Iptacopan hydrochloride capsules | China Drugs List
Public reference information, not medical advice, a prescription or an offer to supply a medicine. Confirm current approval, availability and suitability with licensed professionals.
- Company
- Novartis Pharma Schweiz AG
- Medicine type
- Chemical medicine
- Therapeutic area
- Non-malignant blood disorders
- Indications recorded in the public source
- 1. Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 2. Treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria. Added in China in September 2025: Reduction of proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression; this Chinese indication has conditional approval. The July 2026 US regular approval for slowing kidney function decline in IgA nephropathy has not been treated as an approved Chinese indication.
- Indication source and scope
- Source date(s): 2025, 2026, 2026-07-24. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources.
- Prescribing-information limitations
- Complete official prescribing information obtained. The available full label is from an overseas jurisdiction; a complete current Chinese label remains unavailable. Chinese indications are supported separately by Chinese sources.
- China availability status
- Historical Chinese approval verified; current continuous market availability has not been checked for every product.
- Overseas status
- Japan, United Kingdom: local approval / launch announcements and official price sources obtained. Indications and dates are specified in each price record; other markets not exhaustively reviewed.
- Insurance classification
- Included in national insurance (Category B)
- Insurance edition
- 2025 edition; effective 1 January 2026
- Insurance restrictions
- Limited to: 1. Adults with PNH. 2. Adults with C3G.
- Insurance period
- 2026-01-01 to 2026-12-31
- Insurance verification notes
- Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.
Sources
- https://www.cnpharm.com/upload/resources/file/2025/03/18/170990.pdf
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.nhsa.gov.cn/attach/Ypsn2025/YPSN202500239/YPSN202500239.pdf
- https://www.novartis.com.cn/news/nuohuayansuanyipukepanjiaonanghuomeiguofdachangguipizhunchengweishougeqiemuqianweiyihuopiyongyujianhuanyuanfaxingiganshengongnengxiajiangdebutiyizhiji
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