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.
Broncus Holding Corp. successfully completed a clinical study of the world’s first transbronchial radiofrequency ablation system for lung cancer treatment.
Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat patients with relapsed or refractory multiple myeloma.
Biocity Biopharmaceutics Co. Ltd. is advancing its pipeline of differentiated, modality-independent therapeutics for oncology that include small molecules, monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The Wuxi, China-headquartered company is focused on first-in-class molecules for different modalities that can be combined with other treatments, Biocity Co-founder and Executive Vice President Ivy Wang told BioWorld.
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis.
Peijia Medical Co. Ltd. reported the implant of its Taurustrio transcatheter aortic valve replacement (TAVR) system in a first patient as part of a multi-center trial getting one step closer to launching the first TAVR system for aortic regurgitation (AR) in China.
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis. The randomized, controlled, open-label, multicenter phase III trial compared injectable SKB-264 (also known as KL-A264 and MK-2870) vs. investigator-selected regimens in patients who failed second-line or above prior standard-of-care therapies.
Oricell Therapeutics Co. Ltd. has become the latest Chinese biotech to advance an independently developed CAR T therapy, announcing Aug. 10 that China’s regulatory body gave IND approval for Oricar-017. Oricar-017 is the Shanghai-based biotech’s GPRC5D-directed CAR T therapy developed to treat patients with relapsed or refractory multiple myeloma.
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