Lianbio Co. Ltd. gained its first Asian approval in Macau for Camzyos (mavacamten/Myokardia Inc.) for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The company in-licensed mavacamten rights from Myokardia, now a wholly owned subsidiary of Bristol Myers Squibb Co., in August 2020 for developing and commercializing mavacamten in mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore. Mavacamten was granted breakthrough therapy designation in China in February 2022 for patients with oHCM.
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
Transthera Sciences Inc., a Nanjing, China-based company developing small-molecule therapies in cancer, inflammation and cardiovascular disease, raised ¥260 million (US$38 million) in a series D+ funding round to advance its first drug product.
In its first worldwide licensing deal in the cardiovascular space, Ji Xing Pharmaceuticals Ltd. acquired rights to preclinical-stage PB-6440, in development for diseases including hypertension, from Phasebio Pharmaceuticals Inc.
Structure Therapeutics Inc. raised $33 million in a financing round to speed up clinical trials of its lead assets targeting chronic diseases and to improve its technology platform. Previously known as Shouti Inc., the company also has rebranded itself as Structure to “reflect its foundation in structural biology and computational design.”
Arrowhead Pharmaceuticals Inc. and Vivo Capital LLC have launched a joint venture named Visirna Therapeutics for RNA interference therapeutics in the greater China market. Arrowhead is the majority shareholder of the new entity, while Vivo invested $60 million in the new entity.
Salubris Biotherapeutics Inc. has raised $32 million in financing from its parent company, Shenzhen Salubris Pharmaceuticals Co. Ltd., for the development of its cardiovascular candidate. Funds will be used to continue efforts in an ongoing phase Ib trial and to initiate two additional phase Ib studies in 2022, as well as to expand the company’s pipeline.
RTW Investments LP-backed Ji Xing Pharmaceuticals Ltd. has acquired greater China rights to Cytokinetics Inc.’s omecamtiv mecarbil in a deal worth up to $400 million.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia.
Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.
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