🇭🇰 港交所HBM HOLDINGS-BQwen · 实盘不做把握 7/10不做原因:消息已过时
北京时间·🕒 发布 09-08 20:43:00时区推断·⟳ 抓取 09-08 20:45:50·⚡ 决策 09-13 01:58:55 +4d05h·44.5 天前
和铂医药-B（02142.HK）公告合作方 Windward Bio 的 TSLP 超长效抗体 HBM9378/WIN378 哮喘 POLARIS-1 II期取得阳性中期结果、III期已启动
催化于 2026-09-08 港股收盘后（12:43 UTC / 20:43 HK）披露，至 now（2026-09-13 01:52 HK）已完整经过 9/9、9/10、9/11 三个交易日，市场给出了明确的否定定价：和铂医药-B（02142.HK）自 9/8 收盘 14.55 港元跌至 12.89 港元（-11.4%，其中 9/11 单日 -9.16%、量比 1.74x），科伦博泰生物（06990.HK）自 488.0 跌至 465.2（-4.7%，四连阴），科伦药业（002422.SZ）自 40.76 跌至 39.35。该事件的可交易窗口在 9/9 开盘即已关闭。同时 materiality 也不足：全球权益已授予 Windward Bio，两家上市公司只保留里程碑/分成与大中华区权益，公告未披露任何金额；本次读出的是 FEV1/FeNO/EOS 等 PK/PD 替代终点，而非 III期主要终点（年化急性发作率），属于计划内、券商自 2026 年 6–7 月起已反复覆盖的进度推进，预期差有限。因此不做多；本事件是正面临床进展、无公司级新增净负面事实，价格下跌本身不构成做空催化，也不做空。
📄 原文HBM HOLDINGS-B↗ 原文
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
不做 和铂医药-B（02142.HK）
窗口已过且无正向重定价：催化于 2026-09-08 港股收盘后披露，至 now 已完整经过 9/9–9/11 三个交易日，股价自 9/8 收盘 14.55 港元跌至 12.89 港元（-11.4%，其中 9/11 单日 -9.16%、量比 1.74x），9/9 还出现高开至 15.39 后收 14.44 的高开低走；13周轨迹 100→142→115 处于下行段，「已跌不少」不是做多理由。materiality 亦不足：全球权益已授予未上市的 Windward Bio，公…
不做 科伦博泰生物（06990.HK）
作为 SKB378 的 50/50 共同开发方同日提交一致公告，方向确为正面，但相对其 1112 亿港元市值与 26H1 已商业化收入（总营收 9.78 亿元、药品销售 6.57 亿元 +112%、归母净利 3.88 亿元），一个已对外授权、仅保留未披露分成的大中华区外分子 III期启动弹性极小；且公告后 9/9–9/11 连续三日下跌（488.0→465.2，累计 -4.7%），无任何正向反应，事件已过窗口、无剩余 edge，不做。
不做 科伦药业（002422.SZ）
仅通过控股科伦博泰间接享有 SKB378 权益，敞口二次稀释、无法量化增量；且该催化在 9/8 港股盘后披露，A股 9/9–9/11 三个交易日已同步消化（40.76→39.35，累计 -3.5%），属旧闻且方向未获市场认可，不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
结论摘要
事实：港交所一手披露（2026-09-08 港股盘后）显示被授权方 Windward Bio 的 TSLP 单抗 HBM9378/WIN378 在哮喘 POLARIS-1 II期中期取得阳性 PK/PD 数据（FEV1 安慰剂校正+256 mL、FeNO -43%、EOS -51%、半衰期最长75天、安全性无治疗相关 SAE），并已启动 III期，支持每年两次给药。影响链：分子由和铂医药与科伦博泰 50/50 共同开发，全球（除大中华区等）权益已授权 Windward Bio，故两家上市公司的经济权益仅为未披露金额的里程碑/分成 + 大中华区权益；本次读出为替代终点、III期主要终点尚未验证，属渐进式去风险而非商业化拐点。价格/证据：内部 KB 显示该管线及 Windward Bio 授权关系自 2026 年 6–7 月已被券商研报广泛覆盖（平安证券哮喘行业报告、岗底斯创新药周报），事件本身预期差有限；行情显示 02142.HK 与 06990.HK 在公告后三个交易日均下跌（-11.4% / -4.7%），02142 13周轨迹为 100→142→115 的下行段，9/11 放量大跌且触发因素未能核实。结论：催化已过期、市场未正向重定价、增量金额无法量化且趋势向下，三条独立理由共同指向不做多；事件为正面、无强空事实，也不做空。
消息传播链
- 港股收盘后约1小时43分披露，内容为 Windward Bio 报告的 POLARIS-1 II期阳性中期结果与 III期启动；首发落在闭市后，意味着第一个可交易时段是 9/9 港股开盘。Windward Bio 自身新闻稿的确切首发时刻未能独立核实（检索服务降级）。市场反应:9/9 开盘 14.56 港元（与 9/8 收盘 14.55 基本平开），全天高见 15.39 后收 14.44（-0.76%），冲高回落、无正向定价
- 共同开发方科伦博泰就同一分子（SKB378/WIN378）提交内容一致的公告，确认事件真实性与双方共享全球权益的关系；两个直接上市载体同日披露，不存在跨市场时差套利窗口。市场反应:06990.HK 9/9 -1.43%、9/10 -1.37%、9/11 -1.94%，四连阴，无正向反应
- 另一 NewCo 合作方 Solstice Oncology 以 2.25 亿美元 A轮启动（RA Capital 领投），属中性偏正面事件，不构成本次临床催化的增量事实；9/10 另有 2026 中报（newsId=12328452）。这两份文件使 9/9–9/11 的价格路径混入了本事件以外的信息。市场反应:02142.HK 9/10 -1.73%、9/11 -9.16%（量比1.74x），9/11 的具体触发因素未能核实
