BRIEF—China's NMPA accepts Everest Medicines' filing of Nefecon for IgAN

Shares of Everest Medicines leapt more than 19% to HK$12.22 today, as it announced that its New Drug Application (NDA) for Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) has been accepted by China’s National Medical Products Administration (NMPA), bringing the company an important step closer making this innovative treatment available in China.

If approved, Nefecon will be the first-ever therapeutic option for IgAN in China.

While IgAN is a significant global concern, China has the highest disease prevalence in the world with an estimated 5 million affected by the disease.

Furthermore, chronic kidney disease – a common complication of IgAN – is one of the most serious public health problems in the nation.

Nefecon is Everest Medicines’ lead product candidate across its renal disease portfolio and is the company’s next overall area of commercial focus.

Nefecon is currently marketed by Swedish biotech firm Calliditas Therapeutics under the name Tarpeyo in the USA and in the European Union as Kinpeygo.

The NMPA previously recommended Breakthrough Therapy designation for Nefecon.