Chi-Med is setting a course straight for the Chinese FDA after its targeted therapy hit its PFS target ahead of schedule in neuroendocrine tumors.
Hutchison China MediTech Ltd.’s Phase III SANET-ep study of its anticancer surufatinib has been stopped after early after it met its progression-free survival endpoint in patients with neuroendocrine tumors.
Chi-Med will now arrange for a pre-new drug application meeting with the China National Medical Products Administration to discuss the preparation of the NDA for surufatinib (previously
Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.
The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.
