Denosumab

SHANGHAI, April 15, 2026 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with a full industry chain, announced that the National Medical Products Administration (NMPA) has accepted supplemental Biologics License Application for MAIWEIJIAN (denosumab injection, R&D code: 9MW0321), a product developed by its wholly-owned subsidiary T-mab, for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. MAIWEIJIAN is the first denosumab biosimilar (120mg) approved to market in China. It was initially approved in March 2024 for the treatment of adults and skeletally mature adolescents (defined as at least 1 mature long bone and weighing ≥ 45 kg) with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. In August 2025, the product received approval from the Drug Regulatory Authority of Pakistan as the country's first denosumab biosimilar (120mg), and supply has now commenced. Mabwell has signed formal cooperation agreements for this product in 33 countries, including Brazil, Saudi Arabia, and Indonesia, and has submitted registration applications in 8 countries. Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines. As the first denosumab biosimilar (120mg) launched in China, MAIWEIJIAN possesses early-mover advantages. Compared with bisphosphonates commonly used in clinical treatment, denosumab has the following advantages: Targeted action – It specifically binds to RANKL, blocking the RANKL/RANK/OPG signaling pathway, thereby preventing and treating SREs caused by bone metastases. Superior clinical efficacy – It demonstrates significantly better clinical efficacy than bisphosphonates and remains effective in patients who have failed bisphosphonate therapy. Favorable safety profile – It is not cleared by the kidneys, and patients receiving denosumab experience fewer renal toxicity side effects. Previously, Mabwell published the Phase I and Phase III clinical study results of this product in International Immunopharmacology and the top-tier international journal JAMA Oncology, respectively. Through head-to-head pharmacokinetic comparisons and clinical efficacy studies in patients with bone metastases from solid tumors, the product has been systematically and comprehensively demonstrated to be similar to the reference product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell's mission is "Explore Life, Benefit Health" and its 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. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell 21% more press release views with Request a Demo

TORONTO , April 7, 2026 /PRNewswire/ - Apotex Inc. ("Apotex" or the "Company"), the largest Canadian‑based global pharmaceutical company, today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar to Prolia®, for its authorized indications. These include the treatment of postmenopausal women with osteoporosis at high risk for fracture and the treatment of osteoporosis in men at high risk for fracture. 1 DENOZA is also authorized for the remaining indications of the reference biologic, as outlined in the Product Monograph . The product will be available in a prefilled syringe format. "As a Force for Health, focusing on patient access to appropriate treatment options is a core part of our mission," said Martin Arès, President, Apotex Canada and Rest of World. "Osteoporosis is a significant public health issue, affecting more than 2.3 million Canadians. 2 The approval of DENOZA reflects our continued commitment to helping improve access to treatment options and contributing to a sustainable healthcare system, while offering healthcare professionals and patients additional choices in care." Dr. Angela M. Cheung, Professor of Medicine, KY and Betty Ho Chair in Integrative Medicine, University of Toronto, Senior Physician Scientist at University Health Network, and Founding Director of the University Health Network Osteoporosis Program, added: "Timely access to osteoporosis therapies plays an important role in supporting patient care and helping reduce the impact of this underdiagnosed condition. The introduction of additional treatment options, including biosimilars such as DENOZA, can support healthcare providers and patients by broadening available choices within the current treatment landscape." Dr. Famida Jiwa, President and CEO of Osteoporosis Canada, also welcomed the approval, noting: "Expanding access to therapies is an important step in supporting Canadians living with osteoporosis. The approval of DENOZA adds another option to the range of treatments available within the healthcare system." Healthcare professionals should refer to the complete Product Monograph for detailed information on warnings, precautions, adverse reactions, and patient monitoring requirements. About Apotex Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at . _____________________ 1 Product Monograph: 2 Osteoporosis Canada. Facts and Statistics : View original content to download multimedia: SOURCE Apotex Inc.