关键理由
- 临床层面确为正面进展：II期中期数据显示 FEV1、FeNO、EOS 三项指标均具统计学显著且剂量依赖的改善，半衰期最长75天支持每年两次给药，安全性无治疗相关 SAE，III期已启动——资产的科学与监管风险被实质降低。
- 但交易层面已无 edge：事件于 9/8 港股盘后披露，9/9–9/11 三个交易日 02142.HK 累计 -11.4%、06990.HK -4.7%，市场未做任何正向重定价，且 02142 处于 13 周下行段（142→115）。
- materiality 无法量化：全球权益已授予未上市的 Windward Bio，和铂/科伦博泰只保留未披露金额的里程碑与分成及大中华区权益，本次读出为替代终点而非 III期主要终点，对 112 亿港元（02142）与 1112 亿港元（06990）市值的增量贡献无法估算。
主要风险
- 02142.HK 于 9/11 单日 -9.16%（量比1.74x）的触发因素未能核实（同期有 9/9 Solstice Oncology 2.25 亿美元 A轮融资公告与 9/10 2026 中报），若为新的公司级负面，将进一步压制任何反弹；反之若在周一开盘前出现官方澄清，则本次 AVOID 判断需重估。
- II期中期仅 98 例、终点为 FEV1/FeNO/EOS 等替代指标，III期主要终点（重度哮喘年化急性发作率）尚未验证；同赛道已有 GSK/AZ 的 tezepelumab、恒瑞 SHR-1905（Aiolos/GSK）与 Generate GB-0895（2025年12月启动全球3期）竞争，若完整数据在医学会议上不及标题，存在二次下修风险。
反向证据
- 做多前查反向 · 来源 kb_search · 日期 2026-09-10 · 影响 weakens
未发现针对 02142.HK 的配售/配股/大股东减持公告；但发现 9/9 Solstice Oncology 2.25 亿美元 A轮融资公告（中性偏正面）与 9/10 2026 中报，9/11 单日 -9.16% 的具体触发因素仍未能核实
检索:和铂医药 02142 最新公告 配售 配股 减持 负面 9月 原文 ↗ - 做多前查反向 · 来源 stock_quote · 日期 2026-09-11 · 影响 weakens
02142.HK 公告后三日 -0.76% / -1.73% / -9.16%（累计自 9/8 收盘 -11.4%），13周指数化轨迹 100→142→115 处于下行段，9/9 高开至 15.39 后收 14.44 属高开低走；06990.HK 四连阴累计 -4.7%；002422.SZ 累计 -3.5%。两个直接载体均无正向重定价
检索:02142.HK / 06990.HK 事件后价格走势与13周轨迹 - 做多前查反向 · 来源 kb_search · 日期 2026-06-29 · 影响 weakens
全球权益（除大中华区等）已授予未上市的 Windward Bio，和铂/科伦博泰只保留里程碑与分成；本次公告未披露任何金额，II期中期读出的是 FEV1/FeNO/EOS 等 PK/PD 替代终点、III期主要终点（年化急性发作率）尚未验证，II期完整数据要等医学会议；相对 02142 的 112 亿港元与 06990 的 1112 亿港元市值，增量弹性无法量化
检索:HBM9378/SKB378 权益结构、里程碑金额与本次读出的终点性质 原文 ↗ - 做空前查反向 · 来源 filing · 日期 2026-09-08 · 影响 none
本事件为阳性临床中期数据 + III期启动，属公司级新增正面事实，无监管调查、业绩下修、核心客户流失或多头逻辑证伪等强空催化；9/11 的下跌无法归因于本事件，而价格下跌本身不构成做空理由。做空红线第①条不满足，不开空
检索:本事件是否构成对 02142.HK / 06990.HK 的明确强空催化 原文 ↗
先例如何影响了这次决策
对本次决策的影响:先例缺失未改变结论：本决策的核心依据是事件已过三个完整交易日且价格反向，属窗口关闭与 edge 消失，不依赖历史幅度校准。
方向:无可用对齐先例；但本次事件最强的方向证据来自标的自身的真实反应——同一份催化在 02142.HK 与 06990.HK 上分别带来 -11.4% 与 -4.7% 的三日累计下跌，方向为「正面公告 → 无正向重定价甚至下跌」。
涨幅量级:无高相似、锚干净的先例可用于校准 tp/sl 幅度；本决策为 AVOID，不设定幅度参数。
形态:02142.HK 9/9 高开至 15.39 后收 14.44（低于开盘）、9/11 开 14.00 收 12.89 接近全天低点，呈现典型的高开低走/派发形态，说明该管线利好在盘后公告次日即被用于出货。
工具执行结果 · 成功 17 · 降级 1 · 失败 0 · 取消 0
- search_processed_events 成功 stock_tools HTTP · 29 ms
{"result": "search_processed_events:agent query=`hbm holdings 02142 polaris-1 phase iii tslp | windward bio tslp asthma phase 2 interim results | 和铂医药 hbm9378 win378 哮喘 ii期 中期结果 | 科伦博泰 skb378 tslp 哮喘 iii期`；结构化索引覆盖完整 72 小时；旧记录兼容扫描近 2.8/72 小时、41 条本臂决策(完整)，返回 0 条候选。未命中只表示这些 agent query 表达式没有召回候选，不能据此证明 - fetch_decision_experience 成功 stock_tools HTTP · 11 ms
{ - price_snapshot 降级 stock_tools HTTP · 253 ms
