劲方医药自愿公告：GFH375/VS-7375 多项临床进展积极，但核心海外数据已由Verastem提前发布且美股见光回落

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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
GFH375/VS-7375 (Oral KRAS G12D Inhibitor) Achieves Positive Progress
across Multiple Clinical Studies in China and Abroad,
with Promising Efficacy in Various RAS-mutant Solid Tumors
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 positive progress
in GFH375/VS-7375’s clinical development with latest data disclosed from multiple studies in
China and abroad. In China, GFH375 has received three Breakthrough Therapy Designations
(BTD) for treatment of KRAS G12D-mutant pancreatic cancer, non-small cell lung cancer
(NSCLC) and colorectal cancer (CRC); GFH375 monotherapy has advanced into two
registrational phase III studies in pancreatic cancer and NSCLC. GenFleet’s overseas partner
Verastem Oncology (“Verastem”) has planned to open a registrational phase III study including
multiple regimens of VS-7375 in combination with anti-EGFR therapy or chemotherapy, with
PFS (progression-free survival) and objective response rate (ORR) serving as dual primary
endpoints and overall survival (OS) as secondary endpoint; Verastem has reached alignment
with the U.S. Food and Drug Administration (FDA) on the phase 3 study design.
“We are pleased to see the preliminary efficacy of GFH375 in combination with cetuximab
treating CRC in China, as well as the encouraging efficacy data of GFH375/VS-7375
demonstrated across multiple overseas trials. GFH375 is the world’s first oral KRAS G12D
inhibitor to have entered phase III studies for the treatment of NSCLC and pancreatic cancer.
Furthermore, the product is expected to enter the world’s first front-line phase III study overseas
evaluating a KRAS G12D inhibitor in combination with an anti-EGFR therapy (as a first-line
chemo-free regimen) by the end of this year. We anticipate more innovative monotherapy and

combination regimens of GFH375/VS-7375 will bring hope to global patients.” Stated Yu Wang,
M.D., Ph.D., Chief Medical Officer of GenFleet.



Preliminary data from a combination study in China: GFH375 plus cetuximab in
pretreated CRC and in first-line PDAC

Sponsored by the Company, the study (GFH375X1202) includes a combination
regimen of GFH375 (600 mg QD) plus cetuximab (500 mg/m² Q2W) that demonstrated
encouraging preliminary efficacy and a favorable safety/tolerability profile in patients with
pretreated CRC and first-line PDAC.
As of September 16, 2026, 54 CRC patients had completed at least one post-treatment tumor
assessment. Among them, 100% had distant metastases (57% with lung metastasis, 50% with
liver metastasis, 46% with peritoneal metastasis) upon enrollment; the majority of this CRC
cohort were treated in ≥3rd-line setting post-enrollment (94% of all patients received ≥3rd-line
treatment, and 50% of all patients received ≥4th-line treatment); the overall ORR was 44% in
this cohort, and the disease control rate (DCR) was 89%; the median PFS was 7.3 months (with
median follow-up of 5.4 months), the 4-month PFS rate was 78%. In addition, 24 treatmentnaïve PDAC patients had completed at least one post-treatment assessment, of whom 96% had
distant metastases (liver metastasis 58%, peritoneal metastasis 29%, lung metastasis 14%) upon
enrollment; the ORR was 71% and DCR was 100%; 21 patients remained on treatment.
As of July 22, 2026, a total of 78 CRC and PDAC patients demonstrated a favorable
safety/tolerability profile after treatment of GFH375 (600 mg QD) in combination with
cetuximab (500 mg/m² Q2W). The most common treatment-related adverse events (TRAEs)
included diarrhea, vomiting, nausea and rash, mostly Grade 1-2 and generally manageable. No
TRAEs-related dose discontinuation occurred; no individual Grade 3 TRAE had an incidence
exceeding 5% and there were no Grade 4-5 TRAEs. The cutaneous toxicities observed in this
combination regimen were consistent with the published literature on EGFR antibodies,
representing common adverse reactions well-recognized for cetuximab. Compared with
previously reported GFH375 monotherapy safety data, no new safety signals were identified in
GFH375-related data from this combination regimen. No overlapping toxicities between the
two agents were observed; preliminary data indicated less frequency and severity of hepatic
and hematologic TRAEs compared with late-line GFH375 monotherapy.


