Hengyu Bio Congratulates Biosyngen on Global First IND Approval of Off-the-Shelf CD19-UCAR-Vδ1 T-cell Therapy UTAA09

Apr 25, 2025 10:18 CST Updated 10:18

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Developer of Tumor Cell Immunotherapy Technologies and Products

4On the 24th, according to the official website of CDE,Bo sheng ji medicineGroupDevelopment of a Vd1 T cell-based, CD19-targeting universal off-the-shelf chimeric antigen receptor (CAR)-T cell injection (R&D code:UTAA09 Injection）Clinical TrialObtained from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)Tacit consent。

HENGYU BIOTECHProvided international declaration compliance for this projectCell Library Calibration (CLC) and Replication-Competent Lentivirus Detection (RCL)and other biosafety testing services, in ChinaInternational compliance quality and technology system, rapid delivery and expertiseProject Management in the Industry, Safeguarding the Launch and Overseas Expansion of Innovative Drugs.

AboutUniversal Off-the-Shelf Cell Therapy Drugs

Autologous CAR-T cells have achieved significant clinical success in the treatment of B-cell and plasma cell-derived malignancies. However, the high cost and long patient waiting times caused by their customized manufacturing process severely limit the clinical promotion of this advanced therapy. To achieve better patient accessibility, the development of off-the-shelf universal cell therapy drugs has gradually become a trend.

AboutUTAA09 Injection

UTAA09 Injection isThe First Universal Off-the-Shelf CAR-T Cell Product Submitted by Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD, The product is a UCAR-Vδ1T cell product prepared from the starting raw material of healthy donor apheresis blood. It is reported that thisAlsoGlobalThe First CD19-UCAR-Vδ1T Cell Product Approved for IND with Universal Off-the-Shelf Availability。

UTAA09 Injection not only retains its strong tissue and organ homing ability but also leads globally in CMC manufacturing processes, significantly reducing the cost of cell-based drugs. This creates opportunities for UTAA09 Injection to expand its indications to autoimmune diseases and other conditions in the future.

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According to incomplete statistics, HENGYU BIOTECH has successfully contributed with its internationally compliant biosafety testing services.80+Project AchievementClinical and Market LaunchTest Batch (including40+Overseas Declaration Project), for20+BLA and Commercialization ItemProvide critical support;The declared projects cover a full range of categories (ADC drugs, mono/dual/multi-antibodies, recombinant proteins, CAR-T/CAR-NK, iPSC/MSC, gene editing, AAV gene therapy, etc.).

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About Bo Sheng Ji UCAR-Vδ1T Cell Drug Development Platform

After years of efforts, Bo Sheng Ji Medicine has built a world-leading UCAR-Vδ1T cell drug R&D platform. It has overcome multiple challenges such as large-scale preparation processes, CAR lentivirus transfection, freeze-drying formulation, CAR molecular design, and the establishment of a healthy donor screening system. The company has successively received funding or awards including first place in the National Biotechnology Innovation Center's Cell Therapy "Challenge Project" key technology breakthrough program, second prize in the Yangtze River Delta G60 Science and Technology Corridor Technology and Industry Innovation Competition, the Excellence Project Award in the China Innovation and Entrepreneurship Competition's Disruptive Technology Innovation Competition finals, and TOP40 at the Tumor Diagnosis and Treatment Black Tech Conference.

In addition to the UTAA09 injection recently approved for IND, other UCAR-Vδ1T cell drugs developed by Bo sheng ji medicine science and technology (suzhou) co., LTD, which cover solid tumors, hematologic malignancies, and autoimmune diseases, have also achieved significant progress in preclinical studies. Some of these products were presented at the 2024 AACR Annual Meeting in the United States, receiving positive feedback from peers.

About HENGYU BIOTECH

HENGYUBiologicalRelying on international compliance standards, with excellent quality and technical strength, a one-stop Biosafety service platform focused on macromolecular drugs and CGT drugs has been built. It has passed the EU QP, CNAS, ISO9001 audit certifications, meeting the stringent requirements of global regulatory authorities such as NMPA, FDA, and EMA, providing reliable assurance for innovative pharmaceutical companies.HENGYU BIOTECH has served nearly 300 biopharmaceutical companies, with rich experience in projects and regulatory submissions, and has supported over 80 biopharmaceutical regulatory submission cases.20+BLA and Commercialization ProjectsProvide Critical Support(Including 40+ overseas applicationsCase），Including services such as virus clearance validation, cell bank characterization, commercial batch release, replication-competent virus (RCL, rcAAV, RCR, etc.) detection, and HCD and HCP kits and assays.

HENGYU BIOTECH has rich practical experienceThe technology and quality team adopts advanced systems and management systems, including LIMS and EMS systems that comply with ISPE GAMP5 management requirements, and has establishedFollow the ALCOA+ PrinciplesData management system. Whether it is the IN of biological productsD, BLA ApplicationWhether it is full lifecycle management from reporting to commercial production, HENGYU BIOTECH can provide reliable biosafety and quality control support, offering strong assurance for our clients' success.