It was learned from the Economic Information Daily APP that on July 18th, Hong Kong innovative pharmaceutical company YunDingXinYao-B (01952) announced that the National Medical Products Administration (NMPA) of China has officially accepted the company's supplemental application for the final clinical trial stage complete data of Nefecon. After this supplemental application is approved, Nefecon will become the first and only domestically approved IgA nephropathy causative treatment drug by the National Medical Products Administration (NMPA) of China.

In response, Luo Yongqing, CEO of YunDingXinYao, said that the Nefecon's approved supplementation application has been officially accepted by the NMPA, bringing new hope to more IgA nephropathy patients. "After 20 years of R&D, Nefecon became the first and only domestically approved IgA nephropathy causative treatment drug by the National Medical Products Administration, and also the first and only IgA nephropathy causative treatment drug globally to be fully approved by the US Food and Drug Administration (FDA). It is used to delay the decline in kidney function of primary IgA nephropathy patients with a progressing risk, without baseline proteinuria level restrictions. We look forward to Nefecon receiving full approval in China to better meet the urgent clinical needs of domestic IgA nephropathy patients."

As the world's most common primary glomerular disease, IgA nephropathy is also an important cause of end-stage renal disease or kidney failure. About 50% of IgA nephropathy patients with high progression risk will progress to end-stage renal disease within 10-20 years and require dialysis or kidney transplantation. Public data shows that China has the highest incidence of primary glomerulonephritis in the world, of which IgA nephropathy accounts for 35% to 50%.

After full approval, Nefecon's treatment will have no baseline proteinuria level restrictions, and will delay kidney function decline by 66% in the Chinese population.

According to the data, this supplemental application is based on the complete data of the NefIgArd III clinical study. The NefIgArd III global clinical trial is a randomized, double-blind, multicenter study that evaluated the efficacy and safety of Nefecon (16mg, once daily) compared with placebo in adult patients with primary IgA nephropathy receiving optimized RAS inhibitor therapy. This study lasted for 2 years, including a 9-month Nefecon or placebo treatment period, followed by a 15-month withdrawal and follow-up period.

The global study results show that compared with placebo, Nefecon not only has persistent proteinuria reduction and reduces the risk of microscopic hematuria, but more importantly, it has clinically significant and statistically significant differences in estimating glomerular filtration rate (eGFR) (p<0.0001) and can reduce kidney function decline by 50%. The Chinese subgroup data also showed that Nefecon can reduce kidney function decline by 66%, and is expected to delay progression to kidney failure for up to 12.8 years. It also reduces proteinuria by 43%, and the proportion of patients without microscopic hematuria increased significantly from the baseline of 26.9% to 57.7%, providing better therapeutic effects compared to the global patient population. For Chinese patients with fast disease progression, Nefecon can provide greater benefits in terms of delaying kidney function decline.

Luo Yongqing said,"In IgA nephropathy patients, Asian populations have a 56% higher risk of progression to end-stage renal disease than other populations. Currently there are about 5 million IgA nephropathy patients in China, and more than 0.1 million newly diagnosed patients each year, resulting in a huge unmet clinical need." Therefore, compared with European and American populations, Chinese IgA nephropathy patients progress quickly, which brings heavy disease burden to patients and society.

The product is estimated to have further market potential if the Nefecon supplemental application is approved as it will remove the baseline proteinuria level restriction for treatment, further expand the range of patients eligible for treatment, and bring more benefits to patients.

In the past, the main treatment for IgA nephropathy in China was supportive treatment with renin-angiotensin system (RAS) inhibitors. Due to the lack of specific targeted treatment methods that truly change the progression of the disease from the source, most patients will progress to end-stage renal disease within 15 years of diagnosis and can only rely on hemodialysis or kidney transplantation to maintain their lives, leading to a heavy disease burden.

In November 2023, Nephrogenix received conditional approval from NMPA for a new drug for the treatment of adult patients with primary IgA nephropathy at risk of progression, becoming the first and only NMPA-approved targeted treatment drug for IgA nephropathy in China, filling the gap in China's lack of targeted treatment drugs for IgA nephropathy. It is worth noting that Nephrogenix is also the only drug currently approved by the FDA for the treatment of IgA nephropathy at risk of progression, and there is no baseline proteinuria level limit.

The "dual-innovative process" of Nephrogenix achieves targeted release, and has received certification from authoritative guidelines at home and abroad.

In addition, NEFECON can obtain full FDA approval, which is also related to its innovative design in addition to excellent clinical performance. The "dual-innovative process" of Nephrogenix can target release budesonide to mucosal B cells (including Payer's patches) at the end of the ileum, making it possible for the drug to act on the "source" of the disease and achieve targeted treatment for IgA nephropathy.

It is worth mentioning that Nephrogenix has been recommended by multiple authoritative treatment guidelines at home and abroad. Among them, when the KDIGO guidelines were updated in 2024, experts recommended a different use from the 2021 KDIGO guidelines, recommending Nephrogenix for all patients with proteinuria > 0.75 g/day, and systemic glucocorticoids are only recommended as a last resort. In the 2021 KDIGO guidelines, there are no truly effective specific treatments for the cause of IgA nephropathy. The main treatment for IgA nephropathy is to control blood pressure, reduce proteinuria by inhibiting the renin-angiotensin system, and change lifestyle through supportive treatment.

Currently, Nephrogenix has issued the first prescription in mainland China in May this year, opening a new era in the treatment of IgA nephropathy. In addition, Nephrogenix has been approved in Macau, Hong Kong, and Singapore, and has submitted and successfully obtained acceptance for new drug market approval applications in Taiwan and South Korea at the end of 2023 respectively.