Denosumab biosimilar (T-Mab Biopharma)

SHANGHAI, April 8, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Denosumab Injection (trade name: MAIWEIJIAN, R&D code: 9MW0321) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorization approval by National Medical Products Administration (NMPA) (Drug Approval Number: [GYZZ]S20240010). MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China. MAIWEIJIAN is a fully human recombinant anti-RANKL monoclonal antibody injection, approved to treat giant cell tumor of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development (defined as having at least one mature long bone and a weight of ≥ 45kg). Mabwell published the results of phase 1 and phase 3 clinical studies of the denosumab biosimilar in "International Immunopharmacology" in 2022 and in the top international journal "JAMA Oncology" in 2024, respectively. In the head-to-head pharmacokinetic comparison studies and clinical efficacy comparison studies conducted in patients with bone metastases of solid tumors, it is comprehensively and systematically demonstrated the similarity between 9MW0321 (MAIWEIJIAN) and the originator product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety. Mabwell is also advancing the marketing efforts for other indications of MAIWEIJIAN. Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines. Doctors and patients have a high level of recognition for denosumab. Compared with bisphosphonates commonly used in clinical treatment, denosumab has the following advantages: 1) It is targeted and can block the RANKL/RANK/OPG signaling pathway by specifically binding to RANKL, playing a role in the prevention and treatment of skeletal-related events (SREs) caused by metastases to bone. 2) The clinical efficacy is significantly better than that of bisphosphonates, and it is also effective in patients who have failed bisphosphonates therapy. 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects. About the originator product of denosumab (XGEVA®) In 2019, the originator product XGEVA® was launched in China, approved for the indications: for the treatment of patients with bone metastases of solid tumors and multiple myeloma, to delay SREs or reduce the risk of SREs (pathological fracture, spinal cord compression, bone radiotherapy, bone operation); for the treatment of giant cell tumor of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development (defined as having at least one mature long bone and a weight of ≥ 45 kg). Apart from MAIWEIJIAN, no other biosimilar drugs are currently on the market in China. In 2022, its sales amounted to 427 million yuan in China. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. 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