ASLAN Pharmaceuticals Limited announced that commercialisation of varlitinib in China, if approved, is expected to begin approximately one year earlier than previously anticipated following recent discussions with the Chinese Food and Drug Administration (CFDA) regarding its planned clinical development strategy for varlitinib in biliary tract cancer. ASLAN initiated a pivotal, single-arm, multicentre clinical trial of varlitinib plus capecitabine in China in patients with advanced or metastatic biliary tract cancer who have progressed on at least one line of prior chemotherapy in 2017. Professor Shukui Qin, Chair of the Chinese Society of Clinical Oncology and Deputy Director of the Nanjing 81 Hospital, is the lead investigator for the trial. The trial will assess the safety and efficacy of varlitinib in combination with capecitabine in a total of 68 patients and is now actively enrolling patients. The primary endpoint will be objective response rate. ASLAN expects to report topline data from this trial in late 2018 and, if the primary endpoint is met, subsequently submit its first regulatory filing for approval for second-line biliary tract cancer to the CFDA, ahead of previous timelines that anticipated longer clinical development.