This is a first-in-human, open-label, multicenter Phase I/II study of MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.

开始日期2025-08-01

申办/合作机构

明慧医药（杭州）有限公司

NCT06345482

/ Not yet recruiting临床1/2期

A Phase I/II Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety

Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.

开始日期2024-04-01

申办/合作机构

明慧医药（杭州）有限公司

CTR20250168

/ Not yet recruiting临床1/2期

评价注射用MHB036C联合其他抗肿瘤治疗在晚期肺癌安全性和有效性的I/II期临床研究

I期（剂量递增阶段）主要目的：评估MHB036C联合其他抗肿瘤治疗的安全性和耐受性。次要目的：(1)评估MHB036C联合其他抗肿瘤治疗晚期肺癌的初步疗效；（2）评价总抗[MHB036C（ADC）+MHB036A（裸抗）]、ADC（MHB036C）、以及游离毒素MH30010008的药代动力学特性；评价MHB039A的药代动力学特征；（3）评价MHB036C、MHB039A的免疫原性；（4）评估联合方案在不同TROP2、PD-L1表达人群的疗效。 II期（剂量扩展阶段）主要目的: 评估MHB036C联合其他抗肿瘤方案在特定肺癌人群在的初步疗效。次要目的:(1) 评估MHB036C联合其他抗肿瘤方案DOR、PFS、DCR和OS；（2）评估MHB036C联合其他抗肿瘤方案的安全性和耐受性；（3）评价总抗[MHB036C（ADC）+MHB036A（裸抗）]、ADC（MHB036C）、以及游离毒素MH30010008的药代动力学特性；评价MHB039A的药代动力学特征；（4）评价MHB036C、MHB039A的免疫原性；（5）评估联合方案在不同TROP2、PD-L1表达人群的疗效。

