🇭🇰 港交所HUTCHMEDCodex · 实盘可交易 · 做多市场:港股▲ 赚 +13.23% · 已结算把握 6/10
北京时间·🕒 发布 12:01:00时区推断·⟳ 抓取 12:03:56·⚡ 决策 09-03 12:07:08 +3m12s·54.2 天前
和黄医药与GSK就KRAS-EGFR抗体靶向偶联药HMPL-A830达成全球授权协议
事件为一手港交所内幕消息,1.1亿美元确定首付款对和黄医药收入和研发现金流有可见增量,且GSK背书提升ATTC平台外部验证;但资产仍早期且午后可能跳空,采用小仓限价而非无条件追高。
📄 原文HUTCHMED↗ 原文
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
▲ 赚 +13.23%入场 09-03 午后开盘 @19.57 → 离场 09-04 开盘 @22.28
日 K 取自复盘打分切片 · 蓝点/蓝虚线 = 纸面入场价 · 灰虚线 = 纸面离场 · 持有期红底 = 赚(价格在入场线上方)、绿底 = 亏
💡 交易逻辑GSK授权首付占收入约20%,午后新鲜
怎么买 限价买入 不高于昨收 +6%、当日有效,不成交作废
怎么卖 止盈 +6%(半仓)/+12%(清仓) · 止损 -5% · 时间止损 5日
不做 HUTCHMED(HCM.US)
同一经济权益但当前首个交易窗口在港股午后,美股要等港股反应后再判断是否仍有edge。
不做 葛兰素史克(GSK.US)
交易金额和早期管线相对GSK体量太小,短线基本面弹性不足。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
分时走势
做多 00013.HK 和黄医药
建仓日早于近 30 天,只有日线图
成交明细 · 纸面
做多 00013.HK 和黄医药
| 收益状态 | +13.23% 已平仓 |
|---|---|
| 进场成交 | 2026-09-03 · 午后开盘 · @19.57 |
| 离场成交 | 2026-09-04 · 开盘 · @22.28 |
| 毛收益 | +13.85% |
| 成本 | +0.62% |
| 净收益 | +13.23% |
| 计入收益 | +13.23% |
| 建仓日 | 2026-09-03 · 进场不早于新闻时刻 + 2 分钟 |
收益口径 event_time_plus_2min_10min_walk_open_topup_to_next_open_exchange_calendar_fill_model_local_notional_v9 · method_id m8db1cbc8f2d · 截至 2026-10-27 16:44
研究档案
结论摘要
公告确认和黄医药把HMPL-A830大中华区以外权益授权给GSK,确定首付款1.1亿美元约为2025年收入5.485亿美元的20%,同时保留大中华区权益和后续royalty;这对现金、平台验证和早期管线估值为正。风险在于药物尚未进入I期、里程碑大多高度或有、午后开盘可能快速重定价,因此只做和黄医药(0013.HK)小仓限价多头。
消息传播链
- 港交所披露易发布和黄医药内幕消息公告,确认与GSK达成HMPL-A830授权协议及1.1亿美元首付款。市场反应:公告时港股午休,无法连续成交。
- 公司安排当日中文及英文投资者webcast,说明管理层将进一步解释交易条款和管线定位。
关键理由
- 1.1亿美元首付款相当于和黄医药2025年总收入5.485亿美元约20%,对短期现金和收入确认有实质增量。
- GSK拿下除大中华区外全球权益,验证和黄医药ATTC平台的外部可授权价值,且公司仍保留中国内地、港澳台开发和商业化权利。
- 同类中国biotech出海授权常在首发交易日触发估值重估,但临床前/I期前资产应以小仓和限价控制追高风险。
主要风险
- HMPL-A830预计2026年下半年才启动I期,绝大部分12.95亿美元总潜在付款取决于长期开发、监管和商业里程碑。
- 公告发生在港股午休且为法定披露,午后若高开过大或放量冲高回落,短线edge会迅速下降。
反向证据
- 做多前查反向 · 来源 web · 日期 2026-07-30 · 影响 weakens
2026年中报显示HMPL-A830此前仅为IND获批/计划H2 2026启动全球临床,尚无人体疗效数据。
检索:HMPL-A830 development stage IND clinical trial HUTCHMED 2026 interim 原文 ↗ - 做多前查反向 · 来源 web · 日期 2026-07-30 · 影响 weakens
公司已有约13.7亿美元现金,1.1亿美元首付款不是生存性融资,但仍增加非稀释现金和收入可见度。
检索:HUTCHMED 2026 interim cash balance R&D profitability 原文 ↗
先例如何影响了这次决策
对本次决策的影响:先例支持做多方向,但因样本不足和本次资产更早期,仓位降为small,入场用午后限价而非无条件市价。
方向:相似授权合作对授权方方向偏正,尤其有明确首付款和跨国药企背书时更容易触发重估。
涨幅量级:缺少3条以上高相似、同市场、首发锚干净的可量化样本,不能据此给激进tp/sl。
形态:A股GSK授权案例出现首日大幅冲高,提示追高风险;同一公司2023年交易更大且资产更成熟,本次应折价。
历史先例(按相似度)
- 相似度 7/10 0013.HK 2023-01-23 和黄医药向武田授权fruquintinib海外权益,最高11.3亿美元、含4亿美元首付款。 原文 ↗
用于机制和金额对比,未取得本轮事件研究收益率。
⚠来源层级不符(声明issuer/实为media) — 该行涨幅别用来定止盈止损
相似度依据:同一发行人、同为跨国药企授权合作,但2023年fruquintinib为后期/商业化资产且4亿美元首付款明显大于本次。
经验:同一公司对外授权可显著改善现金和平台估值,但资产阶段越早,兑现概率折价越大。 - 相似度 6/10 688221.SH 2026-02-24 前沿生物向GSK授权两款siRNA药物,获4000万美元首付款、1300万美元近期里程碑和最高9.5亿美元后续付款。 原文 ↗
事件后 +1日 +9.3% · +2日 +4.8% · +3日 -4.2% · +4日 -6.2% · +5日 -12.8%
⚠来源层级不符(声明media/实为primary_disclosure) — 该行涨幅别用来定止盈止损
相似度依据:中国创新药公司与GSK授权合作,同为早期管线出海授权;但A股涨跌停和估值体系不同,且标的不是同公司。
经验:GSK背书叠加可见首付款可触发首日冲高,但也容易在涨停/高开后出现追高风险。
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原文全文
展开原文 · 19,742 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.
