Today (September 28), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,NovartisYipu Kepan Hydrochloride CapsulesClass 5.1 of the registration classificationThe new indication application has been accepted, but the specific indication has not been disclosed. Ipocapam is a specific oral complement B factor inhibitor. Public data speculates that the indication for this application may beUsed to reduce proteinuria levels in adult patients with IgA nephropathy (IgAN). For this indication,IpokPan has been approved by the U.S. FDA in August this year.

Screenshot source: CDE official website

Ipsen Capsules（iptacopan，LNP023）It is an orally administered specific alternative complement pathway factor B inhibitor that efficiently inhibits factor B in the alternative complement pathway.It may treat diseases caused by dysfunction in multiple alternative pathways without affecting other complement pathway-mediated immune responses to microbial invasion, thereby reducing the risk of infections for patients. This productOnce listed by the industry media Evaluate as one of the 10 products worth paying attention toPotential BlockbusterOne of the therapies.

Globally,EpicopanObtained in December 2023FDA ApprovalLaunch, Becoming a TreatmentAdult Paroxysmal Nocturnal Hemoglobinuria (PNH)The first oral monotherapy in China this year.August,FDA Re-ApprovalIpsenixIndications, used forReduce Proteinuria Levels in Adult IgA Nephropathy (IgAN) Patients, these patients are at risk of rapid disease progression.

In China,YipuPossiblePanIn April this yearApproved by NMPAThe first indication, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). On September 5,The third item of the productMarketing ApplicationAccepted by the CDE and proposed for priority review. This time isIpsen's drug candidate files for marketing authorization in China for the fourth time.

According to the previously disclosed information from Novartis, the FDA approvedEptinezumabThe expanded indication for reducing proteinuria levels in adult patients with IgA nephropathy (IgAN) is primarily based on the positive results of the randomized, double-blind, placebo-controlled Phase 3 clinical trial APPLAUSE-IgAN. This trial evaluated 518 adult patients with primary IgAN.EptinezumabEfficacy and safety.

Interim analysis data show that, compared with patients receiving placebo and supportive care,IpsenProteinuria Decreased by 38.3% in the Treatment Group After 9 Months, Meeting the Primary Endpoint of the Trial.Another primary endpoint of the trial is assessed by measuring the annual eGFR slope over 24 months.YipuPossiblePanThe ability to slow the progression of IgAN, with the data expected to be released upon completion of the study in 2025.