SHANGHAI, MAY 14, 2024/NEWS/-- Genting XINYAO (HKEX 1952.HK), a biopharmaceutical company focused on innovative drug and vaccine R&D, clinical development, manufacturing and commercialization, today announced the launch of NAICANG(PUDINEID COLIC CAPSULE, NEFECON) The successful launch of the first prescription in China marks the start of the world's first IgA kidney disease treatment for patients in mainland China, opening a new chapter in the treatment of IgA kidney disease in China.

China is one of the countries with the highest incidence of primary glomerular disease in the world, and IgA kidney disease accounts for about 35% to 50% as a common primary kidney disease. Research Display^[1]Almost all patients with IgA kidney disease are at risk of progressing to end-stage renal disease within their life expectancy and require dialysis or kidney transplantation. At the same time, IgA nephropathy has regional and ethnic differences, especially in the Chinese IgA kidney population, the pathology changes drastically and the disease progresses faster. While the current domestic treatment of IgA nephropathy is based on supportive therapy with RAS inhibitors and systemic immunosuppression, there is a lack of targeted therapeutic approaches that alter disease progression from the source of the disease, i.e. causal therapy.

Mr Lo Yongqing, CEO of Genting Xinyu, said: “It is very pleased to see the resilience and wellbeingThe first prescription in mainland China has successfully landed, bringing innovative treatment options to patients. ResilienceWith a 20-year research history, it became the first non-tumor drug to be included in a breakthrough therapeutic strain by the National Drug Administration of China, and the first and only IgA kidney causative agent in the world to be fully approved by the Food and Drug Administration (FDA), while also the first domestically and only An IgA kidney disease causative agent approved by the National Drug Administration of China (NMPA). Here, I represent the company to help all people with resilienceThank you to all parties who have been approved to enter clinical applications in Mainland China, especially the researchers who participated in the Phase 3 global clinical trial and 62 Chinese patients. China currently has about 500 million IgA kidney disease patients, with more than 10 million confirmed patients added annually, and there is a huge unmet clinical need. We will work actively together to further improve the availability and affordability of medicines, make it more accessible to patients, the world's first causative agent of IgA kidney disease, and continue to help improve the renal diagnostic and disease management ecosystem to benefit more kidney patients. In an effort to promote resilience“As we commercialize in China and Asia, we will continue to fully drive the development of other innovative drugs in the field of kidney disease to benefit more patients.”

Resilience“IgA nephropathy is the most common primary nephroglobulus disease, starting at a younger age and progressing to end-stage renal disease,” said Professor Zhang Wang, Head of Renal Medicine at the First Hospital of Peking University, a member of the Global Steering Committee for Phase III Clinical Study NEFLGard. Compared to the European and American populations, the disease progression of IgA kidney disease in the Chinese population is fast and less predictable, and poses a heavy burden of disease on patients and society. The results of the NeFigard study show that enduranceProtects kidney function, delays patient progress to dialysis or kidney transplantation, significantly reduces urinary protein and blood urea, and is safe and well tolerated. Chinese Population Data Analysis Shows ResilienceReduced renal function decline by 66% and delayed disease progression to dialysis or kidney transplantation by 12.8 years. ResilienceThe approved listing fills the gap in China's IgA nephropathy treatment drug, benefiting patients in China and China, providing clinicians with new treatment options after improving disease prognosis.”

Professor Xie Jingyuan, director of nephrology at Suijin Hospital, Shanghai Jiaotong University School of Medicine, said: “IgA nephropathy in Asia is also one of the main causes of kidney failure among young people in our country. In patients with IgA kidney disease, the Asian population has a 56% higher risk of end-stage renal disease than others, and the disease progresses faster. Once advanced to end-stage renal disease, the medical burden on the individual, family and society is enormous. Therefore, it is necessary to intervene with more active treatment, control the risk of disease progression and delay dialysis or kidney transplantation. For a long time, there has been a lack of specific treatment options for the disease, leading to a huge gap in medical demand. ResilienceAs the world's first drug for the treatment of IgA kidney disease, it has treated more than 100 patients since it was first tried in April last year in Boao, and a follow-up visit found that the drug was more effective in stabilizing kidney function, reducing protein and urine, and was well tolerated by patients. ResilienceThis approval in Mainland China is significant in helping IgA kidney disease patients to start etiotropic therapy as early as possible.”

