Drug profile · Oncolytic adenovirus
Oncorine (H101),
the drug behind China's oncolytic therapy.
Recombinant human adenovirus type 5 injection, made by Shanghai Sunway Biotech. It was approved in China in November 2005, the first genetically engineered oncolytic virus approved anywhere. Here is what it is, what the label covers, and where research has gone since.
Quick answer
What is Oncorine (H101)?
Oncorine (H101, Chinese brand 安柯瑞) is an oncolytic virus drug: a human adenovirus type 5 with the E1B-55kD gene and fragments of the E3 region deleted, designed to replicate preferentially in cancer cells. China's SFDA (now NMPA) approved it in November 2005 under approval number 国药准字 S20060027. The label covers advanced nasopharyngeal carcinoma that has not responded to radiotherapy or chemoradiotherapy, in combination with 5-FU/cisplatin chemotherapy. Chinese researchers have since studied it with TACE for liver cancer and with PD-1 inhibitors.
Nov 2005
Approved in China
SFDA (now NMPA) · 国药准字 S20060027
Liang 2018; drug label
Ad5
Virus backbone
Recombinant human adenovirus serotype 5
Drug label
E1B-55kD + E3
Deleted genes
E3 fragment 78.3–85.8 map units
Drug label
5.0×10¹¹ vp
Per vial
0.5 mL sterile viral solution
Zhang 2022; Yi 2024
−20 °C
Storage
Supplied frozen
Zhang et al., Mol Ther Oncolytics 2022
Class A
Hospital restriction
Label limits use to 三级甲等 hospitals
Drug label
Profile
Oncorine at a glance.
Generic name
Recombinant human adenovirus type 5 injection (重组人5型腺病毒注射液). Research code H101.
Brand: Oncorine · 安柯瑞
Manufacturer
Shanghai Sunway Biotech Co., Ltd. (上海三维生物技术有限公司).
Shanghai, China
Approved indication
Advanced nasopharyngeal carcinoma that has not responded to radiotherapy or chemoradiotherapy, used together with 5-FU/cisplatin palliative chemotherapy.
Label
Liver cancer with TACE
Hepatic-artery infusion with TACE for unresectable HCC. Supported by retrospective cohorts and recommended as an initial-treatment option in the 2022 CSCO consensus.
Retrospective data
Other research uses
Malignant ascites (intraperitoneal), PD-1 combinations in HCC, gastric-cancer liver metastasis and gynaecological cancers.
Small studies · abstracts
Routes studied
Intratumoral injection, hepatic-artery infusion with TACE, and intraperitoneal instillation for malignant ascites.
Physician-determined
Construct
What was changed in the virus
H101 starts from human adenovirus type 5, a common cold virus. According to the drug label, two sets of genes were removed: the E1B-55kD gene and fragments of the E3 region (78.3–85.8 map units). Deleting E1B-55kD is what makes replication tumour-selective; see how it works for the mechanism.
Timeline
Verified milestones
H101 belongs to the same family as ONYX-015, an E1B-55kD-deleted adenovirus developed in the US whose development was stopped in 2003. H101 additionally carries E3-region deletions. It completed a Phase III trial at Sun Yat-sen University Cancer Center and was approved in China in 2005.
| Year | Milestone | Source |
|---|---|---|
| 2004 | Phase III trial: response 78.8% with H101 + cisplatin/5-FU vs 39.6% with chemotherapy alone (head & neck / oesophageal SCC) | Xia et al., Ai Zheng 2004 |
| 2005 | Marketing approval by China's SFDA (November) | Liang, Curr Cancer Drug Targets 2018 |
| 2006 | GMP certificate (August) | Liang, Curr Cancer Drug Targets 2018 |
| 2014–2017 | Retrospective H101 + TACE liver-cancer cohorts published | Dong 2014; Lin 2015; He 2017 |
| 2022–2025 | Cited in CSCO (2022), interventional (2023) and perioperative HCC (2025) Chinese expert consensus documents | See references |
Comparison
Oncorine vs T-VEC (Imlygic)
Patients often ask how Oncorine compares with T-VEC, the only FDA-approved oncolytic virus. They are different viruses, built differently and approved for different cancers. Neither is a substitute for the other.
| Oncorine (H101) | T-VEC (Imlygic) | |
|---|---|---|
| Virus | Adenovirus type 5 | Herpes simplex virus type 1 |
| Key modification | E1B-55kD and E3 fragments deleted | ICP34.5 and ICP47 deleted; expresses GM-CSF |
| First approval | China, November 2005 | US FDA October 2015; EU December 2015 |
| Approved indication | Advanced nasopharyngeal carcinoma (with 5-FU/cisplatin) | Unresectable melanoma |
| Where available | China | US, EU and other markets |
FAQ
Oncorine (H101) — answered.
- Is Oncorine the same as H101?
- Yes. H101 is the research code, Oncorine the international brand name and 安柯瑞 the Chinese brand. The generic name is recombinant human adenovirus type 5 injection (重组人5型腺病毒注射液).
- What is Oncorine approved for?
- The Chinese label covers advanced nasopharyngeal carcinoma that has not responded to conventional radiotherapy or chemoradiotherapy, used together with 5-FU/cisplatin palliative chemotherapy. The Phase III trial behind it, in head & neck and oesophageal squamous cell cancer, reported a 78.8% response rate with H101 + cisplatin/5-FU vs 39.6% with chemotherapy alone. Liver-cancer use with TACE is off-label, supported by later studies and expert consensus.
- Is Oncorine available outside China?
- Oncorine is approved in China and is not approved by the US FDA or the European Medicines Agency. International patients who want H101 are generally treated at Chinese hospitals after a records review.
- Was Oncorine the world's first oncolytic virus?
- It was the first genetically engineered oncolytic virus to receive regulatory approval (China, 2005). Latvia registered Rigvir, an unmodified ECHO-7 virus, in 2004, but its licence was suspended in 2019.
- How is Oncorine different from ONYX-015?
- Both are adenoviruses with the E1B-55kD gene deleted to favour replication in tumour cells. H101 additionally has E3-region deletions. ONYX-015 development was stopped in the US in 2003, while H101 completed Phase III trials in China and was approved in 2005.
Related guides
Oncolytic Virus Therapy (hub)
Overview: what it is, who it may suit, how it's used in China.
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.
- Dong J, et al. Gene therapy for unresectable hepatocellular carcinoma using recombinant human adenovirus type 5. Med Oncol. 2014;31(8):95.
- 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.
- 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.
- 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.
- 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
- Interventional Drug Group, Interventional Physicians Branch, Chinese Medical Doctor Association. 原发性肝细胞癌经动脉内用药与联合用药中国专家共识. Chinese Journal of Internal Medicine. 2023;62(7):785–801. doi:10.3760/cma.j.cn112138-20230202-00049
- 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
Wondering if H101
is an option for you?
Send your imaging, pathology and treatment history. A partner oncologist will review whether Oncorine fits your diagnosis and which route would apply, and reply with a written opinion.
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.