Genting Xinyao announces that the pharmaceutical authorities in Taiwan and South Korea have granted Nefecon accelerated approval for the treatment of primary IgA nephropathy

-- The Ned Accelerated Approval Mechanism (AAD) designation granted by the pharmaceutical administration in Taiwan, which will significantly speed up the approval process in Taiwan and shorten the approval time

• The Ministry of Food and Drug Safety granted Nefecon ODD designation, which will expedite the NEFECON new drug marketing authorization application and approval process in Korea and increase the chance of priority review

-- Nefecon, the world's first treatment for IgA kidney disease in 50 years, has been approved for marketing in the United States and the European Union, and Chinese mainland has accepted new drug marketing authorization applications as a breakthrough treatment

SHANGHAI, Nov. 28, 2022 /PRNewswire/ -- Genting Xinyao (HKEX 1952.HK), a biopharmaceutical company focused on the development and commercialization of innovative drugs to address unmet medical needs in Greater China and other Asian regions, today announced that the drug administrations of Taiwan and South Korea have granted Nefecon (budesonide late-release capsules) accelerated approval for new drug marketing authorization applications and approvals. Nefecon is the world's first treatment for IgA nephropathy in 50 years, and is also the main product in Genting Xinyao's kidney disease portfolio, Chinese mainland it has accepted its new drug marketing authorization application as a breakthrough treatment, which is expected to benefit 5 million IgA nephropathy patients.

Yongqing Lo, CEO of Genting New Yao, said: "We are delighted to see Nefecon receive accelerated approval in Taiwan and South Korea, enabling faster access to disease-first treatments for IgA nephropathy patients in Asia. Although the incidence of primary IgA nephropathy in Asia is much higher than in other parts of the world, there is currently no effective treatment for this chronic disease, further highlighting the critical and urgent need for this innovative drug. ”

The Accelerated Approval Mechanism (AAD) designation granted by the drug administration in Taiwan, indicating that Nefecon will submit a new drug marketing authorization application and obtain priority review in Taiwan based on the key results of the key global Phase 3 clinical study NefIgArd trial Part A, thereby significantly speeding up the approval process and shortening the approval time. At the same time, the Ministry of Food and Drug Safety of Korea granted Nefecon ODD[i] designation, which will speed up the NEFECON new drug marketing authorization application and approval process in Korea and increase the chances of obtaining priority review. China's National Medical Products Administration (NMPA) also accepted Nefecon's application for marketing authorization for Chinese mainland this month, marking another important step in providing the first treatment for primary IgA nephropathy in China. China's NMPA included Nefecon in Breakthrough Therapy (BTD) in December 2020.

Genting Xinyao announced in April this year that the results of decreased proteinuria and stable glomerular filtration rate (eGFR) in the Chinese subgroup after 9 months of treatment with Nefecon were consistent with the main results of the global Phase 3 clinical study NefIgArd Part A. In November 2020, the primary results of Part A of the NefIgArd trial showed that the primary endpoint preset in the study was met. In October 2022, the results of Part A research were published in the journal Kidney International. The results showed that after 9 months of treatment, the urine protein-creatinine ratio (UPCR) in the Nefecon group was reduced by 27% compared with the placebo group, and the UPCR in the Nefecon group and placebo group was reduced by 31% and 5% from baseline, respectively. In terms of renal function protection, after 9 months of treatment, the eGFR of the Nefecon group remained stable, decreasing by only 0.17 ml/min/1.73 m2 from baseline, while the eGFR decreased by 4.04 ml/min/1.73 m2 in the placebo group. The benefit of eGFR in the Nefecon group reached 3.87 ml/min/1.73 m2, which was statistically significant (P = 0.0014). In terms of safety, Nefecon was well tolerated and no serious infection-related adverse events occurred.

Kidney disease is a key focus area for Genting New Yao. In addition to having Nefecon, a late-stage clinical development staple, the company's nephrology portfolio includes EVER001, a new generation of covalently reversible Bruton tyrosine kinase (BTK) inhibitors in clinical development for the treatment of glomerular diseases. The company's in-house R&D team will also continue to develop innovative drugs for kidney disease, and several existing nephropathy R&D programs are in the preclinical stage, with one of the fastest advancing drug candidates for glomerular nephropathy expected to be submitted for clinical trials within the next two years.

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. Nefecon is specially developed for patients with IgA nephropathy, late-release capsules containing budesonide 4mg, covered with enteric-coated coating 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 collection lymph nodes) acting on the terminal ileum, thereby reducing the production of IgA1 antibodies (Gd-IgA1) that induce galactose-deficient galactose deficiency in IgA nephropathy, thereby treating IgA nephropathy in the upstream stage of the 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 and commercialization of innovative drugs to address 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: .

Forward-Looking Statements:

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[i] ODD refers to orphan drug designation

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