The latest analysis results, announced at the 2024 World Congress of Kidney Diseases, further demonstrate resilience for patients in China who are experiencing faster disease progressionOr may provide greater benefits in delaying kidney function decline without affecting the patient's quality of life^[2]。 Positive Results of Global Open Label Expansion (OLE) Study Based on NeFigard Phase III Study Validate Acceptance of EnduranceEfficacy and safety of re-treatment are not affected by the previous treatment cycle^[3], FOR RESILIENCEFuture long-term maintenance therapies provide a solid scientific foundation.

ResilienceNMPA was approved in November 2023 for the treatment of adult patients with primary IgA kidney disease at risk of progression. In addition, resilienceIt has been approved in several countries in Europe, Asia, etc.

In order to meet the enormous clinical needs of IgA kidney disease patients, Genting Shinyao has been committed to improving the accessibility and affordability of medicines for patients through a variety of innovative modes. Enduring this timeThe first prescription is released via the Internet hospital, breaking time and space constraints, providing timely medication to patients and improving patient access to a doctor. As part of the preparation work before the product launch, Genting Xinyao launched an early admission program in Hainan's Boao trial zone, with about 700 patients registered for the project. Macao, China Achieves ResilienceAfter New Drug Listing Approval, Charitable Foundation Launches Patient Assistance Program for Mainland Chinese Citizens to Use Self-Reliance in Macau, ChinaAbout 400 patients signed up for the project to provide funding assistance to patients. At the same time, there are more than 20,000 patient assistance projects of the Chinese Mainland IgA Kidney Patient Registration Foundation. These projects fully embody the resilience of Chinese patientsUrgent unmet medical needs have also paved the way for the rapid commercialization of mainland China.

With ResilienceApproved and commercialized in Mainland China, the Charitable Foundation has launched the Kidney Rehabilitation Assistance Project for Mainland Chinese citizens to exercise their own resilience in Mainland ChinaPartial drug assistance is available to adult patients to help more patients with IgA kidney disease reduce the financial burden, sustainably and routinely receive treatment, improve treatment accessibility, reduce family and social burdens, improve quality of life, and prolong life.

About Endurance(NEFECON)

Resilience(NEFECON) The Budinid Intestinal Capsule, the world's only drug for the treatment of IgA kidney disease, is an immunomodulator that targets intestinal mucosal B cells, reduces kidney function decline by 50%, delays renal decline by 66% in the Chinese population, and is expected to delay the progression of the disease to dialysis or kidney transplantation 12.8 years。 At the same time, Budinid has a high metabolic rate of 90%, which has good safety. ResilienceDeveloped for patients with IgA kidney disease, each capsule contains 4mg of Budinid, through a special formulation process, releasing the mucosal B cells at the end of the intestine (including the Peyre collection lymph nodes), and after the capsule dissolves, the three-layer enveloping pill continuously releases Budinid to a high concentration of the entire target. Area that reduces the production of IgA1 antibodies (gd-IgA1) that induces IgA nephropathic half-lactose deficiency, thereby intervening in the upstream phase of the disease mechanism, achieving the role of treating IgA nephropathy.

In June 2019, Genting XINYao signed an exclusive licensing agreement with Calliditas to acquire and commercialize the development and commercialization of NCAC in Greater China and SingaporeThe right. The agreement was extended in March 2022 to include South Korea within the scope of Genting Shinyao's authorized license.

About Genting Shining

Genting Xinyu is a biopharmaceutical company focused on innovative drug and vaccine R&D, clinical development, manufacturing and commercialization, dedicated to meeting the unmet medical needs of the Asian market. Genting Xinyu's management team has extensive expertise and experience in high-quality R&D, clinical development, pharmaceutical affairs, chemical manufacturing and control (CMC), business development and commercialization operations in leading pharmaceutical companies in China and globally. Genting Xinyu has created a combination of first-of-its-kind or best-in-class medicines for many diseases. The company's therapeutic areas include renal diseases, infectious and infectious diseases, and autoimmune diseases. For more information, please visit the company website:.

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