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Policy / Regulatory

CDE Issues Guidelines for New Drug Benefit-Risk Assessment in Market Approval Filings

Legal / IPPolicy / Regulatory

CNIPA Launches Pilot for Priority Patent Review for Macau Applicants in Mainland China

CompanyDrug

AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes

CompanyDeals

Lion TCR Secures RMB 300 Million in Series B2 Financing to Advance Clinical Studies and Facility Construction

CompanyDrug

LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment

CompanyDrug

CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study

Policy / Regulatory

NMPA Releases 69th Batch of Reference Drugs for Generic Quality Consistency Evaluation

CompanyDeals

BDgene Technology Secures Over RMB 200 Million in Series B Financing Led by Lapam Capital

CompanyDeals

WuXi Biologics Partners with Pharmadule Morimatsu AB for CRDMO Expansion in Singapore

CompanyDrug

CStone Pharmaceuticals’ Gavreto Approved for First-Line RET Fusion-Positive NSCLC Treatment in China

CompanyDrug

CSPC Pharmaceutical’s Biosimilar Omalizumab Accepted for Review by China’s NMPA

CompanyDrug

Henlius Biotech’s HLX13 Biosimilar Gets NMPA Approval for Liver Cancer Clinical Trial