Hengyu Bio Congratulates Neogene Therapeutics on NMPA Approval of NW-101C Injection for Clinical Trials in China

Aug 06, 2025 09:01 CST Updated 09:01

Neowise

Solid Tumor TCR-T Cell Therapy Drug Developer

August 5, 2025, Suzhou, China——Neowise Biotechnology (Suzhou) Co., Ltd.(hereinafter referred to as "Neowise Biotechnology"), a biotechnology company focused on the research and development of TCR-T immunotherapy drugs for solid tumors, announced its self-developed PRAME-targetedAutologous TCR-T Cell Therapy Candidate Product NW-101C InjectionThe Investigational New Drug (IND) application has been approved by the National Medical Products Administration (NMPA).Clinical Trial Implied Permission. This is the first investigational product of Neowise Biotechnology to receive regulatory approval for clinical trials, marking a crucial step forward in the company’s development of TCR-T cell therapy drugs. Meanwhile, NW-101C injection is also the first TCR-T cell therapy candidate product targeting the PRAME antigen to enter the clinical research stage in China, filling a gap in this field.

Hengyu BioProvided international declaration compliance for this projectReplication-Competent Virus Testing (RCL)...and other biosafety testing services, using internationally compliant quality and technical systems, rapid delivery, and professional project management to safeguard the overseas launch of innovative drugs.

AboutNW-101C Injection

NW-101C Injection is a self-developed autologous TCR-T cell therapy candidate product by Neowise Biotechnology, targeting PRAME. PRAME is a tumor antigen target that is highly expressed in various solid tumors but hardly expressed in normal tissues. In preclinical studies, NW-101C Injection demonstrated excellent anti-tumor activity and good safety. The approved indication for NW-101C this time is for advanced malignant solid tumors (including ovarian cancer, malignant melanoma, esophageal squamous cell carcinoma, squamous cell carcinoma of the lung, soft tissue sarcoma, and triple-negative breast cancer) that are HLA-typed with the HLA-A*02:01 subtype, PRAME-positive tumors, and cannot be surgically removed due to recurrence or metastasis.

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According to incomplete statistics, Hengyu Biotechnology has successfully contributed with its internationally compliant biosafety testing services.100+Project AcquisitionClinical and Market LaunchTest Batch Document (Including40+Overseas Declaration Project), for20+BLA and Commercialization ItemProviding critical support;The declared projects cover a full range of categories (ADC drugs, mono/di/multi-antibodies, recombinant proteins, CAR-T/CAR-NK, iPSC/MSC, gene editing, AAV gene therapy, etc.).

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About Neowise Biotechnology

Neowise Biotechnology, Co., Ltd. is an innovative enterprise focused on the development of TCR-T immunocyte therapeutic drugs for solid tumors. Neowise Biotechnology has independently developed a high-throughput, high-sensitivity target antigen-natural TCR discovery platform. By combining computational and experimental validation through iterative feedback, it efficiently screens natural high-affinity TCR sequences that specifically recognize tumor antigens, establishing a globally leading experimentally-validated target antigen-natural TCR pairing database. The company currently has multiple pipelines that have advanced to the clinical trial stage, and positive efficacy and good safety have been observed in clinical trials targeting various solid tumors.

About Hengyu Biotechnology

HengyuBiotechnologyRelying on international compliance standards, with outstanding quality and technical strength, we have built a one-stop Biosafety service platform focused on large molecule drugs and CGT drugs. It has passed audits and certifications such as EU QP, CNAS, and ISO9001, meeting the stringent requirements of global regulatory authorities including NMPA, FDA, and EMA, providing reliable assurance for innovative pharmaceutical companies.Hengyu Bio has served over 300 biopharmaceutical companies, with rich experience in project and submission practices, and has already provided submission cases for over 100 biologics.20+BLA and Commercialization ProjectsProvide Critical Support(Including 40+ overseas applicationsCase），Including services such as viral clearance validation, cell bank characterization, commercial batch release, replication-competent virus (RCL, rcAAV, RCR, etc.) testing, and HCD and HCP kit and assay.

Hengyu Biotechnology has rich practical experienceThe technology and quality team adopts advanced systems and management frameworks, including LIMS and EMS systems that comply with ISPE GAMP5 management requirements, establishingFollow the ALCOA+ PrinciplesData management system. Whether it is IN for biologicsD, BLA ApplicationWhether it is reporting or the entire life cycle management of commercial production, Hengyu can provide reliable biosafety and quality control support, offering strong assurance for our customers' success.