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Breaking News, Trials & Filings

JHL Biotech Receives NMPA Approval

For Phase I & Phase III clinical trial applications for a proposed bevacizumab biosimilar, JHL1149, to treat forms of cancer

By: Betsy Louda

, Contract Pharma

JHL Biotech announced that the National Medical Products Administration of the PRC (NMPA) has approved the company’s Phase I and Phase III Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149, to treat several forms of cancer, including advanced non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer. 

JHL’s China NMPA Phase III trial approval together with the UK MHRA trial approval mark the start of JHL’s global Phase III clinical trial program.

Racho Jordanov, JHL Biotech, co-chairman and chief executive officer said, “We are very excited for our second biosimilar to be approved for clinical trials by the NMPA. This marks the second NMPA approval we have received in just four months and puts us another step closer to our vision of manufacturing biologics of the highest quality from China for the world.”

 

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