迈威生物9MW1911在COPD Ib/IIa期研究中显示降低急性加重的初步疗效信号

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for the contents of this announcement, make no representation as to its accuracy or completeness and expressly
disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the
contents of this announcement.

Mabwell (Shanghai) Bioscience Co., Ltd.
邁威(上海)生物科技股份有限公司

(A joint stock company incorporated in the People ’s Republic of China with limited liability)

(Stock Code: 2493)

VOLUNTARY ANNOUNCEMENT
REGARDING POSTER PRESENTATIONS OF UPDATED CLINICAL
DATA FOR 9MW1911 AT THE EUROPEAN RESPIRATORY SOCIETY
(ERS) CONGRESS 2026
This announcement is made by Mabwell (Shanghai) Bioscience Co., Ltd. (the “Company”) on a
voluntary basis. Please also refer to the overseas regulatory announcement of the Company dated
September 4, 2026.
The Company will present Phase Ib/IIa clinical study data of 9MW1911 in former-smoking
patients with moderate-to-severe COPD as a poster at the European Respiratory Society (ERS)
Congress 2026 to be held in Barcelona from September 5, 2026 to September 9, 2026. Preliminary
efficacy results demonstrate that 9MW1911 exhibits positive efficacy signals in reducing
COPD exacerbations, with a clear downward trend observed in the annualised incidence rate of
moderate-to-severe COPD exacerbations in the medium- and high-dose groups.
There remains uncertainty as to whether the clinical trial results can support the submission of
a marketing application for the drug, whether marketing approval will ultimately be granted,
and when such marketing approval may be obtained. Investors are reminded to pay attention to
potential investment risks. The Company will fulfil its information disclosure obligations in a
timely manner in respect of subsequent developments in accordance with relevant regulations.

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I.

BASIC INFORMATION OF THE DRUG

9MW1911 is an innovative monoclonal antibody independently developed based on a
high-efficiency B-cell screening platform. Classified as Class 1 therapeutic biological product,
it binds to the ST2 receptor with high affinity, thereby blocking the IL-33/ST2 signalling
pathway. Clinical research is being rapidly advanced in China. The Phase Ib/IIa clinical study
(N=80) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) has
been completed. The Phase IIb clinical trial evaluating efficacy and safety in a larger cohort of
COPD patients achieved first-in-patient dosing in July 2025 and completed subject enrolment in
June 2026, and is currently in the subject follow-up phase. An interim analysis is planned to be
conducted upon availability of last-visit data from at least 120 subjects. Subject to assessment of
interim analysis results, initiation of the Phase III clinical study is expected around the end of 2026
to evaluate safety, efficacy and immunogenicity. In addition, the Company has designed a U.S.
Phase IIa clinical protocol based on clinical data of 9MW1911 generated in China, and the clinical
trial application therefor has been approved by the FDA.
II.

DESCRIPTION OF CLINICAL TRIAL

The Phase Ib/IIa clinical study conducted by the Company for 9MW1911 (Study Code:
9MW1911-C03) is a randomised, double-blind, placebo-controlled, multiple-dose, dose-escalation
study, which is to primarily evaluate the safety, tolerability and pharmacokinetic profiles of
9MW1911 in former-smoking subjects with moderate-to-severe COPD, as well as to provide
preliminary evaluation of efficacy and immunogenicity.
A total of 80 participants were enrolled in the study. Subjects were randomised to receive
intravenous infusions of 9MW1911 injection (four dose levels: 100 mg, 300 mg, 600 mg and
900 mg) or placebo, administered once every four weeks. Baseline characteristics were generally
balanced across the dose groups and the placebo group, and the enrolled participants were
predominantly those with blood eosinophil counts <300/ μ L. Pharmacokinetic results showed
that steady-state plasma concentrations were achieved at Week 12. Dose-proportionality analysis
indicated that exposure to 9MW1911 increased in an approximately dose-proportional manner
across the 100-900 mg dose range. 9MW1911 demonstrated a favourable overall safety and
tolerability profile.
Preliminary efficacy results have shown that 9MW1911 exhibits positive efficacy signals in
reducing COPD exacerbations, with a clear downward trend observed in the annualised incidence
rate of moderate-to-severe COPD exacerbations in the medium- and high-dose groups. The
annualised incidence rate of moderate-to-severe exacerbations was reduced by 24% and 81% in the
600 mg and 900 mg dose groups, respectively, compared with the placebo group; the annualised
incidence rate of severe exacerbations was reduced by 47% and 100% in the 600 mg and 900
mg dose groups, respectively, compared with the placebo group. The above results preliminarily
demonstrate the therapeutic potential of 9MW1911 in lowering the risk of COPD exacerbations
and further support its subsequent clinical development in the COPD setting.

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III. RISK WARNING
Given that pharmaceutical products are characterised by high technology, high risks and high
added value, the process from clinical trials, regulatory approval to commercial production
involves lengthy cycles and multiple stages, and is therefore subject to various uncertainties.
Investors are advised to exercise prudence in making investment decisions and to pay due attention
to investment risks.
The Company will actively advance the aforementioned research and development projects and will
strictly adhere to relevant regulations to fulfill its information disclosure obligations in a timely
manner. For information regarding the Company, the announcements published on the media
designated by the Company for disclosure and on the website of the Shanghai Stock Exchange
shall prevail.
Cautionary statement required by Rule 18A.05 of the Rules Governing the Listing of
Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee
that 9MW1911 will ultimately be successfully developed and marketed. Shareholders of the
Company and potential investors are advised to exercise caution when dealing in the shares
of the Company.
By Order of the Board
Mabwell (Shanghai) Bioscience Co., Ltd.
Dr. Liu Datao
Chairman of the Board and Executive Director
Shanghai, the PRC, September 4, 2026

As at the date of this announcement, the directors of the Company are: (i) Mr. Tang Chunshan,
Dr. Liu Datao (Chairman of the Board), Dr. Wu Hai, Mr. Hua Jun and Dr. Gui Xun as executive
directors; and (ii) Mr. Qin Zhengyu, Mr. Zhou Rui, Ms. Li Fan and Ms. Wang Fang as independent
non-executive directors.

