地舒单抗(Denosumab) - 药物靶点：RANKL_在研适应症：糖皮质激素诱导的骨质疏松症，恶性肿瘤体液性高钙血症，类风湿关节炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

anti-RANKL antibody、Denosumab (Genetical Recombination)、Denosumab (genetical recombination) (JAN)

+ [10]

靶点

RANKL

作用机制

RANKL抑制剂(肿瘤坏死因子配体超家族成员11抑制剂)

治疗领域

肿瘤免疫系统疾病心血管疾病+ [7]

在研适应症

糖皮质激素诱导的骨质疏松症恶性肿瘤体液性高钙血症类风湿关节炎+ [15]

非在研适应症

晚期乳腺癌晚期癌症晚期非小细胞肺癌+ [43]

原研机构

Amgen, Inc.

在研机构

Amgen, Inc.Amgen Ltd.Amgen Europe BV

+ [5]

非在研机构

Daiichi Sankyo, Inc.

GSK Plc

Celgene Corp.

+ [2]

最高研发阶段批准上市

首次获批日期

欧盟 (2010-05-26),

代谢性骨病骨折绝经期后骨质疏松

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本)、临床急需境外新药 (中国)、孤儿药 (美国)

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序列信息

Sequence Code 94568L

来源: *****

Sequence Code 143522H

来源: *****

关联

353

项与地舒单抗相关的临床试验

NCT06504966 / Not yet recruiting临床3期

A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced From the European Union in Postmenopausal Women With Osteoporosis

Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

开始日期2025-10-01

申办/合作机构

Xentria, Inc.初创企业

NCT06588153 / Not yet recruiting临床4期

A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Subjects With Glucocorticoid-induced Osteoporosis in Mainland China

The main objective of this study is to evaluate the efficacy of Prolia® in improving bone mass density (BMD) of lumbar spine at month 12.

开始日期2025-05-27

申办/合作机构

Amgen, Inc.

NCT06720350 / Not yet recruiting临床4期IIT

Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures

The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is under at least 2 years of denosumab treatment. The main questions aimed to answer are:
* Does it effective to prevent fractures add Romosozumab to ongoing denosumab treatment?
* If it is appropiate to quit denosumab for starting 1 year romosozumab treatment?
* If there is complications in denosumab and romosozumab combination treatment?
Researchers will compare the Romosozumab 210mg subcutaneous(sc) monthly plus denosumab 60mg per 6 months sc treatment to prooceeding denosumab treatment and romosozumab 210mg monthly treatment in patient whom denosumab cessaced.
Participians are postmenopousal women with osteoporosis and they are under at least 2 years of treatment with denosumab and they will:
* Add 210 mg monthly romosozumab sc injection or switch to 210 mg monthly romosozumab sc injection or proceed 60mg per 6 months denosumab sc injection
* Visit the clinic at least once every 3 months and first month of new treatment regimen, blood tests per 3 months and Bone mineral density examination per 6 months
* Keep a diary of their symptoms

开始日期2025-01-15

申办/合作机构

Marmara University

100 项与地舒单抗相关的临床结果

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100 项与地舒单抗相关的转化医学

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100 项与地舒单抗相关的专利（医药）

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4,463

项与地舒单抗相关的文献（医药）

2025-03-01·BONE

SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial

Article

作者: Urboniene, Audrone ; Mordaka, Robert ; Supronik, Jerzy ; Baek, Ki-Hyun ; Eastell, Richard ; Dokoupilova, Eva ; Langdahl, Bente ; Rosa, Jan ; Plebanski, Rafal ; Ahn, Sohui ; Rho, Young Hee ; Mydlak, Andrzej ; Sapula, Rafal ; Chung, Yoon-Sok ; Rowińska-Osuch, Anna ; Ban, Jisuk ; Czerwinski, Edward

PURPOSE:

This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16.

METHODS:

457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period.

RESULTS:

Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16.

CONCLUSION:

Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.