HUTCHMED (China) Limited
和⿈醫藥(中國)有限公司
(Ɪncorporated in the Cayman Ɪslands with limited liability)
(Stock Code: )
ꞮNSꞮDE ꞮNFORMATꞮON
HUTCHMED ANNOUNCES LꞮCENSꞮNG AGREEMENT WꞮTH GSK FOR
KRAS-EGFR-ANTꞮBODY CONJUGATE CANCER THERAPY
— Exclusive License for HMPL-A830, a first-in-class KRAS-EGFR Antibody-Targeted Therapy Conjugate (“ATTC”),
which is expected to enter clinical trials in H2 2026 —
— HUTCHMED webcasts today at 4:30pm HKT in Chinese (Putonghua) and at 7:30 a.m. EDT / 12:30 p.m. BST /
7:30 p.m. HKT in English —
This announcement is made by HUTCHMED (China) Limited (“HUTCHMED”) pursuant to Rule 13.09(2)(a) of the Rules
Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited and the Ɪnside Ɪnformation Provisions
under Part XꞮVA of the Securities and Futures Ordinance (Cap. 571).
HUTCHMED today announces that its subsidiary, HUTCHMED Limited, has entered into an exclusive development and
license agreement with a subsidiary of GSK plc (“GSK”), granting the GSK subsidiary worldwide rights excluding Mainland
China, Hong Kong, Macau and Taiwan to develop and commercialize HMPL-A830. Clinical development will initially focus
on colorectal, pancreatic and lung cancer indications. The agreement includes a US$110 million upfront payment and
potential development, regulatory and commercial milestone payments, for up to a total of US$1.295 billion, and royalties
on net sales. This first-in-class drug candidate, an Antibody-Targeted Therapy Conjugate (“ATTC”), comprises a highly
selective and potent Kirsten rat sarcoma (“KRAS”) small molecule inhibitor payload conjugated to an anti-epidermal growth
factor receptor (“EGFR”) antibody. An ATTC enables tumor-selective activity of potent, cell-killing payloads by leveraging
antibody-guided therapy.
Colorectal, lung, and pancreatic cancers have the highest incidence of patients with KRAS-altered tumors, who often lack
a safe and durable KRAS therapy. HMPL-A830 is designed to address this need by delivering a KRAS inhibitor directly to
EGFR-expressing tumors, while simultaneously blocking EGFR and KRAS signaling to enhance efficacy, durability, and
tolerability.
Under the terms of the agreement, HUTCHMED Limited will be responsible for the global phase Ɪ development program,
which is expected to start in the second half of 2026 (clinicaltrials.gov identifier NCT07718581). The GSK subsidiary will be
responsible for all subsequent clinical development and commercialization activities outside of Mainland China, Hong
Kong, Macau and Taiwan.
“We are proud to work with GSK, a globally leading biopharmaceutical company that, like HUTCHMED, is committed to
developing innovative new cancer medicines to address significant unmet medical needs worldwide,” said Mr Johnny
Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. “Our ATTCs combine antibodies
with our proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. HMPL-A830 is our third drug
candidate from these novel payload platforms and the first from our platform to be licensed to a global partner, following
two candidates that have entered clinical development. This collaboration marks a significant step in maximizing its
potential as a treatment for patients, unlocking an entirely new class of precision oncology medicines.”
Dr Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said, “This agreement reflects GSK’s
growing leadership across oncology and our commitment to advance the latest innovation for patients living with cancer.
The dual KRAS-EGFR mechanism of HMPL-A830 has the potential to significantly improve upon current standard of care.
We look forward to working with HUTCHMED to progress this innovative asset through development.”
1
License Terms
Under the agreement, HUTCHMED Limited will receive an upfront payment of US$110 million and may receive additional
development, regulatory and commercial milestone payments of up to a total of US$1.185 billion. The GSK subsidiary
GlaxoSmithKline Ɪntellectual Property (No. 4) Limited will also pay tiered royalties on its annual net sales. HUTCHMED
Limited will retain full development and commercialization rights in Mainland China, Hong Kong, Macau and Taiwan. Ɪn
addition, the GSK subsidiary has a right of first negotiation on one earlier stage ATTC drug candidate. The upfront payment
is payable at closing, which is subject to customary closing conditions, including completion of any antitrust regulatory
reviews.
HUTCHMED will host webcasts today on Thursday September 3, 2026 at 4:30 p.m. HKT in Chinese (Putonghua) and at
7:30 a.m. EDT / 12:30 p.m. BST / 7:30 p.m. HKT in English. After registration, investors may access the live webcast at
www.hutch-med.com/event.
BofA Securities is acting as exclusive financial advisor to HUTCHMED.
About HUTCHMED ATTCs
HUTCHMED's ATTCs represent a next-generation approach to precision oncology, combining monoclonal antibodies with
proprietary small-molecule inhibitor payload platforms to deliver dual mechanisms of action. Unlike traditional cytotoxinbased antibody-drug conjugates, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable
responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in both
efficacy and safety.
Built on over 20 years of targeted therapy expertise, the ATTC platforms enable development of drug candidates across
diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve
accessibility to tumors and reduce off-tumor toxicity. This may overcome the on-target, off-tumor toxicity limitations of
systemically-delivered small molecule inhibitors, which in turn could ensure safer long-term use and support combinations
with chemotherapy and immunotherapy in earlier-line treatments.
About KRAS
Rat sarcoma (“RAS”) mutations represent one of the most prevalent and well-established drivers in human oncology,
driving the progression and aggressive pathology of multiple solid tumors. KRAS, the most dominant RAS isoform, is
mutated in approximately 44% of colorectal cancer (“CRC”), 34% of lung adenocarcinoma and up to 89% of pancreatic
ductal adenocarcinoma (“PDAC”) patients. 1 KRAS regulates key downstream pathways, including RAS/MAPK and
PꞮ3K/AKT/mTOR, to drive cell differentiation, proliferation, and survival.
While recent targeted therapies have validated KRAS as a viable therapeutic target, significant clinical gaps persist,
particularly for patients with non-G12C mutations. Most patients eventually experience disease progression driven by
acquired resistance, largely fueled by upstream receptor tyrosine kinase upregulation and secondary KRAS alterations.
Beyond mutation coverage, systemic delivery of pan-KRAS and pan-RAS inhibitors is associated with on-target toxicities,
such as dermatological toxicity reflecting RAS pathway inhibition in normal tissue. These present challenges for dosing,
long-term tolerability, and combination with cytotoxic chemotherapy or immunotherapy backbones that constitute
frontline standard-of-care.
About EGFR
EGFR is a widely expressed receptor tyrosine kinase and established driver of tumor cell proliferation, survival, and disease
progression across multiple solid tumors, including CRC, PDAC, and non-small cell lung cancer (“NSCLC”). Signaling
through EGFR activates the downstream RAS/MAPK and PꞮ3K/AKT/mTOR pathways, positioning the receptor immediately
upstream of KRAS. EGFR has also emerged as a key mediator of resistance to KRAS-targeted therapies, particularly in CRC,
where adaptive feedback and increased upstream EGFR signaling reactivate the MAPK pathway and limit the depth and
durability of KRAS inhibition. Together, these provide a strong rationale for the dual targeting of EGFR and KRAS, not only
in CRC but also additional indications such as PDAC and NSCLC.
About GSK plc
GSK plc is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease
together. Find out more at www.gsk.com.
