Nefecon approved for use in China

Hong Kong-listed biopharmaceutical company Everest Medicines announced to media on Monday that China's National Medical Products Administration has approved its innovative medicine Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

Nefecon was the first-ever treatment for IgAN approved by the United States Food and Drug Administration in December 2021 and the European Medicines Agency in July 2022.

The NMPA approval of the therapy, which is the first approved medicine with an IgAN indication in China, marks a new milestone in IgAN treatment in the country, said the company.

According to medical experts, China has an estimated 5 million IgAN patients - the highest prevalence of primary glomerular diseases in the world, and current non-targeted treatment options for IgAN do not alter disease progression. IgAN patients are at risk of progressing to end-stage renal disease, which often requires dialysis or a kidney transplant.

Professor Zhang Hong from Peking University First Hospital in Beijing said that IgA nephropathy occurs at a young age, and thus imposes a heavy burden on patients and the society.

"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 to target disease origin and delay disease progression," said Rogers Yongqing Luo, chief executive officer of Everest Medicines.

"While actively preparing for the commercial launch of Nefecon and bringing this first-in-disease therapy to patients in China as soon as possible, the company will continue to develop other innovative drug candidates in renal and auto-immune diseases to benefit more Chinese and Asian patients," he said.

The company said that the medicine is expected to receive new drug application approval in Singapore and China's Hong Kong Special Administration soon.