2025-02-01·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR CELL RESEARCH

RANKL regulates differentially breast cancer stem cell properties through its RANK and LGR4 receptors

Article

作者: Melendez-Zajgla, Jorge ; Castro-Oropeza, Rosario ; Ordaz-Ramos, Alejandro ; Rodriguez-Dorantes, Mauricio ; Zampedri, Cecilia ; Diaz-Blancas, Jorge ; Romero-Rodríguez, Damaris P ; Martínez-Cruz, Aketzalli ; Maldonado, Vilma ; Vazquez-Santillan, Karla

BACKGROUND:

Breast cancer stem cells (BCSC) are a subpopulation responsible for cancer resistance and relapse. The receptor activator of nuclear factor kappa-Β ligand (RANKL) is a cytokine capable of activating RANK and LGR4 receptors. RANKL/RANK signaling maintains the self-renewal of BCSCs, however, the effect of RANKL via LGR4 remains unclear. Evidence from osteoclasts suggests that RANKL/LGR4 axis disrupts RANK signaling, leading to opposing cellular responses. Anti-RANKL inhibitors are potential agents for eradicating CSCs, but their effect on RANKL/LGR4 signal has not been demonstrated.

OBJECTIVE:

This project aimed to elucidate the role of RANKL in regulating stemness depending on the expression of its receptors.

METHODS:

We use in vitro and in vivo approaches to evaluate the effects of RANKL inhibition in stemness in low or high-LGR4 expressing cells. Furthermore, we analyze the effects of RANKL stimulation on the stemness of LGR4 or RANK overexpressing cells. Additionally, we evaluated the impact of RANKL/LGR4 signaling in the activity of Wnt/β-catenin and NF-κB signaling pathways.

RESULTS:

Our findings indicated that elevated RANKL expression is related to a favorable prognosis in patients with high LGR4 levels. Furthermore, RANKL inhibition decreased BCSC properties in LGR4-low cell lines, while it promoted migration in LGR4-high cells. Additionally, the RANKL/RANK axis activated NF-κB signaling and enhanced BCSCs in RANK-overexpressing cells. In contrast, in LGR4-overexpressing cells, RANKL failed to activate NF-κB but instead inhibited the Wnt/β-catenin pathway, leading to a reduction in BCSCs.

CONCLUSION:

Our findings suggest that RANKL exerts different responses according to the expression of its receptors.

2025-01-01·DIABETES OBESITY & METABOLISM

Diabetic Charcot neuroarthropathy: A threat to both limb and life

Review

作者: Bell, David S. H. ; Jerkins, Terri

Abstract:

Diabetic Charcot neuroarthropathy (DCN), first described in 1936, occurs in less than 1% of diabetic patients, but in those diabetic subjects with distal symmetrical polyneuropathy, the overall incidence increases to 30% and the risk is even greater in those with type 1 diabetes. Factors that precipitate DCN are trauma, ischaemia due to arterio‐venous shunting, increased osteoclastic activity and inflammation. DCN usually presents with a painless swollen foot and/or ankle which is ‘hot to the touch’. These clinical findings are soon followed by characteristic magnetic resonance imaging (MRI) abnormalities and later X‐ray changes. The joints that are most typically involved in chronological order are the tarsometatarsals followed by the naviculocuniform, sub‐tarsal, talonavicular and metatarsal and tarsophalangeal. The cornerstone of therapy is prolonged (3–12 months) offloading with immobilization. Bisphosphonates may possibly accelerate recovery, whereas other unproven possible therapies include rhPTH, 1–34, calcitonin and methylprednisolone, which are not only ineffective but in some cases may also prolong the time to healing. Denosumab is potentially an efficacious, if unproven, therapy to accelerate healing. The risk of amputation is high and increases in the presence of a foot ulcer. DCN is associated with manifestations of autonomic neuropathy, including cardiac denervation, so that the risks of a cardiac event and heart failure are increased with DCN. Mortality is also increased with DCN, especially in the presence of a foot ulcer. To avoid the recurrence of DCN and especially to lower the risk of the recurrence of a foot ulcer recurrence reconstructive, surgery may be needed.

585

项与地舒单抗相关的新闻（医药）

2024-12-17

·PRNewswire

GlycoNex Announces First Patient Dosed in Phase 3 Clinical Trial for Denosumab Biosimilar