2
About HUTCHMED
HUTCHMED (Nasdaq/AꞮM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. Ɪt is committed
to the discovery and global development and commercialization of targeted therapies and immunotherapies for the
treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house
discovery to patients around the world, with its first four medicines marketed in China, the first of which is also approved
around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow
us on LinkedꞮn.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995.
These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including, without limitation, statements concerning HUTCHMED’s
future plans and prospects, its expectations regarding the therapeutic potential of HMPL-A830 and other drug candidates from the ATTC platform and the further
development of HMPL-A830 and other drug candidates from the ATTC platform in this and other indications, as well as the safety, efficacy, tolerability, scalability or
combinability of all candidates from the ATTC platform. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding the amount and timely receipt of the considerations; satisfaction of the conditions precedent to the consummation of the proposed
transactions (including the ability of the parties to secure regulatory approvals on the terms expected, at all or in a timely manner); the ability of the parties to complete
the proposed transactions; the continued sufficiency of preclinical and clinical data to support development and approval of the ATTC-based R&D candidates in China,
the United States and other jurisdictions; their potential to gain clinical trial approvals from regulatory authorities; the efficacy and safety profile of HMPL-A830 and other
drug candidates from the ATTC platform; the timing and outcome of clinical studies and the sufficiency of clinical data to support an new drug application submission
of HMPL-A830 and other drug candidates from the ATTC platform in China, the United States or other jurisdictions; its potential to gain approvals from regulatory
authorities on an expedited basis or at all; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway
for the ATTC candidates; HUTCHMED or GSK’s ability to fund, implement and complete its further clinical development and commercialization plans for HMPL-A830 and
other drug candidates from the ATTC platform and the timing of these events. Ɪn addition, when or if used herein, the words and phrases “aims,” “anticipates,” “believes,”
“continue,” “estimates,” “expects,” “intends,” “may,” “on track,” “predicts,” “plans,” “potential,” “promising,” “should,” “to be,” “will,” and similar expressions and their
variants, as they relate to HUTCHMED may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future
performance. Although HUTCHMED believes the expectations reflected in such forward-looking statements are reasonable, HUTCHMED can give no assurance that
such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ
materially from those expressed or implied HUTCHMED’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation,
assumptions regarding the safety, efficacy, supply, continued regulatory approval of these therapeutics, and in some cases connected to the risks of the use of other
drug products as combination therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. For further discussion of these and
other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AꞮM. HUTCHMED undertakes
no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European
Union (Withdrawal) Act 2018).
Medical Information
This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different
indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription
drugs including the ones under development.
REFERENCES
1 Singhal A, Li BT & O’Reilly EM. Targeting KRAS in cancer. Nat Med 30, 969–983 (2024). DOꞮ: 10.1038/s41591-024-02903-0
3
By Order of the Board
Edith Shih
Non-executive Director and Company Secretary
Hong Kong, September 3, 2026
As at the date of this announcement, the Directors of the Company are:
Chairman and Non-executive Director:
Dr Dan ELDAR
Executive Directors:
Dr Weiguo SU
(Chief Executive Officer and
Chief Scientific Officer)
Mr CHENG Chig Fung, Johnny
(Acting Chief Executive Officer and
Chief Financial Officer)
Non-executive Directors:
Ms Edith SHꞮH
Ms Ling YANG
Ɪndependent Non-executive Directors:
Dr Renu BHATꞮA
(Senior and Lead Ɪndependent Non-executive Director)
Dr Chaohong HU
Professor TAN Shao Weng, Daniel
Mr WONG Tak Wai
4
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。
HUTCHMED (China) Limited
和黃醫藥(中國)有限公司
(於開曼群島註冊成立的有限公司)
(股份代號:13)
內幕消息
和黃醫藥宣佈與葛蘭素史克就KRAS-EGFR抗體偶聯癌症藥物達成許可協議
— HMPL-A830的獨家許可協議,一款全球首創的KRAS-EGFR 抗體靶向偶聯藥物(ATTC),
預計2026年下半年啟動臨床試驗 —
— 和黃醫藥將於今天中國香港時間下午4時30分舉行中文(普通話)網絡直播,並於美國東部夏令時間上午7時
30分 / 英國夏令時間下午12時30分 / 中國香港時間晚上7時30分舉行英文網絡直播 —
本公告乃由和黃醫藥(中國)有限公司(簡稱「和黃醫藥」或「HUTCHMED」)根據香港聯合交易所有限公司證
券上市規則第 13.09(2)(a)條及證券及期貨條例(香港法例第 571 章)第 XIVA 部項下之內幕消息條文而刊發。
和黃醫藥今日宣佈其附屬公司和記黃埔醫藥(上海)有限公司(HUTCHMED Limited)與GSK plc(簡稱「葛蘭
素史克」)的附屬公司達成一項獨家開發及許可協議,授予該葛蘭素史克附屬公司除中國內地、香港、澳門和台
灣以外的全球範圍內開發和商業化HMPL-A830的權利。臨床開發將首先聚焦於結直腸癌、胰腺癌和肺癌適應症。
協議包括1.1億美元的首付款以及潛在的開發、註冊和商業化里程碑付款,總額可達12.95億美元,外加基於淨銷
售額的特許權使用費。這一全球首創(first-in-class)的抗體靶向偶聯藥物(「ATTC」
)候選藥物,由高選擇性、
高活性的KRAS(Kirsten大鼠肉瘤)小分子抑制劑作為有效載荷,與抗表皮生長因子受體(
「EGFR」)抗體偶聯而
成。ATTC通過抗體引導,使強效的細胞殺傷有效載荷能夠選擇性聚焦於腫瘤組織並發揮活性。
結直腸癌、肺癌和胰腺癌是KRAS基因改變發生率最高的癌症類型,這些患者往往缺乏安全且持久的KRAS療法。
HMPL-A830旨在滿足這一需求,通過將KRAS抑制劑直接遞送至伴有EGFR表達的腫瘤,同時阻斷EGFR和KRAS信
號通路,從而提高療效、持久性和耐受性。
根據協議條款,和記黃埔醫藥(上海)有限公司將負責HMPL-A830的全球I期開發項目,項目預計將於2026年下
半年啟動(clinicaltrials.gov註冊號:NCT07718581)
。葛蘭素史克的附屬公司將負責除中國內地、香港、澳門和
台灣以外地區的所有後續的臨床開發和商業化活動。
和黃醫藥代理首席執行官兼首席財務官鄭澤鋒先生表示:
「我們很高興能與全球領先的生物製藥企業葛蘭素史克
攜手合作,雙方秉持相同的理念,致力於開發創新癌症藥物以解決全球未被滿足的重要醫療需求。我們的ATTC將
抗體與我們專利的小分子抑制劑有效載荷相結合,從而實現雙重作用機制。HMPL-A830是我們創新有效載荷平台
下的第三款候選藥物,也是繼首兩款候選藥物進入臨床開發後,我們平台旗下首個授權予全球合作夥伴的候選藥
物。此次的合作是我們在最大程度釋放該藥物的臨床潛能方面邁出的重要一步,並將開啟一個腫瘤精準治療全新
篇章。」
1
葛蘭素史克高級副總裁、全球腫瘤研發負責人Hesham Abdullah博士表示:「這項合作體現了葛蘭素史克在腫
瘤領域日益提升的領導地位,以及我們致力於推進最前沿創新療法,造福癌症患者的堅定承諾。HMPL-A830的
KRAS-EGFR雙重靶向機制,有望顯著改善目前的標準治療方案。我們期待與和黃醫藥合作,共同推進這一創新藥
物的開發。」
許可條款
根據協議,和記黃埔醫藥(上海)有限公司將收到1.1億美元的首付款,並可能獲得總額可高達11.85億美元的額
外的研發、監管和商業里程碑付款。葛蘭素史克的附屬公司GlaxoSmithKline Intellectual Property (No. 4)
Limited亦將基於年度淨銷售額支付分層的特許權使用費。和記黃埔醫藥(上海)有限公司將保留在中國內地、
香港、澳門和台灣地區的全部研發和商業化權利。此外,該葛蘭素史克的附屬公司對一款更早期階段的ATTC候選
藥物擁有優先談判權。首付款將在交易完成時支付,但需滿足慣例成交條件,包括完成任何反壟斷監管審查。
和黃醫藥將於今天2026年9月3日(星期四)中國香港時間下午4時30分舉行中文(普通話)網絡直播,並於美國
東部夏令時間上午7時30分 / 英國夏令時間下午12時30分 / 中國香港時間晚上7時30分舉行英文網絡直播。投
資者可於www.hutch-med.com/event登記後參與實時網絡直播。
美銀證券(BofA Securities)擔任和黃醫藥的獨家財務顧問。
關於和黃醫藥的ATTC
和黃醫藥的抗體靶向偶聯藥物(ATTC)代表著新一代的精準腫瘤治療,將單克隆抗體和專利靶向小分子抑制劑有
效載荷平台相結合,實現雙重作用機制。不同於傳統的基於細胞毒素的抗體偶聯藥物,ATTC結合了靶向療法,在
臨床前模型中展現出具有協同作用的抗腫瘤活性,並實現持久緩解,在療效和安全性方面均優於單獨使用抗體或
小分子抑制劑。
依託和黃醫藥在靶向治療領域超過二十年的專業積澱,ATTC平台能夠開發覆蓋廣泛腫瘤的候選藥物。通過抗體
引導的靶向遞送以及具有腫瘤特異性的有效載荷釋放技術,ATTC使藥物更易直達腫瘤,並降低對非腫瘤組織的
毒性。這有助於克服全身給藥的小分子抑制劑在非腫瘤靶向毒性方面的限制,從而確保長期用藥的安全性,並支
持在更早的治療線中與化療和免疫療法進行聯合用藥。
關於KRAS
大鼠肉瘤(
「RAS」
)突變是人類腫瘤學中最常見且明確的驅動因素之一,推動著多種實體瘤的進展和侵襲性病理
特徵。KRAS作為最主要的RAS亞型,存在於約44%的結直腸癌、34%的肺腺癌,以及高達89%的胰腺導管腺癌患
者中。1 KRAS調控關鍵的下游通路,包括RAS/MAPK和PI3K/AKT/mTOR通路,從而驅動細胞分化、增殖和存活。
儘管近年來出現的靶向療法已證實KRAS是一個可行的治療靶點,但臨床上仍存在顯著的未被滿足的需求,尤其
是對於攜帶非G12C突變的患者。大多數患者最終會因獲得性耐藥而出現疾病進展,這主要是由上游受體酪氨酸
激酶的上調和繼發性的KRAS改變所驅動。除了突變覆蓋範圍的局限外,全身性遞送泛KRAS和泛RAS抑制劑還會
造成靶向毒性,例如正常組織中因RAS通路抑制導致的皮膚毒性。這些都為給藥方案、長期耐受性以及與細胞毒
性化療或免疫療法為基石的標準治療的聯合用藥帶來了挑戰。
2
關於EGFR
EGFR 是一種廣泛表達的受體酪氨酸激酶,在包括結直腸癌、胰腺導管腺癌和非小細胞肺癌在內的多種實體瘤中,
已 被 證 實 是 腫 瘤 細 胞 增 殖 、 存 活 和 疾 病 進 展 的 驅 動 因 子 。EGFR信 號 通 路 激 活 下 游 的RAS/MAPK和
PI3K/AKT/mTOR通路,使該受體處於KRAS的正上游。EGFR也已成為KRAS靶向治療耐藥的關鍵驅動因素,尤其
是在結直腸癌中,適應性反饋和上游EGFR信號增強會重新激活MAPK通路,從而限制KRAS抑制的深度和持久性。
這些發現共同為EGFR和KRAS的雙重靶向治療提供了強有力的理論依據,不僅適用於結直腸癌,也同樣適用於胰
腺導管腺癌和非小細胞肺癌等其他適應症。
關於葛蘭素史克
葛蘭素史克(GSK)是一家以「彙聚科學、技術與人才,合力超越,共克疾病」為使命的全球生物醫藥公司。如
需更多信息,請訪問www.gsk.com。
關於和黃醫藥
和黃醫藥(納斯達克/倫敦證交所:HCM;香港交易所:13)是一家處於商業化階段的創新型生物醫藥公司,致
力於發現、全球開發和商業化治療癌症和免疫性疾病的靶向藥物和免疫療法。自成立以來,和黃醫藥致力於將自
主發現的候選藥物帶向全球患者,首四個藥物現已在中國上市,其中首個藥物亦於美國、歐洲和日本等全球各地
獲批。欲了解更多詳情,請訪問:www.hutch-med.com或關注我們的LinkedIn專頁。
前瞻性陳述
本公告包含1995年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的
預期,包括(但不限於)有關下述方面的聲明:和黃醫藥未來計劃及前景的陳述、對HMPL-A830和ATTC平台下其他候選藥物的治療潛力的期
望、HMPL-A830和ATTC平台下其他候選藥物在該適應症及其他適應症中進一步臨床研究計劃的期望,以及ATTC平台所有其他候選藥物的安
全性、有效性、耐受性、可擴展性或聯合用藥可能性。前瞻性陳述涉及風險和不確定性。此類風險和不確定性其中包括有關代價金額與是否
及時收到代價的假設、是否達成完成建議交易涉及的先決條件(包括各方能否按預期條款取得監管批准、是否根本能夠取得監管批准或及時
取得監管批准的能力)、各方完成建議交易的能力、是否一直擁有充分的臨床前及臨床數據以支持基於ATTC平台的研發候選藥物在中國、美
國和其他國家進行開發及取得批准、從監管機構獲得臨床試驗批准的可能性、HMPL-A830和ATTC平台下其他候選藥物的療效和安全性特徵、
對研究時間和結果發佈的預期、支持HMPL-A830和ATTC平台下其他候選藥物在中國、美國或其他地區獲批的新藥上市申請的數據充足性、
獲得監管部門快速審批或審批的潛力、監管機構的行動或可影響ATTC候選藥物臨床試驗的啟動、時間和進展或註冊路徑、和黃醫藥或葛蘭素
史克為研發HMPL-A830和ATTC平台下其他候選藥物的其他臨床開發及商業化計劃提供資金、實施並完成該等計劃的能力以及該等事件的發
生時間。此外,於本公告中使用時,「旨在」、「預期」、「認為」、「持續」、「估計」、「預計」、「有意」、「可能」、「按計劃」、「預測」、「計劃」、
「潛在」
、
「有望」
、
「應該」
、
「擬」
、
「將」等詞彙和短語與類似表述及其變體就與和黃醫藥有關而言均可能屬於前瞻性陳述。前瞻性陳述並非過
去事實,亦非對未來表現的保證。雖然和黃醫藥認為該等前瞻性陳述中反映的預期實屬合理,惟和黃醫藥概不能保證該等預期將經證實屬正
確。敬請讀者注意,由於存在各種風險和不確定性,包括(但不限於)有關上述療法的安全性、有效性、供應、持續取得監管批准的假設,
以及在某些情況下與使用其他藥物產品作為聯合療法的風險有關的假設,實際結果、活動水平、安全性、表現或事件及情況可能與和黃醫藥
