Hanmi Pharmaceutical has received approval from the Ministry of Food and Drug Safety (MFDS) to conduct phase 1 clinical trials about HCP1801, a diabetes combination treatment.
HCP1801 combines metformin, the first-line treatment for diabetes, and a base-altered SGLT-2 compound from the original SGLT-2 drug, Forxiga.
Forxiga is a sodium-glucose transport protein 2 (SGLT-2)-inhibitor that helps the kidney remove blood glucose and excrete it through urine. It has an excellent blood glucose lowering effect and an additional advantage in weight loss.
To evaluate the drug's pharmacokinetic properties, safety, and tolerability, the company plans to conduct a randomized, single-dose, cross-over phase 1 clinical trial on 66 patients at Kyungpook National University Hospital.
Even if the company successfully develops the treatment, however, the patent issue remains a variable. According to the ministry’s patent site, Forxiga's has two substance patents that expire in April 2023 and January 2024, respectively, and one formulation patent that expires in 2028. Local companies have tried to get a patent invalidation for Forxiga’s formulation patent but have failed, however.
These shows why local pharmaceutical companies have changed their tactic to avoiding the patent through base-altering strategy.
If Hanmi avoids the substance patent through the base-altering strategy, the company may be able to speed up the launch of generics two years in advance from the nearest patent expiration period of 2023, a company official said.