{ - stock_quote 成功 stock_tools HTTP · 449 ms
{ - kb_search 成功 stock_tools HTTP · 2,872 ms
{ - web_search 成功 Bing RSS · 440 ms
Bing RSS 搜索结果（原始查询:HBM Holdings HBM9378 WIN378 POLARIS-1 phase 2 interim results asthma TSLP September 2026） - stock_quote 成功 stock_tools HTTP · 942 ms
{ - web_search 成功 Bing RSS · 534 ms
Bing RSS 搜索结果（原始查询:和铂医药 02142 股价 下跌 9月11日 港股 创新药） - web_search 成功 Bing RSS · 245 ms
Bing RSS 搜索结果（原始查询:Windward Bio WIN378 POLARIS-1 phase 2 interim asthma TSLP press release） - web_search 成功 Bing RSS · 255 ms
Bing RSS 搜索结果（原始查询:科伦博泰 SKB378 WIN378 哮喘 III期 启动 公告） - kb_search 成功 stock_tools HTTP · 2,318 ms
{ - web_search 成功 Bing RSS · 299 ms
Bing RSS 搜索结果（原始查询:"HBM Holdings" 2142.HK news placement announcement） - web_search 成功 Bing RSS · 230 ms
Bing RSS 搜索结果（原始查询:Windward Bio HBM9378 SKB378 license deal upfront milestone royalties Kelun Harbour BioMed） - kb_search 成功 stock_tools HTTP · 2,376 ms
{ - search_case_library 成功 stock_tools HTTP · 45 ms
{"result": "search_case_library「02142.HK,06990.HK」无历史决策命中(我们过去没在这些标的上决策过,或历史尚未回填)。\n◆ 02142.HK：相关历史决策 46 条 · 其中该标的 ENTER 3 条(6.5%) · 已结算 3 笔 · 胜率 33% · 中位 +0.00% · 均值 -0.08% ⚠️只有 3 笔,样本太薄,只能当线索不能当规律\n◆ 06990.HK：相关历史决策 28 条 · 其中该标的 ENTER 1 条(3.6%) · 已结算 1 笔 · 胜率 100% · 中位 +4.19% · 均值 +4.19% ⚠️只有 1 笔, - web_search 成功 Bing RSS · 977 ms
Bing RSS 搜索结果（原始查询:港股 创新药 BD 授权 临床数据 利好 不涨 见光死 2026年9月） - web_search 成功 Bing RSS · 253 ms
Bing RSS 搜索结果（原始查询:TSLP antibody asthma phase 3 initiation partner stock reaction biotech HK） - kb_fetch_document 成功 stock_tools HTTP · 56 ms
{
原文全文
展开原文 · 10,077 字
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility
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.
和鉑醫藥控股有限公司
HBM Holdings Limited
(incorporated in the Cayman Islands with limited liability)
(Stock Code: 02142)
VOLUNTARY ANNOUNCEMENT
POSITIVE PHASE II INTERIM RESULTS AND INITIATION OF
PHASE III STUDY OF HBM9378/WIN378 IN ASTHMA
This announcement is made by HBM Holdings Limited (the “ Company ” , together with its
subsidiaries, the “ Group ” ) on a voluntary basis to inform the Company ’ s shareholders and
potential investors about the latest business update of the Group.
The board of directors of the Company (the “Board”) is pleased to announce that Windward
Bio AG (“Windward Bio”), the Company’s partner, has reported positive interim results from
the Phase II portion of the POLARIS-1 clinical trial of HBM9378/WIN378, a fully human
ultra-long-acting monoclonal antibody targeting thymic stromal lymphopoietin ( “ TSLP ” ), in
asthma. The Phase III portion of POLARIS-1 has also been initiated.
