-
NMPA Releases 69th Batch of Reference Drugs for Generic Quality Consistency Evaluation
•
The National Medical Products Administration (NMPA) has released the 69th batch of reference drugs for generic quality consistency evaluation (GQCE) work, further enhancing the standards for generic drug quality in the market. This batch includes 10 new specifications and 34 specifications with modifications, reflecting the NMPA’s ongoing commitment to ensuring…
-
BDgene Technology Secures Over RMB 200 Million in Series B Financing Led by Lapam Capital
•
Gene therapy specialist Shanghai BDgene Technology Co., Ltd has successfully raised over RMB 200 million (USD 27.7 million) in a Series B financing round. The round was led by Lapam Capital, with additional investments from Penglai Capital, Hermed Capital, Sunland Fund, and Sprinvest. The funds raised will be allocated towards…
-
WuXi Biologics Partners with Pharmadule Morimatsu AB for CRDMO Expansion in Singapore
•
China-based WuXi Biologics (HKG: 2269) has announced a strategic partnership with Sweden-headquartered Pharmadule Morimatsu AB (HKG: 2155), focusing on the expansion of its Contract Research, Development, and Manufacturing Organization (CRDMO) service center in Singapore. The collaboration encompasses key project lifecycle processes, including design, manufacturing, FAT (Factory Acceptance Test), installation, debugging,…
-
CStone Pharmaceuticals’ Gavreto Approved for First-Line RET Fusion-Positive NSCLC Treatment in China
•
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) of China has granted approval for a supplemental new drug application (sNDA) for Gavreto (pralsetinib). This approval is for the first-line treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC).…
-
CSPC Pharmaceutical’s Biosimilar Omalizumab Accepted for Review by China’s NMPA
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its biosimilar version of Novartis’ (NYSE: NVS) Xolair (omalizumab) for review. This development marks a significant step towards expanding treatment options for patients with allergic asthma and chronic…
-
Henlius Biotech’s HLX13 Biosimilar Gets NMPA Approval for Liver Cancer Clinical Trial
•
Shanghai Henlius Biotech, Inc (HKG: 2696) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its HLX13, a biosimilar of US major Bristol-Myers Squibb’s (BMS, NYSE: BMY) Yervoy (ipilimumab), for the treatment of liver cancer. HLX13: A CTLA-4 Monoclonal Antibody for Cancer TreatmentsHLX13 is a…
-
Chia Tai Tianqing Launches First Batch of F-627 for Neutropenia Treatment in China
•
China-based Chia Tai Tianqing has announced the first batch prescriptions in China for its efbemalenograstim alfa (F-627), an in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion protein. The drug is indicated for the prevention and treatment of neutropenia during chemotherapy in cancer patients. F-627 received marketing approval…
-
Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
•
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in…
