Recently, Henagliflozin Pharmaceuticals received the Certificate of Drug Registration approved by the State Drug Administration, approving the new indication of Henagliflozin (Ruichin®), a Class 1 new drug, sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) proline, which was independently researched and developed by the company: the product, 5mg or 10mg, combined with Regliflozin Phosphate and Metformin is used in patients with type 2 diabetes mellitus whose blood glucose is not yet reached after receiving Metformin monotherapy. adults with type 2 diabetes. This is the second indication for which Henagliflozin has been approved for marketing. Henagliflozin has thus become the only SGLT2i approved for combination therapy with dipeptidyl peptidase-IV inhibitors and metformin in China, which will provide a new therapeutic option for rational drug use in adult patients with type 2 diabetes mellitus.

The approval of this indication for marketing is based on a multicenter, randomized, controlled, double-blind phase III clinical study [1]. The results of this study showed that after 24 weeks of treatment with Henagliflozin and Regliflozin in combination with metformin, the glycated hemoglobin (HbA1c) in the high-dose group of the three-drug combination regimen (Regliflozin 100mg/Henagliflozin 10mg/Metformin) decreased by up to 1.54% from the baseline, and the three-drug combination regimen was able to reduce HbA1c further by 0.52% compared with the corresponding dose of the two-drug combination regimen ~0.65%, providing superior glucose-lowering efficacy.

Professor Yang Wenying of China-Japan Friendship Hospital, the principal investigator of the study, said, "As a new type of oral hypoglycemic drug, SGLT2i, with its unique mechanism of renal excretion, can bring multiple benefits to patients with type 2 diabetes such as lowering glucose, cardiac and renal benefits, etc., and it has obvious advantages over other oral hypoglycemic drugs, which has become one of the most important medications for the treatment of type 2 diabetes mellitus in the clinic. 2 diabetes mellitus needs to be treated in conjunction with the patient's individualized treatment. The treatment of type 2 diabetes mellitus needs to be integrated with the individualized situation of patients, and many patients need to be treated with a combination of multiple drugs [3]. Although the SGLT2i+DPPVi+MET combination regimen has been widely used in clinical practice [4], from the description of the indications for SGLT2i, the approval of the indication for proline Henagliflozin combined with regliflozin phosphate for adult type 2 diabetes mellitus patients who have already received substandard metformin monotherapy fills the gaps of the indications for the combination regimen in China, and will further improve the rational use of medication for the treatment of patients with type 2 diabetes mellitus in China. diabetes in China, which will further improve the rational use of medication in the treatment of patients with type 2 diabetes in China, thus helping patients achieve better compliance and multiple benefits."

Mr. Dai Hongbin, General Manager of Hengrui Pharmaceuticals, said, "We are very pleased to see the further expansion of indications for Ruqin®, which will bring more choices for the rational use of medication for patients with type 2 diabetes mellitus, and which will serve as the evidence base for Ruqin® to continue to develop a variety of glucose-lowering fixed-combination preparations with different mechanisms of action. Currently, NMPA has accepted the marketing application of Henagliflozin + Regliflozin + Metformin fixed combination preparation[5], and we look forward to the triple fixed combination preparation safely and effectively controlling blood glucose while reducing the number of times patients are given medication, to better help patients with type 2 diabetes mellitus."

As an innovative international pharmaceutical company, Hengrui Pharmaceuticals has always adhered to the concept of "patient-centered" R & D innovation, in addition to plowing into the traditional advantages of the field of oncology, the company is also in a number of chronic disease areas continue to layout. In the field of metabolic diseases, the company has new oral hypoglycemic drugs, innovative insulin and compound preparations, GLP-1/GIP dual-targeting, oral small molecule GLP-1RA and other series of products under research and development, which are expected to meet the needs of different types of patients and different stages of treatment in the future, so that Hengrui's innovations will benefit more patients."

https://mp.weixin.qq.com/s?__biz=MzU4Njc2Njc0NA==&mid=2247521280&idx=1&sn=39455232fea07b266e4405f8d90ae14e&chksm=fdf494f7ca831de12415a6795c3805f877438d73c1c440028e9bcd5487acd53857dbbf2d2c16&mpshare=1&scene=1&srcid=07010oMa5K19mYDaBUxv9AcR&sharer_shareinfo=20e70bf6c0053621b63ba693ecfa4027&sharer_shareinfo_first=20e70bf6c0053621b63ba693ecfa4027#rd