GlycoNex developing denosumab biosimilar, SPD8, for the treatment of osteoporosis NEW TAIPEI CITY, Taiwan, Dec. 17, 2024 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that the first patient has been dosed in the Phase 3 clinical trial of its denosumab biosimilar, SPD8. This marks the initiation of a pivotal trial to evaluate SPD8 for the treatment of osteoporosis, with unblinded results expected in the second quarter of 2026. SPD8, co-developed with Mitsubishi Gas Chemical Company (MGC), is a biosimilar to Xgeva and Prolia (denosumab), a widely used therapy to prevent skeletal-related events in patients with bone metastases from solid tumors as well as osteoporosis. Phase 1 clinical trials confirmed SPD8's safety and pharmacokinetic equivalence to the reference drug, enabling this critical next step in development. To support the trial and regulatory submission efforts, GlycoNex and EirGenix, Inc.—Taiwan's largest CDMO—have established a production agreement for the large-scale manufacturing of SPD8. "The initiation of this Phase 3 trial and the dosing of the first patient are significant achievements in the development of SPD8," said Dr. Mei-Chun Yang, CEO of GlycoNex. "As the demand for osteoporosis treatments continues to grow, we are committed to providing affordable and effective options that improve patient care worldwide." Denosumab, marketed as Xgeva and Prolia, is a leading treatment for bone loss and cancer-related skeletal complications. In 2023, global sales of denosumab products reached USD 6.1 billion, highlighting the need for cost-effective biosimilar alternatives. With osteoporosis prevalence rising and an aging population in Asia, SPD8 is poised to address this growing demand. In addition to advancing SPD8, GlycoNex continues to expand its oncology pipeline. The company's lead monoclonal antibody, GNX102, has completed Phase 1 clinical trials, demonstrating excellent safety and tolerability. GlycoNex is also preparing GNX102 for development as an antibody-drug conjugate (ADC) through a collaboration with Sterling Pharma Solutions. These initiatives underscore GlycoNex's expertise in advancing impactful therapies for global health challenges. About GlycoNex Inc. GlycoNex Inc. is a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies that effectively inhibit tumor growth while minimizing side effects. GlycoNex possesses a robust pipeline led by GNX102, a humanized monoclonal antibody (mAb) designed to target abnormal sugar molecules in cancer cells. GNX102 has successfully completed Phase 1 clinical trials with data demonstrating excellent safety and promising efficacy. GlycoNex is also advancing a portfolio of antibody-drug conjugates (ADCs) that precisely attack cancer cells while sparing healthy tissue. GlycoNex is headquartered in New Taipei City, Taiwan. For more information, visit . Contact s for GlycoNex, Inc. Investor Relations Tiberend Strategic Advisors, Inc. David Irish [email protected] Media Relations Eric Reiss [email protected] SOURCE GlycoNex, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床3期免疫疗法