的前瞻性陳述中明示或默示的結果、活動水平、安全性、表現或事件和情況存在實質性差異。前瞻性陳述並非過去事實,亦非對未來表現的
保證。當前和潛在投資者請勿過度依賴這些前瞻性陳述,該等陳述僅在其作出當日有效,並且是以管理層於當日的假設和估計為依據。有關
這些風險和其他風險的進一步討論,請查閱和黃醫藥向美國證券交易委員會、香港聯合交易所有限公司及AIM提交的文件。無論是否出現新
訊息、未來事件或情況或其他因素,和黃醫藥均不承擔更新或修訂本新公告所含訊息的義務。
內幕消息
本公告包含(歐盟)第596/2014號條例(該條例構成《2018年歐洲聯盟(退出)法》定義的歐盟保留法律的一部分)第7條規定的內幕消息。
醫療信息
本公告所提到的産品可能並未在所有國家上市,或可能以不同的商標進行銷售,或用於不同的病症,或採用不同的劑量,或擁有不同的效力。
本文中所包含的任何信息都不應被看作是任何處方藥的推銷、推廣或廣告,包括那些正在研發的藥物。
1
Singhal A, Li BT & O’Reilly EM. Targeting KRAS in cancer. Nat Med 30, 969–983 (2024). DOI: 10.1038/s41591-024-02903-0
3
承董事會命
非執行董事兼公司秘書
施熙德
香港,2026年9月3日
於本公告日期,本公司之董事為:
主席兼非執行董事:
艾樂德博士
非執行董事:
施熙德女士
楊凌女士
執行董事:
獨立非執行董事:
(首席執行官兼首席科學官)
(高級兼首席獨立非執行董事)
蘇慰國博士
鄭澤鋒先生
(代理首席執行官兼首席財務官)
言思雅醫生
胡朝紅博士
陳邵文教授
黃德偉先生
4
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.
HUTCHMED (China) Limited
和⿈醫藥(中國)有限公司
(Ɪncorporated in the Cayman Ɪslands with limited liability)
(Stock Code: )
ꞮNSꞮDE ꞮNFORMATꞮON
HUTCHMED ANNOUNCES LꞮCENSꞮNG AGREEMENT WꞮTH GSK FOR
KRAS-EGFR-ANTꞮBODY CONJUGATE CANCER THERAPY
— Exclusive License for HMPL-A830, a first-in-class KRAS-EGFR Antibody-Targeted Therapy Conjugate (“ATTC”),
which is expected to enter clinical trials in H2 2026 —
— HUTCHMED webcasts today at 4:30pm HKT in Chinese (Putonghua) and at 7:30 a.m. EDT / 12:30 p.m. BST /
7:30 p.m. HKT in English —
This announcement is made by HUTCHMED (China) Limited (“HUTCHMED”) pursuant to Rule 13.09(2)(a) of the Rules
Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited and the Ɪnside Ɪnformation Provisions
under Part XꞮVA of the Securities and Futures Ordinance (Cap. 571).
HUTCHMED today announces that its subsidiary, HUTCHMED Limited, has entered into an exclusive development and
license agreement with a subsidiary of GSK plc (“GSK”), granting the GSK subsidiary worldwide rights excluding Mainland
China, Hong Kong, Macau and Taiwan to develop and commercialize HMPL-A830. Clinical development will initially focus
on colorectal, pancreatic and lung cancer indications. The agreement includes a US$110 million upfront payment and
potential development, regulatory and commercial milestone payments, for up to a total of US$1.295 billion, and royalties
on net sales. This first-in-class drug candidate, an Antibody-Targeted Therapy Conjugate (“ATTC”), comprises a highly
selective and potent Kirsten rat sarcoma (“KRAS”) small molecule inhibitor payload conjugated to an anti-epidermal growth
factor receptor (“EGFR”) antibody. An ATTC enables tumor-selective activity of potent, cell-killing payloads by leveraging
antibody-guided therapy.
Colorectal, lung, and pancreatic cancers have the highest incidence of patients with KRAS-altered tumors, who often lack
a safe and durable KRAS therapy. HMPL-A830 is designed to address this need by delivering a KRAS inhibitor directly to
EGFR-expressing tumors, while simultaneously blocking EGFR and KRAS signaling to enhance efficacy, durability, and
tolerability.
Under the terms of the agreement, HUTCHMED Limited will be responsible for the global phase Ɪ development program,
which is expected to start in the second half of 2026 (clinicaltrials.gov identifier NCT07718581). The GSK subsidiary will be
responsible for all subsequent clinical development and commercialization activities outside of Mainland China, Hong
Kong, Macau and Taiwan.
“We are proud to work with GSK, a globally leading biopharmaceutical company that, like HUTCHMED, is committed to
developing innovative new cancer medicines to address significant unmet medical needs worldwide,” said Mr Johnny
Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. “Our ATTCs combine antibodies
with our proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. HMPL-A830 is our third drug
candidate from these novel payload platforms and the first from our platform to be licensed to a global partner, following
two candidates that have entered clinical development. This collaboration marks a significant step in maximizing its
potential as a treatment for patients, unlocking an entirely new class of precision oncology medicines.”
Dr Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said, “This agreement reflects GSK’s
growing leadership across oncology and our commitment to advance the latest innovation for patients living with cancer.
The dual KRAS-EGFR mechanism of HMPL-A830 has the potential to significantly improve upon current standard of care.
We look forward to working with HUTCHMED to progress this innovative asset through development.”
