# Early Data Show Highly Selective FGFR2 Inhibitor 3HP-2827 Active in Advanced CCA; Chinese Academy of Sciences' Zhou Jian Comments on Potential for Patients With FGFR2 Alterations

- Link: https://www.thailand-business-news.com/pr-news/early-data-show-highly-selective-fgfr2-inhibitor-3hp-2827-active-in-advanced-cca-chinese-academy-of-sciences-zhou-jian-comments-on-potential-for-patients-with-fgfr2-alterations
- Published: 2026-06-02T20:30:00+07:00
- Author: PR Newswire

CHICAGO, June 2, 2026 /PRNewswire/ — At the 2026 American Society of Clinical Oncology(
ASCO) Annual Meeting, 3H Pharmaceuticals released new clinical data for its wholly
owned candidate, 3HP-2827. The ongoing study focuses on patients with advanced cholangiocarcinoma(
CCA) and other solid tumors carrying FGFR2 alterations—an area of persistent and
significant unmet need. The data showed that 3HP-2827, a highly selective FGFR2 
inhibitor, demonstrated encouraging anti-tumor activity in patients with advanced
CCA driven by FGFR2 fusions or rearrangements, as well as notable tumor shrinkage
in FGFR2-mutated solid tumors. On May 31 in Chicago, on the sidelines of the ASCO
meeting, eChinaHealth spoke with Academician Zhou Jian, President of Zhongshan Hospital,
Fudan University. He shared his views on the current treatment landscape for FGFR2-
altered CCA, the clinical profile and future potential of 3HP-2827, and the prospects
for further advances in the field. 

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 3HP-2827 Brings New Hope to Patients with Advanced CCA Harboring FGFR2 Alterations
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Academician Zhou noted that CCA is a highly aggressive cancer, with incidence rising
in both China and worldwide. For patients with advanced disease, the prognosis is
extremely poor—even worse than for hepatocellular carcinoma. Currently, the standard
first-line treatment for advanced CCA remains chemotherapy plus immunotherapy. In
recent years, however, a growing number of new approaches have emerged. Drugs targeting
IDH1 and FGFR, for instance, have already received approval. At this year’s ASCO
Annual Meeting alone, more than 80 abstracts on CCA were presented, with FGFR2-targeted
therapy emerging as a particularly active area of research. Earlier studies have
validated the efficacy of FGFR2 inhibition in CCA, and as these targeted agents 
are refined, the efficacy data continue to improve. Looking ahead, FGFR2-directed
therapy is expected to play a larger role in the treatment of advanced CCA, offering
patients more precise and effective options. 

3HP-2827, a novel and highly selective FGFR2 inhibitor, is being evaluated in a 
multicenter clinical study in China led by Academician Fan Jia and Professor Shen
Lin, with RLY-4008 as the active comparator. To date, the efficacy of 3HP-2827 appears
comparable to the early-stage clinical results reported for RLY-4008, and both agents
have shown superior efficacy compared with pan-FGFR inhibitors. In addition, 3HP-
2827 has demonstrated a favorable safety profile. Of note, the patient population
in the current study was more heavily pretreated: 80% of patients had previously
received an immune checkpoint inhibitor (ICI) in combination with chemotherapy, 
and 60% had undergone prior anti-angiogenic therapy. Additional clinical data will
be important to further evaluate the potential of this approach. 

Based on available data, both RLY-4008 and Pemigatinib have shown greater efficacy
in the first-line treatment of advanced CCA than in the second-line setting. The
latest data for single-agent RLY-4008 show an objective response rate (ORR) of 46.5%
among 144 second-line patients, while the ORR reached 63.6% in a small cohort of
11 first-line patients—though the limited sample size in the first-line group requires
cautious interpretation and further validation. For Pemigatinib, prior phase II 
and the most recent phase III data report an ORR of 35.5% in 146 second-line patients
and 47.0% in 83 first-line patients. To date, 3HP-2827 has generated preliminary
efficacy evidence in the second-line setting. Evaluating its single-agent activity
in the first-line setting to pursue a first-line indication represents an important
next step. 

Academician Zhou said he expects the future first-line treatment paradigm for CCA
to shift toward a multi-drug, multi-modality combination approach integrating chemotherapy,
immunotherapy and targeted therapy. Such a strategy, he noted, is scientifically
sound and could improve both treatment efficacy and patient outcomes. From a safety
perspective, the main adverse reactions linked to 3HP-2827 are FGFR2-related toxicities
affecting the skin and mucosa — a profile distinct from that of chemotherapy or 
immunotherapy. That difference suggests a low risk of overlapping toxicity when 
used in combination, supporting the potential for 3HP-2827 to be added to existing
regimens. In addition, among patients with FGFR2 fusion- or rearrangement-driven
CCA treated with 3HP-2827, two achieved complete disappearance of target lesions,
and the majority experienced substantial tumor shrinkage. Because most CCA patients
are no longer candidates for surgery at initial diagnosis, the pronounced tumor-
shrinking effect of 3HP-2827 opens the door to exploring conversion therapy in the
future — using preoperative single-agent treatment to downstage tumors and expand
the pool of patients eligible for curative resection. 

