Oncology · Oncolytic virotherapy · 2026
Oncolytic virus therapy in China,
explained with the evidence.
Oncorine (H101) is a genetically modified adenovirus designed to replicate in tumour cells and break them open. China approved it in 2005 for nasopharyngeal carcinoma. Chinese centres have since studied it alongside TACE for liver cancer, with PD-1 immunotherapy and for malignant ascites. This guide sets out what the published studies show and where the evidence is still thin.
Quick answer
What is oncolytic virus therapy?
Oncolytic virus therapy uses a virus engineered to replicate preferentially in cancer cells. As it multiplies, it destroys them (oncolysis), and the dying tumour cells can also trigger an anti-tumour immune response. In China, the approved product is Oncorine (H101, 安柯瑞), a recombinant human adenovirus type 5 approved in November 2005. Its approved indication is advanced nasopharyngeal carcinoma in combination with 5-FU/cisplatin chemotherapy. Chinese studies have also tested it with TACE for liver cancer, with PD-1 inhibitors, and by intraperitoneal infusion for malignant ascites.
Nov 2005
Approved in China
First genetically engineered oncolytic virus approved anywhere
Liang, Curr Cancer Drug Targets 2018
78.8% vs 39.6%
Response, Phase III
H101 + cisplatin/5-FU vs chemo alone, head & neck / oesophageal SCC
Xia et al., Ai Zheng 2004
28.7% vs 14.8%
Complete response, HCC
TACE + H101 vs TACE alone, 175 patients (retrospective)
Lin et al., BMC Cancer 2015
40.5% vs 22.4%
3-year survival, HCC
TACE + H101 vs TACE, 476 matched patients (retrospective)
He et al., Chin J Cancer 2017
0
Grade 3–4 events
H101 + nivolumab pilot, n=18; ORR 11.1%
Yi et al., ESMO Open 2024
3
Chinese consensus docs
2022 CSCO · 2023 interventional · 2025 perioperative
See references
How it's used
Where H101 fits in treatment today.
Nasopharyngeal carcinoma
The label covers advanced nasopharyngeal carcinoma that has not responded to radiotherapy or chemoradiotherapy, used with 5-FU/cisplatin palliative chemotherapy. The supporting Phase III trial enrolled head & neck and oesophageal squamous cell cancers.
Label · Phase III
Liver cancer: H101 + TACE
H101 infused through the hepatic artery alongside chemoembolisation for unresectable HCC. The 2022 CSCO consensus recommends it as an option for initial treatment (Child-Pugh A/B, no extrahepatic spread).
Consensus · retrospective data
H101 + PD-1 immunotherapy
Intratumoral H101 followed by a PD-1 inhibitor. Pilot data exist in refractory advanced HCC (n=18), and a Phase II study in gastric-cancer liver metastasis (TROJAN 021) was presented at ASCO 2024.
Pilot / Phase II
Malignant ascites
Intraperitoneal H101 for malignant ascites. In a 40-patient retrospective series, ascites responded in 40% and was controlled in 75% at 4 weeks.
Retrospective series
Other solid tumours
ASCO 2024 abstracts covered intratumoral H101 in gynaecological cancers, and an oncolytic virus with HAIC-mFOLFOX in intrahepatic cholangiocarcinoma. These uses are outside the approved label.
Conference abstracts
Intra-operative perfusion (HCC)
Local perfusion during liver resection to help control local recurrence. The 2025 perioperative consensus calls intra-operative immunotherapy still exploratory.
Evidence IIb · grade C
In brief
How an oncolytic virus targets tumour cells
H101 lacks the adenovirus E1B-55kD gene. Research on a closely related virus showed that normal cells need that gene's protein to export late viral RNA and build new virus, while many tumour cells can manage without it. The virus therefore multiplies mainly in tumour cells, bursts them and spreads to neighbouring tumour cells.
Candidacy
Who may be a candidate
The most-studied setting outside the approved label is hepatocellular carcinoma (HCC) that cannot be removed surgically. The 2022 CSCO consensus describes candidates for H101 + TACE as having Child-Pugh A or B liver function, no spread outside the liver and adequate kidney function. Patients whose advanced HCC has progressed on systemic therapy have been treated with H101 plus a PD-1 inhibitor in a pilot study.
