NMPA Approves Bio-Thera's BAT2306, China's First Secukinumab Biosimilar
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On October 22, 2026, China's NMPA approved Bio-Thera's BAT2306, a biosimilar of secukinumab, making it the first secukinumab biosimilar cleared in China. The approval, under application numbers CXSS2500023/4, follows development aligned with biosimilar guidelines from the NMPA, FDA and EMA. According to DXY Insight database data, the product's global commercial footprint has already been laid out, suggesting planned filings or launches beyond China. What remains open is the pace of market uptake domestically and whether regulatory successes in other jurisdictions follow.
Written by a model from the reports · updated 2 hours ago
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Bio-Thera's BAT2306, a biosimilar of secukinumab, was approved by the NMPA on October 22 as the first secukinumab biosimilar approved in China. The application numbers are CXSS2500023/4. The drug was developed under NMPA, FDA and EMA biosimilar guidelines, and DXY Insight database data show its global commercial footprint has already been laid out.
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