长效G - CSF

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迈威(上海)生物科技股份有限公司自愿披露关于迈粒生 获得国家药品监督管理局批准上市的公告
Shang Hai Zheng Quan Bao· 2025-05-29 21:15
Core Viewpoint - The approval of the drug "Mairuisheng" (Injectable Agrelin α) by the National Medical Products Administration marks a significant milestone for the company, being its first innovative drug to be launched and the first G-CSF drug in China developed using albumin fusion technology [2][3]. Drug Information - Drug Name: Injectable Agrelin α - Dosage Form: Injection - Specification: 20mg/vial - Indication: For adult patients with non-myeloid malignancies undergoing chemotherapy that may cause febrile neutropenia, to reduce the incidence of infections associated with febrile neutropenia [2][3]. Clinical Trial Results - In Phase III clinical trials, the incidence of grade 4 neutropenia during the first cycle of chemotherapy was slightly lower in the 8MW0511 group compared to the control group, and significantly lower in subsequent cycles [4]. Market Demand and Growth - The demand for long-acting G-CSF drugs in China is substantial, with the market expected to reach CNY 10.27 billion by 2025 and CNY 13.54 billion by 2030, indicating a positive market outlook [6]. - Over 50% of new cancer cases globally require chemotherapy, with the number of patients needing the first course of chemotherapy projected to increase from 9.8 million in 2018 to 15 million by 2040, a growth of 53% [5]. Impact on the Company - The launch of 8MW0511 is expected to enhance the company's revenue scale and improve its profitability and core competitiveness, providing a new treatment option for clinical experts and better clinical benefits for patients undergoing chemotherapy [6].