By Fineline Cube 
Transcenta Holding Limited (HKG: 6628) announced that its joint venture, Inhibrx Biosciences, Inc. (NASDAQ: INBX), has achieved a milestone in the ChonDRAgon registration study of the precision‑engineered antibody ozekibart (INBRX‑109) for chondrosarcoma. The positive data will enable Inhibrx to file a Biologics License Application (BLA) with the U.S. FDA by the end of June 2026.
Study Highlights
- Phase III ChonDRAgon – Randomized, controlled trial in metastatic or unresectable conventional chondrosarcoma.
- Primary Endpoint – Objective response rate (ORR) and progression‑free survival (PFS).
- Results – Ozekibart demonstrated a clinically meaningful ORR of 28 % versus 7 % with standard therapy, and a median PFS of 9.4 months versus 4.1 months.
- Safety – Treatment‑emergent adverse events were consistent with the known safety profile of DR5 agonists; no new safety signals were identified.
Ozekibart – A Precision‑Engineered DR5 Agonist
- Tetravalent Design – Enhances avidity for Death Receptor‑5 (DR5), inducing tumor‑selective apoptosis while sparing normal tissue.
- Fast‑Track & Orphan Designations – Received U.S. FDA Fast‑Track status (Jan 2021) and Orphan Drug status (Nov 2021) for metastatic or unresectable conventional chondrosarcoma.
- Commercial Rights – Transcenta holds exclusive development and commercialization rights in Mainland China, Hong Kong, Macau, and Taiwan.
Regulatory Strategy
- BLA Submission – Inhibrx will file the BLA with the FDA by the end of June 2026, leveraging the ChonDRAgon data and the existing Fast‑Track and Orphan designations.
- Global Expansion – Following U.S. approval, Inhibrx plans to seek regulatory clearance in the EU, Japan, and other key markets, with Transcenta spearheading commercialization in Greater China.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially.-Fineline Info & Tech