Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product.
Verastem Oncology Inc. and Genfleet Therapeutics Ltd. have inked a discovery and development deal to advance three oncology discovery programs targeting RAS pathway-driven cancers.
Two new sets of draft guidelines in China aim to strengthen and streamline registration systems while clearly spelling out additional rules for device makers to ensure quality management and controls, including strengthening controls over any outsourced manufacturing and calling of makers of implantable devices to manufacture in house.
Hutchmed (China) Ltd.’s sovleplenib (HMPL-523) met the primary endpoint of durable response rate and all secondary endpoints in the pivotal phase III trial in adults with primary immune thrombocytopenia (ITP) in China.
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
With a U.S. biotech identified as One Bio, Jiangsu Hengrui Pharmaceutical Co. Ltd. has inked an out-licensing deal potentially worth $1.05 billion for its asthma and chronic sinusitis-targeting drug, SHR-1905. The latest deal gives One Bio exclusive rights to develop, produce and commercialize SHR-1905 worldwide, excluding the greater China territory.
Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive impairment, as well as the largest company in China in terms of revenue from the commercialization of cognitive impairment DTx products in 2022.
Hutchmed (China) Ltd.’s sovleplenib (HMPL-523) met the primary endpoint of durable response rate and all secondary endpoints in the pivotal phase III trial in adults with primary immune thrombocytopenia (ITP) in China.
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China. The approval is for treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia (abnormal lipid levels). Tafolecimab marks Innovent's first cardiovascular drug as well as the company’s 10th approval.
With a U.S. biotech identified as One Bio, Jiangsu Hengrui Pharmaceutical Co. Ltd. has inked an out-licensing deal potentially worth $1.05 billion for its asthma and chronic sinusitis-targeting drug, SHR-1905. The latest deal gives One Bio exclusive rights to develop, produce and commercialize SHR-1905 worldwide, excluding the greater China territory.
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