<div id="readability-page-1"><div> SHANGHAI, Dec. 24, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that it has received IND clearance from the U.S. Food and Drug Administration (FDA) for its self-developed anti-ST2 monoclonal antibody (R&amp;D code: 9MW1911) to initiate a Phase IIa clinical study in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). As the first domestic anti-ST2 monoclonal antibody candidate to enter clinical trials, 9MW1911 binds to the ST2 receptor with high affinity to block the IL-33/ST2 signaling pathway. It has already completed a Phase IIa study (N=80) in patients with moderate-to-severe COPD in China.Results showed that 9MW1911 was safe and well-tolerated across all dose groups compared to placebo (N=20), with a similar adverse event incidence (70% vs. 85%). Immunogenicity was negative in all subjects, and no new safety risk signals were identified. Regarding pharmacokinetics, drug exposure increased as doses escalated. An exposure-response model can be preliminary established to define the dose-effect relationship, providing a basis for subsequent dose selection.Pharmacokinetic results suggested that drug exposure increased with escalating doses. An exposure-response model can be preliminary established to define the dose-effect relationship, providing a basis for subsequent dose selection.Efficacy data revealed that the annualized exacerbation rate of COPD demonstrated a dose-dependent decrease in the treatment arms. At the recommended Phase IIb dose (RP2D, N=30), the annualized rate of moderate-to-severe COPD exacerbations was reduced by over 30% compared to the placebo group. Furthermore, the annualized rate of severe exacerbations at the RP2D was reduced by over 40%, and the proportion of patients experiencing severe exacerbations was significantly lower than the placebo group (13.3% vs. 35%).The Phase IIb clinical trial evaluating 9MW1911 in a larger COPD population achieved its first patient dosing in July 2025, with an interim analysis planned after data from at least 120 patients are collected. Based on the evaluation of Phase II outcomes, the company expects to launch a Phase III clinical study by the end of 2026 to further observe the drug's safety, efficacy, and immunogenicity.About MabwellMabwell (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 &#34;Explore Life, Benefit Health&#34; and its vision is &#34;Innovation, from Ideas to Reality.&#34; For more information, please visit www.mabwell.com/en.Forward-Looking StatementsThis 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. &#34;Forward-looking statements&#34; 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, &#34;expect,&#34; &#34;anticipate,&#34; &#34;intend,&#34; &#34;plan,&#34; &#34;believe,&#34; &#34;estimate,&#34; &#34;potential,&#34; &#34;predict,&#34; &#34;project,&#34; &#34;should,&#34; &#34;would,&#34; 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. <img src="https://imageproxy.pbkrs.com/https://edge.prnewswire.com/c/img/favicon.png/query-c2Q9MjAyNS0xMi0yNCZzbj1DTjUzNTA3?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" width="16" height="16" original-src="https://imageproxy.pbkrs.com/https://edge.prnewswire.com/c/img/favicon.png/query-c2Q9MjAyNS0xMi0yNCZzbj1DTjUzNTA3"/> View original content:https://www.prnewswire.com/news-releases/mabwell-receives-ind-clearance-for-novel-anti-st2-monoclonal-antibody-9mw1911-to-initiate-phase-iia-study-302649209.htmlSOURCE Mabwell</div></div>

迈威生物-U

迈威生物-U 已获得 FDA 对其抗 ST2 单克隆抗体 9MW1911 的 IND 批准，以开始在 COPD 患者中进行 IIa 期研究。该药物在之前的试验中显示出安全性和有效性，显著减少了 COPD 的加重发作。迈威生物-U 计划在 2026 年前进行 III 期研究

迈威生物-U 获得 9MW1911 新型抗 ST2 单克隆抗体的 IND 批准，将启动 IIa 期研究