Research & Development
Everest Medicines Nefecon receives Chinese regulatory approval
24 November 2023 -

Everest Medicines' (HKEX 1952.HK), a China-based biopharmaceutical company, announced on Thursday that the company has received approval from China's National Medical Products Administration (NMPA) for its Nefecon intended for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

The product is the first ever treatment for IgAN approved by the US Food and Drug Administration and European Medicines Agency. The company said that the approval represents a new era of IgAN treatment in China.

The global Phase 3 NefIgArd clinical trial was a randomised, double-blind, multi-centre study that evaluated the efficacy and safety of Nefecon at a once-daily dose of 16mg, compared to placebo in adult patients with primary IgAN on optimised RASi therapy. In the global study, Nefecon demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with Nefecon and 15-months of follow-up off drug. The reduction in urine protein creatinine ratio (UPCR) observed with Nefecon treatment was also durable and the proportion of patients with microhaematuria in the Nefecon group declined.

Rogers Yongqing Luo, Everest Medicines chief executive officer, said, 'The NDA approval of Nefecon in China is not only a significant milestone for Everest, but also a landmark for Chinese IgAN patients who will finally have an approved drug with an IgAN indication to treat their illness. Chinese patients have higher incidence rates of IgAN and faster disease progression than the rest of the world. They have an urgent need for innovative therapies like Nefecon to target disease origin and delay disease progression. I would like to extend my gratitude to the regulators, experts, and our staff that made today's approval possible. The NDA approval further establishes our leadership position in nephrology. While the company will actively prepare for the commercial launch of Nefecon and bring this first-in-disease therapy to patients in China as soon as possible, we will also continue to develop other innovative drug candidates in renal and auto-immune diseases to benefit more Chinese and Asian patients.'