China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
Shenzhen Core Medical Technology Co. Ltd. completed a series C round to speed up the development of its left ventricular assist devices (LVAD) for heart failure.
Chinabridge (Shenzhen) Medical Technology Co. Ltd.’s extracorporeal membrane oxygenation (ECMO) machine Lifemotion gained NMPA approval, making it the first domestically developed ECMO unit given a greenlight in China. The approval includes the ECMO machine and the disposable consumables used in combination to treat acute respiratory failure or acute cardiopulmonary failure in seriously ill COVID-19 patients.
Chinese firm Hutchmed Ltd. has out licensed its targeted colorectal cancer drug fruquintinib to Takeda Pharmaceutical Co. Ltd. as it eyes growth opportunities in the U.S., Europe and Japan in a deal totaling up to $1.13 billion. Under the terms of the agreement, Tokyo, Japan-based Takeda will gain an exclusive worldwide license to develop and commercialize the drug in all indications and territories outside of mainland China, Hong Kong and Macau.
Just in time for the Chinese New Year, Mabwell Bioscience Co. Ltd. announced that its U.S. subsidiary, Mabwell Therapeutics Ltd., closed a licensing deal with Disc Medicine Inc. worth up to $412 million for preclinical candidate 9MW-3011, a humanized monoclonal antibody (MAb) that regulates iron metabolism.
Qitan Technology Co. Ltd. has raised ¥700 million (US$104 million) in a series C round led by Meituan Inc. to improve its nanopore sequencing devices and expand its market.
Iaso Biotherapeutics Inc. raised ¥500 million (US$75 million) in a series C1 round as looks for its first drug approval by China after its NDA was accepted for what is claimed to be the first B-cell maturation antigen-targeting CAR T-cell therapy in China.
Bio-Thera Solutions Ltd. has obtained NMPA approval for BAT-1806 to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome. BAT-1806 is the world’s first tocilizumab biosimilar approved for marketing, according to Guangzhou, China-based Bio-Thera.
Shanghai Henlius Biotech Inc. scored NMPA approval for its self-developed anti-PD-1 monoclonal antibody Hansizhuang (serplulimab). It can be used for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.
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