友芝友生物-B(02496)公布，公司自主研发的上皮细胞黏附分子(Ep CAM)和分化簇3(CD3)双靶向的在研 双特异性抗体(Bs Ab)药物M701在中国开展的治疗晚期上皮肿瘤引发的恶性腹水的开发与临床试验结果 已于国际知名医学期刊《实验血液学与肿瘤学》上发表。此举标志着创新疗法的临床价值获得国际医学 （000516）界的认可。 II期研究旨在评估M701腹腔内输注疗法对出现中至大量恶性腹水的晚期上皮性肿瘤患者的疗效与安全 性。本研究共纳入84名患者，其中43名患者被分配至M701组，接受腹腔穿刺及腹腔内M701输注。 M701组的无穿刺生存时间中位数为75天，对照组则为25天，两组存在显著差异(p=0.0065)。亚组分析显 示，不同类型的癌症(包括胃癌、结直肠癌及卵巢癌)均能从M701输注中获益。基线相对淋巴细胞计数 较高(≥13%)的患者获得较佳疗效。与对照组患者相比，M701组患者的总生存时间获得延长。两组患者 的6个月存活率分别为33.3%与12.1%。在M701组别中未观察到任何其他严重不良反应事件。 ...

近日，长春新区政府投资基金投资的创新型生物制药企业益科思特（ExcyteBiopharmaLtd.）宣布，其核 心产品YK012——一款靶向CD3/CD19的双特异性抗体药物，已在美国正式启动针对原发性膜性肾病 （pMN）的一期临床试验。该试验已于2025年11月18日在ClinicalTrials.gov完成注册（编号： NCT07234474），标志着益科思特在自身免疫疾病领域的国际化研发迈出关键一步，也成为长春新区政 府投资基金在生物医药前沿领域投资布局的重要里程碑。 益科思特成立于2016年，是一家专注于双特异性抗体药物研发的创新型生物制药企业，公司建立了完整 的双抗药物开发平台，在药物结构设计、亲和力优化和安全性调控方面具有独特技术优势。研发团队由 具有国际药企丰富经验的核心科学家领衔，围绕CD3/CD19、BCMA/CD3等双抗管线，系统性布局肿瘤 与自身免疫疾病治疗，其技术平台和临床进展已吸引多家国际药企关注。近年来，国产双抗药物海外授 权交易频发，益科思特在自免领域的先行者地位，有望成为下一个具有国际影响力的合作标的。 长春新区政府投资基金于2024年6月便前瞻性地投资益科思特，为公司的早期研 ...

Core Viewpoint - The company has announced mid-term data from a Phase II clinical trial of its dual-targeting bispecific antibody M701 for treating malignant pleural effusion caused by advanced non-small cell lung cancer (NSCLC), showing significant efficacy compared to the control group receiving cisplatin [1][4]. Group 1: Clinical Trial Overview - The Phase II trial (code name: M70103) is a randomized, controlled, multi-center study involving 54 eligible patients with symptomatic malignant pleural effusion after at least one line of systemic therapy [2]. - Patients were randomly assigned in a 1:1 ratio to receive either M701 or cisplatin after thoracentesis [1][2]. - The primary endpoint is puncture-free survival time (Pu FS), while secondary endpoints include objective response rate (ORR), time to next puncture (TTNP), and related symptoms [1]. Group 2: Patient Demographics - The trial included 26 patients in the M701 group and 28 in the cisplatin group, with median ages of 66.5 and 61.5 years, respectively [2]. - Female proportions were 57.7% in the M701 group and 50.0% in the control group, with ECOG performance status scores of 0-1 being 92.3% and 96.4% [2]. - Baseline characteristics were generally balanced between the two groups, with similar proportions of patients having prior thoracentesis and chemotherapy [2]. Group 3: Efficacy Results - M701 demonstrated a longer median puncture-free survival time compared to cisplatin (130 days vs. 85 days, HR=0.80, p=0.542) [3]. - In patients without driver gene mutations, the median survival was not reached for M701 compared to 44.5 days for cisplatin (HR<0.01, p<0.001) [3]. - The objective response rate for malignant pleural effusion was 72.7% for M701 versus 41.7% for cisplatin [3]. Group 4: Safety Results - The incidence of treatment-related adverse events was 3.7% for M701 compared to 10% for cisplatin, with only one serious adverse event related to M701 [3]. - Flow cytometry analysis indicated a significant reduction of Ep CAM+CD45- tumor cells in the pleural effusion after M701 infusion, which was not observed in the cisplatin group [3]. Group 5: Conclusion and Future Plans - M701 shows significant efficacy and good tolerability in treating malignant pleural effusion, particularly in NSCLC patients without driver gene mutations or those with prior chemotherapy [4]. - The ongoing Phase II trial indicates potential for preventing recurrence of pleural effusion, with plans for a pivotal Phase III trial to start in 2026 to validate efficacy and safety in a larger Chinese population [4].

