In September, two COVID-19 vaccines received NMPA approval for emergency use: CanSino’s Convidecia Air and Livzon Pharma’s V-01. Foreign companies gained several new indications as well, including AstraZeneca’s Forxiga (dapagliflozin), Bayer’s Xarelto (rivaroxaban), Novartis’s Xolair (omalizumab) and AstraZeneca/MSD’s Lynparza (olaparib).
In August, China saw the approval of only one new molecular entity (NME), Sinocelltech’s CD20 antibody ripertamab (SCT400). Another two homegrown companies, Zelgen and Alphamab, gained new indications and dosing regimens for their self-developed products as well.
China’s pursuit of innovative oncology drugs remained intense in July, as Chinese regulators granted the first marketing approval for three drugs, namely Simcere’s Cosela (trilaciclib), Lepu Biopharma’s Puyouheng (pucotenlimab) and Roche’s Rozlytrek (Entrectinib).
The month of March saw a string of approvals handed out by the NMPA, with the most significant being two domestically developed anti-PD-1 inhibitors getting green lighted to treat MSI-H/dMMR solid tumors in China for the first time ever.