劲方医药GFH375二期NSCLC数据在WCLC口头报告：ORR 59.2%、DCR 93%，III期已启动

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the contents of this announcement.

GenFleet Therapeutics (Shanghai) Inc.
勁方醫藥科技(上海)股份有限公司
(A joint stock company incorporated in the People’s Republic of China with limited liability)

(Stock Code: 2595)

VOLUNTARY ANNOUNCEMENT
Favorable Phase II Efficacy Data of GFH375 (Oral KRAS G12D Inhibitor)
Monotherapy in Pretreated NSCLC Presented in Oral Session
at 2026 World Conference on Lung Cancer (WCLC)
This announcement is made by GenFleet Therapeutics (Shanghai) Inc. (the “Company” or
“GenFleet”, together with its subsidiaries, the “Group”) on a voluntary basis to inform the
shareholders and potential investors of the Company about the latest business updates of the Group.
The board of directors of the Company (the “Board”) is pleased to announce the updated phase II
data of GFH375 monotherapy in pretreated KRAS G12D-mutant non-small cell lung cancer (NSCLC)
were released in an oral presentation at the World Conference on Lung Cancer (WCLC) on September
14 local time in Seoul. The presentation demonstrated encouraging efficacy of GFH375 at the 600 mg
QD dose level in NSCLC patients, with nearly 100% of enrolled patients having distant metastases
and over 40% having received at least two prior lines of therapy. As of the data cutoff date, 71 patients
had undergone at least one post-treatment evaluation, with an objective response rate (ORR) of 59.2%,
a confirmed objective response rate (cORR) of 52.1% and a disease control rate (DCR) of 93%. In
addition, the median progression-free survival (mPFS) reached 9.6 months (with median follow-up
time of 11 months) among taxane-naïve patients, and the 12-month overall survival rate (OS rate) was
77% (with median follow-up time of 11.2 months) among all patients.
“It is the second selection of GFH375’s NSCLC study data into the WCLC annual meeting,
demonstrating encouraging efficacy in a larger patient population for pretreated NSCLC. Building on
phase I/II data, GFH375 was the first to have received Breakthrough Therapy Designation (BTD) in
China for pretreated KRAS G12D-mutant NSCLC and has entered the world’s first phase III study of
an oral KRAS G12D inhibitor in NSCLC (‘Kylin-Flight 01’) this year. GenFleet features a
comprehensive RAS-inhibiting portfolio spanning diverse targets, molecular modalities and clinical
programs, including GFH375 that is being evaluated in both monotherapy and first-line combination
regimens for NSCLC. We are confident in advancing the ‘Kylin-Flight 01’ study and look forward to

continued positive progress of multiple GFH375 regimens.” stated Yu Wang, M.D., Ph.D., Chief
Medical Officer of GenFleet.
Oral Presentation: Efficacy and Safety of GFH375 Monotherapy in Advanced KRAS G12D-Mutant
NSCLC Patients (Abstract No. 2333)
Presenter: Prof. Ziming Li, Shanghai Chest Hospital
As of September 4, 2026, 75 patients with KRAS G12D-mutant NSCLC were orally administered
with GFH375 at 600 mg QD, of whom 98.7% had distant metastases, including bone metastases
(37.3%), brain metastases (16%), and liver metastases (13.3%). All patients had received prior
platinum-based chemotherapy and immune checkpoint inhibitor (ICI) therapy before the enrollment
(90.7% had received these two prior therapies concurrently); 42.7% had received at least two prior
lines of therapy; 38.7% had received taxanes (including docetaxel); 64% had received ICI therapy
within 90 days prior to their first GFH375 dosing. The mPFS was 8.3 months among all the patients
and was 8.1 months among taxane-pretreated patients; the median OS (mOS) was not reached.
As of June 17, 2026, a total of 75 patients treated with GFH375 monotherapy demonstrated
manageable safety and tolerability. The most common treatment-related adverse events (TRAEs)
included diarrhea, vomiting, and nausea; the majority were graded 1-2 and recovered with supportive
treatments. Grade≥3 TRAEs were primarily diarrhea and ALT elevation. TRAEs were generally
manageable with no TRAEs-related deaths. No new safety signals were observed compared with
previously reported GFH375 monotherapy safety data. The study data suggested that compared with
patients taking ICI (anti-PD1/PD-L1 antibody) over 90 days before the first dosing of GFH375, those
with ICI exposure within 90 days showed poorer safety and tolerability, especially with higher rates
of grade≥3 TRAEs including hepatotoxicity (16.7% vs 0%).
About GFH375/VS-7375
GFH375 is an orally active, potent, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor
designed to bind to the protein of KRAS G12D non-covalently, blocking its interaction with
downstream effector proteins and thereby disrupting the sustained activation of downstream pathways
and effectively inhibiting tumor cell proliferation. Preclinical studies demonstrated dose-and durationdependent inhibition of tumor growth by GFH375 monotherapy; GFH375 also demonstrated low offtarget risk in kinase selectivity and safety target assays. GenFleet entered into a license and earlystage development collaboration with Verastem Oncology (“Verastem”) to advance three novel
oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration
provides Verastem with an exclusive option to obtain a license for each of the three compounds in the
collaboration after the successful completion of pre-determined milestones in a Phase I trial. Verastem
selected GFH375/VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, as its lead program from the
collaboration in December 2023 and the license for GFH375 that was exercised in January 2025 is
the first one from this collaboration. The licenses would give Verastem development and
commercialization rights outside of China while GenFleet would retain rights inside of China.