1
License Terms
Under the agreement, HUTCHMED Limited will receive an upfront payment of US$110 million and may receive additional
development, regulatory and commercial milestone payments of up to a total of US$1.185 billion. The GSK subsidiary
GlaxoSmithKline Ɪntellectual Property (No. 4) Limited will also pay tiered royalties on its annual net sales. HUTCHMED
Limited will retain full development and commercialization rights in Mainland China, Hong Kong, Macau and Taiwan. Ɪn
addition, the GSK subsidiary has a right of first negotiation on one earlier stage ATTC drug candidate. The upfront payment
is payable at closing, which is subject to customary closing conditions, including completion of any antitrust regulatory
reviews.
HUTCHMED will host webcasts today on Thursday September 3, 2026 at 4:30 p.m. HKT in Chinese (Putonghua) and at
7:30 a.m. EDT / 12:30 p.m. BST / 7:30 p.m. HKT in English. After registration, investors may access the live webcast at
www.hutch-med.com/event.
BofA Securities is acting as exclusive financial advisor to HUTCHMED.
About HUTCHMED ATTCs
HUTCHMED's ATTCs represent a next-generation approach to precision oncology, combining monoclonal antibodies with
proprietary small-molecule inhibitor payload platforms to deliver dual mechanisms of action. Unlike traditional cytotoxinbased antibody-drug conjugates, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable
responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in both
efficacy and safety.
Built on over 20 years of targeted therapy expertise, the ATTC platforms enable development of drug candidates across
diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve
accessibility to tumors and reduce off-tumor toxicity. This may overcome the on-target, off-tumor toxicity limitations of
systemically-delivered small molecule inhibitors, which in turn could ensure safer long-term use and support combinations
with chemotherapy and immunotherapy in earlier-line treatments.
About KRAS
Rat sarcoma (“RAS”) mutations represent one of the most prevalent and well-established drivers in human oncology,
driving the progression and aggressive pathology of multiple solid tumors. KRAS, the most dominant RAS isoform, is
mutated in approximately 44% of colorectal cancer (“CRC”), 34% of lung adenocarcinoma and up to 89% of pancreatic
ductal adenocarcinoma (“PDAC”) patients. 1 KRAS regulates key downstream pathways, including RAS/MAPK and
PꞮ3K/AKT/mTOR, to drive cell differentiation, proliferation, and survival.
While recent targeted therapies have validated KRAS as a viable therapeutic target, significant clinical gaps persist,
particularly for patients with non-G12C mutations. Most patients eventually experience disease progression driven by
acquired resistance, largely fueled by upstream receptor tyrosine kinase upregulation and secondary KRAS alterations.
Beyond mutation coverage, systemic delivery of pan-KRAS and pan-RAS inhibitors is associated with on-target toxicities,
such as dermatological toxicity reflecting RAS pathway inhibition in normal tissue. These present challenges for dosing,
long-term tolerability, and combination with cytotoxic chemotherapy or immunotherapy backbones that constitute
frontline standard-of-care.
About EGFR
EGFR is a widely expressed receptor tyrosine kinase and established driver of tumor cell proliferation, survival, and disease
progression across multiple solid tumors, including CRC, PDAC, and non-small cell lung cancer (“NSCLC”). Signaling
through EGFR activates the downstream RAS/MAPK and PꞮ3K/AKT/mTOR pathways, positioning the receptor immediately
upstream of KRAS. EGFR has also emerged as a key mediator of resistance to KRAS-targeted therapies, particularly in CRC,
where adaptive feedback and increased upstream EGFR signaling reactivate the MAPK pathway and limit the depth and
durability of KRAS inhibition. Together, these provide a strong rationale for the dual targeting of EGFR and KRAS, not only
in CRC but also additional indications such as PDAC and NSCLC.
About GSK plc
GSK plc is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease
together. Find out more at www.gsk.com.
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About HUTCHMED
HUTCHMED (Nasdaq/AꞮM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. Ɪt is committed
to the discovery and global development and commercialization of targeted therapies and immunotherapies for the
treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house
discovery to patients around the world, with its first four medicines marketed in China, the first of which is also approved
around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow
us on LinkedꞮn.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995.
These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including, without limitation, statements concerning HUTCHMED’s
future plans and prospects, its expectations regarding the therapeutic potential of HMPL-A830 and other drug candidates from the ATTC platform and the further
development of HMPL-A830 and other drug candidates from the ATTC platform in this and other indications, as well as the safety, efficacy, tolerability, scalability or
combinability of all candidates from the ATTC platform. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding the amount and timely receipt of the considerations; satisfaction of the conditions precedent to the consummation of the proposed
transactions (including the ability of the parties to secure regulatory approvals on the terms expected, at all or in a timely manner); the ability of the parties to complete
the proposed transactions; the continued sufficiency of preclinical and clinical data to support development and approval of the ATTC-based R&D candidates in China,
the United States and other jurisdictions; their potential to gain clinical trial approvals from regulatory authorities; the efficacy and safety profile of HMPL-A830 and other
drug candidates from the ATTC platform; the timing and outcome of clinical studies and the sufficiency of clinical data to support an new drug application submission
of HMPL-A830 and other drug candidates from the ATTC platform in China, the United States or other jurisdictions; its potential to gain approvals from regulatory
authorities on an expedited basis or at all; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway
for the ATTC candidates; HUTCHMED or GSK’s ability to fund, implement and complete its further clinical development and commercialization plans for HMPL-A830 and
other drug candidates from the ATTC platform and the timing of these events. Ɪn addition, when or if used herein, the words and phrases “aims,” “anticipates,” “believes,”
“continue,” “estimates,” “expects,” “intends,” “may,” “on track,” “predicts,” “plans,” “potential,” “promising,” “should,” “to be,” “will,” and similar expressions and their
variants, as they relate to HUTCHMED may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future
performance. Although HUTCHMED believes the expectations reflected in such forward-looking statements are reasonable, HUTCHMED can give no assurance that
such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ
materially from those expressed or implied HUTCHMED’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation,
assumptions regarding the safety, efficacy, supply, continued regulatory approval of these therapeutics, and in some cases connected to the risks of the use of other
drug products as combination therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. For further discussion of these and
other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AꞮM. HUTCHMED undertakes
no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European
Union (Withdrawal) Act 2018).
Medical Information
This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different
indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription
drugs including the ones under development.
