Recently, Gan & Lee Pharmaceuticals published the results of its Phase III clinical trial (GLITTER 2 Study) of insulin glargine (brand name Basalin^??) in the prestigious international academic journal Diabetes, Obesity and Metabolism. This journal is a global authority in the field of medical endocrinology and metabolism research and is ranked 21st out of 145 journals in the endocrinology sector. With its latest impact factor of 5.8 for the year 2023, ranked in the second quartile by the Chinese Academy of Sciences, it has far-reaching influence in the industry.

Gan & Lee Pharmaceuticals' insulin glargine (Basalin^??), launched in the domestic market in 2005 and currently under regulatory review in Europe and the United States of America (USA) as a biosimilar insulin product, must demonstrate high similarity to the reference product per regulatory requirements of the target countries. Accordingly, a randomized, open-label, multicenter Phase III clinical trial was conducted in the U.S. to evaluate the immunogenicity, efficacy, and safety of Gan & Lee's insulin glargine in comparison with its reference product (Lantus^??) in patients with type 2 diabetes mellitus (T2DM). The primary endpoint of the study was the proportion of patients in each treatment group who developed treatment-induced anti-insulin antibodies (AIAs), while secondary endpoints included efficacy and safety mesures, changes in glycated hemoglobin (HbA1c) levels, and a comparative assessment of adverse events.

The article highlights that with respect to immunogenicity, the proportion of subjects with treatment-induced AIA at week 26 was similar between the Gan & Lee glargine treatment group (19.2%) and the reference group (21.3%), with a treatment difference of -2.1 percentage points within the predefined similarity margin (-10.7% to 10.7%). In terms of efficacy, the difference in HbA1c levels between the two groups was -0.08% (90% CI, -0.23 to 0.06), indicating no significant difference. For safety, the overall percentage of subjects experiencing any treatment-emergent adverse events was similar between the Gan & Lee glargine group (80.1%) and the reference group (81.6%). These results demonstrate the biosimilarity of Gan & Lee's insulin glargine to the reference product in terms of immunogenicity, efficacy, and safety.

Kai Du, CEO of Gan & Lee Pharmaceuticals, stated, "The clinical studies conducted in Europe and the U.S. have once again demonstrated the quality and reliability of Gan & Lee's domestically marketed insulin glargine Basalin^? by demonstrating its biosimilarity to the reference product Lantus^?. The marketing application of Basalin^? has been submitted to both the U.S. FDA and the European EMA and are now in the scientific review phase. We look forward to an early market launch of this insulin product in Europe and the United States, bringing benefits to a broader global population of diabetes patients."

Link to the publication：

https://dom-pubs.pericles-prod.literatumonline.com/doi/epdf/10.1111/dom.15560

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin^?), fast-acting lispro injection (Prandilin^?), fast-acting aspart injection (Rapilin^?), mixed protamine zinc lispro injection (25R) (Prandilin^?25), aspart 30 injection (Rapilin^?30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^?30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^?).

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.