Oncolytic virus therapy is a local or regional treatment that is added to other therapies. It does not replace surgery, systemic therapy or radiotherapy where those are indicated. Whether it suits you depends on tumour type and location, liver and kidney function and prior treatment, and only the treating oncologist can judge that.
We ask a partner oncologist to review recent contrast CT or MRI, pathology, liver-function tests and your treatment history before giving an opinion. If H101 isn't a reasonable option, the written review will say so.
Context
How Oncorine compares with other approved oncolytic viruses
Only a handful of oncolytic viruses have been approved worldwide. Each is a different virus approved for a different cancer, so they are not interchangeable. Latvia registered Rigvir, an unmodified ECHO-7 virus, in 2004, but its licence was suspended in 2019. That is why Oncorine is usually described as the first genetically engineered oncolytic virus to be approved.
| Product | Virus | Approved | Indication |
|---|---|---|---|
| Oncorine (H101, 安柯瑞) | Adenovirus type 5, E1B-55kD and E3 fragments deleted | China, November 2005 | Advanced nasopharyngeal carcinoma, with 5-FU/cisplatin |
| Imlygic (talimogene laherparepvec, T-VEC) | Herpes simplex virus 1; ICP34.5 and ICP47 deleted; expresses GM-CSF | US FDA Oct 2015 · EU Dec 2015 | Unresectable melanoma |
| Delytact (teserpaturev, G47Δ) | Herpes simplex virus 1, triple-mutated | Japan, June 2021 (conditional, time-limited) | Malignant glioma |
We found no other oncolytic virus with NMPA marketing approval as of October 2026; several (e.g. OH2) are in clinical trials. Regulatory status can change — confirm with your oncologist.
Published research
Centres with published
H101 clinical research.
Sun Yat-sen University Cancer Center 中山大学肿瘤防治中心
Source of the Phase III head & neck trial (Ai Zheng 2004) and three H101 + TACE liver-cancer cohorts (Med Oncol 2014; BMC Cancer 2015; Chin J Cancer 2017)
Fudan University Shanghai Cancer Center 复旦大学附属肿瘤医院
Department of Integrative Oncology: H101 + nivolumab in refractory HCC (ESMO Open 2024); intraperitoneal H101 for malignant ascites (Mol Ther Oncolytics 2022)
Shanghai Tenth People's Hospital 上海市第十人民医院
TROJAN 021 Phase II — H101 + immune checkpoint inhibitors in liver-metastatic gastric cancer (ASCO 2024, abstract 2635)
First Affiliated Hospital of Xi'an Jiaotong University 西安交通大学第一附属医院
Intratumoral H101 in persistent / recurrent / metastatic gynaecological cancer (ASCO 2024, abstract 5536)
Beijing Tsinghua Changgung Hospital 北京清华长庚医院
Oncolytic virus + HAIC-mFOLFOX in intrahepatic mass-forming cholangiocarcinoma (ASCO 2024, abstract e16265)
Second Affiliated Hospital of Army Medical University 陆军军医大学第二附属医院
H101 + TACE after liver-cancer resection: recurrence and metastasis outcomes (J Gastrointest Oncol 2021)
FAQ
Oncolytic virus therapy — answered.
- Is oncolytic virus therapy approved in China?
- Yes. China's drug regulator (then SFDA, now NMPA) approved Oncorine (H101, recombinant human adenovirus type 5 injection, 安柯瑞) in November 2005, under approval number 国药准字 S20060027. Its approved indication is advanced nasopharyngeal carcinoma that has not responded to radiotherapy or chemoradiotherapy, in combination with 5-FU/cisplatin chemotherapy. We found no other oncolytic virus with NMPA marketing approval. Uses such as liver cancer with TACE are supported by expert consensus and retrospective studies, not by the label.
- Which cancers is H101 used for?
- The approved indication is advanced nasopharyngeal carcinoma, with chemotherapy. The largest body of further research is in unresectable hepatocellular carcinoma together with TACE, which the 2022 CSCO consensus recommends as an option for initial treatment in suitable patients. Smaller studies and conference abstracts cover malignant ascites, gastric-cancer liver metastasis, gynaecological cancers and PD-1 combinations.
- Does oncolytic virus therapy cure cancer?
