Genting Xinyao announced that the Department of Health of Hong Kong, China has approved the world's first New Drug (NDA) application for the treatment of IgA nephropathy with Oxcon ®

SHANGHAI, May 2, 2024 /PRNewswire/ -- Genting Xinyao (HKEX 1952.HK), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative drugs and vaccines, today announced that the Department of Health in Hong Kong, China has approved Nexcan ® (budesonide enteric-coated capsules (Nefecon®) for the treatment of adult patients with primary IgA nephropathy at risk of disease progression. Nexcon ® is the world's first and only fully approved drug by the U.S. Food and Drug Administration (FDA) for the causal treatment of IgA nephropathy. Hong Kong is the fourth region in Genting Xinyao's licensing region, following Macau, Chinese mainland and Singapore, to receive NDA approval from Nexcon. ®

"IgA nephropathy is the most common in the Asian population, and the risk of progression to end-stage renal disease is 53% higher than that of other populations, and the disease progresses more rapidly. With the approval of Nexcon ® in Hong Kong, we will continue to expand Nexcon's ® access in Asia, including actively advancing its commercial launch in Chinese mainland and NDA approvals in South Korea and Taiwan to benefit patients in China and more Asia." "

In the NefIgArd Phase III global clinical trial, Nexcon ® demonstrated a statistically significant and clinically relevant benefit in terms of glomerular filtration rate (eGFR) over two years compared to placebo. The reduction in urine protein-to-creatinine ratio (UPCR) observed in the Naric treatment group was also durable, and the proportion of patients with microscopic hematuria in the Nafukang ® ® treatment group decreased. At the same time, Nexcon ® was generally well tolerated in phase III clinical trials.

Results from the NefIgArd Phase III global clinical trial also showed greater therapeutic efficacy in renal function protection, proteinuria reduction, and microscopic hematuria improvement in the Chinese subpopulation compared to the global population. The mean absolute change from baseline in eGFR at 24 months showed that after 9 months of treatment and 15 months of discontinuation of Nexcon, ®renal function decline was reduced by 66% in the Chinese subpopulation and 50% in the global population. Compared with placebo, patients treated with Nexcan ® in China had a 43% (95% CI 8%, 65%) reduction in UPCR at 24 months and a 31% reduction (95% CI 0, 53) at 9 months, compared with approximately 30% at 9 and 24 months in the global population. At the same time, the proportion of Chinese patients without microscopic hematuria in the Nexam ® group increased significantly from 26.9% at baseline to 57.7% during the observational follow-up period, while it remained at 14.3% in the placebo group.

At the 2024 World Congress of Nephrology in April this year, ®the results of multiple new analyses from the NeflgArd Phase III study further demonstrated the therapeutic effect of Enercon ® in modifying the course of IgA nephropathy, significantly delaying the reduction in eGFR by 30% or the time to progression to renal failure without compromising the patient's quality of life, regardless of baseline UPCR or ethnic background ®. In the same month, positive results were also published in the ®global open-label extension study of the NefIgArd Phase III study, which verified that the efficacy and safety of re-receiving NefIgArd ® treatment were not affected by previous treatment cycles, providing a solid scientific basis for long-term ® maintenance treatment options in the future.

关于耐赋康®(Nefecon®)

Nefecon ®® is budesonide enteric-coated capsules, as the world's only drug for the treatment of IgA nephropathy, is an immunomodulator targeting intestinal mucosal B cells, can slow down 50% of renal function decline, can delay kidney function decline by up to 66% in the Chinese population, and is expected to delay disease progression to dialysis or kidney transplantation for 12.8 years. At the same time, budesonide has a first-pass metabolism degree of 90%, which has a good safety profile. Specially ® developed for patients with IgA nephropathy, each capsule contains 4mg of budesonide, through a special preparation process, budesonide is targeted to the mucosal B cells at the end of the ileum (including Pyle's collecting lymph nodes), after the capsule is dissolved, the three-layer coated pellets continue to release budesonide stably, and the high concentration covers the entire target area, thereby reducing the production of galactose-deficient IgA1 antibody (Gd-IgA1) that induces IgA nephropathy, and then intervenes in the upstream stage of pathogenesis to achieve the effect of treating IgA nephropathy.

In June 2019, Genting Xinyao entered into an exclusive licensing agreement with Calliditas to acquire the rights to develop and commercialize Nexcon ® in Greater China and Singapore. The agreement was extended in March 2022 to include South Korea in the scope of Genting's licensing.

About Genting Xinyao

Genting Xinyao is a biopharmaceutical company focused on the R&D, clinical development, manufacturing and commercialization of innovative drugs and vaccines, dedicated to addressing unmet medical needs in the Asian market. The management team has deep expertise and extensive experience in high-quality R&D, clinical development, regulatory affairs, chemical manufacturing and control (CMC), business development and commercialization operations for leading pharmaceutical companies in China and around the world. The company has developed a first-in-class or best-in-class portfolio of drugs in the treatment areas of renal diseases, infectious and infectious diseases, and autoimmune diseases. For more information, please visit the company's website.

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