The China’s State Food and Drug Administration has granted approval to Sihuan Pharmaceutical to initiate a clinical study of pinoxacin hydrochloride to treat patients with type II diabetes.
Pinoxacin hydrochloride, a category 1.1 drug, is a DPP-4 inhibitor class of oral hypoglycemic agents used to enhance the function of endogenous insulin, improving glycemic control and islet beta-cells function.
During the company’s pre-clinical research, DPP-4 inhibitors have shown potent in-vitro and in-vivo activities, good selection profile, great stability and controllable quality, as well as better tolerance, with long-term administration showing a protective effect on pancreatic beta-cells.
The company’s research also showed that DPP-4 inhibitors will not cause serious side effects such as weight gain and hypoglycaemia when compared to conventional diabetes drugs.
Pinoxacin hydrochloride has good pharmacokinetic characteristics, high oral bioavailability, quick absorption, rapid onset and a longer duration, claims the company.
The company expects the Phase I clinical study to begin in the first half of 2013.
Sihuan Pharmaceutical chairman and CEO Dr Che Fengsheng said the company believes that after the launch, pinoxacin Hhdrochloride will provide physicians and patients with better treatment options.
"Further to obtaining clinical approval for Benapenum, a class of new drug, in January, the company has again successfully obtained clinical approval for another new drug," Fengsheng said.
"This will enable the company to further consolidate its diversified product lines while driving its sustainable growth."