Ganli Pharmaceutical Insulin Glargine (GL-GLA) completed overseas Phase III clinical study

October 18, 2021

Beijing, China/Bridgewater, New Jersey, USA, October 14, 2021-Ganli Pharmaceutical Co., Ltd. (hereinafter referred to as Ganli Pharmaceutical, stock code: 603087.SH) announced that it has successfully completed two overseas randomized, multi-centers The Phase III study aims to compare the proposed biosimilar drug-Ganli Pharmaceutical Insulin Glargine (GL-GLA) with the reference biological drug. These two studies were carried out in patients with type 1 diabetes (N=576) and type 2 diabetes (N=567). The two studies took 26 weeks before and after, and the main purpose was to evaluate the immunogenicity of the treatment-inducing (TI) between Ganli Pharmaceutical Insulin Glargine (GL-GLA) and the control biological drug Lantus® through the pre-defined similarity boundary. Effectiveness. The second main purpose is to evaluate the equivalence and safety of efficacy. In the end, the results of the two studies showed the same immunogenicity of TI. The efficacy evaluation between each group is within the pre-defined similarity boundary, and the conclusion of equivalence is reached. Studies have shown that the safety endpoints of GL-GLA (GL-GLA) and control biologics are comparable. At present, Ganli Pharmaceutical has five varieties of insulin analogues: long-acting insulin glargine injection (Changxiulin®), fast-acting insulin lispro injection (suxiulin®), insulin aspart injection (ruixiulin®) ), pre-mixed protamine zinc recombinant insulin lispro mixed injection (25R) (Su Xiulin ® 25), insulin aspart 30 injection (Rui Xiulin ® 30); and human insulin varieties: pre-mixed protamine human insulin Mixed injection (30R) (Puxulin ® 30), the product covers the three functional segments of long-acting, quick-acting, and pre-mixed insulin markets. At the same time, the company's products cover related medical devices, including reusable insulin injection pens (Xiu Lin pen ®) and disposable injection pen needles (Xiu Lin needle ®).

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