Zhitong Finance App learned that Genting Xinyao (01952) is a biopharmaceutical company focusing on R&D, clinical development, manufacturing and commercialization of innovative drugs and vaccines. Today, it was announced that Nefucan (budesonide enteric capsules, NEFECON) has successfully implemented its first prescription in China, marking that the world's first drug for IgA nephropathy has officially benefited patients in mainland China, opening a new chapter in the treatment of the causes of IgA nephropathy in China.

China is one of the countries with the highest incidence of primary glomerular diseases in the world, and as a common primary glomerular disease, IgA nephropathy accounts for about 35% to 50%. Research shows that almost all patients with IgA nephropathy are at risk of progressing to end-stage nephropathy within their life expectancy and require dialysis or kidney transplantation. At the same time, IgA nephropathy has regional and ethnic differences. In particular, people with IgA nephropathy in China have more severe pathological changes and the disease progresses faster. Currently, domestic treatment plans for IgA nephropathy are mainly supportive treatment with RAS inhibitors and systemic immunosuppression treatment, and there is no targeted treatment to change the progression of the disease from the source of the disease, that is, treatment for the cause.

Luo Yongqing, CEO of Genting Xinyao, said, “We are very happy to see the successful implementation of Nafukang's first prescription in mainland China, bringing innovative treatment options to patients. After 20 years of research and development, Nifukang became the first non-tumor drug to be included as a breakthrough treatment by China's National Drug Administration, and is the world's first and only treatment for IgA nephropathy fully approved by the US Food and Drug Administration (FDA). It is also the first and only treatment for IgA nephropathy in China approved by the China National Drug Administration (NMPA). On behalf of the company, I would like to thank all those who helped Neifukang to be approved for clinical application in mainland China, especially the researchers and 62 Chinese patients who participated in the global Phase 3 clinical study. There are currently about 5 million IgA nephropathy patients in China, and more than 100,000 new patients are diagnosed each year. There is a huge unmet clinical need. We will actively work with all parties to further improve the accessibility and affordability of drugs, so that patients can use and be able to use the world's first causal treatment of IgA nephropathy, and continue to help improve the nephropathy diagnosis, treatment and disease management ecosystem, so that more patients with kidney disease can benefit. While striving to promote the commercialization of Nifukang in China and Asia, we will continue to make every effort to promote the development of other innovative drugs in the field of nephrology to benefit more patients.”

Professor Zhang Hong, member of the Global Steering Committee for Nefukang Global Phase III Clinical Research NefLGard and director of the Department of Nephrology at Peking University First Hospital, said, “IgA nephropathy is the most common primary glomerular disease. It occurs at a young age and can easily progress to end-stage nephropathy. Compared with people in Europe and the US, patients with IgA nephropathy in the Chinese population progressed rapidly and had poor prognosis, putting a heavy burden of disease on patients and society. The results of the NeFigard study showed that resistant to kidney function, delayed progression of patients to dialysis or kidney transplantation, significantly reduced urinary protein and hematuria, and was safe and well tolerated. Data analysis of the Chinese population showed that resistant to fukang decreased kidney function by 66%, and the progression of the disease to dialysis or kidney transplantation was delayed by 12.8 years. “Nifukang's approval for marketing fills the gap in treatment of IgA nephropathy in China, benefits Chinese patients, improves disease prognosis, and brings new treatment options to clinicians.”

Professor Xie Jingyuan, director of the Department of Nephrology at Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, said, “IgA nephropathy is a high incidence in Asia, and it is also one of the main causes of kidney failure among young adults in China. Among patients with IgA nephropathy, the risk of progression to end-stage nephropathy in the Asian population is 56% higher than in other groups, and the disease progresses more rapidly. Once it progresses to terminal kidney disease, it will put a huge medical burden on the patient's individual, family, and society. Therefore, more active treatment is needed to intervene to control the risk of disease progression and delay entry into dialysis or kidney transplantation. There has been a lack of specific treatment options for this disease for a long time, resulting in a huge gap in medical demand. As the world's first drug to treat IgA nephropathy, Nifukang has treated more than 100 patients since it was first tested in Boao in April last year. In follow-up, it was found that the drug is more effective in stabilizing kidney function, reducing proteinuria and hematuria, and is well tolerated by patients. Nifukang's approval for marketing in mainland China is of great significance, helping patients with IgA nephropathy to start causal treatment as soon as possible.”

The latest analysis results announced at the 2024 World Nephrology Congress also further prove that for Chinese patients whose disease progresses rapidly, Tolerant may provide greater benefits in delaying the decline in kidney function without affecting the patient's quality of life. The positive results of the Global Open Label Extension (OLE) study based on the NepGard Phase III study verified that the efficacy and safety of receiving repeated treatment with Nifukan were not affected by previous treatment cycles, providing a solid scientific foundation for future long-term maintenance treatment plans with resistant health care.

Nifucan was approved by the NMPA in November 2023 to treat adult patients with primary IgA nephropathy at risk of progression. Furthermore, Nifukang has been approved in many countries such as Europe, America, and Asia.

In order to meet the huge clinical needs of patients with IgA nephropathy, Genting Xinyao has been committed to improving the accessibility and affordability of medication for patients through various innovative models. This time, Nafukang's first prescription was issued in the form of an internet hospital, breaking time and geographical restrictions, providing patients with timely medication, and improving patients' accessibility to medical treatment. As part of preparations before the product is launched, Genting Xinyao launched an early entry program in the Boao Pilot Zone in Hainan. Approximately 700 patients have registered for the program. After Macau, China received approval for the marketing of the new drug Nefukang, the Charitable Foundation launched a patient assistance program to provide financial assistance to mainland Chinese citizens using Nifukang on their own in Macau, China. About 400 patients registered for the program. At the same time, there are patient assistance programs from the Mainland China IgA Nephropathy Patient Registration Foundation for more than 20,000 people. These projects fully reflect the urgent unmet medical needs of Chinese patients for Nafukang, and also paved the way for rapid commercialization in mainland China.

With the approval and commercialization of Nifukang in mainland China, the Charitable Foundation has launched the “Kidney Care Assistance Program” to provide some drug assistance for mainland Chinese citizens to self-use adult patients in mainland China to help more IgA nephropathy patients reduce their financial burden, receive treatment in a sustainable and standardized manner, improve the accessibility of treatment, reduce the burden on families and society, improve the quality of life, and prolong life.