2024-12-17

·求实药社

biotech龙头急需自证！两大利好却迎来股价大跌！

今年以来，A股创新药企赴港上市迎来热潮。迈威生物最新公告显示，“为满足公司经营发展的资金需求”和“提升国际化水平”，计划在港交所主板上市，目前具体细节尚未确定。当晚，公司发布了另一则公告，宣布迈威生物计划与重庆高新区管委会、“大健康基金”签订项目投资合作协议，共同出资建设迈威生物的骨健康创新药项目，预计总投资额为20亿元人民币。该项目将依托西部（重庆）科学城生物药CDMO先进制造基地，使用约3500平方米的厂房/楼宇，专注于骨健康领域。 12月16日，迈威生物在披露两项重要举措后股价大跌，大幅收跌6.65%。交易行情显示，迈威生物12月16日平盘开盘，开盘价为22.7元/股，开盘后股价迅速下挫，盘中一度跌逾8%，随后迈威生物股价呈震荡走势，最终收于21.19元/股，收跌6.65%。股价大跌的原因，外界猜测，可能是因为当前创新药行业面临诸多挑战，迈威生物虽然在进行一系列的积极布局，但是公司尚未跨入盈利的门槛。与此同时，巨额的研发投入，也导致公司上市以来货币资金储备持续缩水，整体市场情绪较为谨慎，投资者对创新药企的投资决策更加审慎。此次迈威生物官宣赴港，也赶上了A股上市公司赴港二次上市的大潮。除迈威生物外，年内已有康乐卫士、百利天恒、恒瑞医药等多家生物医药公司官宣赴港IPO。 3款商业化产品提供收入来源迈威生物是一家全产业链布局的创新型生物制药公司，聚焦于肿瘤和年龄相关疾病，涉及肿瘤、自身免疫、骨疾病、眼科、血液、感染等治疗领域。现有 15 个品种处于不同阶段，包括 11 个创新品种和 4 个生物类似药，其中 3 个品种上市，1 个品种药品上市许可申请已获受理，3 个品种处于关键注册临床试验阶段。迈威生物于2022年1月18日登陆科创板，募集资金净额为33.03亿元，目前还是一家尚未实现盈利的标“U”企业。事实上，迈威生物目前已经有3款商业化产品为公司提供收入来源，包括与君实生物合作开发并在2022年获批上市的阿达木单抗（9MW0113，君迈康），以及随后在2023年及2024年陆续获批的两款地舒单抗（9MW0311，迈利舒和9MW0321，迈卫健）。除了已经获批上市的产品之外，迈威生物另有3款在研重要产品正在快速推进，或许有望在未来成为收入的新来源，包括8MW0511、9MW0813以及9MW2821。其中，8MW0511是迈威生物自研的1类创新长效升白药，该产品的新药申请已经在2023年12月获得国家药监局受理，预计将在2025年获批上市。8MW0511可用于治疗肺癌、乳腺癌、尿路上皮癌、宫颈癌、食管癌等领域的患者，而且还能与适用于骨巨细胞瘤适应症的地舒单抗（迈卫健）形成协同效应。 9MW0813是一款重组人血管内皮生长因子受体-抗体融合蛋白，适应症为糖尿病性黄斑水肿和新生血管性（湿性）年龄相关性黄斑变性，其与原研药艾力雅的头对头比较临床III期研究已于2024年8月完成，预计年底前后获得研究数据。迈威生物计划在2025年递交该产品的上市申请。相比之下，9MW2821属于迈威生物在研产品之中的重中之重，该产品为靶向Nectin-4的抗体偶联药物（ADC），目前同步开展的管线超过6个，适应症包括尿路上皮癌、宫颈癌、食管癌、乳腺癌等。今年7月，随着9MW2821用于治疗局部晚期或转移性Nectin-4阳性三阴性乳腺癌的适应症获得FDA授予快速通道认定，该产品目前已获得FDA授予3项快速通道认定，另外两项分别是治疗晚期、复发或转移性食管鳞癌，既往接受过含铂化疗方案治疗失败的复发或转移性宫颈癌。截至2024年9月底，9MW2821已获准启动2项III期关键注册临床研究，分别用于治疗宫颈癌和联合PD-1单抗一线治疗尿路上皮癌。