REFERENCES
1 Singhal A, Li BT & O’Reilly EM. Targeting KRAS in cancer. Nat Med 30, 969–983 (2024). DOꞮ: 10.1038/s41591-024-02903-0
3
By Order of the Board
Edith Shih
Non-executive Director and Company Secretary
Hong Kong, September 3, 2026
As at the date of this announcement, the Directors of the Company are:
Chairman and Non-executive Director:
Dr Dan ELDAR
Executive Directors:
Dr Weiguo SU
(Chief Executive Officer and
Chief Scientific Officer)
Mr CHENG Chig Fung, Johnny
(Acting Chief Executive Officer and
Chief Financial Officer)
Non-executive Directors:
Ms Edith SHꞮH
Ms Ling YANG
Ɪndependent Non-executive Directors:
Dr Renu BHATꞮA
(Senior and Lead Ɪndependent Non-executive Director)
Dr Chaohong HU
Professor TAN Shao Weng, Daniel
Mr WONG Tak Wai
4
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。
HUTCHMED (China) Limited
和黃醫藥(中國)有限公司
(於開曼群島註冊成立的有限公司)
(股份代號:13)
內幕消息
和黃醫藥宣佈與葛蘭素史克就KRAS-EGFR抗體偶聯癌症藥物達成許可協議
— HMPL-A830的獨家許可協議,一款全球首創的KRAS-EGFR 抗體靶向偶聯藥物(ATTC),
預計2026年下半年啟動臨床試驗 —
— 和黃醫藥將於今天中國香港時間下午4時30分舉行中文(普通話)網絡直播,並於美國東部夏令時間上午7時
30分 / 英國夏令時間下午12時30分 / 中國香港時間晚上7時30分舉行英文網絡直播 —
本公告乃由和黃醫藥(中國)有限公司(簡稱「和黃醫藥」或「HUTCHMED」)根據香港聯合交易所有限公司證
券上市規則第 13.09(2)(a)條及證券及期貨條例(香港法例第 571 章)第 XIVA 部項下之內幕消息條文而刊發。
和黃醫藥今日宣佈其附屬公司和記黃埔醫藥(上海)有限公司(HUTCHMED Limited)與GSK plc(簡稱「葛蘭
素史克」)的附屬公司達成一項獨家開發及許可協議,授予該葛蘭素史克附屬公司除中國內地、香港、澳門和台
灣以外的全球範圍內開發和商業化HMPL-A830的權利。臨床開發將首先聚焦於結直腸癌、胰腺癌和肺癌適應症。
協議包括1.1億美元的首付款以及潛在的開發、註冊和商業化里程碑付款,總額可達12.95億美元,外加基於淨銷
售額的特許權使用費。這一全球首創(first-in-class)的抗體靶向偶聯藥物(「ATTC」
)候選藥物,由高選擇性、
高活性的KRAS(Kirsten大鼠肉瘤)小分子抑制劑作為有效載荷,與抗表皮生長因子受體(
「EGFR」)抗體偶聯而
成。ATTC通過抗體引導,使強效的細胞殺傷有效載荷能夠選擇性聚焦於腫瘤組織並發揮活性。
結直腸癌、肺癌和胰腺癌是KRAS基因改變發生率最高的癌症類型,這些患者往往缺乏安全且持久的KRAS療法。
HMPL-A830旨在滿足這一需求,通過將KRAS抑制劑直接遞送至伴有EGFR表達的腫瘤,同時阻斷EGFR和KRAS信
號通路,從而提高療效、持久性和耐受性。
根據協議條款,和記黃埔醫藥(上海)有限公司將負責HMPL-A830的全球I期開發項目,項目預計將於2026年下
半年啟動(clinicaltrials.gov註冊號:NCT07718581)
。葛蘭素史克的附屬公司將負責除中國內地、香港、澳門和
台灣以外地區的所有後續的臨床開發和商業化活動。
和黃醫藥代理首席執行官兼首席財務官鄭澤鋒先生表示:
「我們很高興能與全球領先的生物製藥企業葛蘭素史克
攜手合作,雙方秉持相同的理念,致力於開發創新癌症藥物以解決全球未被滿足的重要醫療需求。我們的ATTC將
抗體與我們專利的小分子抑制劑有效載荷相結合,從而實現雙重作用機制。HMPL-A830是我們創新有效載荷平台
下的第三款候選藥物,也是繼首兩款候選藥物進入臨床開發後,我們平台旗下首個授權予全球合作夥伴的候選藥
物。此次的合作是我們在最大程度釋放該藥物的臨床潛能方面邁出的重要一步,並將開啟一個腫瘤精準治療全新
篇章。」
1
葛蘭素史克高級副總裁、全球腫瘤研發負責人Hesham Abdullah博士表示:「這項合作體現了葛蘭素史克在腫
瘤領域日益提升的領導地位,以及我們致力於推進最前沿創新療法,造福癌症患者的堅定承諾。HMPL-A830的
KRAS-EGFR雙重靶向機制,有望顯著改善目前的標準治療方案。我們期待與和黃醫藥合作,共同推進這一創新藥
物的開發。」
許可條款
根據協議,和記黃埔醫藥(上海)有限公司將收到1.1億美元的首付款,並可能獲得總額可高達11.85億美元的額
外的研發、監管和商業里程碑付款。葛蘭素史克的附屬公司GlaxoSmithKline Intellectual Property (No. 4)
Limited亦將基於年度淨銷售額支付分層的特許權使用費。和記黃埔醫藥(上海)有限公司將保留在中國內地、
香港、澳門和台灣地區的全部研發和商業化權利。此外,該葛蘭素史克的附屬公司對一款更早期階段的ATTC候選
藥物擁有優先談判權。首付款將在交易完成時支付,但需滿足慣例成交條件,包括完成任何反壟斷監管審查。
和黃醫藥將於今天2026年9月3日(星期四)中國香港時間下午4時30分舉行中文(普通話)網絡直播,並於美國
東部夏令時間上午7時30分 / 英國夏令時間下午12時30分 / 中國香港時間晚上7時30分舉行英文網絡直播。投
資者可於www.hutch-med.com/event登記後參與實時網絡直播。
美銀證券(BofA Securities)擔任和黃醫藥的獨家財務顧問。
關於和黃醫藥的ATTC
和黃醫藥的抗體靶向偶聯藥物(ATTC)代表著新一代的精準腫瘤治療,將單克隆抗體和專利靶向小分子抑制劑有
效載荷平台相結合,實現雙重作用機制。不同於傳統的基於細胞毒素的抗體偶聯藥物,ATTC結合了靶向療法,在
臨床前模型中展現出具有協同作用的抗腫瘤活性,並實現持久緩解,在療效和安全性方面均優於單獨使用抗體或
小分子抑制劑。
