GSK PLC (LSE:GSK, NYSE:GSK) has received the green light for a speedier US regulatory process for a potential new cancer drug being developed with a Chinese partner.
The pharmaceuticals developer said it has received 'breakthrough therapy designation' from the US Food and Drug Administration (FDA) for the antibody-drug conjugate to treat relapsed or refractory extensive-stage small-cell lung cancer, an aggressive form of the disease.
Breakthrough therapy designation is given for drugs that have the potential to help treat serious conditions and where preliminary clinical evidence may indicate substantial improvement over currently available therapy.
The drug, which currently goes by the name HS-20093 or the code GSK5764227, has shown promising early clinical evidence, the company said, in trials in China.
It is being developed by Chinese biopharmaceutical company Hansoh Pharma for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours.
It is in multiple phase I and II clinical trials in China, with GSK's global Phase I trials for GSK5764227 set to begin in the second half of this year.
GSK acquired exclusive worldwide rights for GSK5764227 from Hansoh earlier this year.