Delving into the Latest Updates on Shenzhen SiBiono GeneTech Co. Ltd. with Synapse

Overview

Basic Info

Introduction

SiBiono is a leading company in the gene therapy industry in China. They have developed a recombinant Ad-p53 adenovirus injection, which was approved by the State Food and Drug Administration in 2003 and became the world's first marketed gene therapy drug. This breakthrough has been recognized as a significant achievement in China's scientific and technological innovation, particularly in the field of cancer treatment. SiBiono has also taken on several national biotech projects and has applied for multiple patents related to their independent innovation achievements.

Tags

Neoplasms

Otorhinolaryngologic Diseases

Mouth and Tooth Diseases

Gene therapy

Oncolytic virus

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	2

Top 5 Drug Type	Count

Oncolytic virus	1
Gene therapy	1

Top 5 Target	Count

p53(Tumor protein p53)	1

Gendicine (recombinant human p53 adenovirus), developed by Shenzhen SiBiono GeneTech Co. Ltd., was approved in 2003 by the China Food and Drug Administration (CFDA) as a first-in-class gene therapy product to treat head and neck cancer, and entered the commercial market in 2004. Gendicine is a biological therapy that is delivered via minimally invasive intratumoral injection, as well as by intracavity or intravascular infusion. The wild-type (wt) p53 protein expressed by Gendicine-transduced cells is a tumor suppressor that is activated by cellular stress, and mediates cell-cycle arrest and DNA repair, or induces apoptosis, senescence, and/or autophagy, depending upon cellular stress conditions. Based on 12 years of commercial use in >30,000 patients, and >30 published clinical studies, Gendicine has exhibited an exemplary safety record, and when combined with chemotherapy and radiotherapy has demonstrated significantly higher response rates than for standard therapies alone. In addition to head and neck cancer, Gendicine has been successfully applied to treat various other cancer types and different stages of disease. Thirteen published studies that include long-term survival data showed that Gendicine combination regimens yield progression-free survival times that are significantly longer than standard therapies alone. Although the p53 gene is mutated in >50% of all human cancers, p53 mutation status did not significantly influence efficacy outcomes and long-term survival rate for Ad-p53-treated patients. To date, Shenzhen SiBiono GeneTech has manufactured 41 batches of Gendicine in compliance with CFDA QC/QA requirements, and 169,571 vials (1.0 × 10¹² vector particles per vial) have been used to treat patients. No serious adverse events have been reported, except for vector-associated transient fever, which occurred in 50-60% of patients and persisted for only a few hours. The manufacturing accomplishments and clinical experience with Gendicine, as well as the understanding of its cellular mechanisms of action and implications, could provide valuable insights for the international gene therapy community and add valuable data to promote further developments and advancements in the gene therapy field.

01 Jan 2018·American journal of translational research

Enrichment and characterization of cancer stem-like cells in ultra-low concentration of serum and non-adhesive culture system.

Article

Author: Dai, Lei ; Li, Chunlei ; Zhang, Hui ; Deng, Hongxin ; Zhang, Yunsheng ; Yan, Fenglian ; Zhang, Junfeng ; Ning, Zhaochen ; Xiong, Huabao ; Shi, Hui ; Si, Chuanping ; Cheng, Lin ; Dong, Guanjun ; Xu, Wei

Cancer stem cells (CSCs) play important roles in tumor initiation, metastasis, and progression. They are also mainly responsible for high treatment failure rates. Identification and characterization of CSCs are crucial for facilitating the detection, prevention, or therapy of cancer. Great efforts have been paid to develop an effective method and the ideal method for CSCs research is still in the going. In our study, we created an ultra-low concentration of serum and non-adhesive (ULCSN) culture system to enrich CSCs from murine lewis lung cancer cell line LL/2 with cell spheres structure and characterize the LL/2 CSCs properties. Their characteristics were investigated through colony formation, spheres formation, chemoresistance, flow cytometry for putative stem cell markers, such as CD133, CD34 and CD45, immunofluorescence staining and tumor initiation capacity in vivo. Tumor spheres were formed within 7-10 days under the condition of ULCSN culture system. Compared with adherent parental LL/2 cells, the colony capacity, chemo-resistance, and expression of stem cell markers increased significantly in addition to tumor-initiating capability in the tumor sphere cells. Using the ULCSN culture system, an available isolation method of lewis lung CSCs was established, which is simple, effective, and inexpensive compared with the cytokines attachment serum free culture method. The stem cell properties of the tumor sphere LL/2 cells reflected the CSCs phenotypes. We developed a useful CSCs model for basic and pre-clinical studies for lung cancer and other types of cancer.

100 Deals associated with Shenzhen SiBiono GeneTech Co. Ltd.

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100 Translational Medicine associated with Shenzhen SiBiono GeneTech Co. Ltd.

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Pipeline

Pipeline Snapshot as of 05 Aug 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

1

Approved

Other

3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Recombinant Human Ad-p53 ( p53 )	Nasopharyngeal Neoplasms More	Approved
Double gene recombinant adenovirus(Shenzhen SiBiono GeneTech)	Neoplasms More	Preclinical
HIV vaccine SeV-G-NP(International AIDS Vaccine Initiative/Id Pharma)	HIV Infections More	Pending
Chlorotrianisene ( ER )	Hepatocellular Carcinoma More	Pending
ivAd-p53 ( p53 )	Neoplasms More	Unknown