IgA Nephropathy Drug with 1,581% Sales Surge Faces Fierce Competition as Qilu Pharmaceutical and Others Enter First-to-File Race

　　【Pharmaceutical Network Product Information】In the field of kidney diseases, IgA nephropathy is undoubtedly a "frequent visitor." It is a very common primary glomerular disease, accounting for approximately 50% of such conditions. The emergence of budesonide enteric-coated capsules has brought breakthrough hope to this field.
 

It is reported that Budesonide Enteric-Coated Capsules received the NMPA Breakthrough Therapy Designation in 2020, were included in the Priority Review and Approval Process in 2022, and were officially approved for marketing in China in November 2023. Currently, only one imported product from a single company has been approved, with Everest Medicines obtaining exclusive commercialization rights for this product in mainland China.
 

In May this year, Everest Medicines' Nefecure (Budesonide Enteric-Coated Capsules, NEFECON) was included in the draft version of the guidelines. It is recommended that IgA nephropathy patients at risk of disease progression undergo nine months of targeted treatment with Budesonide Enteric-Coated Capsules, regardless of proteinuria levels, to reduce pathogenic IgA (Gd-IgA1) (2B). This breakthrough recommendation marks a new phase in the treatment of IgA nephropathy and confirms its status as a cornerstone of first-line treatment for IgA nephropathy.
 

Notably, in the race for the development of generic budesonide enteric-coated capsules, several pharmaceutical companies in China are engaged in fierce competition. On November 25, 2025, the CDE website showed that the marketing application for Qilu Pharmaceutical Co., Ltd.'s Category 4 chemical generic budesonide enteric-coated capsules has been accepted. If this application is approved successfully, it will become the first generic version of this product.
 

However, apart from Qilu Pharmaceutical, CSPC and Herui Pharmaceutical are also striving to obtain the first generic qualification for this variety. As Chinese-produced generics are gradually approved, the market for budesonide enteric-coated capsules may witness a new competitive landscape.
 

IgA nephropathy is a common primary glomerulonephritis in China. Data shows that the total number of patients in China exceeds 5 million, with more than 100,000 new cases annually. The disease presents clinically with symptoms such as edema and hematuria, and is characterized by rapid progression and poor prognosis. Approximately 60% of patients progress to end-stage renal disease within 10 to 15 years.
 

Budesonide Enteric-Coated Capsules as a Key Drug: Recognition of Its Clinical Value Translates into Impressive Market Performance. Data shows that the sales of budesonide in the Chinese market reached 7.5 billion yuan in 2024, representing an 11% year-on-year increase, with the first quarter of 2025 surpassing 1.8 billion yuan in sales again. Meanwhile, Everest Medicines' 2024 financial report also revealed that Nefukang achieved an annual revenue of 353.4 million yuan, marking a 1581% year-on-year increase.
 

In the future, with the mass-market entry of domestically produced generic drugs, this pharmaceutical market will undergo profound changes. From the patient's perspective, the popularization of generic drugs is expected to lower drug prices through market competition, enhance drug accessibility, and enable more patients with heavy financial burdens to access effective medications. From an industry standpoint, this competition will drive companies to improve their R&D and production quality, promoting higher consistency in the evaluation of the quality and efficacy of generics compared to originator drugs. For Everest Medicines, while the impact of generics may bring competitive pressure, it will also help expand the overall market, allowing budesonide to benefit a broader patient population.
 

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