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Latest From Akeso Inc.

Innovent Bags China’s First Homegrown PCSK9 Inhibitor Approval

Sintbilo (tafolecimab) is the first among four late-stage domestically developed PCSK9 Inhibitors to win the nod from China’s drug regulator. Despite lack of public reimbursement coverage, the drug could potentially unseat same-class rivals from Amgen and Sanofi/Regeneron.

China Approvals

Deal Watch: Japan’s SNBL To Re-Absorb US Spinout Satsuma

Shin Nippon Biomedical Laboratories would take over migraine candidate STS101, now under FDA review. Blue Water Vaccines to pick up BPH drug from Veru.

Deal Watch Business Strategies

Chinese Newcomers Look For Niche Immuno-Oncology Opportunities

Chinese pharma companies are continuing to pile into the already overcrowded domestic anti-PD-1/L1 sector in China, but despite the competition and regulatory tightening, the latecomers are looking for opportunities in areas such as cervical and small cell lung cancer with relatively fewer contenders.

China ImmunoOncology

China’s CDE Explains Major Issues Around Conditional Approval Scheme

China's conditional approval system, which is an accelerated pathway, is being increasingly used by pharma firms, but some thorny issues remain such as the impact on full approvals, the scheme’s relation to priority reviews and currently available therapies and deadlines for confirmatory studies. Staff from the country's Center for Drug Evaluation discussed various topics around the system in a recent article.

China Approvals
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