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香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性
或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚
賴該等內容而引致的任何損失承擔任何責任。

Mabwell (Shanghai) Bioscience Co., Ltd.
邁威（上海）生物科技股份有限公司
（於中華人民共和國註冊成立的股份有限公司）

（股份代號：2493）

自願性公告
關於9MW1911在2026年歐洲呼吸學會年會(ERS)
以壁報形式報告最新臨床數據的公告
本公告由邁威（上海）生物科技股份有限公司（「本公司」）自願作出。另請參閱本公
司日期為2026年9月4日刊發的海外監管公告。
本公司將在2026 年9 月5 日-9 月9 日於巴塞羅那舉行的2026 年歐洲呼吸學會年會
(ERS)中，以壁報形式公佈9MW1911針對既往吸煙的中重度COPD患者的Ib/IIa期
臨床研究數據，初步有效性結果顯示，9MW1911在降低COPD急性加重方面展現
出積極的療效信號，中高劑量組中重度COPD急性加重年化發生率呈明顯下降趨
勢。
臨床試驗結果能否支持藥品遞交上市申請、能否最終獲得上市批准以及何時獲得
上市批准尚存在不確定性。敬請廣大投資者注意潛在的投資風險，本公司將按有
關規定及時對後續進展情況履行信息披露義務。

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一、藥品基本情況
9MW1911為一款基於高效B淋巴細胞篩選平臺自主研發的創新單克隆抗體，屬治
療用生物製品1類，可高親和力結合ST2受體，從而阻斷IL33/ST2信號通路。目前
在中國正在快速推進臨床研究，現已完成在中重度慢性阻塞性肺疾病(COPD)患者
中的Ib/IIa期臨床研究（N=80），針對更大樣本量COPD患者的有效性和安全性的
IIb期臨床試驗於2025年7月實現首例給藥，於2026年6月完成受試者入組，目前
處於受試者隨訪階段，計劃在獲得至少120 例受試者的末次訪視數據後開展期中
分析，並計劃在評估期中分析結果的基礎上，有望於2026年底前後啟動III期臨床
研究，以觀察安全性、有效性和免疫原性。此外，本公司基於9MW1911在中國的
臨床研究數據設計了美國IIa期臨床方案，該項臨床試驗申請獲得FDA批准。

二、臨床試驗情況
本公司就9MW1911開展的Ib/IIa期臨床研究（研究代號：9MW1911-C03）為一項隨
機、雙盲、安慰劑對照、多次給藥、劑量遞增研究，主要評價9MW1911在既往吸
煙的中重度COPD受試者中的安全性、耐受性及藥代動力學特徵，並初步評價有
效性及免疫原性。
研究共入組80 例試驗參與者，受試者隨機接受靜脈輸注的9MW1911 注射液
（100mg、300mg、600mg、900mg四個劑量）或安慰劑，每4 周給藥一次。研究
顯示，劑量組及安慰劑組基線特徵總體均衡，納入參與者以血嗜酸性粒細胞計數
<300/ μ L為主。藥代動力學結果表明，第12周時血藥濃度達到穩態。劑量比例分
析提示，在100-900 mg劑量範圍內，9MW1911的暴露量隨劑量增加呈近似劑量比
例性增加。9MW1911整體安全性和耐受性良好。
初步有效性結果顯示，9MW1911 在降低COPD急性加重方面展現出積極的療效
信號，中高劑量組中重度COPD急性加重年化發生率呈明顯下降趨勢。中重度急
性加重年化發生率較安慰劑組在600mg和900mg劑量組分別降低了24%和81%；
重度急性加重年化發生率較安慰劑組在600mg和900mg劑量組分別降低了47%和
100%。上述結果初步展現了9MW1911 降低COPD急性加重風險的治療潛力，並
進一步支持其在COPD領域的後續臨床開發。

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三、風險提示
由於醫藥產品具有高科技、高風險、高附加值的特點，藥品的臨床試驗、報批到
投產的週期長、環節多，容易受到一些不確定性因素的影響。敬請廣大投資者謹
慎決策，注意防範投資風險。
本公司將積極推進上述研發項目，並嚴格按照有關規定及時履行信息披露義務。
有關本公司信息請以本公司指定披露媒體以及上海證券交易所網站刊登的公告為
準。
《香港聯合交易所有限公司證券上市規則》第18A.05條規定的警示聲明：本公司無
法保證9MW1911 最終將成功開發及營銷。本公司股東及潛在投資者於買賣本公
司股份時務請審慎行事。
承董事會命
邁威（上海）生物科技股份有限公司
董事長及執行董事
劉大濤博士
中國，上海，2026年9月4日

於本公告日期，本公司董事為(i)執行董事唐春山先生、劉大濤博士（董事長）、武
海博士、華俊先生及桂勛博士；及(ii)獨立非執行董事秦正余先生、周睿先生、李
凡女士及王芳女士。

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