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 approval of OcuMension Therapeutics’ YUTIQ was based on RWD collected in Hainan province and the phase III clinical trials that have been completed outside of China.
Chinese regulators gave their nod to more pediatric medicines in May 2022, a move in line with the country’s commitment to supporting the development of these drugs.
April 2022 saw a number of foreign and licensed drugs approved in China, with the majority of them in oncology and rheumatology.
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.
Chinese regulators approved 11 drugs in February. Uses and indications ran a wide gamut, including two drugs for atopic dermatitis and six new molecular entities that were approved for the first time.