我们重视您的隐私
我们使用 Cookie 分析网站流量并改善您的体验。请参阅我们的隐私政策。
相关临床试验
18
4 进行中
药物批准
0
批准总数
监管机构
监管机构数
成立时间
N/A
进行中（未招募）
2
11.1%
已完成
5
27.8%
尚未招募
招募中
6
33.3%
撤回
3
16.7%
暂无批准数据
- The FDA has approved Garzulys™ (insulin aspart-fsan), a rapid-acting human insulin analog biosimilar to NovoLog®, for glycemic control in adults and pediatric patients with diabetes mellitus. - Meitheal Pharmaceuticals served as the U.S. Regulatory Agent and holds exclusive U.S. commercialization rights under a license agreement with Emerge Bioscience, the BLA holder. - The approval represents a milestone in Meitheal's strategic expansion from generic injectables into complex biologics and branded products. - Garzulys was developed through a multi-company collaboration involving Tonghua Dongbao, NKF, Xentria, and Meitheal, with two additional insulin biosimilar candidates in the pipeline.
