Therapy Areas: Autoimmune
I-MAB Biopharma Co and Genexine receive Chinese authority's approval for Investigational New Drug application of TJ107
5 November 2018 -

I-MAB Biopharma Co Ltd, a Shanghai-based biotech company focused on innovative biologics in immuno-oncology and autoimmune diseases, and Genexine Inc (KOSDAQ: 095700), a South Korea-listed clinical stage pharma company developing innovative biologics, have received approval from the China National Medical Products Administration (NMPA) for the Investigational New Drug (IND) application for TJ107 (HyLeukin), claimed to be the first and only long-acting recombinant human interleukin-7 (rhIL-7) globally to treat chemotherapy induced lymphopenia and cancer, it was reported on Friday.

The product is an immuno-oncology agent and includes an optimally engineered interleukin-7 (IL-7) molecule based on Genexine's proprietary hybrid Fc (hyFc) technology for half-life extension, with improved stability and ability to be developed. I-Mab has development and commercialisation rights to TJ107 (HyLeukin) in Greater China through an exclusive licensing agreement with Genexine that was agreed in December 2017.

Joan Shen, MD, PhD, president of R&D at I-Mab, said, 'We are pleased that the NMPA has given their greenlight to the IND filing, which is another significant development milestone in advancing our China Portfolio. The clinical potential of TJ107 (HyLeukin) has been recognised and endorsed by the regulatory authorities, since there is no approved treatment globally for lymphopenia, the unmet medical need is substantial.'

Login
Username:

Password: