China is one of the countries with the highest incidence of primary glomerular diseases in the world, with immunoglobulin A (IgA) nephropathy accounting for about 35%~50% of primary glomerular diseases, with about 5 million patients in the country and about 100,000 new confirmed patients every year. These patients have a high probability of progressing to end-stage renal disease within life expectancy and requiring dialysis or kidney transplantation. At present, the treatment regimen for IgA nephropathy in China is mainly supportive therapy with RAS inhibitors and systemic immunosuppressants, and there is a lack of targeted treatment methods to change the progression of the disease from the source of the disease, that is, there is a huge unmet clinical need for cause therapy.
On May 14, the world's only prescription for the treatment of IgA nephropathy drug Acecon ® (budesonide enteric-coated capsules, NEFECON)® in Chinese mainland was launched, and issued in the form of electronic prescriptions in Internet hospitals, breaking the time and geographical restrictions and improving the accessibility of patients to medical treatment. Patients with IgA nephropathy are treated in the Department of Nephrology of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and are prescribed in the Internet hospital according to the doctor's instructions, and the pharmacy will send the medicine to the patient as soon as possible. This marks the official entry of this innovative therapeutic drug into clinical application in Chinese mainland, benefiting patients in Chinese mainland and filling the gap in the treatment of IgA nephropathy in mainland China.
The patient was treated with IgA nephropathy at the Department of Nephrology of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and was prescribed the first prescription of Nepec ® in the Internet Hospital according to the doctor's instructions
Nexcon ® (budesonide enteric-coated capsules, NEFECON)® is available in pharmacies
Data show that IgA nephropathy is a glomerular disease characterized by the deposition of IgA-dominated immune complexes in the mesangial region of the glomeruli, and is also a chronic progressive autoimmune nephropathy, which is characterized by the deposition of IgA-containing immune complexes in the glomeruli, resulting in inflammation and damage to cell tissues, and then clinically manifested as proteinuria and hematuria, and about 50% of patients with IgA nephropathy with high risk of progression will progress to end-stage renal disease within 10-20 years, requiring dialysis or kidney transplantation.
® According to the results of the NefIgArd Phase III study, Nexcon is the world's first and only fully approved drug for the treatment of IgA nephropathy by the U.S. Food and Drug Administration, and the results of the NefIgArd Phase III study showed that Nexcon ® can protect kidney function, delay the progression of patients to dialysis or kidney transplantation, significantly reduce urine protein and hematuria, and is safe and well tolerated.
"IgA nephropathy is the most common primary glomerular disease that presents at a young age and is prone to progression to end-stage renal disease. Compared with the European and American populations, patients with IgA nephropathy in the Chinese population have rapid disease progression and poor prognosis, bringing a heavy disease burden to patients and society," ® said Professor Zhang Hong, a member of the global steering committee of NefIgArd's global phase III clinical study and director of the Department of Nephrology ® at Peking University First Hospital. Analysis of Chinese population data showed that Nexus ® reduced kidney function by 66%, and the time from disease progression to dialysis or kidney transplantation was delayed by 12.8 years. The approval of Nexcom ® fills the gap of non-causal treatment drugs for IgA nephropathy in China, benefits Chinese patients, improves disease prognosis, and brings new treatment options to clinicians.
In view of the harm and prevention of IgA nephropathy to Asian populations, Professor Xie Jingyuan, Director of the Department of Nephrology of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, said: "IgA nephropathy has a high incidence in Asia and is also one of the main causes of kidney failure in young adults in mainland China. Among patients with IgA nephropathy, the risk of progression to end-stage renal disease was 56% higher in the Asian population than in the rest of the population, and the disease progressed more rapidly. Once the disease progresses to end-stage renal disease, it will bring great medical burden to the patient's individual, family and even society, so it is necessary to intervene with more aggressive treatment to control the risk of disease progression and delay the entry into dialysis or kidney transplantation. For a long time, there has been a lack of specific treatment options for the disease, resulting in a huge gap in medical needs. As the world's first drug for the treatment of IgA nephropathy, Nexcon ® has treated more than 100 patients since its pilot trial in Boao in April last year, and found that the drug can effectively stabilize kidney function, reduce proteinuria and hematuria, and is well tolerated by patients. The approval of Nexus ® for marketing in Chinese mainland is of great significance to help patients with IgA nephropathy start treatment as soon as possible. ”
Genting Xinyao CEO Luo Yongqing said he was very pleased to see the successful launch of Nexcon's ® first prescription in Chinese mainland, bringing innovative treatment options to patients. After 20 years of research and development, Nexcon ® has become the first non-oncology drug to be granted Breakthrough Therapy Designation by the National Medical Products Administration of China, and is the first and only drug in the world to be fully approved by the U.S. Food and Drug Administration (FDA) for the treatment of IgA nephropathy, and the first and only drug approved by the National Medical Products Administration of China for the treatment of IgA nephropathy in China. "We will actively work with all parties to further improve the accessibility and affordability of medicines, make this world's first cause-based treatment drug for IgA nephropathy accessible and affordable to patients, and continue to help improve the diagnosis and treatment of kidney disease and disease management ecosystem, so that more patients with kidney disease can benefit." While we strive to promote the commercialization process of Nexcan ® in China and Asia, we will continue to make every effort to promote the development of other innovative drugs in the field of kidney disease to benefit more patients." “
Previously, about 700 patients applied for the program by launching an early access program in the Boao Pilot Zone in Hainan. Following the approval of Nexcon ® in Macau, Chinese mainland, Hong Kong and Singapore, and the successful issuance of its first prescription in Macau at the end of last year, the Foundation launched the Patient Assistance Program, which provides financial assistance to patients who are Chinese mainland citizens who use Nexcon ® on their own in Macau, China, with around 400 patients enrolled in the program. Driven by national policies, more than 100 patients have been treated since Nexkang ® landed in Boao through the green channel in April last year. The successful approval of Nexcan ® has allowed many patients in Chinese mainland to see unprecedented treatment opportunities, and more than 20,000 IgA nephropathy patients in Chinese mainland have registered as the Foundation's patient assistance program, which will become a drug group after the official launch of Nexcon ® in Chinese mainland to meet the huge clinical needs of Chinese patients.
It is understood that on the occasion of the first prescription of Nexcon ®, in order to help patients receive treatment in a sustainable and standardized manner and improve the accessibility of treatment, Beijing Kangmeng Charity Foundation launched the "Kidney Care and Rehabilitation Assistance Project", which will provide some drug assistance for patients who use Nexcan ® on their own in Chinese mainland by Chinese mainland citizens. Specifically, patients with IgA nephropathy who have been clinically diagnosed and are eligible for Nafcon ® treatment and are eligible for project assistance can go to the hospital and be prescribed by a clinician to use 4 boxes of Nefukang ® for their own use, and can get 1 box of Nafcon ® donated drugs, so as to reduce the burden on the patient's family and society, improve the quality of life and prolong life.
Genting Xinyao said that in the future, it will further expand the affordability of this innovative drug, and is committed to including Nafkang ® in the medical insurance list in 2025 to meet the urgent needs of more patients with IgA nephropathy in China and even Asia, and fundamentally change the treatment pattern of patients lacking targeted therapies.