HBM9378/WIN378 is a novel fully human, ultra-long-acting monoclonal antibody with a unique
binding mode to inhibit TSLP. It was engineered for improved potency, extended half-life and
silenced effector function. It is the only known investigational drug that blocks TSLP signaling
by binding to two different sites on TSLP, interfering with the binding of TSLP to both of its coreceptors on the cell surface of epithelial cells.
POLARIS-1 (NCT07120503) is an operationally seamless, global Phase II/III study of HBM9378/
WIN378 in adults with uncontrolled asthma conducted by Windward Bio. The Phase II portion of
the study is a 48-week, randomised, double-blind study evaluating three dose levels of HBM9378/
WIN378 administered subcutaneously against placebo, with primary objectives of characterising
pharmacokinetics, safety, immunogenicity and pharmacodynamic activity, as well as informing
dose selection for Phase III development. The study also evaluates the effect of HBM9378/WIN378
on lung function and biomarkers of airway inflammation. The Phase II portion enrolled a total
of 147 patients, exceeding the initial enrolment target of 120 patients, with the interim analysis
conducted on the first 98 patients. The Phase III portion is evaluating two twice-yearly doses of
HBM9378/WIN378 against placebo, with a primary endpoint of annualized asthma exacerbation
rate in patients with severe asthma.
1
The interim analysis demonstrated the following at Week 24 after a single dose of HBM9378/
WIN378:
(i)
Dose-dependent mean increases in forced expiratory volume in one second (“FEV1”) of up to
174 mL (placebo-adjusted mean increase up to 256 mL, p = 0.033);
(ii)
Dose-dependent mean reductions in fractional exhaled nitric oxide (“FeNO”) of up to 24
parts per billion (or a 43% reduction; p = 0.006); and
(iii) Reductions in mean blood eosinophil count ( “ EOS ” ) of up to 200 cells/µL (or a 51%
reduction; p < 0.0001).
FEV1 is a key measure of lung function, while FeNO and EOS are key markers of inflammation
that correlate with asthma exacerbations. Near-maximal effects were observed as early as Week 2
and sustained through Week 24. The interim analysis demonstrated a half-life of up to 75 days. The
interim results and population pharmacokinetic modelling support the potential for twice-yearly
dosing of HBM9378/WIN378.
HBM9378/WIN378 was well tolerated, with favorable safety results, and there were no
treatment-related serious adverse events, withdrawals or discontinuations observed as of the
data cut-off date. Adverse events were balanced between the active treatment arms and placebo.
Less than 1% of participants experienced injection site reactions, and 2% developed anti-drug
antibodies, a measure of immunogenicity, which had no impact on the pharmacology of HBM9378/
WIN378.
Two twice-yearly doses have been selected for the Phase 3 portion of POLARIS-1, which is
designed to evaluate the effect of HBM9378/WIN378 on annualized asthma exacerbation rate and
other key efficacy measures in patients with severe asthma. The Phase 3 portion of the study has
been initiated by Windward Bio who plans to begin a second Phase 3 study, POLARIS-2, in the
first half of 2027. Data from the Phase 2 portion of POLARIS-1 will be presented at an upcoming
medical congress.
About HBM9378/WIN378
HBM9378/WIN378 is a novel fully human, ultra-long-acting monoclonal antibody with a unique
binding mode to inhibit thymic stromal lymphopoietin (TSLP). This clinically validated target
plays a key role in the development and progression of a wide array of immunological diseases,
including asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal
polyps, and eosinophilic esophagitis. HBM9378/WIN378 was engineered for improved potency,
extended half-life and silenced effector function. It is the only known investigational drug that
blocks TSLP signaling by binding to two different sites on TSLP, interfering with the binding
of TSLP to both of its co-receptors on the cell surface of epithelial cells. Phase 2 interim results
support the potential of twice-yearly dosing. HBM9378/WIN378 produced significant, sustained
and dose-dependent increases in FEV1, a measure of lung function, together with significant and
sustained reductions in FeNO and blood eosinophils — key markers that correlate with asthma
exacerbations. HBM9378/WIN378 is being evaluated in the global Phase 2/3 POLARIS-1 study
in asthma and the Phase 2 SIRIUS study in COPD, with a second pivotal Phase 3 asthma trial,
POLARIS-2, planned to begin in the first half of 2027. HBM9378/WIN378 (also known as
SKB378) started as a co-development project jointly conducted by Harbour BioMed and KelunBiotech, with both parties equally sharing global rights. Windward Bio licensed the global rights
(excluding Greater China and several Southeast and West Asian countries) for this molecule from
Harbour BioMed (also known as HBM9378) and Kelun-Biotech (also known as SKB378).
2
Cautionary Statement: We cannot guarantee that HBM9378/WIN378 will be successfully
developed or ultimately marketed by the Company and/or its collaboration partners. Shareholders
and potential investors of the Company are advised to exercise due care when dealing with the
shares of the Company.
Forward Looking Statement
Forward-looking statements in this announcement, including those concerning the clinical
development of HBM9378/WIN378 and the timing of future studies, are subject to risks and
uncertainties and may not materialise. Shareholders and potential investors of the Company should
not place undue reliance on such statements and should seek professional advice where appropriate.
