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BAT1706 is a proposed bevacizumab biosimilar for the treatment of patients with metastatic colorectal cancer, metastatic or locally recurrent breast cancer, locally advanced, metastatic or recurrent non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Bio-Thera's BAT1706 has successfully completed a global Phase III comparative clinical study which was a multicenter, randomized, double blind, study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of BAT1706 versus EU-bevacizumab plus chemotherapy in patients with advanced non squamous non-small cell lung cancer.
Bio-Thera has filed the commercial license application for BAT1706 with the China National Medical Products Administration (NMPA) and also more recently with the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). Biomm will be responsible for filing the dossier in Brazil.
This partnership will leverage Biomm's strong local presence, sales and marketing capabilities in Brazil. Bio-Thera will be responsible for full development, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.
"Bio-Thera is pleased to partner with Biomm to commercialize our bevazcizumab biosimilar program in Brazil", said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership is the first to expand Bio-Thera's presence into Brazil, an important pharmaceutical market for biosimilars and innovative drugs."
"Biomm is committed to expanding its portfolio in biotechnology with a long-term vision, especially in oncology where is critical to expand the access to modern treatments", says Heraldo Marchezini, CEO of Biomm. "We are pleased to partner with Bio-Thera Solutions, given its expertise in research and development of such important biopharmaceuticals."
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in the next generation antibody discovery and engineering, the company has advanced five candidates into late-stage clinical trials and one of which, QLETLI® (格乐立®), a biosimilar to adalimumab, is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, Crohn's disease or uveitis in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
About Biomm SA
Biomm's mission is to develop, produce and market global competitive biomedicines with quality and accessibility. The company's focus is developing biological products, aiming to guarantee national self-sufficiency. Due to its innovator DNA, the company is pioneer in biotechnological drugs in Brazil. Founded in 2002, Biomm's headquarters and factory are in Nova Lima (MG), with capacity to produce 20 million of insulin per year, based on advanced and innovative technologies that guarantee the medicines quality. The company is listed on the Brazilian stock exchange (BVMF: BIOM3). For further information access www.biomm.com
Source: Bio-Thera Solutions
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