A Single-Blind, Placebo-Control, Randomized Phase 2 Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.

开始日期2024-12-01

申办/合作机构

康霈生技股份有限公司

NCT06005441

/ Completed临床2期

A Phase 2b, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection Compared With CBL-A1 and CBL-A2 for Reducing Abdominal Subcutaneous Fat

This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 for reducing subcutaneous fat.

开始日期2023-11-10

申办/合作机构

康霈生技股份有限公司

NCT05736107

/ Completed临床2期

A Randomized, Placebo-Controlled, Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat

This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.

开始日期2023-05-30

申办/合作机构

康霈生技股份有限公司

100 项与白藜芦醇/姜黄素相关的临床结果

登录后查看更多信息

100 项与白藜芦醇/姜黄素相关的转化医学

登录后查看更多信息

100 项与白藜芦醇/姜黄素相关的专利（医药）

登录后查看更多信息

项与白藜芦醇/姜黄素相关的文献（医药）

2025-05-15·Aesthetic Surgery Journal

Efficacy and Safety of CBL-514 Injection in Reducing Abdominal Subcutaneous Fat: A Randomized, Single-Blind, Placebo-Controlled Phase II Study

Article

作者: DuBois, Janet ; Ho, Wilson W S ; Ling, Yu-Fang ; Gold, Michael ; Sheu, An-Yi ; Chou, Yin-Chia ; Schlessinger, Joel ; Dayan, Steven ; Goodman, Greg J

Abstract:

Background:

A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.

Objectives:

To further evaluate the efficacy and safety of CBL-514 for abdominal subcutaneous fat reduction.

Methods:

In this single-blind, randomized, parallel-group, placebo-controlled Phase 2 trial, 76 participants were randomized (2:1) to receive up to 4 CBL-514 treatments (2 mg/cm2, maximum 600 mg/treatment) or placebo, administered subcutaneously to the abdomen every 4 weeks. Two follow-up visits were conducted at 4 and 8 weeks following final treatment. Changes in abdominal subcutaneous fat thickness and volume were measured by ultrasound. The primary endpoint was the proportion of participants with subcutaneous fat volume loss of ≥150 mL from baseline compared with placebo.

Results:

In the intention-to-treat population, a significantly higher proportion of CBL-514-treated participants achieved ≥150 mL subcutaneous fat volume reduction from baseline compared with placebo-treated participants at both follow-up visits. At 8 weeks post final treatment, 69.6% of CBL-514-treated participants lost ≥150 mL subcutaneous fat, compared with none in the placebo group (P < .001). Moreover, 60.9% of participants in the CBL-514 group further achieved the ≥200 mL subcutaneous fat loss threshold. Of the 28 participants in CBL-514 group (n = 50) who lost ≥150 mL subcutaneous fat, 42.9% (12/28 participants) achieved this target after a single treatment. The most common treatment-emergent adverse events were injection site reactions and were of mild-to-moderate severity.

Conclusions:

CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, promising alternative therapy for effective targeted subcutaneous fat reduction.

Level of Evidence: 2:

2022-10-13·Aesthetic surgery journal

Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction

Article

作者: Chang, Kao-Jung ; Sheu, An-Yi ; Ling, Yu-Fang ; Goodman, Greg J ; Ho, Wilson W S

Abstract:

Background:

CBL-514 is a novel injectable drug that may be safe and efficacious for localized abdominal subcutaneous fat reduction.

Objectives:

The aim of this study was to assess the safety and efficacy of CBL-514 in reducing abdominal subcutaneous fat volume and thickness.

Methods:

This Phase IIa, open-label, random allocation study consisted of a 6-week treatment period and follow-up at 4 and 8 weeks following the last treatment. Participants were randomly allocated to receive 1.2 mg/cm2 (180 mg), 1.6 mg/cm2 (240 mg), or 2.0 mg/cm2 (300 mg) of CBL-514 with up to 4 treatments, each comprising 60 injections into the abdominal adipose layer. Changes in abdominal subcutaneous fat were assessed by ultrasound at follow-up visits. Treatment-emergent adverse events were recorded.

