# OriCell's GPC3 CAR-T Receives NMPA Clearance for Confirmatory Phase II Trial in Late-Line Advanced Hepatocellular Carcinoma

- Link: https://www.thailand-business-news.com/pr-news/oricells-gpc3-car-t-receives-nmpa-clearance-for-confirmatory-phase-ii-trial-in-late-line-advanced-hepatocellular-carcinoma
- Published: 2026-06-08T07:08:00+07:00
- Author: PR Newswire

SHANGHAI, June 8, 2026 /PRNewswire/ — OriCell Therapeutics Holdings Limited ( The"
Company" or "Oricell") , announced that its proprietary GPC3-targeted autologous
CAR-T therapy, Ori-C101, has received clearance from China’s National Medical Products
Administration (NMPA) to proceed into a confirmatory Phase II clinical trial in 
patients with GPC3-positive advanced hepatocellular carcinoma (HCC). The study is
designed as a prospective, randomised, open-label, multi-centre registration trial
evaluating the efficacy and safety of Ori-C101 in patients who have failed two or
more prior lines of therapy.

This marks the first GPC3-directed immune cell therapy anywhere in the world to 
enter a confirmatory trial, and the first CAR-T product for a liver cancer indication
to reach a Phase II randomised controlled study — a milestone that underscores China’s
potential to lead the next wave of innovation in cell therapy for solid tumours.

**HCC, a disease with few options at the late line**

Hepatocellular carcinoma is among the most prevalent malignancies globally, with
China alone accounting for roughly 410,000 new cases and 317,000 deaths each year.
For patients whose disease has progressed through both immune checkpoint inhibitors(
ICI) and tyrosine kinase inhibitors (TKI), options are essentially exhausted: existing
second-line agents were developed for patients intolerant of, or progressing on,
first-line sorafenib, and nothing has been approved beyond that point. The unmet
need is acute.

**Phase I data of Ori-C101: robust efficacy and manageable safety**

Results from the Phase I BEACON study were featured as an oral presentation at the
2026 American Society of Clinical Oncology (ASCO) Annual Meeting, which recently
wrapped up in Chicago, drawing significant attention from the oncology community.
All enrolled patients had failed at least two prior lines of therapy, including 
both TKI and ICI treatment.

Key results:

**Objective response rate (ORR):** 50% across the evaluable population; 66.7% in
the recommended Phase II dose (RP2D) cohort; 100% in the highest dose cohort (DL4)

**Speed of response:** 89% of responders had already achieved objective response
by their first post-infusion assessment, with marked tumour shrinkage

**Overall survival (OS):** Median OS of 21.4 months in the overall population; 12-
month survival rate of 69.3% — more than double the roughly 10.6-month historical
median seen with available second-line agents, heralding a potential new era of 
long-term survival for patients with advanced HCC

**Safety:** Cytokine release syndrome (CRS) was manageable; no immune effector cell-
associated neurotoxicity syndrome (ICANS) or off-target toxicity was observed, and
tolerability was favourable across the study population

**Notable case:** One patient achieved partial response at first assessment, progressed
to complete response by month four, and remains in remission at 24 months

**Mechanism and broader potential**

GPC3 (Glypican-3) is overexpressed in more than 70% of hepatocellular carcinomas,
as well as in gastric cancer, lung squamous cell carcinoma, and ovarian clear cell
carcinoma — making it a highly specific and compelling target for cancer therapy.
Ori-C101 is engineered to identify and eliminate GPC3-positive tumour cells with
precision, drawing on two proprietary platforms: Ori^(®)Ab (AI-assisted antibody
discovery and engineering) and Ori^(®)Armoring (structure-enhanced cell platform).

Ori-C101’s profile has the potential to support use in earlier lines of treatment,
and GPC3’s expression across multiple tumour types provides a strong scientific 
rationale for future indication expansion. As the confirmatory trial advances, the
goal of treatment in advanced HCC has the potential to shift from controlling disease
to achieving durable remission — or even cure.