Forward-looking Statements
Specific information in this announcement may contain or constitute forward-looking words that are
not historical facts. They can be identified by using forward-looking terminology, such as “predict”,
“believe”, “plan”, “forecast”, “expect”, “will”, “may”, “should” and other words of similar meanings.
Based on the management’s current beliefs, plans, estimates and expectations of the Company’s
operation and market trends subject to changes beyond control, the forward-looking terminology
reflects the Company’s beliefs, plans, estimates and expectations of future development. Actual
outcome in the future may differ significantly from forward-looking words owing to market, policy,
and R&D uncertainties, among others. Subject to the above-mentioned uncertainties, the Company
makes no expressed or implied guarantee as to the accuracy, completeness or feasibility of this
presentation, and you are cautioned not to solely rely on such forward-looking words. Neither the
company nor any of its directors, officers, employees, shareholders, agents, related parties, consultants
or representatives will be liable to you or any other person for consequences resulting from using this
presentation. Investors are advised to exercise due diligence with reference to the company’s official
disclosures for decision-making.

GLOSSARY OF TECHNICAL TERMS
「ALT」

Alanine Aminotransferase

「BTD」

Breakthrough Therapy Designation

「cORR」

confirmed overall response rate

「cPR」

confirmed partial response

「DCR」

disease control rate

「ICI」

immune checkpoint inhibitor

「KRAS」

Kirsten RAS, a member of the RAS family of proteins

「MAPK」

mitogen-activated protein kinase, a family of proteins
involved in transmitting signals from cell surface receptors
to the nucleus

「mOS」

median overall survival

「NSCLC」

non-small cell lung cancer

「ORR」

overall response rate

「OS rate」

overall survival rate

「PD-1/PD-L1」

programmed death-1 / programmed death-ligand 1

「PFS」

progression free survival

「QD」

quaque die

「RAS」

ras sarcoma, a family of proteins that are critical regulators
of cellular signaling pathways; it primarily includes
HRAS, KRAS, and NRAS

「TRAEs」

Treatment-related adverse events

「WCLC」

World Conference on Lung Cancer

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 it will be able
to develop, or ultimately market GFH375 successfully. Shareholders and potential investors of the
Company are advised to exercise caution when dealing in the shares of the Company.
By order of the Board
GenFleet Therapeutics (Shanghai) Inc.
Dr. Qiang LU
Chairman and Executive Director
Hong Kong, September 15, 2026
As at the date of this announcement, the Board comprises: (i) Dr. Qiang LU, Dr. Jiong LAN and Ms. ZHANG
Wei as executive directors; (ii) Mr. ZHU Jingyang and Ms. TAO Sha as non-executive directors; and (iii) Ms.
Christine Shaohua LU-WONG, Dr. ZHOU Demin and Mr. LI Bo as independent non-executive directors

