Zhangjiang Pharma Valley Companies Achieve Global Firsts with Breakthrough Innovations

Jan 19, 2026 20:32 CST Updated 20:32

NEUREGEN

Novel Gene Therapy Drug Developer

Vitalgen

Gene and Cell Therapy Drug Developer

Recently,Zhangjiang Pharm Valley Companies Successively Welcome Multiple Pieces of Good News, FromIND Tacit PermissionFrom approval for marketing to obtaining international orphan drug certification, these achievements not only demonstrate the R&D strength of Zhangjiang Pharm Valley companies but also bring new hope for diagnosis and treatment to patients with related diseases.

SHANGHAI OUTDO BIOTECH CO.,LTD's Helicobacter Pylori Antibody Oral Mucosal Exudate Test Kit Approved for Marketing

(Image source: Zhangjiang Release)

Recently,Zhangjiang Pharm Valley Enterprise SHANGHAI OUTDO BIOTECH CO.,LTD.Self-developed Helicobacter pylori antibody oral mucosal exudate detection kit (colloidal gold method) utilizing international patented technology receives NMPA Class III medical device registration approval for market launch.

The Helicobacter pylori antibody oral mucosal exudate test kit includes a test card and a sample collection tube (containing sample processing solution). Clinical trial results show that, using Helicobacter pylori blood antibody test results and UBT breath test results as reference methods, the sensitivity of this product is 97.67% and 93.03%, respectively, and the specificity is 97.44% and 96.15%, respectively.This product non-invasively and conveniently detects Hp antibodies through exudates from human oral mucosa, being the world's first.。

NEUREGEN's World's First Glioblastoma Transdifferentiation Therapy Receives CDE IND Implied Permission

January 15, 2026Zhangjiang Pharm Valley Company NEUREGENAnnounced that the company's independently developedThe World's First Innovative Drug NRG-103 Injection Based on In-situ Transdifferentiation Technology, has obtained the CDE's new drug clinical trial (IND) tacit approval, and will soon officially launch a registration clinical study targeting high-grade gliomas. This is another significant advancement for NRG-103 following its FDA IND approval in the United States.

NRG-103 Injection is a disruptive innovative therapy independently developed by NEUREGEN for high-grade gliomas, based on its globally leading in-situ transdifferentiation technology innovation platform. Addressing the biological complexity and treatment limitations of high-grade gliomas, NRG-103 Injection employs a triple mechanism design of "in-situ cell transdifferentiation + oncolytic virus + immune enhancement": while the new-generation recombinant oncolytic virus selectively replicates and kills glioma cells and utilizes cytokines to enhance immune killing ability, the in-situ transdifferentiation technology further converts residual/escaped tumor cells into non-proliferating cells. Through this combination of multiple mechanisms, NRG-103 improves the therapeutic effect on high-grade gliomas and fundamentally solves the problems of tumor escape and recurrence.

NRG-103 Injection has obtained FDA Orphan Drug Designation (ODD) in April 2025 and was the first to receive FDA IND approval in July 2025, making NEUREGEN the world's first biopharmaceutical company to have an in-situ transdifferentiation tumor gene therapy approved for formal clinical trials.

Shanghai Tianze Yuntai Biomedical Co., Ltd.'s VGN-R08b Granted Orphan Drug Designation, Achieving Three Key FDA Approvals Cumulatively

January 15,Zhangjiang Pharm Valley EnterprisesShanghai Tianze Yuntai Biomedical Co., Ltd.Shanghai Tianze Yuntai Biomedical Co., Ltd. announced that its self-developed AAV gene therapy product VGN-R08b for the treatment of Gaucher disease has been granted Orphan Drug Designation (ODD) by the FDA.

This designation marks the third critical qualification that VGN-R08b has received from the U.S. FDA in the field of Gaucher disease treatment, signifying the continued recognition by the U.S. FDA of the product's therapeutic potential in this area.

VGN-R08b is a recombinant AAV gene supplementation therapy designed for GBA1 gene mutations, aiming to restore GCase activity at the source by delivering a functional GBA1 gene to improve metabolic abnormalities and alleviate neural damage.As the world's only gene therapy in development and the first in China to treat nGDVGN-R08b has demonstrated good safety and potential to delay disease progression in an investigator-initiated clinical study conducted at Xinhua Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. Its registrational clinical study for nGD has been approved for conduct in China.

Source: Zhangjiang Release, NEUREGENShanghai Tianze Yuntai Biomedical Co., Ltd.