YouCarty Participates in Formulating Award-Winning Group Standard Recognized as a Top Ten Exemplary Case in Shanghai 2024

Recently, the Shanghai Market Supervision Administration, the Shanghai Civil Affairs Bureau (Shanghai Social Organization Administration), and the Shanghai Federation of Industry and Commerce announcedNotice on Typical Cases of Shanghai Group Standards for 2024 (Hushi Jianbiao Chuang [2024] No. 435). The group standard, "Application Guidelines for Space Enclosure Systems in the Production of Cell Therapy Products," issued by the Shanghai Pharmaceutical Quality Association, has been awarded one of the "Top Ten Cases" in the 2024 Shanghai Group Standards Typical Cases.

As an innovative leader in cell therapy products-SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD participated in the development of this group standard and is also one of the first commitment execution units. Wang Wei, Quality Director of Unicar-therapy, and Dr. Li Minghao, Production Director, as the main drafters of the document, participated in the drafting of various sections including the composition, application, and bio-safety control measures for closed systems used in the production of cell therapy products.

The group standard was issued onImplemented and effective in January 2024, this is the world's first application guideline for closed processes in cell-based drug manufacturing, reflecting Shanghai's technical superiority and industrial cluster status in the field of cell therapy. The group standard aims to standardize equipment qualification and production management requirements for space-closed systems (cell preparation isolators and supporting culture systems) used in the manufacturing of cell therapy products. This reduces potential risks of external contamination, cross-contamination, mix-ups, and biosafety hazards during the production process, enhances the sterility assurance level of manufacturing processes, and improves medication safety.

UNICAR-THERAPY will continue to leverage its world-class synthetic biology and artificial intelligence technologies.The R&D innovation and industrialization capabilities of CAR-T cell therapy technology and products are in line with international cutting-edge technologies, injecting strong new momentum into the development of the cell and gene therapy industry.

About UNICAR-THERAPY

SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD (hereinafter referred to as"UNICAR-THERAPY") is a company dedicated toFrontierBiopharmaceuticals for Cell Therapy Technology Innovation and TranslationLeadingEnterprise, with multiple original core technology platforms, includingSMART Small Nucleotide Gene Regulation Empowerment Technology Platform, MADDS Antibody Innovation Drugability Technology Platform, 6H Production Quality Control Platform, etc.Currently`, Company`AlreadyInNorth Shanghai Biomedical ParkLandedBillion-level Gene and Cell Therapy Research and Industry Center，BuildCompletedInternational first-class immunotherapy tumor innovation technology transformation center and advanced, high-end genetically engineered immune cell industry chain center. UNICAR-THERAPYAlreadyIn China and abroadMultipleWell-knownHealthcareInstitutional cooperation, successfully treatedThousandsExample: Advanced Cancer Patients。UNICAR-THERAPY Product PipelineAbundant，Including autologousCAR-T technology, universal CAR-T technology, in vivo CAR technology, indications coverageHematological tumors, solid tumors, and autoimmune diseases.CurrentlyAlreadyThere are threePaymentfirst-in-class/first-in-safeThe product is inRegistered Clinical StudyPhase.ssCART-19 InjectionCanBreakthrough UseTreatment of CAR-T Contraindications in Central Nervous System Leukemia (commonly known as "CNSL"),ObtainFDA Orphan Drug Designation, GrantedIncludedNMPAList of Breakthrough Therapies,Has enteredKey Clinical Stage；U16InjectionFor Non-CD19-targeted lymphoma treatment product, with significant efficacy, is about to enter the critical clinical stage; U87InjectionFully human-derivedCAR-T products, with proposed indications covering various malignant tumors such as lung cancer, triple-negative breast cancer, pancreatic cancer, nasopharyngeal cancer, and colorectal cancer, are currently in Phase I of registrational clinical trials.