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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴該等內容引致的任何損失承
擔任何責任。

GenFleet Therapeutics (Shanghai) Inc.
勁方醫藥科技（上海）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：2595）

自願公告
GFH375（口服 KRAS G12D 抑制劑）II 期單藥治療
經治 NSCLC 優效數據登陸 2026 世界肺癌大會口頭報告
本公告由勁方醫藥科技（上海）股份有限公司（「本公司」或「勁方」
，連同其附屬公司統
稱「本集團」）自願刊發，以知會本公司股東及潛在投資者有關本集團最新業務動態。
本公司董事會（「董事會」）欣然宣佈，GFH375 單藥治療經治 KRAS G12D 突變型非小細
胞肺癌的 II 期試驗更新數據，於當地時間 9 月 14 日登陸今年在首爾舉行的世界肺癌大會
（WCLC）口頭報告。該報告展現了 GFH375 在 600 mg QD 劑量水平下對 NCSLC 患者的
優秀療效，入組患者中近 100%存在遠處轉移、40%以上既往接受兩線及以上治療：截至數
據截止日，71 名患者完成至少一次治療後評估，客觀緩解率（ORR）為 59.2%、確認的客
觀緩解率（cORR）為 52.1%、疾病控制率（DCR）為 93%。此外，既往未曾接受紫杉類藥
物治療的患者中位無進展生存期（mPFS）達到 9.6 個月（中位隨訪時間為 11 個月），所有
患者的 12 個月總生存率（12-month OS rate）為 77%（中位隨訪時間為 11.2 個月）。
勁方首席醫學官汪裕博士表示：
「這是 GFH375 治療 NSCLC 的臨床數據第二次入選 WCLC，
在更大的人群樣本中展現了治療經治 NSCLC 的優秀療效。基於 I/II 期數據，GFH375 在國
內率先獲得經治 KRAS G12D 突變型 NSCLC 的突破性療法認定（BTD），並於今年進入全
球首個口服 KRAS G12D 抑制劑治療 NSCLC 的 III 期研究（
「‘麒麟-飛 01’」）。勁方擁有多
靶點、多分子類型和多元臨床方案的 RAS 療法矩陣，GFH375 治療 NSCLC 方案也包括單
藥治療及一線聯合療法。我們有信心推進‘麒麟-飛 01’研究，並期待該產品多項療法不斷
取得積極進展。」

口頭報告：GFH375 單藥治療 KRAS G12D 突變型晚期非小細胞肺癌的療效和安全性數據
（摘要編號：2333）

報告人：上海市胸科醫院李子明教授
截至 2026 年 9 月 4 日，共有 75 名 KRAS G12D 突變型 NSCLC 患者接受 600 mg QD 口服
GFH375 治療，其中98.7%的患者存在遠處轉移，包括骨轉移（37.3%）、腦轉移（16%）
、
肝轉移（13.3%）等。所有患者入組前均接受過含鉑化療及免疫檢查點抑制劑治療（90.7%
既往同步接受過兩種治療），42.7%的患者入組前已接受兩線及以上治療；38.7%的患者既
往接受過紫杉類藥物（包括多西他賽），64%的患者入組後首次口服 GFH375 之前 90 天內
接受過免疫檢查點抑制劑（ICI）治療。所有患者的 mPFS 為 8.3 個月、既往曾經接受紫杉
類藥物治療的患者 mPFS 為 8.1 個月，中位總生存期（mOS）未達到。
截至 2026 年 6 月 17 日，75 名患者接受 GFH375 單藥治療後顯示安全性/耐受性可控。多
數治療相關不良事件（TRAEs）為 1-2 級，最常見的 TRAEs 包括腹瀉、嘔吐、噁心等，多
數經支持治療後恢復；3 級及以上 TRAEs 主要為腹瀉和 ALT 升高，TRAEs 整體可控，無
導致死亡的 TRAEs；與既往報導的 GFH375 單藥治療安全性數據相比，未出現新的安全信
號。研究數據提示，若患者首次口服 GFH375 之前 90 天接受 ICI（PD-1/PD-L1 單抗）治
療，其安全性/耐受性不及兩種治療間隔期超過 90 天的患者人群，尤其表現在更高的 3 級
以上肝毒性（16.7% vs 0%）等 TRAEs 發生率。
關於 GFH375/VS-7375
GFH375 為口服高活性、高選擇性小分子 KRAS G12D（ON/OFF）抑制劑，通過非共價形
式結合 KRAS G12D 蛋白，抑制其與下游效應蛋白結合，從而在細胞中破壞 KRAS G12D
對下游通路的持續活化，最終高效抑制腫瘤細胞增殖。臨床前研究已顯示 GFH375 單藥對
腫瘤生長的抑制效應隨用藥劑量和週期增長而提升，且在激酶選擇性和安全性靶點測試中
顯示低脫靶風險。勁方與 Verastem Oncology
「（Verastem」）就勁方開發的三款有 RAS/MAPK
驅動癌症的產品達成了授權及早期合作開發協議。該合作賦予 Verastem 獨家選擇權，以就
該等三款產品在成功達成 I 期臨床試驗預先設定的里程碑後獲得各自許可。於 2023 年 12
月，Verastem 選擇 GFH375/VS-7375 作為其合作的領頭項目，並於 2025 年 1 月對 GFH375
獲得許可、乃該合作框架內誕生的第一個許可。該等許可將賦予 Verastem 在中國境外的開
發和商業化權利，而勁方保留中國境內的該等權利。

