How investigational new drug studies completed at China site led to expedited regulatory approval for sponsor's orphan drug

As an emerging biotech company developing antibody based therapeutics for oncology and non-oncology indications, Transcenta needed a full suite of studies for its investigational new drug (IND) package on Osemitamab (TST001), an antibody targeting a protein overexpressed in solid tumors. Knowing that Labcorp's facility in Shanghai had all the capabilities and experience needed to run the study, assist in finalization of the IND package and aid in regulatory submission, Transcenta felt confident in selecting the Shanghai site as its early development partner