On November 26, Otsuka Pharmaceutical announced that its innovative drug Speliclone (Voyxact) has received FDA accelerated approval for the treatment of adult patients with primary Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression, to significantly reduce proteinuria.Can achieve once-a-month dosing.
Thus, the development of long-acting IgA nephropathy treatment drugs has entered the research and development stage.August and September this yearNovartis' Atrasentan and Iptacopan were approved in China for IgA nephropathy during the same period,RemeGen's Telitacicept proposed for inclusion in the priority review category in China,For the treatment of adult patients with primary immunoglobulin A (IgA) nephropathy who are at risk of progression.
IgA Nephropathy Has Become a Recent Industry Trend, with Multiple New Products Launched, Turning the Blue Ocean Red.PreviouslyIgA Nephropathy Treatment DrugsThe most successful variety isBudesonide Enteric-Coated Capsules,Budesonide Enteric-Coated Capsules (Nefukang®) is the world's first causative treatment drug for IgA nephropathy, and has been successively approved by the three major authoritative bodies—the U.S. FDA, the European EMA, and China's NMPA—as the world’s first causative treatment for IgA nephropathy.The original research company is Calliditas. In 2019, Everest Medicines acquired the commercialization rights for Greater China and Singapore, and it was conditionally approved for marketing in China on November 24, 2023.
Currently, only one company has been approved for import, and Everest Medicines has obtained the exclusive commercial rights to this product in mainland China.In May this year, Everest Medicines' Nefukang was included in the draft guidelines, recommending a 9-month course of budesonide enteric-coated capsules for IgA nephropathy patients at risk of disease progression, without restriction based on proteinuria levels, to reduce pathogenic IgA (Gd-IgA1) (2B).This breakthrough recommendation marks a new phase in the treatment of IgA nephropathy, confirming its status as a cornerstone for first-line therapy in IgA nephropathy.Budesonide Enteric-Coated Capsules as a Blockbuster Drug: Recognition of Its Clinical Value Translates into Impressive Market Performance. Data shows that the sales revenue of budesonide in the Chinese market reached 7.5 billion yuan in 2024, representing an 11% year-on-year increase, with first-quarter sales in 2025 breaking through 1.8 billion yuan once again.Everest Medicines' 2024 financial report also shows that Nefukang achieved an annual revenue of 353.4 million yuan, representing a year-on-year increase of 1581%.Such a high market growth rate naturally draws attention from generic drug companies. On November 25, 2025, the CDE website showed that the marketing application for Qilu Pharmaceutical Co., Ltd.'s Category 4 chemical generic drug, Budesonide Enteric-Coated Capsules, has been accepted.In addition to Qilu Pharmaceutical, CSPC and Herui Pharmaceutical are also striving to obtain the first generic qualification for this variety.The patent for the compound budesonide has long expired, and the difficulty in generic production lies only in the manufacturing process. Transforming this hormonal component into an enteric capsule requires a certain level of technical expertise.NefukangAdopting TARGIT™ patented pH-sensitive enteric coating technology.Notably, the shortage of budesonide enteric-coated capsules triggered widespread discussion in July this year, leaving many patients in fear of drug scarcity. At that time, the product was only manufactured by Patheon Pharmaceuticals Inc (overseas), leading to insufficient production capacity.Soon in August, Everest Medicines announced that its application for production expansion had been approved, timely resolving the drug shortage issue. This clearly shows that there is absolutely no worry about the sales of Budesonide Enteric-Coated Capsules.IgA nephropathy is a common primary glomerulonephritis in China, with data showing that the total number of patients in China exceeds 5 million, and more than 100,000 new cases are added each year. The clinical manifestations of the disease include edema, hematuria, etc., characterized by rapid progression and poor prognosis, with approximately 60% of patients progressing to end-stage renal disease within 10-15 years.If a domestic company successfully imitates Budesonide Enteric-Coated Capsules, the market potential is limitless.↓⭐Follow Yaotong Society, gain insights into industry trends ↓Submission/Corporate Cooperation/Content Communication:Editor-in-Chief of PharmaTong Society—Huaji Meiren (Ww_150525)*Please indicate remarks and purpose when adding.
