Project for Potential Osteoarthritis Global Player

StarryBio is a biotechnology company strategically established to pursue the acquisition and commercialization of regional rights for TG-C, an investigational cell and gene therapy for the treatment of knee osteoarthritis. The project is focused on securing commercialization rights in Greater China and the US, with the potential to expand into additional territories depending on strategic opportunities.

TG-C is an allogeneic, gene-modified cell therapy administered as a single intra-articular injection. It has been developed to reduce pain, improve joint function, and potentially modify disease progression through immune modulation and cartilage repair mechanisms.

The U.S. Phase 3 clinical development program enrolled more than 1,000 patients across two pivotal studies conducted under an FDA Special Protocol Assessment (SPA). In July 2026, the first Phase 3 topline results were announced. While the study did not achieve statistical significance on its co-primary efficacy endpoints because of a higher-than-anticipated placebo response, the TG-C treatment arm demonstrated clinically meaningful improvements in pain and function, maintained a favorable safety profile, and showed a lower rate of total knee replacement compared with the placebo group. A second Phase 3 study remains ongoing and is expected to provide additional evidence regarding the overall clinical profile of TG-C.

The project is based on the view that, despite the outcome of the first Phase 3 trial, TG-C remains one of the most advanced clinical-stage cell and gene therapies for knee osteoarthritis. Subject to future clinical, regulatory, and commercial developments, the acquisition of regional commercialization rights may provide an opportunity to participate in the development and commercialization of a late-stage regenerative medicine asset in Greater China and the US.