- It is not a standalone cure. In retrospective liver-cancer studies, adding H101 to TACE roughly doubled complete-response rates (28.7% vs 14.8%). Median overall survival improved modestly (12.8 vs 11.6 months) and 3-year survival was higher in a matched cohort (40.5% vs 22.4%). In a pilot of H101 + nivolumab for refractory HCC, 11.1% of patients responded. H101 is best understood as an add-on that may help selected patients.
- Is it safe?
- In the Phase III trial, the main side effects were fever (45.7%), injection-site reactions (28.3%) and flu-like symptoms (9.8%). With TACE in liver cancer, fever above 38.5 °C was more common than with TACE alone (64.4% vs 46.6%), while pain, ascites and acute renal failure rates were similar. A pilot study combining H101 with nivolumab reported no grade 3–4 events. See our safety page for details.
- How is H101 given?
- In the liver-cancer TACE studies, 1.0×10¹² viral particles in 10 mL saline were infused through the catheter into the hepatic artery feeding the tumour. In the PD-1 pilot, two vials (5.0×10¹¹ viral particles each) were injected into one tumour on days 1 and 3. From day 8, H101 was repeated every 2 or 4 weeks alongside nivolumab every 2 weeks. For malignant ascites it has been given intraperitoneally after drainage. The exact plan is set by the treating oncologist.
- Can international patients receive H101 in China?
- H101 is used at Chinese hospitals after review by a treating oncologist. The drug label restricts its use to Class A tertiary (三级甲等) hospitals. The usual route is to send imaging, pathology and labs for a remote review, receive a written opinion on candidacy, then travel for in-person assessment and treatment. We coordinate records translation, hospital booking and the medical visa.
- Is there a virus that kills cancer cells?
- Yes. That is what oncolytic ('cancer-killing') viruses are designed to do. Three genetically engineered ones have regulatory approval: Oncorine (H101) in China (2005), T-VEC (Imlygic) in the US and EU (2015) for melanoma, and Delytact (G47Δ) in Japan (2021, conditional) for glioma. They are real, regulated treatments, but they work as part of combination care and are not miracle cures.
- Is any oncolytic virus FDA-approved?
- Yes, one: talimogene laherparepvec (T-VEC, Imlygic), a modified herpes simplex virus approved in October 2015 for unresectable melanoma. Oncorine (H101) is not FDA- or EMA-approved. Patients who want H101 specifically generally need to be treated in China.
- How much does oncolytic virus therapy cost in China?
- Cost depends far more on the treatment plan than on the drug alone. A TACE-combination course includes interventional-radiology procedures, imaging and inpatient stays, and PD-1 combinations add the immunotherapy drug. Because plans vary widely, we don't publish a single price. After a partner oncologist reviews your records, you receive an itemised written quote for the specific plan proposed.
- Where can I get oncolytic virus therapy?
- For Oncorine (H101), at Chinese hospitals; the centres listed above have published H101 research. T-VEC is available for melanoma in the US, EU and some other markets. Many other oncolytic viruses are only available in clinical trials. For H101, start with a remote records review so the oncologist can confirm candidacy before you travel.
- Is oncolytic virus therapy the same as immunotherapy or CAR-T?
- It is related but different. Oncolytic viruses kill tumour cells directly and can also stimulate anti-tumour immunity, so they are often grouped with immunotherapies. CAR-T uses the patient's own genetically engineered T cells and is approved mainly for blood cancers. Oncolytic viruses are being studied with PD-1 checkpoint inhibitors to make 'cold' solid tumours more responsive.
Related guides
Oncorine (H101) drug profile
Approval, genetic construct, approved indication and milestones.
Read the guideHow oncolytic viruses work
Selective replication, tumour lysis and turning 'cold' tumours 'hot'.
Read the guideH101 + TACE for liver cancer
Evidence, guideline status and treatment protocol for HCC.
Read the guideH101 + PD-1 immunotherapy
Combination data, malignant ascites and immune-microenvironment changes.
Read the guideSafety & side effects
Adverse-event rates from the Phase III trial and combination studies.
Read the guideClinical evidence & guidelines
Key studies, ASCO 2024 abstracts and three Chinese consensus documents.
Read the guideOncology second opinion
Senior Chinese oncologist reviews your imaging and pathology remotely.
