Nefecon NDA is currently under Priority Review in China and expected to receive approval in 2H 2023
SHANGHAI, April 5, 2023 /PRNewswire/ -- 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.
About Nefecon
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it reaches the Peyer's patch region of the lower small intestine. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include cardio-renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
Advertisement
SHANGHAI, April 5, 2023 /PRNewswire/ -- 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.
Advertisement
"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.
About Nefecon
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it reaches the Peyer's patch region of the lower small intestine. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include cardio-renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
View original content:https://www.prnewswire.com/news-releases/everest-medicines-announces-new-drug-application-acceptance-by-singapore-hsa-for-nefecon-for-the-treatment-of-primary-iga-nephropathy-301790876.html
SOURCE Everest Medicines
