Mabwell's Novel Anti‑IL‑11 Monoclonal Antibody 9MW3811 Approved by NMPA to Initiate Phase II Clinical Trial in Pathological Scarring - Thailand PR News

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# Mabwell's Novel Anti‑IL‑11 Monoclonal Antibody 9MW3811 Approved by NMPA to Initiate Phase II Clinical Trial in Pathological Scarring

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  Published on 11 November 2025 #####  Author

#####   [ CISION PRNewswire ](https://thailandbusinessnews.net/author/cision/)

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SHANGHAI, Nov. 11, 2025 /PRNewswire/ — Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that its novel anti‑IL‑11 monoclonal antibody 9MW3811 has received approval from the China National Medical Products Administration (NMPA) to initiate a Phase II clinical trial for pathological scarring. 9MW3811 becomes the world’s first IL‑11‑targeting therapeutic to enter clinical stage for this indication.

Interleukin‑11 (IL‑11) is a cytokine that plays a critical role in chronic inflammation and fibrosis across multiple organs, including the lungs, skin, kidneys, and liver. 9MW3811 is a proprietary IL-11-targeting humanized monoclonal antibody developed by Mabwell, classified as a Category 1 therapeutic biologic with independent intellectual property rights. It is designed to bind IL‑11 with high affinity and effectively inhibit abnormal activation of the IL‑11/IL‑11Rα signaling pathway. This intervention helps block the pathological progression of fibrosis‑related diseases.

Key advantages of 9MW3811 include:

 Higher target affinity and stronger signaling blockade capability A long half‑life exceeding one month, making it suitable for chronic diseases requiring long‑term treatment

Preclinical studies have shown that 9MW3811 demonstrated significant efficacy in multiple models such as pulmonary fibrosis, and showed potential application value in fibrosis related diseases such as hypertrophic scar and abnormal endometrial bleeding. Especially in human derived keloid animal models, 9MW3811 can effectively alleviate the process of skin fibrosis and reduce the volume of existing scars. 9MW3811 has been approved to initiate clinical studies in China, US and Australia for indications including advanced malignant tumors and idiopathic pulmonary fibrosis (IPF), and has completed Phase I trials in healthy volunteers in Australia and China. The results demonstrate favorable safety and a half-life exceeding one month, placing it at a leading position globally for this target. The Phase II clinical trial of 9MW3811 for pathological scarring is planned to start at the end of 2025.

IL 11 is also closely related to the occurrence of aging related diseases (Nature, 2024). Mabwell has reached an exclusive license agreement with CALICO Life Sciences, a company under Alphabet focusing on innovative anti aging therapies, for 9MW3811. In addition to having broad application prospects in multi-organ fibrotic diseases including IPF, thyroid eye disease, skin fibrosis, renal fibrosis, hepatic fibrosis and cardiac fibrosis, 9MW3811 also has potential application prospects in aging-related diseases such as chronic conditions caused by cellular senescence, age-related frailty, and longevity.

About Pathological scarring

Pathological scarring, encompassing hypertrophic scars, keloids, and contracture scars, is notably driven by IL-11-mediated fibroblast-to-myofibroblast transdifferentiation via upregulation of extracellular matrix and α-smooth muscle actin (α-SMA), as demonstrated in the study "CD39 Fibroblasts Enhance Myofibroblast Activation by Promoting IL-11 Secretion in Hypertrophic Scars" in Journal of Investigative Dermatology (2022). Targeting IL-11 signaling effectively reduces α-SMA positive fibroblasts, halting scar progression. According to Frost &amp; Sullivan data, there are approximately 25 million patients with pathological scars worldwide (about 7.4 million in China), with incidence rates continuing to rise. The number of Chinese patients is expected to exceed 10 million by 2030. Therefore, IL-11-targeted therapy holds significant clinical value and market potential.

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](https://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 link ](https://www.prnasia.com/story/archive/4821248_CN21248_0?rand=89749)

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network
```

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