Read the guideSources
References
- Oncorine (重组人5型腺病毒注射液) prescribing information, 国药准字 S20060027 — indication: advanced nasopharyngeal carcinoma unresponsive to radiotherapy or chemoradiotherapy, in combination with 5-FU/cisplatin palliative chemotherapy; construct: E1B-55kD and E3 (78.3–85.8 mu) gene fragments deleted.
- Liang M. Oncorine, the world first oncolytic virus medicine and its update in China. Curr Cancer Drug Targets. 2018;18(2):171–176.
- Xia ZJ, Chang JH, et al. Phase III randomized clinical trial of intratumoral injection of E1B gene-deleted adenovirus (H101) combined with cisplatin-based chemotherapy in treating squamous cell cancer of head and neck or esophagus. Ai Zheng. 2004;23(12):1666–1670.
- O'Shea CC, et al. Late viral RNA export, rather than p53 inactivation, determines ONYX-015 tumor selectivity. Cancer Cell. 2004;6(6):611–623.
- Lin XJ, Li QJ, Lao XM, Yang H, Li SP. Transarterial injection of recombinant human type-5 adenovirus H101 in combination with transarterial chemoembolization (TACE) improves overall and progressive-free survival in unresectable hepatocellular carcinoma (HCC). BMC Cancer. 2015;15:707.
- He CB, Lao XM, Lin XJ. Transarterial chemoembolization combined with recombinant human adenovirus type 5 H101 prolongs overall survival of patients with intermediate to advanced hepatocellular carcinoma: a prognostic nomogram study. Chin J Cancer. 2017;36(1):59.
- Dong J, et al. Gene therapy for unresectable hepatocellular carcinoma using recombinant human adenovirus type 5. Med Oncol. 2014;31(8):95.
- Wu K, You N, Zheng L. Effects of recombinant human adenovirus type 5 combined with transarterial chemoembolization on postoperative metastasis and recurrence of hepatocellular carcinoma patients. J Gastrointest Oncol. 2021;12(6):2999–3007.
- Yi L, Ning Z, Xu L, et al. The combination treatment of oncolytic adenovirus H101 with nivolumab for refractory advanced hepatocellular carcinoma: an open-label, single-arm, pilot study. ESMO Open. 2024;9(2):102239.
- Zhang Y, Qian L, Chen K, et al. Intraperitoneal oncolytic virotherapy for patients with malignant ascites: characterization of clinical efficacy and antitumor immune response. Mol Ther Oncolytics. 2022;25:31–42.
- ASCO 2024 Annual Meeting, J Clin Oncol 2024;42(16_suppl): abstract 2635 (Yuan M et al., TROJAN 021 — H101 + immune checkpoint inhibitors in liver-metastatic gastric cancer, Phase II); abstract 5536 (Zhang Q et al., intratumoral H101 in persistent/recurrent/metastatic gynecological cancer); abstract e16265 (Wang T et al., oncolytic virus + HAIC of mFOLFOX for intrahepatic mass-forming cholangiocarcinoma).
- CSCO Immunotherapy Expert Committee; Shanghai Anti-Cancer Association Tumor Biotherapy Committee. 基因重组溶瘤腺病毒治疗恶性肿瘤临床应用中国专家共识(2022年版). China Oncology (中国癌症杂志). 2023;33(5). doi:10.19401/j.cnki.1007-3639.2023.05.013
- 肝细胞癌围手术期免疫治疗多学科协作专家共识(2025版). Chinese Journal of Digestive Surgery. 2025;24(6):678–689. doi:10.3760/cma.j.cn115610-20250609-00278
Send your scans
for an honest candidacy review.
Share recent CT/MRI, pathology, liver-function results and your treatment history. A partner oncologist will send a written opinion on whether oncolytic virus therapy fits your case and which route might apply. If another approach would serve you better, the opinion will say so plainly.
This page is for general education only and is not medical advice. Oncolytic virus therapy is not suitable for every patient or every cancer. In China, Oncorine (H101) is approved only for advanced nasopharyngeal carcinoma in combination with chemotherapy; other uses described here are supported by retrospective studies, small trials, conference abstracts or expert consensus rather than large randomised trials. Treatment decisions are made by the treating oncologist after reviewing your records. We are an independent patient-coordination service and are not affiliated with the manufacturer.