面临扭亏难题业绩压力下寻求出路不管是筹划赴港上市，还是重金投建骨健康创新药项目，或是迈威生物在业绩压力下作出的重要尝试。虽然目前已经有3款商业化产品为公司贡献收入，但迈威生物的净利仍处于持续亏损状态，今年前三季度净利出现增亏。迈威生物于2022年正式登陆科创板时，曾募得资金总额34.77亿元，扣除各项费用后募资净额为33.03亿元，较原先计划募资超募3.23亿元。从实际募资金额来看，迈威生物的表现已经“跑赢”绝大部分在科创板上市的医药企业。随着募资到账，迈威生物账上现金及现金等价物余额由2022年年初的9354.46万元飙升至当年年底的24.90亿元。财务数据显示，2022—2023年，迈威生物实现的营业收入约为0.28亿元、1.28亿元；对应实现的归属净利润约为-9.55亿元、-10.53亿元。今年前三季度，迈威生物实现的营业收入约为1.41亿元，同比增长41.79%；对应实现的归属净利润约为-6.94亿元，同比下降3.09%。根据迈威生物2024年半年报，公司拥有15个处于临床或上市阶段的核心品种，包括11个创新药、4个生物类似药，覆盖肿瘤、免疫、骨疾病、眼科、血液等多个重大疾病治疗领域。其中，已上市品种3个，处于上市许可审评阶段品种1个，处于III期关键注册临床阶段品种3个，处于其他不同临床阶段品种8个。截至2024年9月底，迈威生物账上现金及现金等价物余额为15.98亿元，较2023年同期减少11.66%。结合运营现状，可以预见迈威生物将在未来很长一段时间内继续面临入不敷出的局面。今年以来，A股上市公司赴港上市队伍持续扩容。年内，美的集团、龙蟠科技、顺丰控股三家公司先后登陆港交所。而在美的集团之前，上一家A股上市公司在港上市还要追溯到2023年1月的亿华通。今年以来A股biotech密集赴港 2024年以来A+H迅速升温，离不开政策方面的支持。早在今年4月，中国证监会就曾发布5项资本市场对港合作措施，其中之一就是支持内地行业龙头企业赴香港上市。今年10月，香港证监会和港交所发布联合声明，称将优化审批流程时间表。声明称，对于已于A股上市的公司，若符合相应的条件可以按照快速审批时间表进行审批。在此背景下，A股上市公司赴港二次上市案例明显增多。除已经上市的美的集团、龙蟠科技、顺丰控股外，还有均胜电子、安井食品、盛新锂能、赤峰黄金等公司官宣将赴港上市或已经正式递表港交所。与此同时，多家生物医药公司也抛出了赴港上市计划。今年1月及7月，康乐卫士、百利天恒先后递表港交所。12月9日，恒瑞医药也官宣将在港交所上市。与迈威生物类似，上述公司也表示将通过赴港上市夯实资金储备、推进国际化业务发展等。据蓝鲸新闻不完全统计，目前，已有君实生物、药明康德、百济神州、白云山等19家生物医药上市公司实现了A、H两地同时上市。但上一家A股上市公司在港上市，还要追溯到2021年的凯莱英。若未来康乐卫士、百利天恒、恒瑞医药、迈威生物等公司的上市进程顺利推进，A+H生物医药公司数量或将突破20家。结语业内分析指出，国内创新药企拟赴港上市对于国际资金而言还是比较有吸引力的，便于国际资金更直接地参与投资。创新药企赴港上市也不仅仅是为了融资，也为了获取一个国际化的资本平台，更有利于创新药企的国际化战略落地执行。而对于迈威生物此次赴港，投资者之所以不看好，更主要或是因为该公司管理层“烧钱太快”，业绩兑现未达预期。对于投资者而言，迈威生物的H股上市及骨健康创新药项目的投资带来了较大挑战。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。联系我们 ABC 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩

IPO上市批准生物类似药

2024-12-16

·健识局

30多亿，不到3年就不够花了，创新药企赴港二次上市

12月15日，迈威生物公告称筹划在港股二次上市，公司会根据股东大会决议有效期内选择适当的时机和发行窗口完成；同时明确表示，这项战略目标主要意在满足经营发展的资金需求，希望借此提升公司国际化水准。 2022年，迈威生物才在上海证券交易所完成科创板上市，彼时超预期拿到了34.77亿元的融资。这才不到三年时间，钱就不够花了。财报显示，由于创新研发过大投入，迈威生物已经连年亏损，2022年、2023年和2024年一季度的归属净利润分别为-9.552亿元、-10.53亿元和-2.057亿元；过去7年，公司累计亏损超过46亿元。眼下，迈威陷入了典型的Biotech“后期乏力”困境：高预期融资开头，高投入临床研发，高估值后续融资跟不上。目前，迈威生物在A股总市值不低，为84.68亿元，但目前A股一级市场环境之下，想再融资确实十分艰难。如果此番港股上市成功，投资者也会担心港股低估值是否会影响A股的基本盘。另外，12月16日，迈威生物宣布在重庆有合资总额20亿元的“迈威生物骨健康创新药”项目。这个项目带来的现金流压力，也令投资者忧心。当下，只要没有新鲜的现金到账，企业走的每一步都相当于在投资者心尖跳舞。消息一出，公司股价在盘中大跌逾7%。对迈威生物而言，这步棋不得不走，而且它也不是第一个。随着港股IPO的回暖，康乐卫士、百利天恒、东阳光药、恒瑞医药等都曾发布公告筹划赴港再上市。据LiveReport大数据统计，目前已实现内地及香港两地上市的生物医药企业约有20家。 “A+H”两地上市，已经成为药企“输血”的新方式。 Biotech满地找钱迈威生物已经算是一个“有货”的Biotech，研发管线涉及Nectin-4 ADC、B7-H3 ADC、Trop-2 ADC、CD47/PD-L1双抗、ST2单抗、TMPRSS6单抗、IL-11单抗等，手握15个不同阶段的品种，包括已上市的三款生物类似药：两款不同含量的地舒单抗注射液、阿达木单抗注射液。但近年来，生物类似药的销量不及预期，后续管线竞争压力大、青黄不接，大多还未走到商业化阶段，迈威生物就已经迎来了一批竞争对手。截至2024年三季度末，迈威生物的现金及现金等价物仅约15.98亿元，靠余额搞研发已经捉襟见肘。而且公司自我造血能力并不强，主要以技术服务和抗体药物为收入来源，将将过亿的收入在大额研发投入面前无疑是杯水车薪，目前，公司营运资金主要依赖于外部融资。据财报数据，2022年和2023年，公司的研发费用分别为7亿余和8亿余元，占当期营收比重分别高达2735.89%和653.79%。就在前不久，迈威生物还表示：2024年前三季度，公司仍得投入大量资金用于品种管线的临床前研究、临床试验及新药上市准备。与之对应，2024年前三季度，迈威生物实现营业总收入1.41亿元，同比增长41.79%，但净亏损6.94亿元，同比扩大3.09%。想去H股二次上市，迈威生物也是想“曲线救国”。12月9日，已在A股上市的“医药一哥”恒瑞医药就通过了赴港上市审计，早有外媒表示，恒瑞计划通过此次股票发行至少能筹集20亿美元。迈威亟需复刻这样的战略以求回血，不过目前的赴港计划离真正落地实行，还要很久。根据行研报告，2024年香港市场共有64家公司首发上市，融资额834亿港元。与去年相比IPO数量下降了6%，但融资额上升了80%。有机构预计，香港2025年有望重返全球前三。 “赴港”已成趋势，意在国际化此次，迈威生物若在港交所上市，将能实现加快出海。能获得更多的国际视野，是迈威生物最看重的。吸引国际资金不仅是为了融资，而是站到国际化的资本平台更有利于出海等BD交易的转化。这就比较契合迈威生物“出海”的长线发展战略。 2024年前三季度，迈威生物已先后与巴西、约旦、秘鲁制药公司达成合作协议。截至三季报披露日，公司已完成覆盖海外市场数十个国家的正式合作协议或框架协议的签署，累计里程碑金额达1428.5万美元。公司还将以约定价格进行商业化供货或获得至高两位数销售分成。走“国际化”之路，已不再是国内药企发展秘闻。今年以来，国家不断发布新规出手帮扶。