By order of the Board
HBM Holdings Limited
Dr. Jingsong Wang
Chairman and Executive Director
Hong Kong, 8 September 2026
As at the date of this announcement, the Board comprises Dr. Jingsong Wang, Mr. Youchen Chen
and Dr. Ian Yi Liu as executive Directors; and Dr. Robert Irwin Kamen, Dr. Xiaoping Ye, Dr.
Albert R. Collinson and Ms. Weiwei Chen as independent non-executive Directors.
3
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。
和鉑醫藥控股有限公司
HBM Holdings Limited
（於開曼群島註冊成立的有限公司）
（股份代號：02142）
自願公告
HBM9378/WIN378治療哮喘的
II期臨床取得陽性的中期結果及III期研究啟動
本公告由和鉑醫藥控股有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願
作出，以告知本公司股東及潛在投資者有關本集團的最新業務更新。
本公司董事會（「董事會」）欣然宣佈，本公司的合作夥伴 W i n d w a r d B i o A G
（「Windward Bio」）已公佈HBM9378/WIN378（一款靶向胸腺基質淋巴細胞生成素
（「TSLP」）的全人源超長效單克隆抗體）用於治療哮喘的POLARIS-1臨床試驗II期
部分取得陽性的中期結果。POLARIS-1的III期部分亦已啟動。
HBM9378/WIN378是一款新型全人源超長效單克隆抗體，具有獨特的結合模式，
可有效抑制TSLP。該抗體經工程化改造，具有更強的效力、延長的半衰期及效應
功能沉默。HBM9378/WIN378是目前已知唯一一款通過雙位點結合TSLP來阻斷其
信號通路的在研藥物，能夠干擾TSLP與其兩個共受體在上皮細胞表面的結合。
POLARIS-1(NCT07120503)是一項由Windward Bio開展的無縫銜接的全球性II/III期
臨床研究，旨在評估HBM9378/WIN378用於未控制哮喘的成人患者。該研究的II期
部分是一項為期48周的隨機、雙盲研究，主要評估皮下注射HBM9378/WIN378三個
劑量水平相較安慰劑的藥代動力學、安全性、免疫原性和藥效學活性，並為III期研
究的劑量選擇提供依據。該研究亦同時評估HBM9378/WIN378對肺功能和氣道炎
症生物標誌物的影響。該II期部分共入組147例患者，超出初始120例的入組目標，
其中中期分析基於前98例患者的數據。其III期部分正在評估兩種每年兩次給藥劑
量的HBM9378/WIN378對比安慰劑的療效，主要終點為重度哮喘患者的年化哮喘
急性發作率。
1
中期分析結果顯示，HBM9378/WIN378單次給藥後第24周：
(i)
第一秒用力呼氣容積（「FEV1」）呈現劑量依賴性均值增加，最高達174 mL（經
安慰劑校正後的均值增幅最高達256 mL，p=0.033）；
(ii) 呼出氣一氧化氮分數（「FeNO」）呈現劑量依賴性均值降低，最高降幅達24十
億分率（降幅百分比為43%，p=0.006）；及
(iii) 血嗜酸性粒細胞計數（「EOS」）均值降低，最高降幅達200 cells/µL（降幅百分
比為51%，p<0.0001）。
FEV 1 為肺功能的關鍵指標，而 FeNO 及 EOS 則為與哮喘急性發作相關的關鍵炎
症標誌物。上述效應早在第 2 周已觀察到接近最大值，並一直持續至第 24 周。
中期分析顯示半衰期可長達75 天。中期分析結果及群體藥代動力學模型支持
HBM9378/WIN378採用每年兩次給藥方案。
HBM9378/WIN378耐受性及安全性良好，截至數據截止日期，未觀察到治療相關
嚴重不良事件、退出或停藥。治療組與安慰劑對照組的不良事件發生率相當。注
射部位反應發生率低於1%，抗藥物抗體發生率為2%（該指標用於評估免疫原性，
對HBM9378/WIN378的藥理學特徵並無影響）。
POLARIS-1 的III期部分已採用兩種每年兩次給藥的劑量方案，旨在評估
HBM9378/WIN378對重度哮喘患者的年化哮喘急性發作率及其他關鍵療效指標的
影響。該研究的III期部分已由Windward Bio啟動，Windward Bio計劃於2027年上
半年啟動第二項III期臨床研究POLARIS-2計劃。POLARIS-1的II期研究數據將在
即將召開的醫學會議上公佈。
關於HBM9378/WIN378
HBM9378/WIN378是一款新型全人源超長效單克隆抗體，具有獨特的結合模式，
可有效抑制胸腺基質淋巴細胞生成素(TSLP)。該靶點已獲臨床驗證，在哮喘、慢
性阻塞性肺疾病(COPD)、慢性鼻竇炎伴鼻息肉及嗜酸性粒細胞性食管炎等多種
免疫性疾病的發生和進展中發揮關鍵作用。HBM9378/WIN378 經工程化改造，
具有更強的效力、延長的半衰期及效應功能沉默。HBM9378/WIN378 是目前已
知唯一一款通過雙位點結合TSLP來阻斷其信號通路的在研藥物，能夠干擾TSLP
與其兩個共受體在上皮細胞表面的結合。II期中期結果支持其每年兩次給藥的潛
力。HBM9378/WIN378 可顯著、持續且呈劑量依賴性地增加FEV（
1 肺功能衡量
指標），同時顯著且持續地降低FeNO和血嗜酸性粒細胞計數 —— 上述均為與哮
喘急性發作相關的關鍵標誌物。HBM9378/WIN378 正在進行針對哮喘的全球性
II/III期POLARIS-1研究和針對COPD的II期SIRIUS研究，其中第二項針對哮喘的
2
關鍵性III期試驗POLARIS-2 計劃於2027 年上半年啟動。HBM9378/WIN378（亦
稱SKB378）最初由和鉑醫藥與科倫博泰共同開發，雙方共同享有其全球權益。
Windward Bio自和鉑醫藥（分子內部代號：HBM9378）與科倫博泰（分子內部代
號：SKB378）獲得了該分子的全球權益（大中華區及部分東南亞和西亞國家除
外）。
警示聲明：我們無法保證本公司及 ╱ 或其合作方能成功開發或最終銷售
HBM9378/WIN378。本公司股東及潛在投資者在買賣本公司股份時務請審慎行
事。
前瞻性聲明
本公告中的前瞻性聲明（包括有關HBM9378/WIN378的臨床開發及未來研究時間
表的聲明）涉及風險及不確定性，且可能無法實現。本公司股東及潛在投資者不
應過分依賴該等聲明，並應在適當情況下尋求專業意見。
承董事會命
和鉑醫藥控股有限公司
主席兼執行董事
王勁松博士
香港，2026年9月8日
於本公告日期，董事會包括執行董事王勁松博士、陳侑晨先生及劉毅博士；以及
獨立非執行董事Robert Irwin Kamen博士、葉小平博士、Albert R. Collinson博士
及陳維維女士。
3
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.
和鉑醫藥控股有限公司
HBM Holdings Limited
(incorporated in the Cayman Islands with limited liability)
