Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer

Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received an indication extension from China’s National Medical Products Administration (NMPA) for its biologic drug nimotuzumab. This new approval marks an expansion of the drug’s use beyond its original authorization in nasopharyngeal carcinoma (NPC) to now include pancreatic cancer.

Supporting Evidence from Phase III Study
The new indication for nimotuzumab is supported by the results of a Phase III study, which demonstrated the efficacy of the anti-epidermal growth factor receptor (EGFR) molecule in inhibiting cancer cell growth. The study’s findings highlight the potential of nimotuzumab as a treatment option for pancreatic cancer patients.

Nimotuzumab’s Long-standing Use and Global Impact
Nimotuzumab has a long history of use in Cuba, dating back to 1998, where it has been utilized in the treatment of various cancers. This approval by the NMPA not only expands access to the drug for pancreatic cancer patients in China but also underscores the global recognition of nimotuzumab’s therapeutic potential.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry