By Fineline Cube 
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its inebilizumab injection has received a second indication approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with immunoglobulin G4‑related disease (IgG4‑RD). The approval followed a priority‑review designation on 8 February 2025, underscoring the drug’s expanding therapeutic reach.
What is Inebilizumab?
- Mechanism – A depleting monoclonal antibody that targets CD19‑expressing B‑cells, reducing pathogenic autoantibody production.
- Development History – Hansoh Pharma secured exclusive rights to develop and commercialize the drug in mainland China, Hong Kong, and Macau via a 2019 licensing agreement with Viela Bio (now part of Amgen).
- Global Regulatory Milestones – Approved by the U.S. FDA (2020), Japan’s MHLW (2021), and the EMA (2022).
Key Regulatory Timeline
| Date | Event | Region |
|---|---|---|
| 24 May 2019 | Licensing agreement with Viela Bio | Mainland China, HK, Macau |
| Feb 2025 | Priority review granted for IgG4‑RD indication | China |
| Mar 2022 | First Chinese NMPA approval for AQP4‑positive NMOSD | China |
| Jan 2023 | Added to National Reimbursement Drug List (NRDL) | China |
| Nov 2024 | NRDL renewal | China |
Implications for Patients and the Market
- Broader Therapeutic Options – Patients with IgG4‑RD, a rare autoimmune condition, now have access to a targeted biologic that directly depletes disease‑causing B‑cells.
- Reimbursement Advantage – Inclusion on the NRDL enhances affordability and accessibility across China’s public healthcare system.
- Strategic Positioning – Hansoh Pharma strengthens its portfolio in the rapidly growing biologics market, leveraging its Amgen partnership for global distribution.-Fineline Info & Tech