06 April 2023 | Thursday | News
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Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Singapore Health Sciences Authority (HSA) 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 NDA acceptance in Singapore marks the second territory, after Mainland China in November 2022, in which Everest has progressed Nefecon to successful NDA filing as a first-in-disease treatment therapy. The Company expects to receive NDA approval in Singapore in 2023.
"This milestone is a testament to Everest's ability to successfully advance much-needed, first-in-disease drug candidates through regulatory pathways across multiple regions in Asia, as we work to bring critical treatment options to patients as quickly as possible," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We also plan to submit NDAs for Nefecon in South Korea, Hong Kong and Taiwan regions this year. Renal disease is a key focus area for Everest, and disease prevalence in Asia is much higher than in other areas of the world. Leading with Nefecon as our anchor product, we are building a pipeline of promising renal drug candidates to address huge unmet medical needs."
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. Nefecon 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 for the approximately five million IgAN patients in China. In addition, South Korea's Ministry of Food and Drug Safety (MFDS) granted Global Innovative product on Fast Track (GIFT) designation to Nefecon in February as the first non-oncology product included in the program. Such inclusion would accelerate regulatory review time by 25% and allow for rolling review. The Taiwan Food and Drug Administration awarded Accelerated Approval Designation (AAD) to Nefecon in November 2022.