Now drugmakers can gain instant access to hospitals in Hainan province right after their innovative drugs are approved by China’s National Medical Products Administration to skip market entry hurdles.
Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers.
HONG KONG – Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, received conditional approval for use by the general public from China’s National Medical Productions Administration (NMPA), two days after filing for conditional market authorization.
SHENZHEN – To accelerate the development of cell therapies, China’s NMPA has introduced a dual-track regulatory pathway that allows companies to seek an IND with data from investigator-initiated trials.
HONG KONG – Chinese med-tech regulators said in December that conditional approvals are now available to medical devices after the government created speedy review channels for devices that the country needs.
BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month.
HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).
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.