依託和黃醫藥在靶向治療領域超過二十年的專業積澱,ATTC平台能夠開發覆蓋廣泛腫瘤的候選藥物。通過抗體
引導的靶向遞送以及具有腫瘤特異性的有效載荷釋放技術,ATTC使藥物更易直達腫瘤,並降低對非腫瘤組織的
毒性。這有助於克服全身給藥的小分子抑制劑在非腫瘤靶向毒性方面的限制,從而確保長期用藥的安全性,並支
持在更早的治療線中與化療和免疫療法進行聯合用藥。
關於KRAS
大鼠肉瘤(
「RAS」
)突變是人類腫瘤學中最常見且明確的驅動因素之一,推動著多種實體瘤的進展和侵襲性病理
特徵。KRAS作為最主要的RAS亞型,存在於約44%的結直腸癌、34%的肺腺癌,以及高達89%的胰腺導管腺癌患
者中。1 KRAS調控關鍵的下游通路,包括RAS/MAPK和PI3K/AKT/mTOR通路,從而驅動細胞分化、增殖和存活。
儘管近年來出現的靶向療法已證實KRAS是一個可行的治療靶點,但臨床上仍存在顯著的未被滿足的需求,尤其
是對於攜帶非G12C突變的患者。大多數患者最終會因獲得性耐藥而出現疾病進展,這主要是由上游受體酪氨酸
激酶的上調和繼發性的KRAS改變所驅動。除了突變覆蓋範圍的局限外,全身性遞送泛KRAS和泛RAS抑制劑還會
造成靶向毒性,例如正常組織中因RAS通路抑制導致的皮膚毒性。這些都為給藥方案、長期耐受性以及與細胞毒
性化療或免疫療法為基石的標準治療的聯合用藥帶來了挑戰。
2
關於EGFR
EGFR 是一種廣泛表達的受體酪氨酸激酶,在包括結直腸癌、胰腺導管腺癌和非小細胞肺癌在內的多種實體瘤中,
已 被 證 實 是 腫 瘤 細 胞 增 殖 、 存 活 和 疾 病 進 展 的 驅 動 因 子 。EGFR信 號 通 路 激 活 下 游 的RAS/MAPK和
PI3K/AKT/mTOR通路,使該受體處於KRAS的正上游。EGFR也已成為KRAS靶向治療耐藥的關鍵驅動因素,尤其
是在結直腸癌中,適應性反饋和上游EGFR信號增強會重新激活MAPK通路,從而限制KRAS抑制的深度和持久性。
這些發現共同為EGFR和KRAS的雙重靶向治療提供了強有力的理論依據,不僅適用於結直腸癌,也同樣適用於胰
腺導管腺癌和非小細胞肺癌等其他適應症。
關於葛蘭素史克
葛蘭素史克(GSK)是一家以「彙聚科學、技術與人才,合力超越,共克疾病」為使命的全球生物醫藥公司。如
需更多信息,請訪問www.gsk.com。
關於和黃醫藥
和黃醫藥(納斯達克/倫敦證交所:HCM;香港交易所:13)是一家處於商業化階段的創新型生物醫藥公司,致
力於發現、全球開發和商業化治療癌症和免疫性疾病的靶向藥物和免疫療法。自成立以來,和黃醫藥致力於將自
主發現的候選藥物帶向全球患者,首四個藥物現已在中國上市,其中首個藥物亦於美國、歐洲和日本等全球各地
獲批。欲了解更多詳情,請訪問:www.hutch-med.com或關注我們的LinkedIn專頁。
前瞻性陳述
本公告包含1995年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的
預期,包括(但不限於)有關下述方面的聲明:和黃醫藥未來計劃及前景的陳述、對HMPL-A830和ATTC平台下其他候選藥物的治療潛力的期
望、HMPL-A830和ATTC平台下其他候選藥物在該適應症及其他適應症中進一步臨床研究計劃的期望,以及ATTC平台所有其他候選藥物的安
全性、有效性、耐受性、可擴展性或聯合用藥可能性。前瞻性陳述涉及風險和不確定性。此類風險和不確定性其中包括有關代價金額與是否
及時收到代價的假設、是否達成完成建議交易涉及的先決條件(包括各方能否按預期條款取得監管批准、是否根本能夠取得監管批准或及時
取得監管批准的能力)、各方完成建議交易的能力、是否一直擁有充分的臨床前及臨床數據以支持基於ATTC平台的研發候選藥物在中國、美
國和其他國家進行開發及取得批准、從監管機構獲得臨床試驗批准的可能性、HMPL-A830和ATTC平台下其他候選藥物的療效和安全性特徵、
對研究時間和結果發佈的預期、支持HMPL-A830和ATTC平台下其他候選藥物在中國、美國或其他地區獲批的新藥上市申請的數據充足性、
獲得監管部門快速審批或審批的潛力、監管機構的行動或可影響ATTC候選藥物臨床試驗的啟動、時間和進展或註冊路徑、和黃醫藥或葛蘭素
史克為研發HMPL-A830和ATTC平台下其他候選藥物的其他臨床開發及商業化計劃提供資金、實施並完成該等計劃的能力以及該等事件的發
生時間。此外,於本公告中使用時,「旨在」、「預期」、「認為」、「持續」、「估計」、「預計」、「有意」、「可能」、「按計劃」、「預測」、「計劃」、
「潛在」
、
「有望」
、
「應該」
、
「擬」
、
「將」等詞彙和短語與類似表述及其變體就與和黃醫藥有關而言均可能屬於前瞻性陳述。前瞻性陳述並非過
去事實,亦非對未來表現的保證。雖然和黃醫藥認為該等前瞻性陳述中反映的預期實屬合理,惟和黃醫藥概不能保證該等預期將經證實屬正
確。敬請讀者注意,由於存在各種風險和不確定性,包括(但不限於)有關上述療法的安全性、有效性、供應、持續取得監管批准的假設,
以及在某些情況下與使用其他藥物產品作為聯合療法的風險有關的假設,實際結果、活動水平、安全性、表現或事件及情況可能與和黃醫藥
的前瞻性陳述中明示或默示的結果、活動水平、安全性、表現或事件和情況存在實質性差異。前瞻性陳述並非過去事實,亦非對未來表現的
保證。當前和潛在投資者請勿過度依賴這些前瞻性陳述,該等陳述僅在其作出當日有效,並且是以管理層於當日的假設和估計為依據。有關
這些風險和其他風險的進一步討論,請查閱和黃醫藥向美國證券交易委員會、香港聯合交易所有限公司及AIM提交的文件。無論是否出現新
訊息、未來事件或情況或其他因素,和黃醫藥均不承擔更新或修訂本新公告所含訊息的義務。
內幕消息
本公告包含(歐盟)第596/2014號條例(該條例構成《2018年歐洲聯盟(退出)法》定義的歐盟保留法律的一部分)第7條規定的內幕消息。
醫療信息
本公告所提到的産品可能並未在所有國家上市,或可能以不同的商標進行銷售,或用於不同的病症,或採用不同的劑量,或擁有不同的效力。
本文中所包含的任何信息都不應被看作是任何處方藥的推銷、推廣或廣告,包括那些正在研發的藥物。
1
Singhal A, Li BT & O’Reilly EM. Targeting KRAS in cancer. Nat Med 30, 969–983 (2024). DOI: 10.1038/s41591-024-02903-0
3
承董事會命
非執行董事兼公司秘書
施熙德
香港,2026年9月3日
於本公告日期,本公司之董事為:
主席兼非執行董事:
艾樂德博士
非執行董事:
施熙德女士
楊凌女士
執行董事:
獨立非執行董事:
(首席執行官兼首席科學官)
(高級兼首席獨立非執行董事)
蘇慰國博士
鄭澤鋒先生
(代理首席執行官兼首席財務官)
言思雅醫生
胡朝紅博士
陳邵文教授
黃德偉先生
4
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