Overseas clinical progress of VS-7375 in multiple monotherapy and combination
trials; a first-line phase III PDAC study to be opened by year end

Preliminary data from multiple overseas monotherapy and combination trials of VS-7375
sponsored by Verastem also demonstrated promising therapeutic prospects and a favorable
safety profile in Caucasian patients across different dose levels.
In the PDAC trial of VS-7375 monotherapy at 900 mg QD, 22 patients were treated in ≥2nd-

line setting post-enrollment, with at least one dose of treatment as of data cutoff date; as of
October 7, 2026, the confirmed ORR (cORR) was 41% in this patient cohort and the DCR was
86% (with median follow-up of 6.4 months); 2 patients achieved complete responses, with one
confirmed and the other still on treatment; the majority of patients (16/22) remained on
treatment. The confirmed ORR reached 50% among the 8 patients (8/22) that received 2nd-line
treatment post-enrollment. Verastem has planned to open a registrational phase III study in firstline PDAC by the end of 2026, to evaluate VS-7375 at 900 mg QD in combination with antiEGFR therapy or chemotherapy (AG or mFOLFIRINOX). Additionally, monotherapy or
combination regimens of VS-7375 are also being evaluated in phase 2 registration-directed
trials for treatment of NSCLC and CRC.
As of September 29, 2026, 48 solid tumor patients were treated with VS-7375 monotherapy at
900 mg QD with a median relative dose intensity level of 97% and demonstrated a favorable
and manageable safety profile across tumor types. TRAEs were primarily low-grade
gastrointestinal (GI), including nausea, vomiting and diarrhea, and the vast majority were
effectively treated with standard supportive care measures; no clinically meaningful cytopenias
or liver function abnormalities were reported; compared with previously reported data, no
clinically meaningful cumulative toxicity was observed with long-term dosing. There were no
overlapping adverse events observed in VS-7375 combined with anti-EGFR therapy; GI
TRAEs in the combinations with standard-of-care therapies were comparable to VS-7375
monotherapy, together with no meaningful differences in liver function test elevations or
increased risk of hematologic and neuropathy TRAEs.

Reference:
1. Pharmacovigilance analysis of cutaneous adverse drug reactions for cetuximab,
panitumumab, and necitumumab based on EudraVigilance and WHO VigiAccess, Frontiers
in Pharmacology, 2026

About GFH375/VS-7375
GFH375 is an orally active, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor
designed to bind to the protein of KRAS G12D non-covalently, thereby disrupting the activation
of downstream pathways and effectively inhibiting tumor cell proliferation. Preclinical studies
demonstrated dose-dependent inhibition in models bearing KRAS G12D mutation; GFH375
also demonstrated low off-target risk in kinase selectivity and safety target assays. GenFleet
entered into a license and early-stage development collaboration with Verastem to advance three
novel oncology discovery products related to RAS/MAPK pathway-driven cancers. The

collaboration provides Verastem with an exclusive option to obtain a license for each of the
three products in the collaboration after the successful completion of pre-determined milestones
in a Phase I trial. Verastem selected GFH375/VS-7375 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 within 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
“AG”

nab-paclitaxel and gemcitabine

“BTD”

Breakthrough Therapy Designation

“CR”

complete response

“CRC”

colorectal cancer

“DCR”

disease control rate

“FDA”

Food and Drug Administration

“GI”

gastrointestinal

“HRAS”

Harvey RAS, a member of the RAS family proteins

“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

“NRAS”

neuroblastoma RAS, a member of the RAS family
proteins

“NSCLC”

non-small cell lung cancer

“ORR”

overall response rate

“OS”

overall survival

“PDAC”

pancreatic ductal adenocarcinomas

“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

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, October 15, 2026
As at the date of this announcement, the Board of the Company comprises: (i) Dr. Qiang LU, Dr. Jiong
LAN and Ms. ZHANG Wei as executive directors; (ii) Mr. ZHU Jingyang as non-executive directors;
and (iii) Ms. Christine Shaohua LU-WONG, Dr. ZHOU Demin and Mr. LI Bo as independent nonexecutive directors