和医疗器械的发展，临床治疗方式和习惯也日新月异。未来，远大医疗器械事业群将继续秉承“以临床和患者需求为核心”的理念，为中国医疗事业的进步添砖加瓦。持续推进高端医疗器械研发打造全球领先精准介入诊疗平台心脑血管精准介入诊疗领域是远大医药核心战略领域之一，公司秉承“精准治疗”的理念，围绕通路管理、结构性心脏病及心衰三个方向进行全方位布局，搭建高端医疗器械产品集群，目前该板块已布局27款产品，有6款产品在研，其中通路管理方向已有20款产品，结构性心脏病已有1款产品在中国获批上市。远大医药在该板块已实现“无源+有源”创新器械平台的全面建设，其中，武汉光谷有源器械研发生产基地和常州无源器械研发生产基地已投入使用，聚焦结构性心脏病领域的上海器械研发中心正式揭牌成立。目前该板块已经和加拿大、德国、意大利、瑞士等多国临床中心或者研发平台进行技术合作，逐步开启迈向全球化研发新进程。公司致力于将该板块打造成为中国乃至全球领先的“心脑血管精准介入诊疗平台”。大家都在看▲远大医药携手六家健康科技企业，共探商业健康险创新发展新路径▲远大医药创新RDC产品ITM-11国内III期临床试验完成首例患者入组给药▲全国爱肝日｜钇90的独白↑↓ 上下滑动了解更多➤关于远大医药远大医药是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。公司以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。「稳增长、强创新、谋布局」，远大医药将继续秉承「综合优势、创新引领和全球拓展」的发展理念，采用「自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展」策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。 ➤前瞻性声明本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

上市批准临床3期

2025-04-09

·GlobeNewswire-Health Care

Barbara Weber, M.D., Elected to ITM Supervisory Board

Garching / Munich, Germany, April 09, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the election of Barbara Weber, M.D., to its Supervisory Board, effective May 01, 2025. The election occurred at ITM’s Extraordinary General Meeting. Dr. Weber is the President, Chief Executive Officer and Founder of Tango Therapeutics (Nasdaq: TNGX). She has over 25 years of executive and research and development leadership experience in biotech, venture capital and at major pharmaceutical companies, including Novartis (NYSE: NVS) and GlaxoSmithKline (NYSE: GSK). ITM’s Supervisory Board and the company overall will benefit from Dr. Weber’s deep expertise as it advances its lead Phase 3 candidate, n.c.a. 177Lu-edotreotide (ITM-11), and continues advancing its radiopharmaceutical pipeline and medical radioisotope manufacturing business. “Dr. Weber’s impressive track record in building transformative oncology biotech companies speaks volumes for her business acumen and her dedication to improving the lives of people living with cancer. Her profound industry and scientific knowledge, including her demonstrated ability to bring novel compounds through the clinic to FDA approval, will be an invaluable asset to ITM,” said Udo J. Vetter, Chairman of the Supervisory Board of ITM. “The expansion of our Supervisory Board and its insights ensures that ITM is optimally positioned to continue accelerating the growth of its radiopharmaceutical pipeline and medical radioisotope business.” Dr. Weber is a physician-scientist with a distinguished clinical and academic career and extensive leadership expertise in global pharmaceutical development. As the President, Chief Executive Officer and Founder of Tango Therapeutics, she led the company’s transition to being publicly listed and the development of its precision oncology product candidates based on the genetic principle of synthetic lethality. As a Venture Partner at Third Rock Ventures, she led teams in creating new oncology drug discovery companies, including Tango Therapeutics, Neon Therapeutics (acquired by BioNTech (Nasdaq: BNTX)) and Relay Therapeutics (Nasdaq: RLAY). “As a physician and business executive devoted to fighting cancer, I recognize the significant potential of targeted radiopharmaceutical therapy to improve the precision oncology treatment paradigm and outcomes for patients. I look forward to working with ITM’s Supervisory Board and Leadership Team as the company plans an NDA submission for ITM-11 and expands its pipeline with various promising alpha- and beta-emitting radioisotopes coupled with novel targeting agents,” said Dr. Weber. Prior to her tenure at Third Rock Ventures, Dr. Weber was Senior Vice President, Oncology Translational Medicine at Novartis and Vice President, Oncology Discovery and Translational Medicine at GlaxoSmithKline, where she was instrumental in leading clinical studies and obtaining FDA approvals for numerous drugs including Zykadia®, Kisqali®, Vijoice® and Promacta®. Dr. Weber received her Doctor of Medicine from the University of Washington and has been affiliated with the University of Pennsylvania, Yale University and the Dana-Farber Cancer Institute. She is a member of the Board of Directors at Tango Therapeutics, Revolution Medicines Inc. (Nasdaq: RVMD), Parabilis Medicines and Sesame Therapeutics. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.com Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachments 20250409_Barbara Weber, M.D., Elected to ITM Supervisory Board Barbara Weber, M.D., Elected to ITM Supervisory Board

