In This Article:
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Patent life covering Imeglimin in China extended to 2039
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Ongoing partnership discussions to develop and market Imeglimin in China, the world's second largest type 2 diabetes market
LYON, France, January 20, 2025--(BUSINESS WIRE)--Regulatory News:
POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announced that China's National Intellectual Property Administration ("CNIPA") has granted Poxel patent ZL201980015603.X for Imeglimin, a first-in-class drug targeting mitochondrial dysfunction and marketed in Japan for the treatment of type-2 diabetes.
This new patent protects the use of Imeglimin for type-2 diabetic patients with moderate to severe renal impairment until 2039. The granting of the patent further supports ongoing discussions initiated by Poxel to develop and market Imeglimin in China, following the Company's recovery of the rights to this product in Asian countries other than Japan1 from Sumitomo Pharma. The Company also holds 3 additional patents in China covering Imeglimin’s synthesis process.
The prevalence of diabetic patient with chronic kidney disease is high in China, corresponding to around 27% of the country's diabetic population, or nearly 32 million patients2. Diabetes is also the leading cause of end-stage renal failure in this country, i.e. requiring dialysis or a kidney transplant.
China is one of Poxel's priority targets for the development and marketing of Imeglimin, where the decisions taken by the Japanese Agency for Pharmaceuticals and Medical Devices, could potentially reduce future regulatory and development times.
"The granting of this patent by the Chinese authorities is in line with our corporate development strategy and represents a partnering opportunity for a biotech company in this strategic territory. Indeed, the medical needs of the Chinese sub-population of type-2 diabetic patients with renal impairment are huge, and this sub-population is in great demand for a safe and efficacious therapeutic solution. We are pursuing our discussions with a view to a strategic partnership for the development and commercialization of Imeglimin, focusing primarily on China, South East Asian countries, as well as other very specific territories enabling us to maximize the approval of Imeglimin already achieved in Japan, thereby reducing the development efforts to be undertaken on a country-by-country basis", stated Thomas Kuhn, Chief Executive Officer of Poxel.