China-based Innovent Biologics Inc. (HKG: 1801) announced that the Macau Special Administrative Region drug authority has approved its self‑developed recombinant monoclonal antibody Xinbimin (teprotumumab N01 Injection) for the treatment of thyroid eye disease (TED).
Regulatory Milestones
Authority
Approval Date
Indication
Status
Macau SAR
5 Sep 2025
Thyroid eye disease
Approved
China NMPA
3 Mar 2025
Thyroid eye disease
Approved – first IGF‑1R antibody in China
First IGF‑1R‑targeting antibody to receive approval in China.
Expands Innovent’s portfolio beyond oncology into rare autoimmune disorders.
Phase III Clinical Highlights
Endpoint
Result
Clinical Significance
≥ 2 mm proptosis reduction (24 wk)
85.8 %
Demonstrates robust ocular volume control.
Clinical Activity Score (CAS) 0‑1
83.5 %
Indicates marked inflammation suppression.
Diplopia improvement
66 %
Improves patient quality of life.
Safety profile: No new safety signals; adverse events comparable to placebo.
Investigator commentary: “The data confirm Xinbimin’s unique mechanism of action and its potential to fill a critical unmet need in TED management.”
Market Impact
Market Size – Global TED market estimated at $1.2 B, with China accounting for ~30 %.
Competitive Landscape – Currently dominated by steroids and orbital decompression; no approved biologics in China until Xinbimin.
Commercial Outlook – Expected to capture a significant share of the Chinese TED market, driven by strong efficacy data and first‑in‑class status.
Company Perspective
CEO Statement – “Macau’s approval reinforces our commitment to delivering innovative, life‑changing therapies to patients worldwide. Xinbimin’s success in Phase III underscores the therapeutic potential of IGF‑1R blockade in autoimmune diseases.”
Future Plans – Initiating post‑marketing surveillance in Macau and expanding enrollment in ongoing Phase IV studies to evaluate long‑term safety and real‑world effectiveness.-Fineline Info & Tech
By Fineline Cube 