Company Announcements

SHANGHAI , May 20, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the supplemental application for MAIWEIJIAN (Denosumab Injection, R&D code: 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab, has been approved by the National Medical Products Administration (NMPA) for additional indications of bone metastases from solid tumors and multiple myeloma (for the treatment of patients with bone metastases from solid tumors or patients with multiple myeloma, to delay or reduce the risk of skeletal-related events (pathological fracture, spinal cord compression, bone radiotherapy, or bone surgery)).

MAIWEIJIAN is one of the first-tier approved biosimilars of Xgeva^® in China. Marketing authorization application of MAIWEIJIAN was approved by the NMPA on March 2024 for the treatment of unresectable giant cell tumor of bone or cases where surgical resection may cause severe dysfunction, including adult patients and skeletally mature adolescent patients (defined as having at least 1 mature long bone and a body weight of ≥45kg). In terms of overseas commercialization, in August 2025, the product received registration approval from the Drug Regulatory Authority of Pakistan, marking the first biosimilar of Xgeva^® approved in Pakistan, and the product has already been supplied in the country. Mabwell has signed formal cooperation agreements for 9MW0321 with 33 countries including Brazil, Colombia, Indonesia, Singapore, Pakistan, Thailand, Egypt, Peru, Saudi Arabia, Vietnam, and Malaysia. Registration applications have been submitted to 8 countries such as Jordan, Egypt, and Brazil.

Due to its satisfactory therapeutic efficacy, denosumab is recommended by multiple expert consensuses or in clinical treatment guidelines. As one of the first-tier biosimilars of Xgeva^® marketed in China, MAIWEIJIAN boasts prominent first-mover advantages. Compared with bisphosphonates commonly used in clinical practice, denosumab has the following strengths:

1. It features targeted action. It specifically binds to RANKL to block the RANKL/RANK/OPG signaling pathway, thereby preventing and treating skeletal-related events caused by bone metastasis;
   
   
2. Its clinical efficacy is markedly superior to that of bisphosphonates, and it remains effective in patients with treatment failure after bisphosphonate therapy;
   
   
3. It enjoys favorable safety profiles as it is not eliminated via renal pathways, leading to a lower incidence of nephrotoxic adverse reactions in patients treated with denosumab.

Previously, Mabwell successively published the Phase I and Phase III clinical research findings of denosumab biosimilar in International Immunopharmacology and JAMA Oncology, one of top-tier international journals, respectively. Through "head-to-head" pharmacokinetic comparison and clinical efficacy comparison studies conducted in patients with solid tumor bone metastases, the similarities between 9MW0321 and the reference original drug in terms of pharmacokinetics, pharmacodynamics, clinical efficacy and safety have been fully and systematically verified.

About Mabwell

Mabwell (688062.SH, 02493.HK) 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 www.mabwell.com/en.

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.

View original content:https://www.prnewswire.com/news-releases/mabwell-announces-nmpa-approval-of-supplemental-application-for-additional-indications-of-maiweijian-denosumab-injection-302778306.html

SOURCE Mabwell