(Stock Code: 02142)
VOLUNTARY ANNOUNCEMENT
POSITIVE PHASE II INTERIM RESULTS AND INITIATION OF
PHASE III STUDY OF HBM9378/WIN378 IN ASTHMA
This announcement is made by HBM Holdings Limited (the “ Company ” , together with its
subsidiaries, the “ Group ” ) on a voluntary basis to inform the Company ’ s shareholders and
potential investors about the latest business update of the Group.
The board of directors of the Company (the “Board”) is pleased to announce that Windward
Bio AG (“Windward Bio”), the Company’s partner, has reported positive interim results from
the Phase II portion of the POLARIS-1 clinical trial of HBM9378/WIN378, a fully human
ultra-long-acting monoclonal antibody targeting thymic stromal lymphopoietin ( “ TSLP ” ), in
asthma. The Phase III portion of POLARIS-1 has also been initiated.
HBM9378/WIN378 is a novel fully human, ultra-long-acting monoclonal antibody with a unique
binding mode to inhibit TSLP. It was engineered for improved potency, extended half-life and
silenced effector function. It is the only known investigational drug that blocks TSLP signaling
by binding to two different sites on TSLP, interfering with the binding of TSLP to both of its coreceptors on the cell surface of epithelial cells.
POLARIS-1 (NCT07120503) is an operationally seamless, global Phase II/III study of HBM9378/
WIN378 in adults with uncontrolled asthma conducted by Windward Bio. The Phase II portion of
the study is a 48-week, randomised, double-blind study evaluating three dose levels of HBM9378/
WIN378 administered subcutaneously against placebo, with primary objectives of characterising
pharmacokinetics, safety, immunogenicity and pharmacodynamic activity, as well as informing
dose selection for Phase III development. The study also evaluates the effect of HBM9378/WIN378
on lung function and biomarkers of airway inflammation. The Phase II portion enrolled a total
of 147 patients, exceeding the initial enrolment target of 120 patients, with the interim analysis
conducted on the first 98 patients. The Phase III portion is evaluating two twice-yearly doses of
HBM9378/WIN378 against placebo, with a primary endpoint of annualized asthma exacerbation
rate in patients with severe asthma.
1
The interim analysis demonstrated the following at Week 24 after a single dose of HBM9378/
WIN378:
(i)
Dose-dependent mean increases in forced expiratory volume in one second (“FEV1”) of up to
174 mL (placebo-adjusted mean increase up to 256 mL, p = 0.033);
(ii)
Dose-dependent mean reductions in fractional exhaled nitric oxide (“FeNO”) of up to 24
parts per billion (or a 43% reduction; p = 0.006); and
(iii) Reductions in mean blood eosinophil count ( “ EOS ” ) of up to 200 cells/µL (or a 51%
reduction; p < 0.0001).
FEV1 is a key measure of lung function, while FeNO and EOS are key markers of inflammation
that correlate with asthma exacerbations. Near-maximal effects were observed as early as Week 2
and sustained through Week 24. The interim analysis demonstrated a half-life of up to 75 days. The
interim results and population pharmacokinetic modelling support the potential for twice-yearly
dosing of HBM9378/WIN378.
