Poxel Advances Global Strategy with Key Patent for Imeglimin in China
Expanding Innovative Treatments for Chronic Metabolic Diseases
Poxel, a clinical-stage biopharmaceutical company focused on developing cutting-edge treatments for chronic diseases with metabolic origins, has reached a significant milestone in its journey to bring its innovative drug, Imeglimin, to China. Known for tackling serious conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, Poxel announced that China’s National Intellectual Property Administration (CNIPA) has granted a crucial patent (ZL201980015603.X) for Imeglimin. This patent specifically protects its use in treating type-2 diabetes patients with moderate to severe renal impairment, a growing health concern in China. The protection extends through 2039, marking a major step in Poxel’s commitment to addressing metabolic diseases in high-need markets.
Imeglimin: A Revolutionary Approach to Type-2 Diabetes
Imeglimin is a first-in-class drug that targets mitochondrial dysfunction, a key factor in the development of type-2 diabetes. It has already been successfully launched in Japan, where it is marketed as a treatment for type-2 diabetes. With the newly granted patent, Poxel gains exclusive rights to market Imeglimin in China for type-2 diabetes patients who also suffer from significant kidney impairment. This demographic is critical in China, where chronic kidney disease (CKD) is highly prevalent among diabetic patients. The patent aligns with Poxel’s broader goal of expanding Imeglimin’s presence in Asia, particularly following the recovery of its rights from Sumitomo Pharma for regions outside Japan.
Addressing a Growing Health Crisis in China
China represents a vast opportunity for Imeglimin, given its substantial diabetic population. Recent data reveals that nearly 27% of diabetics in China—approximately 32 million individuals—are also affected by chronic kidney disease. Diabetes remains the leading cause of end-stage renal failure in the country, increasing the demand for effective treatments that address both diabetes and its complications. Many patients with advanced CKD require dialysis or kidney transplants, underscoring the urgency for innovative therapies like Imeglimin.
The high prevalence of these conditions, coupled with limited safe and effective treatment options, positions Imeglimin as a game-changer. The drug’s unique mechanism of action improves mitochondrial function, enhances insulin sensitivity, and minimizes the harmful effects of diabetes, making it a vital option for patients with renal impairment.
Strengthening Intellectual Property for Imeglimin
The Chinese patent also includes protections for three additional patents related to Imeglimin’s synthesis process, further bolstering Poxel’s intellectual property portfolio. These patents ensure exclusivity over the drug’s manufacturing and commercialization in China, solidifying the company’s position in one of the largest and fastest-growing pharmaceutical markets globally.
“The strategic importance of these patents cannot be overstated,” said Thomas Kuhn, CEO of Poxel. “They establish a strong foundation for our entry into the Chinese market and highlight our commitment to providing innovative solutions for patients with significant unmet medical needs.”
Building Partnerships for Market Success
To capitalize on this opportunity, Poxel is actively engaging with potential partners in China. The company is focused on establishing strategic collaborations to support the development and commercialization of Imeglimin in China and Southeast Asia. Leveraging the regulatory decisions from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Poxel aims to streamline the regulatory approval process in China, expediting Imeglimin’s entry into this crucial market.
Strategic partnerships allow Poxel to navigate the complexities of China’s regulatory and commercial landscape effectively. By collaborating with local entities, the company can leverage their expertise and infrastructure while mitigating the risks of entering a new market.
Addressing Unmet Medical Needs
The rising prevalence of type-2 diabetes and associated comorbidities such as CKD in China highlights the urgent need for comprehensive treatment solutions. Many traditional diabetes medications can worsen kidney damage, making Imeglimin’s safety profile and efficacy particularly appealing for patients and healthcare providers.
Additionally, the growing awareness of the importance of managing diabetes-related complications is driving demand for treatments that address both conditions simultaneously. China’s healthcare system is under increasing pressure to provide holistic care for its diabetic population, creating a significant opportunity for Poxel.
Aligning with a Broader Global Strategy
The patent grant for Imeglimin aligns with Poxel’s overarching strategy of global expansion and partnership development. Thomas Kuhn emphasized the importance of this milestone, stating, “The patent is in line with our corporate development strategy and opens up new opportunities to establish Poxel as a key player in the global metabolic disease treatment market.”
Kuhn highlighted the vast unmet medical needs among Chinese patients, particularly those with type-2 diabetes and renal impairment, and reiterated the company’s commitment to delivering safe and effective therapeutic solutions.
Read more: Poxel Secures Patent in China for Imeglimin Use in Type-2 Diabetic Patients with Renal Impairment