Everest Medicines announced that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China has accepted its New Drug Application (NDA) for Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. The Company expects to receive NDA approval in Macao in 2023. The NDA acceptance in Macao marks the third region, after Mainland China in November 2022 and Singapore in April 2023, in which Everest has successfully filed Nefecon® as a first-in-disease treatment therapy.

Nefecon® has already been approved and marketed in the United States, the European Union and the UK. The NDA for Nefecon® in mainland China is currently under Priority Review and is expected to be approved in the second half of this year. It was the first non-oncology medicine to receive Breakthrough Therapy Designation in China, reinforcing the urgent need of Nefecon® as a first-in-disease therapeutic option in the nation.

Nefecon® has been available for clinical use in Shanghai Ruijin Hospital's Hainan subsidiary through an early-access program since April.