Results:

Higher doses of CBL-514 (unit dose, 2.0 and 1.6 mg/cm2) significantly improved the absolute and percentage reduction in abdominal fat volume (P < 0.00001) and thickness (P < 0.0001) compared with baseline. Although the COVID-19 pandemic halted some participant recruitment and follow-ups, analysis was unaffected, even after sample size limitations.

Conclusions:

CBL-514 injection at multiple doses up to 300 mg with a unit dose of 2.0 mg/cm2 is safe, well-tolerated, and reduced abdominal fat volume and thickness by inducing adipocyte apoptosis. Although other procedures exist to treat abdominal fat, they have limitations and may cause complications. At a dose of 2.0 mg/cm2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, nonsurgical abdominal fat reduction in dermatologic clinics.

Level of Evidence: 4:

Medicina (Kaunas, Lithuania)

Modern and Non-Invasive Methods of Fat Removal

Article

作者: Szpila, Gabriela ; Stojko, Michał ; Żmudka, Karol ; Hawranek, Michał ; Piłat, Patrycja ; Smolarczyk, Joanna ; Nocoń, Jakub ; Moll, Martyna

Adipocytes accumulate triacylglycerols as an energy store, thereby causing an increase in the adipose tissue volume. Weight gain can be prevented through damage to the adipocyte structure or an increase in the body’s metabolic rate. Commonly used methods to disintegrate the cell membrane of adipocytes include injection lipolysis, cryolipolysis, ultrasonic lipolysis, radiofrequency lipolysis, laser lipolysis, carboxytherapy, and lipolysis using an electromagnetic field. The names of these methods suggest which substances are being used, and their main advantages are a very low invasiveness, as well as effectiveness. However, new discoveries in medicine, along with individuals’ desire to improve their appearance, have resulted in numerous studies on more ways of reducing body fat. Great potential is seen in beige adipocytes, which can be transformed, i.e., “recruited” from white adipocytes, or synthesized de novo; they also show thermogenic properties. One of the stimuli inducing the formation of beige adipocytes is cold and B3-adrenergic stimulation. Based on these findings, the researchers created, for example, cooling clothing. Additionally, curcumin and natural anthocyanins have proven to be helpful in the treatment of obesity and diabetes, by stimulating the secretion of glucagon-like peptide-1, and inducing the formation of beige adipocytes. Another study showed that the conversion of white adipose tissue is indirectly influenced by interleukin-6 secreted by the muscles, the expression of which is increased in people actively exercising. Moreover, there is potential in adenosine analogs, fenoldopam, rhubarb, the herbal extract Ephedra sinica Stapf, electroacupuncture simulation, and the drug CBL-514. Despite knowledge and experience, the ideal method for a quick and noticeable, but safe and non-invasive reduction of body fat has not been found yet. The research conducted nowadays may bring us closer to the development of a universal method, and turn out to be a breakthrough in the fight against overweight and obesity.

项与白藜芦醇/姜黄素相关的新闻（医药）

2025-04-17

·PRNewswire

Caliway Selected to Present CBL-514 Phase 2 Study Results for Dercum's Disease at World Orphan Drug Congress USA 2025