Currently, most FGFR2-targeted agents in clinical development are aimed at CCA patients
with FGFR2 fusions or rearrangements. In contrast, patients with FGFR2-mutated solid
tumors have few options, with no approved therapies to date. FGFR2 mutations occur
across a wide range of solid tumors — including biliary tract cancers, gynecologic
malignancies, melanoma, colorectal cancer, lung cancer, gastric cancer and urothelial
carcinoma — representing a patient population larger than that of FGFR2 fusions 
or rearrangements. The longstanding lack of a targeted treatment for this group 
highlights a significant unmet medical need. The activity observed with 3HP-2827
suggests a potential new treatment approach for these patients. 

The clinical data released by 3H Pharmaceuticals at the meeting showed that among
patients with FGFR2-mutated solid tumors, 3HP-2827 achieved a best objective response
rate (ORR) of 57.1% and a disease control rate (DCR) of 100%. Although the number
of enrolled patients remains small at this stage, the cohort already includes multiple
clinically relevant FGFR2 mutation sites, including N549K, Y375C, C382R and F276C.
Looking ahead, the clinical development program for 3HP-2827 should continue to 
gather additional data in FGFR2-mutated solid tumors and initiate a multi-histology
basket trial, with the goal of further evaluating its potential in this patient 
population. 

In the interview, Academician Zhou Jian of Zhongshan Hospital, Fudan University,
discussed the latest clinical data on 3HP-2827, a highly selective FGFR2 inhibitor,
in patients with FGFR2-altered advanced CCA and other solid tumors. He noted that
while chemotherapy plus immunotherapy remains the current standard first-line treatment
for advanced CCA, FGFR2-targeted therapy is emerging as an important precision medicine
approach. Looking ahead, Zhou recommended pursuing first-line treatment studies,
combination therapy regimens and basket trials targeting FGFR2 mutations — strategies
that could further expand the reach of precision oncology. 

**Note:** 3HP-2827 is a highly selective FGFR2 inhibitor independently developed
by 3H Pharmaceuticals. It works by specifically inhibiting FGFR2 phosphorylation,
blocking the FGFR2 signaling pathway and producing anti-tumor activity. The drug
is designed to offer a more effective and better-tolerated treatment option for 
patients with FGFR2 alterations, especially those who have developed resistance 
to prior therapies. 

**About Academician Zhou Jian

Academician Zhou Jian is a member of the Chinese Academy of Sciences and a leading
authority in hepatobiliary oncology and liver transplantation. He currently serves
as President of Zhongshan Hospital, Fudan University, and Executive Deputy Director
of the Liver Cancer Institute at Fudan University. 

He holds numerous prestigious academic appointments, including Executive Chair of
the National Health Commission’s Expert Committee for the _Guidelines on the Diagnosis
and Treatment of Primary Liver Cancer_, President of the Chinese Society of Oncology
for the Chinese Medical Association, Chairman of the Asia-Pacific Primary Liver 
Cancer Expert (APPLE) Association, and Chairman of the Chinese Society of Clinical
Oncology (CSCO) Expert Committee on Hepatocellular Carcinoma. He also serves on 
the Executive Council of the Asian Pacific Association for the Study of the Liver(
APASL) and is Vice President and Secretary-General of the Chinese College of Surgeons,
Chinese Medical Doctor Association.

Recognized as one of China’s leading physician-scientists, he has been honored with
a National Science Fund for Distinguished Young Scholars award, a Chang Jiang Distinguished
Professorship from the Ministry of Education, and a National "Ten Thousand Talents
Program" designation as a Leading Talent in Scientific and Technological Innovation.
He is a five-time recipient of the National Science and Technology Progress Award,
having served as the principal investigator for one award and as a co-principal 
investigator for two others.

Academician Zhou has authored or co-authored over 154 peer-reviewed articles as 
first or corresponding author in journals such as _The Lancet,_ _The New England
Journal of Medicine,_ _Cell,_ _Journal of Clinical Oncology,_ _The Lancet Gastroenterology&
Hepatology,_ _The Lancet Oncology,_ _Signal Transduction and Targeted Therapy,_ 
and _Cell Research_, earning an H-index of 100. 

**Contact:Li Hao
[hao.li@3hpharma.com](https://www.thailand-business-news.com/pr-news/hao.li@3hpharma.com)

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