On December 22, according to the NMPA official website,Hainan Herui PharmaceuticalSubmittedCategory 4Generic DrugBudesonide Enteric-Coated CapsulesApproved for marketing, capturing the first domestic generic drug, breaking Everest Medicines' exclusive position in the igAN targeted treatment market, and reshaping the competitive landscape in this field.

Screenshot source: NMPA

Budesonide Enteric-Coated CapsulesIs aBudesonideAn innovative oral targeted delayed-release formulation for the treatment of adult patients with primary IgA nephropathy at risk of progression. As the world's first causative treatment for IgA nephropathy,Budesonide Enteric-Coated CapsulesNot only fills the gap in China for treating IgA nephropathy from the source of the disease, but also provides patients with an innovative treatment option.

Budesonide Enteric-Coated CapsulesThe original research company isCalliditasAs a重磅drug, in 2019, Everest Medicines introduced the commercial rights of this product in Greater China and Singapore from Calliditas. On November 21, 2023, it was approved for marketing in China under the trade name.Nefukang, for the treatment of adult patients with primary immunoglobulin A (IgA) nephropathy who are at risk of progression, to reduce proteinuria levels. Starting from January 1, 2025.Budesonide Enteric-Coated CapsulesOfficially included in medical insurance reimbursement.

Screenshot source: Mosun Medicine Medical Insurance Catalog Database (Check Data. Find Mosun)

NefukangIn the seven months after its market launch, it contributed 353 million yuan in revenue to Everest Medicines, representing a year-on-year increase of 1581%. It accounted for half of the company's sales and is currently in a phase of rapid volume expansion. Data from Mosentropy Pharma shows that, for the first half of 2025, budesonide-related formulations...(Enteric-coated capsules included)With sales exceeding 4.5 billion yuan in hospitals across China, the enteric capsules ranked among the top five in their category, further solidifying their significant position in the field of nephrology.

Screenshot source: All-terminal Hospital Sales Database (Check Data, Find Moxone)

In the Chinese market,Everest MedicinesAsBudesonide Enteric-Coated CapsulesThe exclusive commercial party in mainland China, dominating the in-hospital market with a 100% share.

CurrentlyBudesonide Enteric-Coated CapsulesOnlyEverest MedicinesOne company has been approved for import. This timeHainan Herui PharmaceuticalSuccessfully approved and secured the first domestic generic, breaking Everest Medicines' exclusive position in the igAN causal treatment market.

In the generic drug layout, there are currentlyQilu PharmaceuticalAndCSPC Zhongnuo Pharmaceutical(Shijiazhuang)Four generic applications have been submitted and are all under review.

In addition,Budesonide Enteric-Coated CapsulesWith its innovative mechanism of action and clinical advantages, it has been recommended by several authoritative treatment guidelines both in China and internationally. Currently, companies such as Guangdong Hengjian Pharmaceutical and Shaanxi Licai Pharmaceutical are conducting BE trials on this variety.

Budesonide Enteric-Coated CapsulesThe patent will expire in May 2029, and the Category 3 patent declaration indicates that generic drugs can be marketed immediately after the patent expires. If the patent is not extended, marketing efforts may end up benefiting others. It remains unclear whether Everest Medicines will adjust its strategy, as its previously announced 2030 strategy explicitly aims to achieve revenue of 15 billion yuan.

Screenshot source:Global Marketed Drug Patents(Check data. Find MoEntropy)

As of now, Hainan Herui Pharmaceutical Co., Ltd.(Including Subsidiaries)A total of 27 varieties have been approved and passed the evaluation, among whichSodium Cefotaxime for Injection、Ketotifen Fumarate Oral Solution、Budesonide Enteric-Coated Capsules、Mesalazine Enteric-Coated Sustained-Release CapsulesFour varieties have passed the evaluation for the first time.

END

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