CBL-514, Caliway's novel small molecule drug, was selected for data presentation at the World Orphan Drug Congress USA 2025, highlighting its promising Phase 2 study results (CBL-0201DD) for Dercum's Disease Treatment. The Phase 2 topline results met all primary and secondary endpoints, with 64.5% of painful lipomas showing ≥ 50% dimension reduction or complete clearance (per-protocol population), and pain being reduced by 4.7 points (on a 10-point scale). The program has advanced to a U.S. FDA-approved Phase 2b study (CBL-0202DD), with subject recruitment expected to be completed by Q3 2025, representing a potential breakthrough for patients with no approved treatment options. TAIPEI, April 17, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) announced today that it has been invited to present the clinical results of its CBL-514 Phase 2 study (CBL-0201DD) in Dercum's Disease at the upcoming World Orphan Drug Congress USA 2025, to be held in Boston on April 24, 2025. CBL-514 is a novel 505(b)(1) small-molecule drug developed by Caliway. It has previously demonstrated promising results in the field of medical aesthetics. CBL-514 is also being investigated for Dercum's Disease— a rare disease characterized by the growth of painful lipomas, with no approved treatment to date. According to the CBL-0201DD Phase 2 study results, 64.5% of painful lipomas showed dimensions reduction of more than 50% or complete clearance after CBL-514 treatments, with more than half of painful lipomas achieved this outcome after only one CBL-514 treatment. The pain score was also reduced by 4.7 points (out of 10). These results support CBL-514's potential as a first-in-class treatment for Dercum's disease, offering new hope to patients by significantly reducing lipoma size and pain. The World Orphan Drug Congress USA is a leading global conference focused on rare disease and orphan drug development. Bringing together over 2,000 participants from academia, regulatory agencies, pharmaceutical and biotech companies, patient advocacy groups, and investors. The event serves as a key platform for advancing scientific innovation, regulatory policies, and access strategies in rare disease therapies. Being selected to present at the most important event for all rare disease stakeholders, not only highlights the clinical potential of CBL-514 in rare disease treatment, but also underscores Caliway's ongoing commitment to addressing unmet medical needs. The drug has entered a U.S. FDA-approved Phase 2b clinical study (CBL-0202DD), which is currently ongoing and expected to complete patient recruitment by Q3 2025. If successful, CBL-514 could become the first approved treatment for Dercum's Disease, offering a long-awaited therapeutic option for patients worldwide. CBL-514 Study Presentation Info at World Orphan Drug Congress USA: Conference: World Orphan Drug Congress USA 2025 Date & Time: April 24, 2025 (Thursday), 10:40 AM (Eastern Time) Presentation Title: Efficacy and Safety of CBL-514, a Novel Lipolytic Injectable, in the Treatment of Dercum's Disease: Phase 2 Study Results Location: Boston Convention & Exhibition Center | Theater 2 – Hall C For more details on the World Orphan Drug Congress USA 2025, please visit: the official website. About Dercum's Disease Dercum's disease is a rare disorder characterized by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk. The pain is chronic (>3 months), symmetrical, often disabling, and resistant to traditional analgesics. The etiology of Dercum's disease remains unknown. There is no approved drug nor recommended standard treatment for Dercum's disease yet. The current treatment options, including surgical removal, liposuction, electrotherapy, and inflammation inhibitors, are symptomatic, and the efficacies are limited with numerous adverse events. The clinical need for Dercum's disease remains unmet. According to the Global Dercum's Disease Market Research Report, the global Dercum's disease treatment market size in 2022 was $11.8 billion. With a compound annual growth rate (CAGR) of 6.76%, the global market of Dercum's disease treatment in 2032 is estimated to expand to $22.7 billion. About CBL-514 CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. CBL-514 has demonstrated fewer side effects, superior efficacy, and fewer required treatments compared with existing surgical procedures and other non-invasive localized fat reduction solutions. Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite and weight rebound management. A derivative compound, CBL-514D, is being developed for indications including rare diseases such as Dercum's disease and Obstructive Sleep Apnea (OSA). As of the end of November 2024, Caliway has enrolled a total of 520 subjects in clinical studies related to CBL-514. To date, 10 clinical studies have been completed with results available, and all these studies have met their primary efficacy endpoints and safety parameters. CBL-514 has demonstrated precise efficacy with a favorable safety profile across multiple indications, showing outstanding statistical significance ( p<0.00001 or p<0.0001) in both ITT and FAS populations. Caliway plans to initiate subject recruitment for two pivotal global Phase 3 studies for localized fat reduction in the second half of 2025. About Caliway Biopharmaceuticals Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: Disclaimer This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change. SOURCE Caliway Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期孤儿药

