SHANGHAI, Nov. 02, 2018 – I-MAB Biopharma Co., Ltd. ("I-Mab"), a Shanghai-based biotech company exclusively 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, jointly announced that China National Medical Products Administration (NMPA) has officially approved the Investigational New Drug (IND) application for TJ107 (HyLeukin?), the first and only long-acting recombinant human interleukin-7 (rhIL-7) globally to treat chemotherapy induced lymphopenia and cancer.
“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,” said Joan Shen, M.D., Ph.D., President of R&D at I-Mab. “The clinical potential of TJ107 (HyLeukin) has been recognized and endorsed by the regulatory authorities, since there is no approved treatment globally for lymphopenia, the unmet medical need is substantial.”
TJ107 (HyLeukin) is an immuno-oncology agent comprised of an optimally engineered interleukin-7 (IL-7) molecule based on Genexine’s proprietary hybrid Fc (hyFc) technology for half-life extension, with for half-life extension, improved stability and developability. I-Mab has development and commercialization rights to TJ107 (HyLeukin) in Greater China through an exclusive licensing agreement with Genexine in December 2017.
“The IND approval in China for Hyleukin-7 clinical trial is a very important progress in its development and the data generated from the study in cancer patients with lymphopenia will significantly contribute to the global development of Hyleukin-7 as an antitumor immunotherapeutic.’ commented by Kyudon Kim, Ph.D., President at Genexine, Inc..
“Our long term goal is to develop TJ107 into a potential global first-in-class immuno-oncology therapy,” Shen added.
About I-Mab Biopharma
I-Mab is a dynamic and fast-growing global player exclusively focused on developing first-in-class and best-in-class biologics in the areas of immuno-oncology and autoimmune diseases through internal R&D capabilities and global partnerships. I-Mab’s pipeline is driven by the company’s development strategy to address unmet needs in China and to bring innovative assets to the world. The company is prepared to submit additional INDs in order to initiate clinical trials in China and the US, including multiple Phase II and Phase III studies. I-Mab is on a fast track toward becoming an end-to-end fully integrated biopharma company. The company has been well-recognized by capital markets with the recent US$220 million Series C financing representing one of the largest amounts ever raised by an innovative biotech company in China. www.i-mabbiopharma.com
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both adult and pediatric growth hormone deficiencies, currently in multinational phase II trials. GX-188E, therapeutic DNA vaccine for HPV-associated diseases, is in Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia II/III. Founded in 1999, Genexine has over 140 employees, and half of them are scientists with MSc, or Ph.D. www.genexine.com