On November 25, according to the CDE official website,Qilu PharmaceuticalSubmitted Category 4 Generic Drugs——Budesonide Enteric-Coated CapsulesThe listing application has been accepted. The Mosentropy pharmaceutical database shows,Previously marketed budesonide formulations mainly include suspension for inhalation, nasal spray, inhalation aerosol, and inhalation powder.Not yet available in ChinaBudesonide Enteric-Coated CapsulesGeneric drug companies approved.

Source of screenshot: CDE official website

Budesonide Enteric-Coated Capsules(Product name: Nefukang)Is the world's firstIgA Nephropathy Etiological Treatment Drug, byCalliditas TherapeuticsR&D. November 2023,Budesonide Enteric-Coated CapsulesApproved in China, becoming the only drug approved for the treatment of IgA nephropathy in the country.

BudesonideIt is a type of glucocorticoid drug with anti-inflammatory effects.Budesonide Suspension for InhalationAs the main budesonide formulation currently available in the Chinese market,Data from MaxEntropy Pharma shows,Budesonide Suspension for InhalationInTotal hospital sales across all terminals exceeded 5.3 billion yuan in 2024, with a year-on-year growth of 31.94%. Sales surpassed 2 billion yuan in the first half of 2025, indicating significant market potential.Period.AndBudesonide Enteric-Coated CapsulesAchieved sales exceeding 90 million yuan in the first half of 2025.

Source of screenshot: Mosentropy Medicine All-Terminal Hospital Sales Database

As of now, only the original research drug has been launched in China, as an exclusive product. In terms of generic drug development,Budesonide Enteric-Coated CapsulesIn China, Hainan Herui Pharmaceutical, CSPC PHARMACEUTICAL GROUP LIMITED (Shijiazhuang), and Qilu Pharmaceutical Co., Ltd. have submittedBudesonide Enteric-Coated CapsulesThe listing applications have been accepted and are currently under review. The battle for the first generic drug has begun.Who will be the lucky one to have the flower? We'll wait and see.

Screenshot source: Mosec Pharm China Drug Evaluation Database

Currently, Qilu Pharmaceutical(Including subsidiaries)The number of varieties declared for production and currently under review has exceeded 35. Since the beginning of this year, more than 20 varieties have been reported for production and are under review, including,Budesonide Enteric-Coated Capsules、Capmatinib Hydrochloride TabletsAbout 10 varieties currently have no generic drugs approved in China, and Qilu Pharmaceutical is expected to obtain the first domestic generic approval.

Source of screenshot: Mosentropy China Drug Evaluation Database

Since the beginning of this year, Qilu Pharmaceutical(Including subsidiaries)More than 25 products have been approved and passed the evaluation, among whichIxazomib Citrate Capsules、Ibrutinib Tablets、Etoposide Injection、Amisulpride Injection、Olanzapine for InjectionFive products are the first to pass the evaluation.

This time, Qilu Pharmaceutical Co., Ltd. submittedBudesonide Enteric-Coated CapsulesThe listing application has been accepted, and if it is approved smoothly, it is expected to become the first domestically produced generic drug in China. This drug is the world's first causative treatment for IgA nephropathy, and the acceptance of this enteric-coated capsule generic drug is expected to further provide a new option for the treatment of IgA nephropathy.

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