Corning Jereh Pharmaceutical-B (09966) announced that the company has recently received two IND approvals from the State Food and Drug Administration, as detailed below:
(i) An IND approval to initiate a Phase Ia/Ib clinical trial of the Group's self-developed PD-L1/OX40 bispecific antibody KN052. The Phase Ia/Ib clinical trial aims to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of KN052 in the treatment of advanced solid tumors. The study will also be expanded in specific tumors based on selected doses; and
(ii) An IND approval to initiate a Phase II clinical trial of the Group's self-developed PD-L1/CTLA-4 bispecific antibody KN046. The Phase II clinical trial was designed to evaluate the efficacy, safety and tolerability of Inlitas ® (Acytinib) developed in conjunction with Pfizer (NYSE:PFE) in advanced NSCLC therapy, and to enroll patients with advanced or metastatic PD-L1 positive (TPS≥1%) NSCLC subjects who did not receive systemic therapy.