Oricell Therapeutics Advances Ori-C101, the World’s First GPC3-Targeted CAR-T Therapy, into Pivotal Phase II Trial for Late-Line Hepatocellular Carcinoma

Today, Qrigincell Therapeutics announced that itsSelf-developed GPC3 CAR-T Cell TherapyOri-C101，Approved by the National Medical Products Administration (NMPA) of China to proceed into a Phase II confirmatory clinical trial for GPC3-positive, late-line hepatocellular carcinoma (HCC).

“Confirmatory Clinical Trial” The core objective is to confirm the efficacy and safety of the drug, providing key evidence for drug registration applications.

Ori-C101 AdvancementThe events of the Phase II confirmatory clinical trial mark that the regulatory pathway for Ori-C101 has been clarified, with the expectation of submitting a marketing application after completing the study and obtaining key efficacy and safety data.

According toPublic information shows that,Ori-C101It is the world’s first GPC3-targeted immune cell therapy to enter pivotal clinical trials. This means that, if all goes well,Ori-C101 is poised to become the world’s firstFor the Treatment of Liver CancerGPC3 CAR-T Drugs。

Ori-C101 is a targetedAutologous CAR-T cell therapy targeting GPC3 is primarily developed for the treatment ofPrimary Hepatocellular Carcinoma。GPC3It is highly expressed in over 70% of hepatocellular carcinoma cases and also shows significant expression in various solid tumors, including gastric cancer, lung squamous cell carcinoma, and ovarian clear cell carcinoma, making it a highly promising specific target for anti-tumor therapy.

Ori-C101 is based on Qrigincell Therapeutics' proprietaryOri®Ab (AI Antibody Discovery and Engineering Platform) and Ori®Armoring (Structurally Enhanced Cell Platform)Development, capable of efficiently identifying and killing GPC3-positive tumor cells.

Currently,Ori-C101 hasCompleted investigator-initiated trials (IIT) and registered Phase I clinical trials.

In 2021, Qrigincell Therapeutics reported at the ASCO 2021 Annual MeetingIIT Data for Ori-C101,At that time, an exceptional response was observed in a patient with last-line disease: after a single dose, the patient’s first efficacy assessment was a partial response (PR), with a 96.1% reduction in target lesions (from 155.45 mm to 6 mm) and a 99.1% decrease in alpha-fetoprotein (AFP) levels (from >80,000 ng/mL to 742 ng/mL).Overall Survival (OS) in the Past 3 Years。

In 2026, Qrigincell Therapeutics reported on Ori-C101 at the ASCO 2026 Annual MeetingLate-stage terminal hepatocellular carcinoma (HCC)Results from the Phase I clinical trial (BEACON) showed that among 18 efficacy-evaluable subjects, the ORR reached 50%;RecommendationIPhase IDose (RP2D) group ORR reached 66.7%; Highest Dose Group(DL4) ORR reached 100%；89% of responders achieved an objective response with significant tumor shrinkage at the first assessment post-infusion;mOS in the overall population reached 21.4 months, with a 12-month survival rate of 69.3%.. Furthermore, one case of deep remission was observed in this study: the patient achieved partial response (PR) at the initial assessment, complete response (CR) at the 4-month assessment, and the duration of response has reached 24 months, with continued benefit currently. The study demonstratesIt has controllable safety and good tolerability.

Based on the efficacy and safety demonstrated in investigator-initiated trials (IITs) and Phase I registration clinical trials, Ori-C101 has shown potential as a next-generation therapeutic agent for hepatocellular carcinoma.

Therefore, inOri-C101CompletedFollowing registration for Phase I clinical trials, Qrigincell Therapeutics andCommunicated with the National Medical Products Administration and received strong support from regulatory and government authorities, resulting in approvalOri-C101Enter Phase II confirmatory clinical trial.

ThePhase II confirmatory clinical trial is aA prospective, randomized, controlled, open-label, nationwide, multicenter registrational clinical trial designed to evaluate Ori-C101 in patients with advanced hepatocellular carcinoma who have previously failed two or more lines of therapyEfficacy and safety. The study is about to be conducted and will beLed by Professor Fan Jia, an Academician of the Chinese Academy of Sciences and affiliated with Zhongshan Hospital, Fudan University, and Professor Qin Shukui, a Qiantang Scholar and affiliated with Nanjing Tianyinshan Hospital, China Pharmaceutical University, this initiative was carried out through nationwide multicenter collaboration.

Notably, in the first half of 2026, Qrigincell Therapeutics completed two rounds of financing, namely$70 million in Series C1 financing and1.1hundred million U.S. dollars in Pre-IPO round financing, both of these massive financings will supportDevelopment of Ori-C101, drivingClinical Studies of Ori-C101 and Future Commercial Activities

Further Reading:Qrigincell Therapeutics Announces $70 Million in Series C Financing to Accelerate Global Development of CAR-T for Solid Tumors

China is at the global forefront in the field of CAR-T research for solid tumors.

First, CARsgen Therapeutics submitted the world’s firstMarketing Application for CAR-T Cell Therapy in Solid Tumors. Currently, Legend Biotech'sClaudin18.2 CAR-T DrugThe marketing application for Shu Rui Ji Ao Lun Sai Injection is under review.

Next isQrigincell Therapeutics' CAR-T Project for Liver CancerOri-C101 ProgressPhase II Confirmatory Clinical Trial.

In addition, there are many domestic companies developing CAR-T for solid tumors, including Yimu Feng,Saidansai, Shanghai Cell Therapy Group, ImmuneOnco Biopharmaceuticals, Huadao Bio, Cytopeutics, etc.

Further Reading:World’s First Solid Tumor CAR-T Therapy Files for Marketing Approval, from CJ Bio