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达伯特®(氟泽雷塞片
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一周医药速览(07.07-07.11)
Cai Jing Wang· 2025-07-11 08:29
Group 1 - Jichuan Pharmaceutical's "Children's Constipation Granules" has received a registration application acceptance notice, marking it as the first innovative traditional Chinese medicine specifically for treating pediatric constipation [1] - The product is expected to be the first Class 1 pediatric-specific drug for constipation following the release of the clinical research guidelines in 2024 [1] Group 2 - Innovent Biologics' drug Daberat® has become the first KRAS G12C inhibitor approved in Macau, providing a new targeted therapy for patients with advanced non-small cell lung cancer [2] - In a Phase II clinical trial, Daberat® demonstrated an objective response rate (ORR) of 49.1%, a median progression-free survival (PFS) of 9.7 months, and a 12-month overall survival (OS) rate of 54.4% [2] Group 3 - Sinovac Biotech's special shareholders meeting approved the election of 10 new directors proposed by SAIF Partners, who committed to support the company's dividend distribution plan [3] - The new board members aim to work closely with management to restore trading of the company's common stock and enhance long-term shareholder value [3] Group 4 - Ganli Pharmaceutical expects a net profit increase of 100.73% to 114.12% for the first half of 2025, with projected profits between 600 million to 640 million yuan [4] - The company achieved market share expansion through two rounds of insulin procurement, with a significant 32.6% increase in agreement volume during the 2024 procurement [4] Group 5 - Ascentage Pharma's new Bcl-2 inhibitor, Lisangtuo® (APG-2575), has been conditionally approved for marketing in China, becoming the first Bcl-2 inhibitor for chronic lymphocytic leukemia/small lymphocytic lymphoma [5] - This marks Ascentage Pharma's second innovative drug to be approved and enter the commercialization stage [5] Group 6 - United Biomedical's UBT37034 injection has received FDA approval for clinical trials, showing significant weight reduction effects when combined with GLP-1 analogs in preclinical studies [6] - The combination therapy demonstrated superior weight loss effects compared to other investigational drugs [6]
信达生物:创新药达伯特成为澳门首个获批的中国企业自主研发的KRAS G12C抑制剂
Cai Jing Wang· 2025-07-09 02:31
安全性方面,治疗相关不良事件以1-2级为主,包括贫血、各类检查相关的不良反应,通过剂量调整及 支持治疗可有效控制,未观察到预期外的严重毒性反应。氟泽雷塞片在刚发布的《2025 CSCO非小细胞 肺癌诊疗指南》中获KRAS G12C突变治疗一级推荐,为KRAS G12C突变患者提供了兼具精准靶向性、 持久疗效与良好耐受性的治疗新选择。 该推文指出,此次达伯特®在澳门获批上市,标志着信达生物创新药物在大中华区的又一重要突破。信 达生物达伯舒®、达攸同®、信必乐®、达伯坦®等创新产品已在印度尼西亚、中国香港、中国澳门、 中国台湾等多个地区获批上市。另外多款产品在巴西、墨西哥、哥伦比亚、印度等地拟注册申报上市 中,有望为广大拉丁美洲、东南亚地区患者带去更多创新疗法。 (企业公众号) 7月9日,信达生物官方公众号发布消息。披露首款中国企业自主研发的KRAS G12C抑制剂达伯特® (氟泽雷塞片,Fulzerasib)已正式获得中国澳门特别行政区药品监管部门批准上市,成为澳门首个获 批的中国自主研发KRAS G12C抑制剂,为澳门KRAS G12C突变型晚期非小细胞肺癌(NSCLC)患者带 来全新精准靶向治疗方案。 推文 ...