2025-03-07

·创鉴汇

“不止罕见”，2024年至今167家罕见病创新药公司获融资！

▎药明康德内容团队编辑第18个国际罕见病日刚刚过去，今年的主题“不止罕见”不仅呼吁社会关注这一群体的多元面貌，更提醒我们——在医学与创新的共同推动下，罕见病的“解法”正加速破冰。罕见病的治疗和新药研发虽荆棘密布，但也不乏大型药企投入与新兴力量的突围，资金与创新的碰撞，正为全球3亿罕见病患者推开一扇扇希望之窗。回顾2024年至今，全球至少有167家罕见病创新药公司获得融资。值得关注的亮点包括：跨国药企支持共建创新生态：投资机构中不乏大型药企的身影，如百时美施贵宝（BMS）参与Attralus B轮融资以及COUR Pharmaceuticals A轮融资、诺华（Novartis）支持FundaMental Pharma种子轮融资，大型药企深度参与构建管线协同。 AI与大数据重塑药物发现：AI驱动的新药研发公司融资活跃，如剂泰医药C轮融资1亿美元、Manas AI获2460万美元种子轮融资、Model Medicines获1475万美元资金支持，技术覆盖靶点预测、分子设计及临床优化。细胞与基因疗法（CGT）备受关注：得益于技术成熟度提升，多家CGT疗法研发公司获得融资。细胞疗法如Kyverna Therapeutics IPO筹得3.67亿美元、Sonoma Biotherapeutics的Treg细胞疗法获4500万美元，基因疗法如Tune Therapeutics和Beacon Therapeutics分别获1.75亿美元和1.7亿美元B轮融资。 Kyverna Therapeutics成功登陆纳斯达克 Kyverna Therapeutics是一家临床阶段的细胞疗法研发公司，致力于为自身免疫性疾病和炎症疾病研发新疗法。其治疗平台结合T细胞工程和合成生物学技术，可抑制和消除导致疾病的自身反应性免疫细胞。Kyverna Therapeutics的候选管线KYV-101及其异构体KYV-201是一种CAR-T细胞疗法，旨在治疗B细胞介导的自身免疫性疾病。KYV-101特异性地靶向CD19，这是一种在B细胞表面表达的蛋白，参与各类恶性肿瘤及自身免疫性疾病如重症肌无力、僵人综合征和系统性硬化等罕见病。该药物获得了美国FDA授予的快速通道资格，用于治疗重症肌无力和多发性硬化。 2024年2月，Kyverna Therapeutics宣布完成3.19亿美元的超额IPO。 GondolaBio获3亿美元A轮融资 GondolaBio是BridgeBio Pharma公司成立的一家新公司。BridgeBio Pharma公司将把针对红细胞生成性原卟啉症、α-1抗胰蛋白酶缺乏症和结节性硬化症等罕见病的早期临床期和临床前项目转移到GondolaBio公司并由其继续进行开发。 8月，公司在Viking Global Investors LP、Patient Square Capital、红杉资本（Sequoia Capital）等投资机构的支持下成立并获得3亿美元的分期融资。 Zenas BioPharma连续完成两轮融资 Zenas成立于2021年，致力于开发免疫治疗药物。