Genting Xinyao announced that the Center for Drug Evaluation of the National Medical Products Administration of China intends to include Nefecon as a priority review for the treatment of primary IgA nephropathy

SHANGHAI, Dec.
30, 2022 /PRNewswire/ -- Genting Xinyao (HKEX 1952.
HK), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative drugs and vaccines to address unmet medical needs in Greater China and other Asian regions, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) announced its intention to transfer Nefecon on its official website on December 26 (budesonide late-release capsules) for the treatment of adult patients with primary IgA nephropathy at risk of disease are included in the priority review
.
This is another major development
after the NMPA accepted its application for marketing authorization for new drugs in November this year.
Previously, Nefecon was included in the breakthrough therapy variety
.

Luo Yongqing, CEO of Genting Xinyao, said: "We are very pleased to see that the NMPA intends to include Nefecon in the priority review, which is expected to further accelerate the review process of the first treatment for this disease
.
We will work closely with the NMPA to bring this innovative therapy to Chinese patients
as soon as possible.
" ”

Nephropathy is one of Genting New Yao's key focus areas, and Nefecon is the flagship product
in this area.
The Company recognizes that there is a significant unmet medical need in the nephrology space and is developing other promising pipelines of therapeutics for glomerular diseases
.

About Nefecon

Nefecon is an oral targeted budesonide late-release capsule that is currently the world's first targeted therapy for IgA nephropathy in adults at risk of progression to reduce proteinuria levels
.
Nefecon is an innovative oral targeted late-release formulation of budesonide, a glucocorticoid with strong glucocorticoid activity and weak mineralocorticoid activity with a very high
degree of first-pass metabolism 。 Developed specifically for patients with IgA nephropathy, the late-release capsules containing budesonide 4mg are coated with enteric-coated so that the drug can reach the ileum intact, and the budesonide-coated pellets contained in each Nefecon capsule target mucosal B cells (including Pyle collecting lymph nodes) acting on the mucosal B cells at the end of the ileum, thereby reducing the production of IgA1 antibodies (Gd-IgA1) that induce galactose-deficient predisposing to IgA nephropathy, thereby treating IgA nephropathy
in the upstream stage of pathogenesis 。 In June 2019, Genting Xinyao entered into an exclusive licensing agreement with Calliditas to acquire the rights to
develop and commercialize Nefecon in Greater China and Singapore.
The agreement was expanded in March 2022 to include South Korea in Genting Xinyao's license
.

About Genting Xinyao

Genting Shinyao is a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative drugs and vaccines, committed to meeting unmet medical needs
in the Asian market.
Genting Xinyao's management team has deep expertise and extensive experience
in high-quality clinical development, drug administration, chemical manufacturing and control (CMC), business development and operations in China and leading global pharmaceutical companies.
Genting Xinyao has created a number of drug portfolios that have the potential to become firsts of their kind or best-in-class in the world, most of which are in the advanced stages
of clinical trials.
The company's therapeutic areas include heart and kidney diseases, autoimmune diseases, infectious and infectious diseases
.
For more information, visit the company website: www.
everestmedicines.
com
.

Forward-Looking Statements:

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.
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.
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