Shanghai Henlius Biotech, Inc.

Overview

Shanghai Henlius Biotech, Inc. is a leading biopharmaceutical company specializing in the development and commercialization of monoclonal antibody drugs. Henlius is renowned for its high-quality biosimilar products, as well as its innovative pipeline of novel therapies targeting cancer and autoimmune diseases.

Therapeutic areas

API / Drug Master Files

Shanghai Henlius Biotech, Inc. holds 2 active (2 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• MANUFACTURING & CONTROL OF RHUPH20Active2026-03-10
• MANUFACTURING AND CONTROL OF RHUPH20Active2025-10-24

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Shanghai Henlius Biotech, Inc. in our records. PharmaTek screens the full directory against live FDA enforcement data.