公司主要管线Obexelimab是一种双功能单克隆抗体，旨在同时靶向CD19和FcγRIIb，以抑制B细胞、浆母细胞和表达CD19的浆细胞的活性。Obexelimab的临床开发计划包括正在进行的针对罕见病IgG4相关疾病的3期注册性临床试验，该疗法已经在五项包括198名受试者的临床试验中显示出显著的临床疗效和安全性，尤其是在自身免疫性疾病方面。 2024年5月，公司完成2亿美元的C轮融资，并在9月成功登陆纳斯达克。 ITM获1.88亿欧元融资 Isotope Technologies Munich（ITM）是一家放射性药物研发公司，致力于为难治性肿瘤提供新型放射性分子精准治疗和诊断。公司将放射性同位素与能够治疗一系列肿瘤的靶向分子相结合，研发精准肿瘤学产品管线。目前，ITM公司已有多条放射性核素疗法（TRT）进入临床阶段。其中，核心管线ITM-11（edotreotide）是一种肽类药物，能特异性地靶向神经内分泌肿瘤受体，其使用无载体添加 (no carrier added, nca) 的镥-177进行标记。目前ITM-11已经进入临床3期试验阶段，针对胃肠胰神经内分泌肿瘤（GEP-NETs）的治疗。 2024年6月，ITM宣布完成1.88亿欧元融资，旨在推动创新放射性药物管线研发，并为公司用于治疗胃肠胰神经内分泌肿瘤的3期候选药物ITM-11做好商业准备。此外，ITM还将利用这笔资金提高其Lutetium-177和Actinium-225的生产能力，扩大其医用放射性同位素的产线，为其全球供应网络提供备受需要的放射性同位素资源。康霈生技成功IPO上市康霈生技（Caliway Biopharmaceuticals）主要开发用于治疗目的的新型小分子药物。旗下重要候选药物CBL-514是一款可以破坏注射部位脂肪细胞的潜在“first-in-class”小分子疗法。该药物已取得在临床2期试验CBL-0201EFP的积极顶线结果，显示CBL-514在改善橘皮组织严重程度方面具有统计学和临床显著的疗效。同时公司正在积极拓展CBL-514用于治疗多种适应症，包括罕见病德库姆病的治疗。 2024年10月，公司成功IPO上市，募集资金64亿新台币。 Abcuro获2亿美元C轮融资 Abcuro是一家致力于研发免疫疗法治疗自身免疫性疾病和癌症的临床阶段生物技术公司，新型抗体是公司研究的重点。其核心药物管线Ulviprubart是一款靶向KLRG1的在研单抗疗法，能够选择性地清除具有高细胞毒性的T细胞，同时保留初始T细胞、调节性T细胞和中枢记忆T细胞。该药物设计用于治疗由高细胞毒性T细胞介导的疾病，包括包涵体肌炎以及T细胞大颗粒淋巴细胞性白血病（T-LGLL）。美国FDA和欧洲药品管理局（EMA）均已授予Ulviprubart治疗体肌炎的孤儿药资格。 2025年2月，Abcuro宣布完成总额达2亿美元的C轮融资。所得资金将用于完成评估Ulviprubart治疗包涵体肌炎疗效与安全性的注册性2/3期MUSCLE临床试验。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。更多数据内容推荐点击“在看”，分享创鉴汇健康新动态