高管变更临床3期

2025-03-14

·医药魔方Invest

核药收入狂飙，远大医药净利大涨超30%

2025年3月12日，远大医药发布年报：收益116.45亿港元，同比增长约10.6%；期内溢利24.66亿港元，同比增长约31.3%。尤其亮眼的是，2024年远大医药核药抗肿瘤诊疗板块收入约5.89亿港元，同比增长176.6%，核心产品易甘泰®钇[90Y]微球注射液据称已进入快速放量期。远大医药表示，基于良好的业绩表现，今年董事会建议派发2024年度末期股息每股0.26港元，共约9.10亿港元。年报发布后，3月13日，远大医药盘中股价大涨超21%，成交额超4.6亿港元，收盘价报6.27港元，单日涨幅近19.7%。事实上，这是远大医药2021年以来首次净利润和每股收益同比增长。可见，正是易甘泰®2022年上市后的放量，帮助远大医药走出了集采阴影——当年“押宝”核药、推动创新转型的策略，在2024年看到了回报。远大医药2020年至2024年营业收入和净利润图片来源：wind 如今，“全球四家在肿瘤治疗方面实现核药商业化应用的创新药企之一”的头衔之下，远大医药持续以年超20亿港元的研发投入推进多款核药和RDC产品，可以想见，随着未来创新管线的兑现，远大医药也将完成从“传统药企并购一哥”到“创新核药一哥”的转身。核药爆发，重磅产品箭在弦上易甘泰®钇[90Y]微球注射液的销售业绩，无疑担得起“爆发力最强”的称号。 2024年，该重磅产品拿下了近5亿港元销售收入，同比增速超140%，累计治疗近2000例患者。凭借在核药领域85%的收入贡献占比，易甘泰®钇[90Y]微球注射液已成长为支撑远大医药放射性药物板块的核心支柱。作为全球唯一一款用于结直肠癌肝转移选择性内放射治疗「SIRT」的产品，易甘泰®钇[90Y]微球注射液自2022年国内获批上市后，便实现快速放量。而其出色的业绩表现，则主要得益于临床治疗优势——该产品在原发性肝癌和结肠癌肝转移领域为大量用药选择有限的患者提供了全新治疗选择，能够实现肝癌降期并帮助患者实现临床治愈，这正是过去传统治疗手段无法实现的。从年报来看，远大医药核药抗肿瘤诊疗板块共有约800名员工，其中全球销售人员便超过500人，人均销售收入近100万港元。而在易甘泰®钇[90Y]微球注射液之后，核药板块的另一款重磅产品也即将走向商业化。截至2024年年底，远大医药在RDC领域有3款产品处于临床III期阶段，分别是前列腺癌诊断核药TLX591-CDx、透明细胞肾细胞癌诊断核药TLX250-CDx和胃肠胰神经内分泌瘤治疗性核药ITM-11。其中，TLX591-CDx预计今年可以完成III期临床研究。而该药在海外市场的表现，也足见其商业前景。得益于优异的临床诊断优势，TLX591-CDx在海外上市仅两年累计取得超7亿美元收入，而作为远大医药在核药产品领域的重要合作伙伴，核药公司Telix也迎来了股价攀升，市值突破100亿澳元。今年3月份，远大医药曾1.3亿元出售Telix部分股权，所得款项则用于集团在未满足需求领域的临床开发计划，包括与Telix合作开展的项目。另外，用于诊断透明细胞肾细胞癌的RDC药物TLX250-CDx向FDA递交的新药上市申请，则已获得受理，并进入了优先审评。目前，远大医药的自研核药销售首选美国市场准入。从公开的年报交流纪要来看，远大医药希望今年起，每年至少有一个产品向FDA递交临床申请，2028-2029年，首个产品完成临床试验并向FDA递交上市申请，并凭借自身及联营公司在海外的注册临床营销体系推动自研核药出海。后来者借力强势布局事实上，在核药这一超百亿元级别的蓝海市场，远大医药并非最早的闯入者。由于核素的放射性和半衰期，注定了核药的开发和市场布局迥异于一般药物。而风险性，则决定了其在研发、生产和经营的过程中，受到多方面特殊监管，有着令人望而生畏的进入壁垒。即便层层打通全产业链关卡，拿到药品批文要想迅速实现药品销售放量，也是难乎其难。品牌认知和物流配送，都是重大障碍。