开始日期-

申办/合作机构

明慧医药（杭州）有限公司

100 项与 MHB039A 相关的临床结果

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100 项与 MHB039A 相关的转化医学

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100 项与 MHB039A 相关的专利（医药）

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项与 MHB039A 相关的新闻（医药）

2025-08-08

·佰傲谷BioValley

明慧医药！Pre-IPO轮融资1.31亿美元

2025年8月7日，明慧医药宣布完成1.31亿美元的Pre-IPO轮融资。本轮融资由奥博资本（OrbiMed）领投，启明创投（Qiming Venture Partners）联合领投，现有股东泰福资本（TF Capital）持续支持。本轮融资将主要用于加速明慧医药临床阶段核心项目的推进，重点支持PD-1/VEGF双特异性抗体及其抗体偶联药物（ADC）的联合治疗开发策略，同时也将用于外用JAK抑制剂在中国的上市准备及商业化进程。明慧医药的核心产品明慧医药成立于2018年，是一家处于临床后期阶段的创新型生物医药公司，专注于肿瘤和免疫相关疾病领域。据该公司所公开披露，其核心产品包括：一款外用JAK抑制剂、一款皮下注射型IGF-1R抗体、一款PD-1/VEGF双特异性抗体、一款TROP2 ADC，以及一款B7-H3 ADC。外用JAK抑制剂：MH004（托法替尼依托康米）在2024年11月完成在中国进行的针对12岁及以上轻中度特应性皮炎（AD）患者的III期临床研究的揭盲及初步统计分析，结果显示试验成功达到主要研究终点。明慧医药表示已经在中国递交MH004的上市申请。皮下注射型IGF-1R抗体：MHB018A是国内首个针对IGF-1R靶点的皮下注射剂型，相对静脉输注便利性大幅提升。目前，MHB018A已经推进III期临床研究，以评估治疗活动性中重度甲状腺相关眼病。 PD-1/VEGF双抗：MHB039A是由明慧医药自主研发的PD-1/VEGF抗体，明慧医药拥有完全自主知识产权。此前，MHB039A的1期临床中显示出良好的耐受性和安全性，在经过大量预处理的复发/难治性实体瘤中显示出积极的抗肿瘤活性。此外，MHB039A可与多种治疗手段联合使用治疗实体瘤。目前，MHB039A处于临床II期，正在评估与该公司开发的一款TROP-2 ADC联合用药治疗晚期肺癌患者。 TROP2 ADC：MHB036C是明慧医药基于其Topo I ADC技术平台（SuperTopoi™）开发的TROP-2 ADC候选药物，明慧医药拥有完全自主知识产权。MHB036C于2023年首次获批开展治疗晚期实体瘤的临床试验。在I/II期临床试验中，MHB036C展现出良好的安全性和积极的疗效。目前，MHB036C正在评估与MHB039A联用治疗晚期肺癌患者。 B7-H3 ADC：MHB088C同样是基于SuperTopoi™平台开发的创新ADC药物，目前处于III期临床阶段，用于评估二线治疗二线小细胞肺癌。在I/II期中，MHB088C在300多名晚期或转移性实体瘤患者中进行了评估，显示出良好的安全性和良好的疗效。2025年5月，明慧医药与齐鲁制药达成合作，齐鲁制药以最高可达13.45亿元人民币的总付款获得了MHB088C在大中华区（包括中国大陆、香港、澳门和台湾）的权益。手握热门的PD-1/VEGF双抗实际上，明慧医药融资的重点推进项目就是PD-1/VEGF双抗。在PD-1(L1)/VEGF双抗开发管线当中，明慧医药的MHB039A以临床II期（与MHB036C联用）的进度处于全球前列。尤其是在PD-1(L1)/VEGF双抗已经展现出下一代免疫治疗核心潜力的背景下，国内多款PD-1(L1)/VEGF候选药物高调出海，MHB039A也吸引了业内的关注目光。 MHB039A在早期临床中所报告的安全性和抗肿瘤活性，也支持了MHB039A进一步开发。随着MNC们的纷纷下场，MHB039A未来的身价可能还在持续增加。延伸阅读：PD-1(L1) X VEGF 热浪来袭值得注意的是，明慧医药的PD-1/VEGF双抗的开发策略是与其ADC联合开发，这在证明PD-1/VEGF双抗具有成为免疫联用治疗核心之外，也增加了明慧医药ADC的潜在价值。不可忽视的ADC平台除了PD-1/VEGF双抗MHB039A之外，明慧医药的ADC平台也不可忽视。明慧医药开发了一个SuperTopoi™平台，根据公开资料统计，除了被列为核心产品的MHB088C（B7-H3 ADC）和MHB036C（TROP2 ADC）之外，还有4款临床阶段的ADC管线，以及1款处于临床前阶段的ADC；靶点涉及IGF-1R、c-MET、B7H4、PSMA等创新靶点。 MHB088C作为明慧医药进度最快的ADC管线，于2025年5月正式进入III期临床，开发进度仅落后于第一三共的DS-7300、翰森的HS-20093以及宜联的YL-201。在该背景下，MHB088C获得了来自齐鲁制药的青睐。 2025年5月9日，明慧医药宣布与齐鲁制药达成独家许可和合作协议，齐鲁制药获得在大中华区（包括中国大陆、香港、澳门和台湾）的权益，明慧医药有资格获得最高达13.45亿元人民币的总付款，包括2.8亿元人民币的首付款和近期里程碑，以及10.65亿元人民币的开发、监管和销售里程碑付款，以及高达两位数的净产品销售分成。明慧医药将保留大中华区外的MHB088C全球权利，并继续推进这些地区的开发工作。来自齐鲁的合作，进一步验证了明慧医药ADC平台的价值。同时增加了明慧医药其它ADC管线的潜在价值。小结明慧医药将本次融资称为“Pre-IPO”，下一步目标就是IPO。随着创新药企IPO回暖，无论是今年多家药企成功登陆港交所，还是科创板第五套上市标准的重启，都表明市场对于创新药企的信心呈现出显著的积极变化。明慧医药一手握着核心的ADC，一手握着大热的PD-1/VEGF，将可能成为中国创新药企的一匹黑马。参考资料： 1.明慧医药《明慧医药完成1.31亿美元Pre-IPO轮融资，持续加速创新管线推进与全球布局》 2.明慧医药《明慧医药宣布：创新JAK外用药MH004在轻中度特应性皮炎III期临床试验中达到主要终点》 3.明慧医药《明慧医药甲状腺眼病药物 MHB018A 注射液启动III期临床研究》 4.https://www.minghuipharma.com/newsinfo/975898.html 5.https://www.minghuipharma.com/newsinfo/1041263.html · · · · · · · ·

抗体药物偶联物临床3期IPO临床2期引进/卖出

2025-08-07

·FierceBiotech

Minghui raises $131M \'pre-IPO\' round to bankroll JAK inhibitor launch, ADC trials