HBM9378/WIN378 was well tolerated, with favorable safety results, and there were no
treatment-related serious adverse events, withdrawals or discontinuations observed as of the
data cut-off date. Adverse events were balanced between the active treatment arms and placebo.
Less than 1% of participants experienced injection site reactions, and 2% developed anti-drug
antibodies, a measure of immunogenicity, which had no impact on the pharmacology of HBM9378/
WIN378.
Two twice-yearly doses have been selected for the Phase 3 portion of POLARIS-1, which is
designed to evaluate the effect of HBM9378/WIN378 on annualized asthma exacerbation rate and
other key efficacy measures in patients with severe asthma. The Phase 3 portion of the study has
been initiated by Windward Bio who plans to begin a second Phase 3 study, POLARIS-2, in the
first half of 2027. Data from the Phase 2 portion of POLARIS-1 will be presented at an upcoming
medical congress.
About HBM9378/WIN378
HBM9378/WIN378 is a novel fully human, ultra-long-acting monoclonal antibody with a unique
binding mode to inhibit thymic stromal lymphopoietin (TSLP). This clinically validated target
plays a key role in the development and progression of a wide array of immunological diseases,
including asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal
polyps, and eosinophilic esophagitis. HBM9378/WIN378 was engineered for improved potency,
extended half-life and silenced effector function. It is the only known investigational drug that
blocks TSLP signaling by binding to two different sites on TSLP, interfering with the binding
of TSLP to both of its co-receptors on the cell surface of epithelial cells. Phase 2 interim results
support the potential of twice-yearly dosing. HBM9378/WIN378 produced significant, sustained
and dose-dependent increases in FEV1, a measure of lung function, together with significant and
sustained reductions in FeNO and blood eosinophils — key markers that correlate with asthma
exacerbations. HBM9378/WIN378 is being evaluated in the global Phase 2/3 POLARIS-1 study
in asthma and the Phase 2 SIRIUS study in COPD, with a second pivotal Phase 3 asthma trial,
POLARIS-2, planned to begin in the first half of 2027. HBM9378/WIN378 (also known as
SKB378) started as a co-development project jointly conducted by Harbour BioMed and KelunBiotech, with both parties equally sharing global rights. Windward Bio licensed the global rights
(excluding Greater China and several Southeast and West Asian countries) for this molecule from
Harbour BioMed (also known as HBM9378) and Kelun-Biotech (also known as SKB378).
2
Cautionary Statement: We cannot guarantee that HBM9378/WIN378 will be successfully
developed or ultimately marketed by the Company and/or its collaboration partners. Shareholders
and potential investors of the Company are advised to exercise due care when dealing with the
shares of the Company.
Forward Looking Statement
Forward-looking statements in this announcement, including those concerning the clinical
development of HBM9378/WIN378 and the timing of future studies, are subject to risks and
uncertainties and may not materialise. Shareholders and potential investors of the Company should
not place undue reliance on such statements and should seek professional advice where appropriate.
By order of the Board
HBM Holdings Limited
Dr. Jingsong Wang
Chairman and Executive Director
Hong Kong, 8 September 2026
As at the date of this announcement, the Board comprises Dr. Jingsong Wang, Mr. Youchen Chen
and Dr. Ian Yi Liu as executive Directors; and Dr. Robert Irwin Kamen, Dr. Xiaoping Ye, Dr.
Albert R. Collinson and Ms. Weiwei Chen as independent non-executive Directors.