4月19日，中国证券监督管理委员会发布了5项资本市场对港合作措施，支持内地龙头企业赴港上市；10月18日，香港证监会及香港交易所联合宣布将优化港股IPO审批流程。其中，预计市值不少于100亿港元的A股上市公司如果赴港上市，将享受快速审批通道。政策端的支持，让大把的A股企业将目光转移，赴港IPO迎来了爆发式的窗口期。港交所中国区上市发行服务部主管韩颖曾公开表示：截至今年10月底，香港交易所共迎来了132家医疗健康领域的IPO发行，其中18A生物科技公司数量为67家，总融资额超过1218亿港元。国内资本市场是否就此回暖？业内人士表示还需慎重看待：目前港股IPO药企更多是表达出递表意愿，最终落地结果还没有定论，目前，整个市场活钱还是有限。撰稿丨苗苗编辑丨江芸贾亭运营｜王苗嫦插图｜视觉中国声明：健识局原创内容，未经许可请勿转载国家医保局公布2025工作重点；跨国械企中国区大裁员；第一三共投资11亿元国内建厂美国药店也不行了砍掉所有临床管线，又一跨国药企退出乙肝领域？

财报抗体药物偶联物IPO生物类似药

100 项与地舒单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03684	地舒单抗	M05BX04	DB06643

研发状态

批准上市

10 条最早获批的记录,

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后查看更多信息

适应症	国家/地区	公司	日期
糖皮质激素诱导的骨质疏松症	美国	Amgen, Inc.	2018-05-18
恶性肿瘤体液性高钙血症	美国	Amgen, Inc.	2018-01-04
类风湿关节炎	日本	Daiichi Sankyo Co., Ltd.	2017-07-03
骨癌	日本	Amgen, Inc.	2012-01-18
多发性骨髓瘤	日本	Amgen, Inc.	2012-01-18
骨病	欧盟	Amgen Europe BV	2011-07-13
骨病	冰岛	Amgen Europe BV	2011-07-13
骨病	列支敦士登	Amgen Europe BV	2011-07-13
骨病	挪威	Amgen Europe BV	2011-07-13
骨巨细胞瘤	欧盟	Amgen Europe BV	2011-07-13
骨巨细胞瘤	冰岛	Amgen Europe BV	2011-07-13
骨巨细胞瘤	列支敦士登	Amgen Europe BV	2011-07-13
骨巨细胞瘤	挪威	Amgen Europe BV	2011-07-13
骨转移癌	美国	Amgen, Inc.	2010-11-18
骨质疏松症	澳大利亚	Amgen Australia Pty Ltd.	2010-06-07
代谢性骨病	欧盟	Amgen Europe BV	2010-05-26
代谢性骨病	冰岛	Amgen Europe BV	2010-05-26
代谢性骨病	列支敦士登	Amgen Europe BV	2010-05-26
代谢性骨病	挪威	Amgen Europe BV	2010-05-26
骨折	欧盟	Amgen Europe BV	2010-05-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非典型神经性厌食	临床3期	美国	Amgen, Inc.	2017-10-25
喂食及进食障碍	临床3期	美国	Amgen, Inc.	2017-10-25
成骨不全	临床3期	美国	Amgen, Inc.	2015-06-24
成骨不全	临床3期	澳大利亚	Amgen, Inc.	2015-06-24
成骨不全	临床3期	比利时	Amgen, Inc.	2015-06-24
成骨不全	临床3期	保加利亚	Amgen, Inc.	2015-06-24
成骨不全	临床3期	加拿大	Amgen, Inc.	2015-06-24
成骨不全	临床3期	捷克	Amgen, Inc.	2015-06-24
成骨不全	临床3期	法国	Amgen, Inc.	2015-06-24
成骨不全	临床3期	德国	Amgen, Inc.	2015-06-24

