TaiMed Biologics received Taiwan’s regulatory approval to conduct Phase II clinical trials for its organ transplant rejection prevention drug, expanding its study beyond the US market.
The treatment, known as TregCel (TRK-001), will be tested at three major Taiwanese medical centers including National Taiwan University Hospital, alongside Northwestern Memorial Hospital in the US. The company plans to complete patient enrollment within a year.
The drug, developed in partnership with US-based TRACT Therapeutics, targets the NT$153 billion (US$51.1 billion) global immunosuppressant market projected for 2027. Market research firm GII estimates the sector will grow at 13.4% annually from US$21.6 billion in 2020.
TaiMed CEO Jeff Yang said the company has developed technology to purify and expand regulatory T cells, which occur rarely in human bodies. If successful, TaiMed could seek Regenerative Medicine Advanced Therapy designation, potentially accelerating the drug’s path to market.
The treatment could qualify for seven-year market exclusivity under orphan drug regulations, though success in early-stage trials doesn’t guarantee final approval or commercial viability.