免疫疗法细胞疗法IPO快速通道基因疗法

2025-02-11

·SYNAPSE

2025年2月11日全球新药进展早知道

1. 石药集团「奥马珠单抗」新适应症获批上市 2 月 10 日，石药集团宣布，其附属公司石药集团巨石生物开发的注射用奥马珠单抗生物类似药（商品名：恩益坦）的新适应症已获得 NMPA 批准上市，用于治疗中至重度持续性过敏性哮喘。这是该药在中国获批的第 2 个适应症。恩益坦是石药集团开发的一款人免疫球蛋白 E（IgE）人源化单克隆抗体，为茁乐（罗氏和诺华开发）的生物类似药。此前，恩益坦已于 2024 年 9 月获批上市，用于治疗采用 H1 抗组胺药治疗后仍有症状的成人和青少年（12 岁及以上）慢性自发性荨麻疹患者，是国内首个以生物制品 3.3 类注册分类获批上市的奥马珠单抗生物类似药。 2. 百时美施贵宝CAR-T疗法治疗MZL 2期临床试验成功 2月10日，BMS宣布，评估 Breyanzi®（lisocabtagene maraleucel）用于复发或难治性惰性B细胞非霍奇金淋巴瘤成年患者的2期TRANSCEND FL试验，在边缘区淋巴瘤（MZL）队列中达到其主要终点。结果显示，Breyanzi在这些患者中展现出具有统计学意义及临床意义的总缓解率（ORR）。该研究还达到了完全缓解率（CRR）这一关键次要终点。在顶线分析中，Breyanzi持续展现出持久缓解效果及一致的安全性，未观察到新的安全信号。这项研究标志着Breyanzi在第五种癌症类型中展现出临床意义上的获益，代表其在所有靶向CD19的CAR-T疗法中覆盖B细胞恶性肿瘤类型最广泛，进一步证明了Breyanzi同类最优及疾病领域最优的特性。 3. 局部大面积减脂！创新药CBL-514临床II期成功 2月10日，Caliway生物制药公司宣布其CBL-514第二项2b期研究（CBL-0205）结果达到终点。CBL-514是一种用于大面积局部脂肪减少的在研药物。这项研究是CBL-514在进入3期临床试验前的最后一次2b期研究，结果显示CBL-514在局部脂肪减少方面具有显著疗效。CBL-0205是一项在美国和加拿大15个地点进行的多中心、双盲（参与者和结果评估者）、随机、安慰剂对照的临床研究，研究共招募了173名患有中度（3级）或重度（4级）腹部脂肪堆积的参与者，并使用腹部脂肪评级量表（AFRS）进行评估。每位参与者在腹部皮下接受多达4次研究药物治疗，每次治疗间隔3周，最后一次治疗后进行4周和8周的疗效和安全性随访。MRI数据显示，CBL-514组的54.2%的参与者在最后一次治疗后四周达到至少20%的脂肪体积减少，而安慰剂组为0%。 4. 罗氏CD20单抗「奥妥珠单抗」申报狼疮性肾炎新适应症近日，罗氏公布奥妥珠单抗（obinutuzumab，Gazyva/Gazyvaro）治疗活动性狼疮肾炎患者的III期REGENCY研究的详细分析，并发表于《新英格兰医学杂志》。研究显示，接受奥妥珠单抗+标准疗法（霉酚酸酯和糖皮质激素）治疗的患者有46.4%在76周时实现了完全肾脏缓解（CRR），而接受标准疗法的患者有33.1%达到了CRR（调整后差异为13.4%，95% CI：2.0%-24.8%；P=0.0232）。罗氏在新闻稿中表示，奥妥珠单抗是全球首款在狼疮性肾炎随机III期临床试验中证明完全肾脏缓解（CRR）获益的CD20单抗。根据2024年财报，罗氏已于2024年12月向FDA递交狼疮性肾炎新适应症的上市申请。这意味着，奥妥珠单抗将成为首个获得FDA批准用于治疗狼疮性肾炎的CD20靶向疗法。 5. 科济药业通用型BCMA CAR-T首例受试者四周时评估为sCR 2月10日，科济药业宣布，基于THANK-u Plus™平台开发的通用型BCMA CAR-T，其首例入组患者在第28天访视疗效评估为严格意义上的完全缓解（sCR）和微小残留病（MRD）阴性。该患者为复发/难治性多发性骨髓瘤IgA-λ型（R-ISS分期II期），既往曾经接受过3线联合药物治疗和自体造血干细胞移植，末次治疗后疾病进展入组临床试验。患者接受临床方案中的最低剂量组的CAR-T细胞输注后发生1级CRS，予以退热、托珠单抗治疗后恢复，未见ICANS和其他CAR-T治疗免疫相关不良反应，整体安全性良好。该CAR-T产品计划用于治疗复发/难治性多发性骨髓瘤（R/R MM）或复发/难治性浆细胞白血病（R/R PCL）。公司预估于今年下半年分享更多数据信息。 1. 超1.6亿美元！百奥泰出售一款生物类似药美国市场商业化权益 2 月 10 日，百奥泰宣布已与 Intas Pharmaceuticals 就戈利木单抗生物类似药 BAT2506 签署授权许可及商业化协议。Intas 将拥有 BAT2506 在美国市场的独占商业化权益。该合作总金额最高至 1.645 亿美元。根据协议条款，百奥泰将负责 BAT2506 的研发、生产以及商业化供应，Intas 将通过其美国子公司 Accord BioPharma 负责 BAT2506 在美国市场的商业化。百奥泰可获得总金额最高至 1.645 亿美元，其中包括 2100 万美元首付款、累计不超过 1.435 亿美元里程碑付款，以及净销售额的两位数百分比作为收入分成。内容来源于网络，如有侵权，请联系删除。

上市批准临床成功引进/卖出

100 项与白藜芦醇/姜黄素相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
脂肪团	临床2期	美国	康霈生技股份有限公司	2023-01-09
红细胞生成性原卟啉症	临床2期	美国	康霈生技股份有限公司	2023-01-09
痛性肥胖症	临床2期	美国	康霈生技股份有限公司	2022-10-03
皮下脂肪疾病	临床2期	澳大利亚	康霈生技股份有限公司	2020-02-03

