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泽璟制药: 泽璟制药关于自愿披露ZG006和ZG005在2025年美国临床肿瘤学会(ASCO)年会发布临床数据及最新进展的公告
Zheng Quan Zhi Xing· 2025-06-02 08:26
Core Viewpoint - The announcement highlights the clinical data and latest progress of ZG006 and ZG005, which will be presented at the 2025 ASCO annual meeting, indicating the company's ongoing commitment to advancing its innovative oncology therapies [1]. Group 1: ZG006 Overview - ZG006, also known as Alveltamig, is a trispecific antibody drug developed by the company and its subsidiary, Gensun Biopharma Inc., targeting DLL3 and CD3, and has received orphan drug designation from the FDA [1][2]. - ZG006 is the first-in-class molecule targeting DLL3, showing potential to be a best-in-class therapy [1]. Group 2: ZG006 Clinical Data - In the ZG006-002 study, 48 patients with refractory advanced small cell lung cancer were randomized to receive either 10 mg or 30 mg Q2W treatment, with objective response rates (ORR) of 62.5% and 58.3%, respectively [2][3]. - The disease control rates (DCR) were 70.8% for the 10 mg group and 66.7% for the 30 mg group, with safety profiles showing no treatment-related adverse events leading to permanent discontinuation [3]. - In the ZG006-001 study, 47 patients received varying doses of ZG006, with confirmed ORR of 75.0% for 10 mg, 53.8% for 30 mg, and 58.3% for 60 mg, indicating strong anti-tumor activity [4][5]. Group 3: ZG005 Overview - ZG005, known as Nilvanstomig, is a recombinant humanized bispecific antibody targeting PD-1 and TIGIT, positioned as an innovative immunotherapy for various solid tumors [6][7]. - ZG005 is among the first of its kind to enter clinical research globally, with no similar mechanism drugs approved yet [6]. Group 4: ZG005 Clinical Data - In the ZG005-001 study, 55 patients with advanced cervical cancer were treated, showing an ORR of 40.9% and DCR of 68.2% in the 20 mg/kg group [7]. - The safety profile was favorable, with 83.6% of patients experiencing treatment-related adverse events (TRAE), predominantly grade 1-2 [7]. - In the ZG005-003 study, 60 patients with first-line cervical cancer were treated, with the 20 mg/kg group showing an ORR of 82.1% and DCR of 96.4% [8][9]. Group 5: ZGGS15 Overview - ZGGS15 is a recombinant humanized bispecific antibody targeting LAG-3 and TIGIT, representing a novel approach in tumor immunotherapy [10][11]. - It is the first of its kind to enter clinical research globally, with no similar mechanism drugs approved yet [10]. Group 6: ZGGS15 Clinical Data - In the ZGGS15-001 study, 22 patients were enrolled, with a DCR of 35.3% among evaluable patients [12]. - The safety profile showed that 90.1% of patients experienced TRAE, with no dose-limiting toxicities observed [12][13].
2025 ASCO年会即将揭幕 国产创新药多项研究成果亮相国际舞台
Xin Lang Zheng Quan· 2025-05-27 08:41
Core Insights - The 2025 ASCO Annual Meeting will take place from May 30 to June 3 in Chicago, showcasing significant advancements in innovative drug development from Chinese pharmaceutical companies [1][5] - Multiple drugs with "first-in-class" or "best-in-class" potential have been selected for oral presentations, highlighting the R&D capabilities of Chinese biotech firms [1] Group 1: Company Highlights - Innovent Biologics has seven studies selected for oral presentations, including IBI363 (PD1xIL2 bispecific antibody) with clinical data on non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and malignant pleural mesothelioma (MLN) [1] - China Biologic Products has twelve studies selected, with four classified as "latest breakthrough abstracts" (LBA), notably the combination of bemarituzumab and anlotinib for first-line treatment of NSCLC [1] - Kelun-Biotech will present six research outcomes, focusing on SKB264 (TROP2 ADC), A167 (PD-L1 monoclonal antibody), and A400 (RET inhibitor) [2] Group 2: Drug Development Focus - Antibody-drug conjugates (ADCs) are a major focus for domestic pharmaceutical companies at this year's meeting, with several companies showcasing their ADC products [2] - Baiyuntianheng's bispecific ADC BL-B01D1 (EGFRxHER3) will present Phase I clinical data for small cell lung cancer (SCLC) and NSCLC [3] - Zai Lab's ZG006 (DLL3xCD3 tri-antibody) will release Phase II dose expansion data for SCLC patients, along with updates on other dual-target antibodies [3] Group 3: Key Clinical Data - The combination therapy of vidutolimab and trastuzumab for HER2-positive gastric cancer will be presented in a rapid oral report [4] - The c-MET ADC RC108 will also update its progress during the meeting [4] - The ASCO 2025 meeting is positioned as a crucial platform for Chinese innovative drug companies to showcase their breakthroughs in key indications, further promoting the internationalization of domestic innovations [5]