Mabwell Announces First Overseas Commercial Shipment of Denosumab Injection

SHANGHAI, Dec. 16, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with an integrated industry chain, announced that it has completed the first commercial shipment of its Denosumab Injection to the overseas market. This delivery marks the official entry of the product into clinical application overseas and represents a major step in the company's globalization strategy.

Mabwell's two Denosumab Injection products (marketed in China as MAILISHU and MAIWEIJIAN) have previously received the marketing authorization from the Drug Regulatory Authority of Pakistan (DRAP). Furthermore, the company has submitted the marketing authorization application in several other key markets, including Jordan, Egypt, and Brazil.

Demonstrating strong manufacturing compliance standards, T-mab, a wholly-owned subsidiary of Mabwell, has successfully passed Good Manufacturing Practice (GMP) on-site inspections conducted by multiple overseas regulatory authorities earlier this year, achieving "zero deficiency" results for its Denosumab production lines.

"This marks a significant milestone in Mabwell's global commercialization layout," said Mr. Hu Huiguo, Director, Senior Vice President, and Secretary of the Board at Mabwell. "The company has already signed formal agreements covering dozens of countries across overseas markets. We are actively advancing the registration to launch our products in more countries to further enhance the global accessibility of Denosumab Injection and meet the unmet needs of patients worldwide."

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 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.

SOURCE Mabwell