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06005441 (CBL-0205, PRNewswire) 人工标引	临床2期	皮下脂肪疾病	173	CBL-514	膚窪鹽糧獵願鹹製網築(網選淵鏇膚淵鹽構積構) = 願膚鹽獵衊衊製簾壓構鬱襯膚積壓廠淵襯窪糧 (選淵願觸壓憲構鏇憲壓 ) 达到更多	积极	2025-02-10
				Placebo	膚窪鹽糧獵願鹹製網築(網選淵鏇膚淵鹽構積構) = 遞範糧鬱壓顧製鑰膚製鬱襯膚積壓廠淵襯窪糧 (選淵願觸壓憲構鏇憲壓 ) 达到更多
NCT05736107 (CBL-0204, PRNewswire) 人工标引	临床2期	腹部肥胖	107	CBL-514	淵膚觸鏇網糧憲選製鏇(鹽鹹壓獵選製襯窪獵鏇) = 鹹網築齋蓋觸積願築願範糧簾選製窪獵獵網蓋 (簾積糧憲壓鏇觸顧願窪 ) 更多	积极	2024-12-11
				Placebo	淵膚觸鏇網糧憲選製鏇(鹽鹹壓獵選製襯窪獵鏇) = 繭鏇蓋淵觸壓顧鬱顧積範糧簾選製窪獵獵網蓋 (簾積糧憲壓鏇觸顧願窪 ) 更多
NCT05632926 (CBL-0201EFP, PRNewswire) 人工标引	临床2期	脂肪团	12	CBL-514	襯鏇餘築鏇築繭膚製餘(選遞築餘網願窪網遞餘) = 廠簾鹽築壓簾蓋廠鏇顧顧壓繭願鹹願簾夢顧壓 (鑰鑰網糧膚願簾構齋窪, 0.9) 达到更多	积极	2024-04-25
NCT05836779 (CBL-0201EFP, PRNewswire) 人工标引	临床2期	脂肪团	23	CBL-514	壓襯遞鑰網獵積遞鹽範(窪鑰鹹艱憲遞蓋淵鏇製) = 觸餘襯鬱繭觸壓積廠遞願齋鑰觸憲製鏇範築窪 (糧衊獵糧願鏇艱憲鹽衊, 1.3) 达到	积极	2024-04-25
NCT04575467 (CTgov)	临床2期	皮下脂肪疾病	25	CBL-514 (CBL-514 320 mg)	壓願積醖艱遞選醖衊築 = 築鏇積鑰醖鏇憲築獵網鬱廠築構網襯齋憲積齋 (鹹遞選憲獵廠夢衊齋遞, 繭廠醖獵積鹽構鬱範襯 ~ 鑰獵糧憲願蓋鑰願衊醖) 更多	-	2024-03-28
				CBL-514 (CBL-514 480 mg)	壓願積醖艱遞選醖衊築 = 鑰範觸繭觸遞築齋築淵鬱廠築構網襯齋憲積齋 (鹹遞選憲獵廠夢衊齋遞, 鏇範繭顧齋願鑰網廠獵 ~ 鹹鏇網壓構選獵餘簾積) 更多
NCT04897412 (CBL-0202, PRNewswire) 人工标引	临床2期	皮下脂肪疾病	76	CBL-514	鏇膚選願觸鬱鑰壓獵製(窪範簾襯簾艱選簾積顧) = 膚遞遞簾膚襯網齋鑰齋簾糧餘構鑰蓋觸憲蓋築 (獵醖蓋積選膚遞鑰選繭 ) 更多	积极	2023-12-26
				Placebo	-
NCT04897412 (CBL-0202 , PRNewswire) 人工标引	临床2期	皮下脂肪疾病	76	CBL-514	夢淵餘構繭糧蓋鬱衊獵(鏇蓋膚製齋範築鏇衊壓) = 觸願獵觸壓憲鬱鑰鹹糧鬱膚鹽築鑰範憲蓋窪鹽 (鹹醖鑰蓋積鹹夢願膚鹹 ) 达到更多	积极	2023-10-02
				Placebo	夢淵餘構繭糧蓋鬱衊獵(鏇蓋膚製齋範築鏇衊壓) = 構鹹艱齋獵淵憲衊鬱鬱鬱膚鹽築鑰範憲蓋窪鹽 (鹹醖鑰蓋積鹹夢願膚鹹 ) 达到更多
NCT05387733 (CBL-0201DD, PRNewswire 1 \| PRNewswire 2) 人工标引	临床2期	痛性肥胖症	12	CBL-514	鑰積壓襯鏇鏇簾鏇艱獵(衊夢觸獵選鬱築淵襯糧) = in the high-dose group was reduced by 51.3% (p<0.0001) and 54.7% (p<0.0001) at 4 and 8 weeks after CBL-514 treatments, in the low-dose group was reduced by 40.0% (p=0.0002) and 34.7% (p<0.0001) at 4 and 8 weeks after CBL-514 treatments. 觸遞築襯繭鏇簾壓襯廠 (餘積醖觸獵選選衊觸構 ) 达到更多	积极	2023-09-13