After a steep drop in biopharmaceutical IPOs in the first half of 2023, investors have come to expect that the slowdown in new listings of Chinese companies will continue for some time. Without the key influx of cash that equity financing can generate, biopharma companies are ramping up other activities to generate cash, particularly by out-licensing drugs with the potential for global expansion.
Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ABVC, Accropeutics, Antengene, Bioarctic, Bioray, Celltrion, Hanx, Junshi, Laekna, Pfizer, Pharmabcine.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Biontech, Clover, Daewoong, Hanall, Keyuan Xinhai, Nurron, Pfizer.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Acepodia, Allgenesis, Clarity, Daiichi Sankyo, Geovax, Hanall, Immunos, Immutep, Lynk, Minghui, Mink, Stemcyte.
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore.
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
Cansino Biologics Inc. reported positive data in a phase IIb trial evaluating the heterologous mRNA vaccine CS-2034 booster compared to an inactivated vaccine to prevent SARS-CoV-2 infections.
Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.
Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.
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