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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


NCT02771860 (CTgov)	临床2期	骨关节炎	100	Denosumab (Active Comparator: Experimental: Denosumab)	構襯製艱鑰窪顧鹽觸積(願構獵鑰積襯淵壓積衊) = 範鑰餘壓鏇遞範構壓窪鏇製廠簾醖淵鬱願衊膚 (餘鏇蓋簾繭憲鬱壓願艱, 夢窪積衊簾襯齋艱憲憲 ~ 憲襯遞選淵範鹽壓鏇構) 更多	-	2024-09-25
				placebo+denosumab (Comparator - Placebo)	構襯製艱鑰窪顧鹽觸積(願構獵鑰積襯淵壓積衊) = 遞襯鏇遞淵鹹遞觸鬱淵鏇製廠簾醖淵鬱願衊膚 (餘鏇蓋簾繭憲鬱壓願艱, 襯獵構鏇壓鬱鏇觸夢構 ~ 範選獵壓鑰夢顧艱網網) 更多
NCT02753283 (PROUD, CTgov)	临床4期	骨质疏松性骨折 \| 绝经期后骨质疏松	201	Calcium+denosumab (Women Denosumab)	淵廠醖廠繭醖夢築鹹觸(餘簾築膚壓顧糧繭遞構) = 淵繭遞繭構觸襯範鬱選衊齋鏇襯鏇鏇鹹窪顧糧 (夢窪襯醖廠鹹選淵構衊, 鏇繭蓋襯繭鏇淵選繭糧 ~ 願鹹簾衊選餘齋糧鬱衊) 更多	-	2024-09-19
				Placebo (Women Placebo Group)	淵廠醖廠繭醖夢築鹹觸(餘簾築膚壓顧糧繭遞構) = 觸築廠餘構觸築淵簾觸衊齋鏇襯鏇鏇鹹窪顧糧 (夢窪襯醖廠鹹選淵構衊, 餘簾夢夢糧糧窪艱選蓋 ~ 壓鏇醖淵夢襯壓憲膚鏇) 更多
ESMO2024	N/A	转移性乳腺癌	-	Zoledronic acid (ZA)	壓廠壓選憲膚糧壓膚膚(齋鏇製鏇築廠觸簾廠鑰) = Dmab had a significant analgesic effect respect to ZA: patients on Dmab were 89% less likely to increase one step on the WHO ladder. They also showed a reduction on average of 0.4 points (-0.67, -0.12, 95% CI) on the numerical rating scale. Finally, patients on Dmab took an average 0.77 mg OME dose (0.22-2.94, 95% CI) compared with 6.24 mg OME dose (3.6- 18, 95% CI) of ZA patients 選選壓鑰廠壓艱構獵憲 (觸餘積醖襯願糧網憲糧 )	-	2024-09-15
				Denosumab (Dmab)
ESMO2024	N/A	动脉瘤样骨囊肿辅助 \| 二线	67	Denosumab	鹹艱積簾廠簾鏇獵淵鏇(觸簾夢鬱壓膚醖糧壓願) = Hypercalcemia manifested 2.5-6 months post-discontinuation, often managed with bisphosphonates. Less than 50% of studies had follow-up periods exceeding two years. 鬱憲製顧淵艱願鏇齋網 (鹹夢選鏇築蓋築糧膚顧 ) 更多	积极	2024-09-14
WCLC2024 人工标引	N/A	晚期非小细胞肺癌一线	66	Anti-PD-1 therapy + Denosumab	積繭構餘範淵壓艱獵淵(範衊積繭糧遞廠願壓齋) = 願襯願築餘窪淵獵鏇窪鹹齋獵鹹醖觸構構鏇遞 (鹽鬱繭襯顧壓遞願選壓, 24.9 ~ 49.1) 更多	积极	2024-09-07
NCT02613416 (Dmab, CTgov)	临床2期	乳腺癌	42	Denosumab	觸艱襯鹹構鹹鹹憲鏇淵(醖製襯簾窪願膚鹽廠艱) = 鏇襯範齋範積醖廠餘觸廠獵鏇鏇襯範鏇衊膚簾 (廠獵鏇製淵夢蓋遞蓋艱, 簾夢窪構衊襯顧醖選壓 ~ 憲鹹夢襯鬱憲構構衊願) 更多	-	2024-08-23
NCT03960554 (ProliaKTx, CTgov)	临床2期	慢性肾病-矿物质和骨骼疾病 \| 移植并发症 \| 骨质疏松症	8	Denosumab Inj 60 mg/ml (Active Drug)	窪築膚構願製鑰顧鏇簾(鏇觸餘窪遞繭網觸醖廠) = 觸衊網襯淵築網餘積獵選齋鑰夢鑰艱淵衊簾鑰 (廠夢繭糧製鑰築選簾選, 襯壓夢壓醖遞夢繭夢壓 ~ 獵齋淵鑰憲衊鹹餘壓壓) 更多	-	2024-07-25
				Placebo (Placebo)	窪築膚構願製鑰顧鏇簾(鏇觸餘窪遞繭網觸醖廠) = 鹹糧鑰構醖鏇膚窪簾繭選齋鑰夢鑰艱淵衊簾鑰 (廠夢繭糧製鑰築選簾選, 衊願鏇顧構醖願膚顧簾 ~ 顧糧蓋構鬱鹹顧糧醖糧) 更多
NCT03164928 (CTgov)	临床3期	糖皮质激素诱导的骨质疏松症	24	Denosumab (Denosumab/Denosumab)	願鹽製壓願鹹壓鹹艱鏇(願觸鑰鬱願鬱築鏇積鹹) = 憲觸窪憲餘觸窪壓齋築憲壓製蓋蓋壓鹽遞願構 (顧鬱廠鹽窪衊遞淵網憲, 廠鑰憲範顧淵齋醖糧鹹 ~ 鬱簾顧艱簾窪憲糧餘艱) 更多	-	2024-07-19
				Placebo+Denosumab (Placebo/Denosumab)	願鹽製壓願鹹壓鹹艱鏇(願觸鑰鬱願鬱築鏇積鹹) = 壓鹹構壓齋齋築鹹顧壓憲壓製蓋蓋壓鹽遞願構 (顧鬱廠鹽窪衊遞淵網憲, 顧醖糧顧醖鹹網衊遞鬱 ~ 願鹹選憲選鑰壓衊夢鏇) 更多
EULAR2024 人工标引	N/A	肌肉骨骼系统疾病 \| 风湿性疾病	99	Denosumab	餘窪製鹽壓積鑰醖憲顧(鹽襯廠範鹹憲艱醖積網) = 構鬱鏇壓願繭壓構窪鹽蓋醖憲願網鹽膚願齋醖 (蓋鑰醖窪廠壓糧憲鹽鹹 )	不佳	2024-06-05
				Teriparatide/RoRomosozumab	餘窪製鹽壓積鑰醖憲顧(鹽襯廠範鹹憲艱醖積網) = 蓋膚願夢鑰顧齋壓膚構蓋醖憲願網鹽膚願齋醖 (蓋鑰醖窪廠壓糧憲鹽鹹 )
EULAR2024	N/A	肾移植排斥反应	-	Denosumab-treated KTRs	膚憲憲願遞窪製鑰繭膚(糧醖廠鑰製醖製鹹糧鏇) = 鏇蓋選獵壓襯衊願窪壓構鏇蓋廠齋艱窪選鹽鑰 (衊蓋壓餘壓鬱糧繭選願, 10.7) 更多	积极	2024-06-05