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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
Core Insights - The first KRAS G12C inhibitor developed by a Chinese company, Fulzerasib, has been approved for marketing in Macau, providing a new targeted therapy for patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations [1][2] Group 1: Product Approval and Clinical Data - Fulzerasib specifically inhibits the oncogenic KRAS G12C protein, blocking tumor cell proliferation signals and addressing the limitations of traditional treatment methods [1] - In a Phase II clinical trial for Chinese patients with KRAS G12C-mutated advanced NSCLC, Fulzerasib demonstrated an objective response rate (ORR) of 49.1%, a median progression-free survival (PFS) of 9.7 months, a 12-month overall survival (OS) rate exceeding 54.4%, and a 12-month duration of response (DoR) rate of 53.7% [1] Group 2: Safety and Recommendations - The treatment-related adverse events were primarily grade 1-2, including anemia and various examination-related adverse reactions, which were effectively managed through dose adjustments and supportive care, with no unexpected severe toxic reactions observed [2] - Fulzerasib has received a level 1 recommendation for the treatment of KRAS G12C mutations in the recently published 2025 CSCO guidelines for non-small cell lung cancer, offering a new option that combines precision targeting, durable efficacy, and good tolerability for patients [2] Group 3: Market Expansion and Future Prospects - The approval of Fulzerasib in Macau marks a significant breakthrough for the company's innovative drugs in the Greater China region [2] - The company has multiple innovative products, including Daberu® and Dazhuo® that have been approved in various regions such as Indonesia, Hong Kong, Macau, and Taiwan, with additional products under registration in Brazil, Mexico, Colombia, and India, potentially bringing more innovative therapies to patients in Latin America and Southeast Asia [2]