HONG KONG – I-Mab Biopharma (Shanghai) Co. Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for its CD73 antibody, getting the go-ahead for a phase I/II trial of TJD-5 in patients with advanced solid tumors.
BEIJING – China has finally written all its drug-related reforms into law, as it passed the amendment of its drug administration law in late August, the amendment to take effect on Dec. 1. Those moves carry one goal: to bring more and better drugs into the Chinese market as quickly as possible.
HONG KONG – China has approved the fourth homegrown CD47 antibody to start clinical trials, intensifying the local CD47 race. Chinese biologics developer I-Mab Biopharma (Shanghai) Co. Ltd. said it received the go-ahead for the clinical study of TJC-4, its differentiated fully human CD47 monoclonal antibody for treating advanced malignant tumors.
HONG KONG – China biopharma pioneer Chia Tai Tianqing Pharmaceutical Holdings Co. Ltd. said its self-developed chemical oncology, Focus V (anlotinib hydrochloride capsules), is now approved for a second indication to treat soft tissue sarcoma, becoming the only approved therapy for this rare cancer in China.