Core Viewpoint - The company Yuzhiyou Biotech (02496) has announced mid-term data from its Phase II clinical trial of the bispecific antibody M701 for treating malignant pleural effusion caused by advanced non-small cell lung cancer (NSCLC), which was presented at the 2025 European Society for Medical Oncology (ESMO) conference [1] Group 1: Clinical Trial Overview - The study is a randomized, controlled, multicenter, open-label Phase II trial (code name: M70103) focusing on malignant pleural effusion in advanced NSCLC [2] - Participants were randomly assigned in a 1:1 ratio to either the treatment group receiving M701 or the control group receiving cisplatin after thoracentesis [2] - The primary endpoint is puncture-free survival (Pu FS), while secondary endpoints include objective response rate (ORR), time to next puncture (TTNP), and related symptoms [2] Group 2: Patient Demographics - As of March 7, 2025, 54 eligible patients with symptomatic malignant pleural effusion were enrolled, with 26 in the treatment group and 28 in the control group [3] - The median age was 66.5 years for the treatment group and 61.5 years for the control group, with a balanced baseline condition between the two groups [3] Group 3: Efficacy Results - The treatment group showed a longer median puncture-free survival of 130 days compared to 85 days in the control group, with a hazard ratio (HR) of 0.80 [4] - Notably, patients without driver gene mutations benefited significantly, with a median survival not reached compared to 44.5 days in the control group [4] - The objective response rate for malignant pleural effusion was 72.7% in the treatment group versus 41.7% in the control group [4] Group 4: Safety Results - The incidence of treatment-related adverse events was 3.7% for M701 compared to 10% for cisplatin, with only one serious adverse event linked to M701 [4] Group 5: Conclusion and Future Plans - M701 demonstrated significant efficacy and good tolerability compared to cisplatin, supporting further clinical development, especially for NSCLC patients without driver gene mutations [5] - A pivotal Phase III trial is planned to start in 2026 to validate the efficacy and safety of M701 in a larger Chinese population [5]

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HB0043 in the United States, marking a significant advancement in the treatment of autoimmune diseases [1] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug is developed for treating various difficult-to-treat autoimmune diseases, showing stronger efficacy in animal models compared to monoclonal antibodies [1] - HB0043 is the world's first bispecific antibody targeting IL-17A and IL-36R, potentially overcoming the limitations of existing single-target therapies [1] Group 2: Market Potential - Current IL-17A inhibitors and IL-36R monoclonal antibodies have shown positive effects in multiple indications, but there are still limitations in their single-dimensional intervention for some patients [1] - The dual-target approach of HB0043 is expected to provide new treatment strategies for immune-mediated inflammatory skin diseases and fibrotic diseases [1] - The innovative mechanism of HB0043 positions it as a first-in-class (FIC) product with broad potential applications in Th17 and IL-36 related immune-mediated diseases [1]

Core Insights - Huahai Pharmaceutical's subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HB0043, a bispecific antibody targeting IL-17A and IL-36R, aimed at treating various autoimmune diseases [1][2] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug has shown superior efficacy compared to monoclonal antibodies in various animal disease models, including atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [1] - HB0043 offers a new approach to targeted therapy for immune-mediated inflammatory skin diseases and fibrotic diseases, addressing the limitations of single-factor blocking therapies [1] Group 2: Market Potential - As the first bispecific drug globally targeting both IL-17A and IL-36R, HB0043 is expected to overcome the limitations of existing single-target therapies [2] - Current treatments, such as IL-17A inhibitors and IL-36R monoclonal antibodies, have shown positive effects in multiple indications but may still fall short in addressing inflammation in some patients [2] - The innovative dual-target mechanism of HB0043 positions it as a first-in-class (FIC) therapy with broad potential applications in various Th17/IL-36 related immune-mediated diseases [2]