Minghui Pharmaceutical’s funding round was led by new investor OrbiMed along with Qiming Venture Partners.\n Minghui Pharmaceutical has secured $131 million in what the company describes as a “pre-IPO” round to fuel the potential launch of its dermatitis cream in China as well as various clinical-stage oncology and immunology assets.The Shanghai-based biotech said part of the funds will be used to support a hoped-for commercial launch in China of MH004, a phase 3-stage pan-JAK inhibitor topical cream. An approval application is currently being considered by Chinese regulators, following a phase 2 success against dermatitis in 2023.Some of the fresh funds will also be used to push forward with Minghui’s various clinical programs, including a PD-1/VEGF bispecific antibody called MHB039A and a TROP-2-directed antibody-drug conjugate dubbed MHB036C. The biotech began evaluating the two assets as a combination therapy in a phase 2 advanced non-small cell lung cancer study that kicked off in May.There’s also a B7-H3-targeted ADC called MHB088C. In May, Qilu Pharmaceutical paid out 280 million Chinese yuan ($38 million) for the greater China rights to the therapy, which is currently in trials for solid tumors, including in subgroups of patients with small cell lung cancer and metastatic castration-resistant prostate cancer.“This financing marks an important milestone as we continue to advance a globally competitive pipeline and enter our next stage of growth,” Minghui’s CEO Guoqing Cao, Ph.D., said in an Aug. 7 release. “We\'re grateful for the confidence and support of our investors and remain committed to delivering innovative medicines that improve outcomes for patients worldwide.” Today’s funding round was led by new investor OrbiMed along with Qiming Venture Partners. Previous backer TF Capital joined other new investors such as BioTrack Capital, 5Y Capital, New Day Fund and Wider Link Enterprise Investment to contribute to the fundraise.“Minghui has built a compelling portfolio of novel drug candidates targeting critical unmet medical needs,” said Kan Chen, Ph.D., partner and co-lead of healthcare at Qiming Venture Partners.

$Minghui raises $131M \'pre-IPO\' round to bankroll JAK inhibitor launch, ADC trials$

临床2期IPO

2025-08-07

·EndPoints

Chinese biotech Minghui raises $131M to advance its PD-1xVEGF bispecific

A Chinese biotech developing a PD-1xVEGF bispecific and other antibody-drug conjugates has secured a nine-figure raise from blue-chip investors. Shanghai-based Minghui Pharmaceutical raised $131 million in what it called a “pre-IPO” financing, the company announced Thursday. The round was co-led by OrbiMed, one of the biggest life science investors in the US, and Qiming Venture Partners, the China-based firm that routinely invests in the country’s early-stage science. The PD-1xVEGF bispecific field has been hot lately thanks to Summit and Akeso, whose drug ivonescimab is undergoing Phase 3 studies in lung cancer. Some of the trials based in China showed it to be superior to Merck’s best-selling immunotherapy Keytruda, but the data have been less straightforward when tested in Western patients . Nonetheless, the data are attractive enough that Summit has had discussions with AstraZeneca about a potential $15 billion deal, according to a report last month from Bloomberg . Those talks followed another high-profile deal in the space: Bristol Myers Squibb teamed up with BioNTech in an agreement that could be worth more than $10 billion. Pfizer has also jumped into the space, partnering with 3SBio in a deal that closed last month and could be worth more than $6 billion. Merck licensed a PD-1xVEGF bispecific last year as well from LaNova Medicines that could see Merck on the hook for more than $3 billion. In Thursday’s press release , Minghui said its new funds will go “with a particular focus” toward its own PD-1xVEGF bispecific, which is called MHB039A and is currently in Phase 2 trials. Last November, Minghui said it was “exploring strategic partnerships” for the program after reading out Phase 1 dose-escalation data. Minghui also noted that the bispecific is being tested in combination with an unnamed TROP2-directed antibody-drug conjugate. The biotech’s other pipeline programs include a topical JAK inhibitor currently under NDA review in China, an IGF-1R antibody being tested in Phase 3 studies for thyroid eye disease, and a B7-H3 antibody-drug conjugate that’s in a Phase 3 for small cell lung cancer. It’s not entirely clear when Minghui last put together a financing, though the company says on its website that it raised “over $70 million” in 2020. A spokesperson for Minghui didn’t immediately respond to a request for comment.

抗体药物偶联物临床2期临床3期临床1期免疫疗法

100 项与 MHB039A 相关的药物交易

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研发状态

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
晚期乳腺癌	临床2期	中国	明慧医药（杭州）有限公司	2025-08-07
乳腺癌	临床2期	中国	明慧医药（杭州）有限公司	2025-08-07
晚期恶性实体瘤	临床2期	中国	明慧医药（杭州）有限公司	2024-03-01
晚期癌症	临床申请批准	中国	明慧医药（杭州）有限公司	2025-03-11
肺癌	临床申请批准	中国	明慧医药（杭州）有限公司	2024-12-16

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临床结果

适应症

分期

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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


NCT06345482 (Biospace) 人工标引	临床1期	实体瘤	-	MHB039A	鬱選遞獵鏇襯淵鹹齋積(壓網廠醖鹹積繭淵窪築) = 繭選獵觸壓醖簾艱鬱艱醖簾選襯窪鹹廠遞範餘 (鏇襯淵艱淵餘蓋顧簾鑰 )	积极	2024-11-06