Hengyu Bio Congratulates Keyi Pharma on CDE's IND Approval for KQ-2002 CAR-T Cell Injection

Nov 26, 2024 09:46 CST Updated 09:46

Novatim

Innovative Drug Developer for Tumor Immunotherapy

On November 25, 2024, according to the public announcement on the CDE official website,Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Novatim's Self-Developed Enhanced Dual-Target Autologous CAR-T Product Targeting CD19&CD22KQ-2002, intended for the treatment ofAdult Relapsed/Refractory Acute B Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, has received clinical trial tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

HENGYU BIOTECHProvided in this project are those conforming to the regulatory requirements for applications in China.Replication-Competent Lentivirus Testing（RCL）Bio-safety testing services, with internationally compliant quality and technical systems, rapid delivery, and professional project management, safeguard the overseas launch of innovative drugs.

About KQ-2002

KQ-2002It is based on Novatim's independently developed core technology—the enhanced dual-target CAR-T platform—and the self-developed CD19&CD22 enhanced dual-target autologous CAR-T product, primarily targetingAdult Relapsed/Refractory Acute B Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin LymphomaCombination therapy targeting CD19 and CD22 can cover various cellular subpopulations of patients with primary and relapsed B-cell malignant hematological tumors, bringing new therapeutic hope and deep, long-lasting treatment effects to patients.

Reference: NovatimWeChat Official Account

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According to incomplete statistics, HENGYU BIOTECH has successfully contributed with its internationally compliant biosafety testing services.60+Project AcquisitionClinical and Market LaunchTest Batch Document (Including35+China-US dual filing projects), with a comprehensive coverage of filing categories (antibody/recombinant protein, gene therapy, cell therapy, RCL, rcAAV, RCR, etc.).

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About Novatim

Novatim Immune Therapeutics (Zhejiang) Co., Ltd. was founded in 2018. As a biopharmaceutical technology enterprise focusing on the research and development of innovative drugs for cancer immunotherapy and clinical applications, it is committed to efficient and groundbreaking R&D innovation based on clinical needs and differentiation. The company has established three major R&D platforms: bispecific antibody platform, nano bispecific ADC platform, and enhanced dual-target CAR-T platform. It has independently developed over 10 novel and differentiated potential FIC/BIC pipelines from scratch.

Based on the bifunctional antibody platform, the company has independently developed China's first βγ-biased PD1/IL2 fusion protein, which is currently in Phase Ib clinical trials in China as a monotherapy or in combination with PD-L1 monoclonal antibody, and has also obtained IND approval in the United States; based on the nano bispecific antibody ADC platform, the company has independently developed the world’s first nano bispecific antibody ADC, which is about to obtain IND approvals in both China and the United States; based on the enhanced dual-target CAR-T platform, the company has independently developed the world’s first dual-target CAR-T with a parallel enhanced structure, which is currently in clinical PhaseⅠ/Ⅱa.

About HENGYU BIOTECH

HENGYUBiologicalRelying on international compliance standards, with excellent quality and technical strength, a one-stop Biosafety service platform focused on large molecule drugs and CGT drugs has been established. It has passed audits and certifications by the EU QP, CNAS, and ISO9001, 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, providing critical support for over 60 clinical and market approval cases of biologics.Hold (Exceed35 itemsChina-US Dual Filing Project）, including virus clearance validation, cell bank characterization, commercial batch release, replication-competent virus (RCL, rcAAV, RCR, etc.) testing, HCD and HCP kits and assays, among other services.

HENGYU BIOTECHWith 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, establishingFollowALCOA+ PrincipleData management system. Whether it is the IN of biological productsD、BLA ShenReport or commercial production and full life cycle management,HENGYUAll can provide reliable biosafety and quality control support, offering strong assurance for customers' success.