Tianjin Tiancheng Preclinical Drug Evaluation Co., Ltd. Files IPO Prospectus as a Leading CRO in China’s Cell and Gene Therapy Sector

Tianjin Tiancheng New Drug Evaluation

Abbreviation:Tiancheng New Drug Evaluation

Booth No.: A03

Tianjin Tiancheng New Drug Evaluation Co., Ltd. (formerly Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co., Ltd.) isChina Merchants GroupA wholly-owned subsidiary of Tianjin Institute of Pharmaceutical Research，Focusing on Preclinical Drug Research Services, integrating three national-level technical platforms for pharmacodynamics, pharmacokinetics, and toxicology of innovative drugs. It has completed multiple platform construction projects and new drug development initiatives under the National 863 Program, the National 973 Program, the 1035 Project, and the National Major Science and Technology Projects during the “Ninth Five-Year Plan” to the “Thirteenth Five-Year Plan” periods. Meanwhile, it undertakes the construction and operational tasks for several key entities, including the State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, the Tianjin Key Laboratory of Pharmacokinetics and Pharmacodynamics, the Tianjin Engineering Center for Non-clinical Evaluation Technologies of New Drugs, the Tianjin Comprehensive Research Center for Generic Drug Consistency Evaluation, and the Tianjin Biopharmaceutical Comprehensive Service Platform. It has now developed into a well-known domestic preclinical research and development service organization (CRO) with distinctive technical expertise.

CompanyPossesses NMPA's nine GLP certifications and international AAALAC accreditation，Passed the FDA GLP on-site inspection,Accredited by the China National Accreditation Service for Conformity Assessment (CNAS), China Food and DrugProficiency testing in bioanalysis at the Institute for Product Testing, established multiple advanced technical platforms including cell therapy evaluation, advanced formulation assessment, and pediatric drug evaluation. Cumulatively served over 400 clients, completed more than 1,400 projects, and obtained clinical trial approvals for over 100 candidates (including dual submissions to China and the US). Research achievements have beenScience and Technology Award of the Chinese Association for Laboratory Animal Sciences, Fujian Provincial Science and Technology Progress Award, Tianjin Municipal Science and Technology Progress Award, Tianjin Binhai New Area Science and Technology Progress Award, and other honors. Its technical expertise and service capabilities have been widely recognized by the industry.

 14:45-15:10

Non-Clinical Evaluation Strategies and Key Considerations for iPSC-Derived Cell Products

Ge Peng

Tiancheng New Drug Evaluation

Deputy General Manager, IACUC Chair

Guest Profile

Researcher, Deputy General Manager of Tianjin Tiancheng New Drug Evaluation Co., Ltd., and Chair of the IACUC.With over 15 years of experience in pharmaceutical toxicology, laboratory animal science, preclinical evaluation of medical devices, and biosafety research, has completed more than 200 preclinical evaluations for drugs, biological products, and medical devices, published over 20 papers, and obtained four invention and utility model patents.Extensive project experience in GLP study design and analysis, biocompatibility studies for medical devices, and animal behavior research. Accumulated substantial research experience in the design of clinical trials for biological drugs, as well as in the design and management of animal laboratories and biosafety laboratories. Successfully completed China’s first long-term toxicity studies in non-human primates for biological drugs, and preclinical toxicological evaluations of pediatric drugs in juvenile beagle dogs (JAX studies).

Professional Affiliations:

Secretary-General of the Preclinical Professional Committee, China Biotechnology Association;

Secretary-General of the Committee on Drug Toxicology and Safety Evaluation, Tianjin Pharmacological Society;

Member of the Expert Pool for Laboratory Animals, Tianjin Municipal Science and Technology Commission;

Member of the Tianjin Municipal Environmental Protection Bureau’s Biosafety Expert Pool;

Expert in the Review of Import and Export of Special Articles for Tianjin Customs;

Member of the Toxicology Professional Committee, Chinese Association for Laboratory Animal Sciences;

● Cell Biology Laboratory

● Molecular Biology Laboratory

● Radioisotope Testing Laboratory

● Pathology Laboratory

● Genotoxicity Laboratory, Reproductive Toxicity Laboratory

● Analytical Laboratory

   ▶10 LC/MS systems, >10 LC/UV/FL/FSA systems

   ▶Microplate Reader/MSD/dPCR

Fully compliant with AAALAC regulations: animal cage washing and decontamination room, feed storage room, cage storage room, quarantine room, animal laboratory, diagnostic and treatment room, animal exercise area, and necropsy room.

● Monkey Husbandry and Use

● Canine Breeding and Utilization

● Husbandry and Use of Common Mice and Rats

● Husbandry and Use of Transgenic Mice and Rats

● Housing and Use of Domestic Rabbits

● Guinea Pig Husbandry and Use

● Husbandry and Use of Miniature Pigs

Tianjin Tiancheng New Drug Evaluation Co., Ltd.

Tel: 022-8484 5325

Email: BD@tipr.com.cn

Address: No. 308 Huiren Road, Binhai Science and Technology Park, Binhai High-Tech Zone, Tianjin

Welcome to Tiancheng New Drug

To drive technological breakthroughs, industrial integration, policy alignment, and international cooperation in China’s cell and gene therapy (CGT) sector, and to propel the Chinese CGT industry to the forefront of global competition, the China Society for Gene and Cell Therapy (CSGCT) Conference was established.

Building on its close ties with the American Society of Gene & Cell Therapy (ASGCT), the 2025 CSGCT Annual Meeting will bring togetherLeading scientists, clinical experts, multinational pharmaceutical companies, and overseas investment institutions bring the most cutting-edge developments in the global cell and gene therapy field.Cutting-edge research advancements, technologies and applications, market access information, high-quality collaborative projects, and matchmaking with overseas investors and investment opportunities, building a platform for in-depth exchange and cooperation between China’s cell and gene therapy industry and the global industrial chain.

The conference closely addressed the industry's hotspots, pain points, and bottlenecks, featuring1 Main Forum + 18 High-End Sub-Forums, coveringLatest Advances in Global Gene Therapy, Immune Cell Therapy, In Vivo CAR-T, Adult Stem Cells and Exosomes, iPSC-Derived Cell Therapies, Small Nucleic Acid Drugs, Gene Editing, Oncolytic Viruses, and Tumor Vaccines, as Well as CMC and Testing, AI-Driven Drug Discovery, Registration and Regulation, and Investment, Financing, and Business Development Matchmakingetc.Comprehensive coverage of the entire industry chain.

2025 The 2nd China Cell and Gene Therapy (CSGCT) Conference

September 12-13, 2025

Zhongguancun National Independent Innovation Demonstration Zone Exhibition and Trading Center [Conference Center]

For more details, please scan the QR code to visit the official conference website.