**Principal investigators**

The confirmatory Phase II study is a nation-wide, multi-centre trial co-led by Professor
Fan Jia (Academician of the Chinese Academy of Sciences and Honorary President of
Zhongshan Hospital, Fudan University) and Professor Qin Shukui (Qiantang Scholar
and Professor at Nanjing Tianyinshan Hospital, China Pharmaceutical University).

In a joint statement, the two investigators said: "In our earlier work on late-line
advanced HCC, the BEACON study delivered important progress. GPC3 is specifically
overexpressed in HCC and represents an ideal therapeutic target, yet GPC3-directed
CAR-T approaches have historically been constrained by the immunosuppressive tumour
microenvironment. BEACON was designed precisely to break through that barrier and
find a new, accessible path for patients who have exhausted their options. The preliminary
results from this novel ‘armoured’ GPC3 CAR-T construct — showing strong objective
response rates with a manageable safety profile — not only address an evidence gap
in late-line refractory HCC but offer broader lessons for innovative immune cell
therapies in solid tumours. We look forward to the Phase II randomised controlled
study, and to obtaining the expected results under rigorous scientific design, comprehensive
management, and strict quality control."

OriCell co-founder, Chairman and Chief Executive Officer Dr. Yang Huanfeng commented:"
We are deeply grateful to the NMPA Centre for Drug Evaluation and relevant government
authorities for their strong support of innovative drug development, and to Academician
Fan, Professor Qin and their teams for their trust and active participation. This
approval validates the scientific soundness and feasibility of our technology platform
and marks a new stage of growth for OriCell. With a clear regulatory pathway now
in place, we will push forward with Ori-C101’s confirmatory clinical development,
with the aim of bringing a genuinely new treatment option to patients as quickly
as we can. We believe this progress will also underpin China’s strategy for taking
innovative medicines global and competing actively in international markets."

**About OriCell Therapeutics**

OriCell Therapeutics is a clinical-stage, globally oriented biotechnology company
committed to pioneering cancer immunotherapy. Focused on addressing unmet medical
needs in oncology and immunology, the company has built a robust pipeline spanning
both solid and haematological tumours, powered by three proprietary technology engines:
Ori^(®)AB (AI-assisted antibody discovery and engineering), Ori^(®)Armoring (structure-
enhanced cell platform), and Ori^(®)OnGo (classic, rapid, and in vivo manufacturing
platform). The company’s clinical translation capabilities have earned broad international
recognition, with multiple data readouts selected for oral presentations at leading
conferences including ASCO and EHA, and published in top-tier journals such as _The
Lancet Haematology_. OriCell is accelerating its global expansion, driven by a commitment
to continuous innovation and the ambition to bring new hope to cancer patients worldwide.
For more information, please visit [www.oricell.com](http://www.oricell.com/).

**Forward-Looking Statements**

This press release contains forward-looking statements. These statements are not
historical facts, but rather predictions about future events based on the beliefs,
assumptions, and information currently available to the management of OriCell Therapeutics
Holdings Limited (the "Company"). Words and phrases such as "anticipate," "believe,""
continue," "could," "estimate," "expect," "intend," "plan," "potential," "predict,""
project," "should," "target," "will," "would," and similar expressions are intended
to identify forward-looking statements, though not all forward-looking statements
contain these identifying words. Such statements involve known and unknown risks,
uncertainties, and other important factors that could cause the Company’s actual
results, performance, or achievements to differ materially from those expressed 
or implied. Any forward-looking statements contained in this press release speak
only as of the date of this release. The Company wishes to clarify that this announcement
is intended solely to communicate research and clinical development progress, is
for reference by healthcare professionals only, is not promotional in nature, and
does not constitute a recommendation for the use of any unapproved drug or indication.

---

  |  This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. |

---

 
**Read the original article :** [OriCell's GPC3 CAR-T Receives NMPA Clearance for Confirmatory Phase II Trial in Late-Line Advanced Hepatocellular Carcinoma ](http://www.prnasia.com/story/archive/4977753_CN77753_0?rand=184833)