China’s NMPA approved Nefecon in late 2023 for the treatment of primary IgAN in adults who are at risk of disease progression

Nefecon

Everest Medicines announces commercial launch of Nefecon in China for the treatment of IgA nephropathy. (Credit: Christina Victoria Craft on Unsplash)

Everest Medicines, a biopharmaceutical company listed in Hong Kong, has announced the launch of IgA nephropathy (IgAN) drug Nefecon in China, issuing its first prescription.

Nefecon is an oral, delayed-release formulation of budesonide, a corticosteroid known for its potent glucocorticoid effects and minimal mineralocorticoid activity.

The drug is specifically designed to release budesonide in the distal ileum, targeting mucosal B-cells that play a role in the pathogenesis of IgAN.

The enteric-coated capsule ensures that it passes through the stomach intact, releasing its active ingredients only upon reaching the targeted site in the intestine.

Everest Medicines CEO Rogers Yongqing Luo said: “The commercialisation of Nefecon in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China.

“Nefecon has undergone a 20-year research and development process, become the first non-oncology therapeutic to receive Breakthrough Therapy Designation in China by the China National Medical Products Administration (NMPA), and the first ever treatment for IgAN to receive full approval from the US Food and Drug Administration (FDA).

“It is also the first approved medicine with an IgAN indication by the NMPA in China.”

The NMPA approved Nefecon in November 2023 for the treatment of primary IgAN in adults who are at risk of disease progression. The drug has also gained approval in various other regions, including multiple countries across Europe, the US, and Asia.

Everest Medicines secured the rights to develop and commercialise Nefecon in mainland China, Hong Kong, Macau, Taiwan, and Singapore through an exclusive, royalty-bearing license agreement with Calliditas in June 2019.

The agreement was further extended in March 2022 to include South Korea, expanding Everest Medicines’ potential market for Nefecon in Asia.