前瞻性聲明
本公告包含的特定資訊可能包含或可能構成非歷史事實的前瞻性陳述。前瞻性陳述可通過
使用如下具有前瞻性的詞彙辨識，例如「預計」
、
「相信」
、
「計劃」
、
「預估」
、
「期望」
、
「將」
、
「應」和其他具有類似含義的詞彙。前瞻性陳述反映了勁方醫藥科技對未來發展
「可能」、
的信念、計劃、預估以及期望，是基於公司管理層目前對於公司的經營情況和市場變化情
況（該等變化情況不受其控制）所持的信念、計劃、預估以及期望而作出。受市場、政策、
研發等不確定性因素影響，實際結果可能與該等前瞻性陳述有較大差異。在前述不確定性
的前提下，勁方醫藥科技對該聲明的準確性、完整性或可實現性不作任何明示或暗示的保

證，並提請您注意不應單獨依賴於該等前瞻性陳述，公司及其任何董事、管理人員、僱員、
股東、代理人、關聯方、顧問或代表均不因使用該聲明而對您或其他人士承擔任何責任。
請您審慎評估，並參考公司正式文件作出決策。

技術詞彙表
「ALT」

穀丙轉氨酶

「BTD」

突破性療法認定

「cORR」

確認的客觀緩解率

「cPR」

確認達到部分緩解

「DCR」

疾病控制率

「ICI」

免疫檢查點抑制劑

「KRAS」

Kirsten RAS，RAS 家族蛋白的成員之一

「MAPK」

絲裂原活化蛋白激酶，一般能使細胞表面受器向細胞體傳
遞信息的蛋白質家族

「NSCLC」

非小細胞肺癌

「mOS」

中位總生存期

「ORR」

客觀緩解率

「OS rate」

總生存率

「PD-1/PD-L1」

程序性死亡受體 1/程式性死亡配體 1

「PFS」

無進展生存期

「QD」

每日一次

「RAS」

大鼠肉瘤，是一組蛋白質，細胞信號傳遞的重要調控因數，
主要包括 HRAS、KRAS 和 NRAS

「TRAEs」

治療相關不良事件

「WCLC」

世界肺癌大會

根據香港聯合交易所有限公司證券上市規則第 18A.05 條的警示聲明：本公司無法保證能
夠成功開發或最終上市銷售 GFH375。本公司股東及潛在投資者在買賣本公司股份時應謹
慎行事。
承董事會命
勁方醫藥科技（上海）股份有限公司
董事長兼執行董事
呂強博士

香港，2026 年 9 月 15 日
於本公告日期，本公司董事會包括：(i)執行董事呂強博士、蘭炯博士及張巍女士；(ii)非執行董事朱競陽先生
及陶莎女士；及(iii)獨立非執行董事盧韶華女士、周德敏博士及李波先生。