GMAX Zhengzhou Manufacturing Site Breaks Ground
HANGZHOU, China, Dec. 15, 2020 /PRNewswire/ -- Gmax Biopharm today holds ground-breaking ceremony for its Zhengzhou, China manufacturing site which is the production base for its GMA102 (T2D), GMA105 (obesity), and GMA301A/B (PAH for adult and children) drugs to be launched between 2023-2025, upon approval of respective clinical trials. The facility will begin production in 2025 and has a target annual capacity to produce metabolic drugs for 1M patients and PAH drugs for 200,000 patients. Total investment is estimated at $250M. Both modern fedbatch and profusion lines will be installed to ensure high product quality and cost efficiency.
"We are extremely excited about this event as 3 GMAX's products are entering into registration trial in 2021. As all the drugs have demonstrated superior efficacy and tolerability in earlier phase of clinical trials compared to the leading competitors, we are confident that once lunched, these drugs will fulfil a significant share of unmet medical needs for patients in respective indications. Our modern facility enables us to have direct control on product delivery," says Dr. Jing, GMAX Biopharm CEO.
About GMA102 and GMA105: the world's only Mab GLP-1R agonist for T2D/Obesity, GMA102 and GMA105 is the same humanized anti-GLP-1R Mab (IgG2) carrying a GLP-1 fragment. GMAX completed phase 1b/2a trial in 2020 and plan to start phase III trial in China in 2021. Superb clinical data in earlier stage trials show that in T2D, GMA102 is a candidate of super long acting (2QW) and solution with robust efficacy standing head-to-head with the leading competitors. In Obesity, it offers outstanding weight reduction when dosed 1QW. Both GMA102 and GMA105 exhibited excellent tolerability throughout the early clinical studies.
About GMA301: the first Mab drug developed for PAH, GMA301 is a humanized mAb (IgG4) against endothelin receptor type A (ETa). It has demonstrated excellent efficacy, safety and tolerability. Its long half-life makes it a promising candidate to optimize drug convenience (1MQ). Orphan drug designation has been granted by FDA. Phase 1a clinical trial in Australia was completed in 2020. International dose escalating phase 1b studies in PAH patients are ongoing in China and US.
About Gmax Biopharm LLC: Gmax is a clinical stage company established in 2010 and headquartered in Hangzhou, China. It's a global company focusing on R&D, production and commercialization of antibody drugs targeting GPCRs. Gmax mainly works in cardiovascular, metabolic and cancer areas. Currently there are four drug development programs in different stages of clinical trials: GMA 102 (type 2 diabetes), GMA105 (obesity), GMA301A (PAH for adult), and GMA 301B (PAH for children). Two of nine developmental drugs currently in pre-clinical stage are expected to enter clinical trial n=on 2021: GMA106 (obesity/NASH/T2DM) and GMA306 (PAH/lung fibrosis). Its unique Bibody technology empowers acting on two or more different targets to improve drug efficacy or broaden indications. All assets are proprietary and GMAX owns global IP rights.
SOURCE Gmax Biopharm LLC