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Dr. Zifei Yuan, CTO of Gan & Lee Pharmaceuticals, said, “After the three insulin products recently submitted in the US FDA, it is another exciting milestone that the MAA submission of Gan & Lee Insulin Glargine biosimilar was positively validated by EMA and entered into scientific evaluation stage.
- Gan & Lee Pharmaceuticals' Overseas Clinical Research on Three Insulin ...
Recently, Gan & Lee Pharmaceuticals published the results of...
- Gan & Lee Pharmaceuticals' Overseas Clinical Research on Three Insulin ...
May 29, 2024 · Passing the GMP inspection is an important milestone for subsequent commercialization of domestically produced insulin in the European Union by Gan & Lee's partner Sandoz. It also strengthens the company's global competitiveness and lays a solid foundation for more international business cooperation and market expansion in the future.
In 2018, Gan & Lee Pharmaceuticals signed a commercialization and supply agreement with Sandoz. Under the terms of the agreement, Sandoz has the right to commercialize the three Gan & Lee biosimilars upon approval in specific regions, including the United States, Europe, and other key territories.
In October 2023, Gan & Lee Pharmaceuticals presented data from two overseas Phase III clinical studies of Basalin ®️ at the 59th European Association for the Study of Diabetes (EASD) Annual Meeting.
Recently, Gan & Lee Pharmaceuticals published the results of the Phase I clinical trial of three insulin products – Basalin ®️ (insulin glargine), Prandilin ®️ (insulin lispro), and Rapilin ®️ (insulin aspart) - in the peer-reviewed journal Diabetes, Obesity and Metabolism.
Jun 1, 2021 · This randomized, double-blind, three-way crossover trial (NCT04236895) compared the PK and PD properties of GL-GLA, a proposed biosimilar IG by Gan & Lee, US- and EU-licensed Lantus ® (US-IG and EU-IG) in 114 male subjects with type 1 diabetes (mean±SD age 42±8 years, BMI 25.8±2.0 kg/m²).
Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products.
