Monday, 09 December 2019

JHL Biotech receives China approval for cancer Biosimilar

16 October 2018 | News

The proposed bevacizumab biosimilar, JHL1149, treats 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 Biotech announced that the National Medical Products Administration of the PRC (NMPA) has approved JHL'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 CEO stated, "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."

 

JHL has a bigpipeline of biosimilar candidates under development, and two Asia-based world-class biologics manufacturing facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards. JHL Biotech is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity and the China Development Industrial Bank

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