过去很长时间，国内核药市场份额几乎被中国同辐和东诚药业双寡头收割。2018年起，后来者远大医药选择了“借力”，通过数起收购和合作，加速在核药领域的布局——先是收购Sirtex向核药全球化布局迈出关键一步，而后收购北京普尔伟业，获得了放射性药品生产许可证和经营许可证。拿下入场券后，远大医药下一步筹划的就是产业链和产品。一方面，它通过与江苏省原子医学研究所和中国生态环境部核与辐射安全中心形成战略合作，构建了从研发、生产到监管的完整核药产业链；另一方面，它的目光放眼全球，选择与Telix合作，引入了多款RDC药物。事实上，核药抗肿瘤诊疗板块是远大医药全球化程度最高的板块之一。过去数年里，这家药企联合Sirtex并与Telix和ITM合作，搭建了肿瘤介入技术平台和RDC技术平台。与此同时，为强化自主创新根基，远大医药携手山东大学成立了远大医药－山东大学放射药物研究院。如此种种布局，都助力了其打造“全球技术引进+本土研发迭代”的双轮驱动模式，而这正是其核药管线临床转化效率位居行业前列的关键支撑。眼下，远大医药的核药研发平台已经储备了24条创新管线，自研产品多达50%。其中，处于注册性研发阶段的管线有12条，大多处于临床后期。三大板块发力，构筑创新护城河核药之外，作为一家横跨介入诊疗科技、制药科技、生物科技三大领域的药企，远大医药同样在创新转型，主要途径便是通过快速收购引进和加速研发的方式，针对性强化呼吸及危重症和五官科领域。 2024年，呼吸及危重症板块实现收入17.1亿港元，同比增长26.9%。具体来看，其在售产品覆盖鼻炎、支气管炎、肺炎、哮喘、慢性阻塞性肺部疾患等多个适应症。核心产品切诺（桉柠蒎肠溶胶囊）、恩卓润®比斯海乐®和恩明润®比斯海乐®均为全国独家品种，处于细分领域的领先地位。从未来业绩驱动来看，其核心动力则主要来自Ryaltris®复方鼻喷剂NDA受理及对百济制药的收购。目前，远大医药已完成百济制药100%股权的变更登记，并获得其技术领先的鼻喷制剂技术平台。同时，百济制药的产品也将与远大医药的鼻喷剂形成产品组合，全面满足轻、中、重度过敏性鼻炎患者的用药需求。另一个拉动远大医药业绩增长的板块，则是五官科。其中，创新眼药领域是远大医药的重要战略方向之一。从后续产品来看，用于治疗翼状胬肉的创新改良型新药CBT-001在中国开展的III期临床研究完成了首例患者入组给药；用于眼科术后抗炎镇痛的激素纳米混悬滴眼液GPN00833完成了在中国开展的III期临床研究并成功达到了临床终点；用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768 (TP-03，洛替拉纳滴眼液，0.25%)则已向药监局递交了NDA并获得受理。同时，远大医药持续拓展产业布局，于年内与联拓生物、Tarsus以及箕星药业达成战略合作，扩充了目前全球首款且唯一一款获批治疗轻、中、重度干眼的无防腐剂、多剂量、无菌包装鼻喷雾剂酒石酸伐尼克兰鼻喷雾剂（OC-01）在内的多款全球创新产品。如今，这家药企在仿制药集采压力下，已经收到创新转型的回报。而回顾远大医药的战略布局，不难发现其业绩持续增长的背后，实则是一套清晰的逻辑，即通过全球视野布局前沿技术，再以本土化能力和自研能力将其快速实现商业化，与此同时，借助收购全方位补强。一组数据显示，2024年，远大医药在研发及项目投入的22.7亿港元，已经推动了63项重大里程碑进展，新增14款商业化产品。不过有些不足的是，远大医药2024年的毛利率出现了下滑，同比下降约4个百分点至57.9%。未来，远大医药的市场表现如何，很大程度上取决于上述产品能否转化为更多可期待的增长点，以及并购后的整合效应。我们也将继续保持关注。推荐阅读 Biotech转型CDMO成功！东曜药业2024年首次扭亏为盈超125亿元BD，让康宁杰瑞盈利了 Copyright © 2025 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床3期放射疗法财报上市批准

100 项与镥[177Lu]依多曲肽相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
SSTR阳性胃肠胰神经内分泌肿瘤	临床3期	中国	ITM Solucin GmbH	2025-02-11
SSTR阳性胃肠胰神经内分泌肿瘤	临床3期	中国	远大医药（中国）有限公司	2025-02-11
肺神经内分泌肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
肺神经内分泌肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27
肺神经内分泌肿瘤	临床3期	西班牙	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	西班牙	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03049189 (COMPETE, Company_Website \| NEWS) 人工标引	临床3期	胃肠胰神经内分泌肿瘤	309	ITM-11	鑰膚鬱夢構膚蓋糧壓網(鏇壓獵願廠廠獵築齋選) = 鏇餘壓鑰遞廠築艱膚選夢鏇憲繭繭顧膚顧餘簾 (觸餘齋範鑰襯製鹹夢鑰 ) 达到更多	积极	2025-01-28
NCT03049189 (COMPETE, Company_Website \| NEWS) 人工标引	临床3期	胃肠胰神经内分泌肿瘤	309	Everolimus	鑰膚鬱夢構膚蓋糧壓網(鏇壓獵願廠廠獵築齋選) = 鹽窪醖獵艱鏇鏇鏇糧觸夢鏇憲繭繭顧膚顧餘簾 (觸餘齋範鑰襯製鹹夢鑰 ) 达到更多	积极	2025-01-28
NCT04194125 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM	鏇鏇鹽鏇餘憲艱淵鏇願(觸餘製繭艱壓憲蓋齋壓) = 蓋齋衊繭艱餘鏇膚憲獵鹹構衊壓顧鏇糧窪醖齋 (獵簾鑰遞鬱膚積構淵鏇, 16.0 ~ NR) 更多	积极	2023-10-22
NCT04194125 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM (panNET)	鏇鏇鹽鏇餘憲艱淵鏇願(觸餘製繭艱壓憲蓋齋壓) = 淵願糧醖選憲網鹹憲鏇鹹構衊壓顧鏇糧窪醖齋 (獵簾鑰遞鬱膚積構淵鏇, 14.0 ~ NR)	积极	2023-10-22
SNMMI2023	N/A	胃肠胰神经内分泌肿瘤	-	4 cycles of PRRT	醖選艱觸夢繭艱獵廠衊(顧窪齋餘簾鏇膚遞構簾) = 27 of these 36 patients (75%; 14 SI-NET; 4 CUP-NET; 9 P-NET) experienced PD in iStaging 願鏇鏇夢鬱網顧獵廠鑰 (鹽製膚獵鹽憲鹽憲餘願 ) 更多	-	2023-08-28
SNMMI2022	N/A	胃肠胰神经内分泌肿瘤	-	[177Lu]DOTATOC (GEP-NET patients)	鏇選構醖簾鹽蓋構顧鬱(繭遞鏇築願夢選艱顧願) = 願壓糧觸廠憲網鏇遞廠製鬱網鏇憲範醖廠觸鑰 (遞築築襯網齋積顧鑰蓋 ) 更多	-	2022-08-08
SNMMI2019	N/A	-	-	Lu-177 DOTA-LM3	艱網糧顧壓獵淵廠齋願(繭範鹽構鑰築夢夢鹽憲) = 齋鏇簾繭顧窪壓衊壓顧餘齋艱淵淵廠夢鹹壓積 (憲衊壓選齋顧齋糧憲廠 ) 更多	-	2019-05-21
SNMMI2019	N/A	-	-	Lu-177 DOTATOC	艱網糧顧壓獵淵廠齋願(繭範鹽構鑰築夢夢鹽憲) = 淵鹽夢繭鬱觸鹹夢窪鬱餘齋艱淵淵廠夢鹹壓積 (憲衊壓選齋顧齋糧憲廠 ) 更多	-	2019-05-21
NCT03049189 (COMPETE, ESMO2018)	临床3期	胃肠胰神经内分泌肿瘤	300	Everolimus	艱淵鑰構鑰淵窪觸築膚(鑰鑰網鑰餘獵淵網淵顧) = 鹹齋淵廠憲蓋鑰願範遞膚廠鬱選淵鹽衊製積夢 (鬱範夢壓繭窪鹽願鏇鹹 )	-	2018-10-21