SHANGHAI, China, Nov 4, 2020 -- Genor Biopharma Co. Inc, a pre-commercial stage biopharmaceutical company focused on developing and commercializing immune-oncology therapeutics, announced that its New Drug Application (NDA) for its infliximab biosimilar GB242 to National Medical Products Administration (NMPA) is under review. Genor submitted NDA on October 27 2020 and NMPA accepted on the NDA on November 3 2020, which again demonstrated strong execution capabilities of Genor team.
The NDA is based on the multi-center, randomized, double-blind, parallel Phase 3 clinical trial in China to evaluate the safety and efficacy of GB242 compared to Remicade in combination with methotrexate at a dose level of 3 mg/kg administered intravenously in adult patients with rheumatoid arthritis (RA) patients.
GB242 is a biosimilar product candidate to infliximab, which is sold under the trade name Remicade in China. Similar to infliximab, GB242 is able to bind to TNF-α at low doses and thus suppresses the body’s nature response to TNF-α and ameliorates inflammatory responses and autoimmune disease. The Phase 3 study enrolled 570 patients and the primary endpoint of the study is equivalent efficacy of ACR20 at week 30. Based on the study results, GB242 shows similar efficacy comparing to Remicade, and no clinically significant difference in terms of immunogenicity between GB242 and Remicade.
About Genor Biopharma
Genor Biopharma Co. Ltd (“Genor”) is a biopharmaceutical powerhouse focusing on developing and commercializing oncology and autoimmune drugs. Genor has successfully developed drug candidates targeting pathways with blockbuster potentials, encompassing top three oncology targets and five out of the ten bestselling drugs globally. Genor has leveraged primarily in-house capabilities in establishing a pipeline of 15 targeted drug candidates with tremendous commercialization potentials in China that cover both proven and novel biological pathways.
Genor’s leadership team boasts more than 15 years of industry experience on average with proven track record and a well-balanced combination of expertise. Genor currently has more than 400 employees across 3 sites in China - Shanghai Zhangjiang, Yunnan Yuxi, and Beijing office, as well as lab in South San Francisco, US, among which 80% are R&D and clinical specialists.