Hyftor® is the global commercial brand name, and Xianluoli® is its Chinese brand name developed by Nobelpharma. It is a topical mTOR inhibitor gel. It locally inhibits abnormal mTOR pathway hyperactivation in skin lesions, reducing the size and redness of facial angiofibromas without significant systemic drug absorption.
Main Indications
Treatment of facial angiofibromas associated with tuberous sclerosis complex (TSC) in adults and children aged 6 years and older.
Clinical Research
Global multicenter phase III double-blind placebo-controlled pivotal trials fully validated its lesion reduction efficacy for TSC-related facial angiofibromas;
Comparative registration trials confirmed high lesion response rate after 12 weeks of twice-daily topical administration versus blank vehicle gel;
Long-term open-label extension cohort studies demonstrated sustained lesion improvement and low treatment discontinuation rate due to adverse reactions;
Concentration gradient research verified balanced cutaneous efficacy and local tolerability of the 0.2% gel formulation;
Chinese domestic registration trials confirmed stable lesion improvement and controllable local skin reactions for local TSC patient populations including pediatric patients.
Common Side Effects
Common mild adverse reactions: Application site dryness, pruritus, erythema, skin irritation and burning sensation;
Laboratory abnormalities: No obvious systemic laboratory index fluctuations due to limited transdermal absorption;
Severe but uncommon risks: Severe local contact dermatitis, persistent facial skin erosion and secondary bacterial infection at application sites.
Approval Status in China
Original drug Hyftor® (Chinese brand: Xianluoli) was officially approved for marketing in China on March 28, 2023, with the specification of 10g per tube (0.2% sirolimus). It is currently a prescription dermatology drug included in China’s Category B medical insurance catalogue.
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