3
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。
和鉑醫藥控股有限公司
HBM Holdings Limited
（於開曼群島註冊成立的有限公司）
（股份代號：02142）
自願公告
HBM9378/WIN378治療哮喘的
II期臨床取得陽性的中期結果及III期研究啟動
本公告由和鉑醫藥控股有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願
作出，以告知本公司股東及潛在投資者有關本集團的最新業務更新。
本公司董事會（「董事會」）欣然宣佈，本公司的合作夥伴 W i n d w a r d B i o A G
（「Windward Bio」）已公佈HBM9378/WIN378（一款靶向胸腺基質淋巴細胞生成素
（「TSLP」）的全人源超長效單克隆抗體）用於治療哮喘的POLARIS-1臨床試驗II期
部分取得陽性的中期結果。POLARIS-1的III期部分亦已啟動。
HBM9378/WIN378是一款新型全人源超長效單克隆抗體，具有獨特的結合模式，
可有效抑制TSLP。該抗體經工程化改造，具有更強的效力、延長的半衰期及效應
功能沉默。HBM9378/WIN378是目前已知唯一一款通過雙位點結合TSLP來阻斷其
信號通路的在研藥物，能夠干擾TSLP與其兩個共受體在上皮細胞表面的結合。
POLARIS-1(NCT07120503)是一項由Windward Bio開展的無縫銜接的全球性II/III期
臨床研究，旨在評估HBM9378/WIN378用於未控制哮喘的成人患者。該研究的II期
部分是一項為期48周的隨機、雙盲研究，主要評估皮下注射HBM9378/WIN378三個
劑量水平相較安慰劑的藥代動力學、安全性、免疫原性和藥效學活性，並為III期研
究的劑量選擇提供依據。該研究亦同時評估HBM9378/WIN378對肺功能和氣道炎
症生物標誌物的影響。該II期部分共入組147例患者，超出初始120例的入組目標，
其中中期分析基於前98例患者的數據。其III期部分正在評估兩種每年兩次給藥劑
量的HBM9378/WIN378對比安慰劑的療效，主要終點為重度哮喘患者的年化哮喘
急性發作率。
1
中期分析結果顯示，HBM9378/WIN378單次給藥後第24周：
(i)
第一秒用力呼氣容積（「FEV1」）呈現劑量依賴性均值增加，最高達174 mL（經
安慰劑校正後的均值增幅最高達256 mL，p=0.033）；
(ii) 呼出氣一氧化氮分數（「FeNO」）呈現劑量依賴性均值降低，最高降幅達24十
億分率（降幅百分比為43%，p=0.006）；及
(iii) 血嗜酸性粒細胞計數（「EOS」）均值降低，最高降幅達200 cells/µL（降幅百分
比為51%，p<0.0001）。
FEV 1 為肺功能的關鍵指標，而 FeNO 及 EOS 則為與哮喘急性發作相關的關鍵炎
症標誌物。上述效應早在第 2 周已觀察到接近最大值，並一直持續至第 24 周。
中期分析顯示半衰期可長達75 天。中期分析結果及群體藥代動力學模型支持
HBM9378/WIN378採用每年兩次給藥方案。
HBM9378/WIN378耐受性及安全性良好，截至數據截止日期，未觀察到治療相關
嚴重不良事件、退出或停藥。治療組與安慰劑對照組的不良事件發生率相當。注
射部位反應發生率低於1%，抗藥物抗體發生率為2%（該指標用於評估免疫原性，
對HBM9378/WIN378的藥理學特徵並無影響）。
POLARIS-1 的III期部分已採用兩種每年兩次給藥的劑量方案，旨在評估
HBM9378/WIN378對重度哮喘患者的年化哮喘急性發作率及其他關鍵療效指標的
影響。該研究的III期部分已由Windward Bio啟動，Windward Bio計劃於2027年上
半年啟動第二項III期臨床研究POLARIS-2計劃。POLARIS-1的II期研究數據將在
即將召開的醫學會議上公佈。
關於HBM9378/WIN378
HBM9378/WIN378是一款新型全人源超長效單克隆抗體，具有獨特的結合模式，
可有效抑制胸腺基質淋巴細胞生成素(TSLP)。該靶點已獲臨床驗證，在哮喘、慢
性阻塞性肺疾病(COPD)、慢性鼻竇炎伴鼻息肉及嗜酸性粒細胞性食管炎等多種
免疫性疾病的發生和進展中發揮關鍵作用。HBM9378/WIN378 經工程化改造，
具有更強的效力、延長的半衰期及效應功能沉默。HBM9378/WIN378 是目前已
知唯一一款通過雙位點結合TSLP來阻斷其信號通路的在研藥物，能夠干擾TSLP
與其兩個共受體在上皮細胞表面的結合。II期中期結果支持其每年兩次給藥的潛
力。HBM9378/WIN378 可顯著、持續且呈劑量依賴性地增加FEV（
1 肺功能衡量
指標），同時顯著且持續地降低FeNO和血嗜酸性粒細胞計數 —— 上述均為與哮
喘急性發作相關的關鍵標誌物。HBM9378/WIN378 正在進行針對哮喘的全球性
II/III期POLARIS-1研究和針對COPD的II期SIRIUS研究，其中第二項針對哮喘的
2
關鍵性III期試驗POLARIS-2 計劃於2027 年上半年啟動。HBM9378/WIN378（亦
稱SKB378）最初由和鉑醫藥與科倫博泰共同開發，雙方共同享有其全球權益。
Windward Bio自和鉑醫藥（分子內部代號：HBM9378）與科倫博泰（分子內部代
號：SKB378）獲得了該分子的全球權益（大中華區及部分東南亞和西亞國家除
外）。
警示聲明：我們無法保證本公司及 ╱ 或其合作方能成功開發或最終銷售
HBM9378/WIN378。本公司股東及潛在投資者在買賣本公司股份時務請審慎行
事。
前瞻性聲明
本公告中的前瞻性聲明（包括有關HBM9378/WIN378的臨床開發及未來研究時間
表的聲明）涉及風險及不確定性，且可能無法實現。本公司股東及潛在投資者不
應過分依賴該等聲明，並應在適當情況下尋求專業意見。
承董事會命
和鉑醫藥控股有限公司
主席兼執行董事
王勁松博士
香港，2026年9月8日
於本公告日期，董事會包括執行董事王勁松博士、陳侑晨先生及劉毅博士；以及
獨立非執行董事Robert Irwin Kamen博士、葉小平博士、Albert R. Collinson博士
及陳維維女士。
3
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