Manufacture of first GMP batch
The successful GMP manufacture of Shorla’s first sterile oncology product was recently completed via state of the art robotic filling technology in our European GMP accredited partner facility. This important milestone will support the submission of Shorla’s imminent license application to the US FDA.
FDA Pre-IND meeting
Shorla Pharma have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (‘FDA’) on our oncology drug SH-111. This product will have a significant clinical benefit to children suffering from Leukemia and Shorla are delighted to be supported by the Children’s Oncology Group (‘COG’) in the US in advocating for this much needed drug.