Everest Medicines, a biopharmaceutical company dedicated to developing, manufacturing, and commercializing innovative medicines and vaccines, has announced that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China, has accepted its New Drug Application (NDA) for Nefecon®. This NDA pertains to the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. The company anticipates receiving NDA approval in Macao in 2023. This marks the third region, following Mainland China in November 2022 and Singapore in April 2023, where Everest has successfully filed Nefecon® as a first-in-disease treatment therapy.

Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, highlighted the company's dedication to making this groundbreaking therapy available to as many patients in Asia as possible, addressing the substantial unmet needs in a region with a significantly higher prevalence of IgAN than the global average. Approval in Macau will expand coverage to more patients in the Greater Bay area. After the successful filing of Nefecon® in Macao, the company plans to extend the availability to South Korea and Taiwan, further broadening its patient base in addition to the estimated 5 million patients in mainland China.

Nefecon® has already received approval and is being marketed in the United States, the European Union, and the UK. The NDA for Nefecon® in mainland China is currently undergoing Priority Review, with approval anticipated in the latter half of the year. Notably, Nefecon® was the first non-oncology medicine to be granted Breakthrough Therapy Designation in China, underscoring its critical role as a first-in-disease therapeutic option within the nation. An early-access program for Nefecon® has been established at Shanghai Ruijin Hospital's Hainan subsidiary, enabling clinical use since April.