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◆ Overall Capabilities of the Platform

  1. Guangdong Engineering Research Center for Cellular and Genetic Therapy Innovative Drugs (Co-construction)

One-stop Public Service Platform for R&D and Evaluation of Cellular and Genetic Therapy Products in the Guangdong-Hong Kong-Macao Greater Bay Area

 LEWWIN PHARM, together with Shenzhen Pregene (which possesses dual core technology platforms for nanobody development and CAR-T drug development), the Cancer Research Center of The Hong Kong University of Science and Technology (a world-class university), and the Macau Institute for Applied Research in Medicine and Health of Macau University of Science and Technology, jointly established the “One-stop Public Service Platform for R&D and Evaluation of Cellular and Genetic Therapy Products in the Guangdong-Hong Kong-Macao Greater Bay Area”. This platform aims to provide one-stop service offerings, undertaking one or multiple customized services in the form of outsourcing for cellular and genetic therapy drug projects, including pilot-scale production, scale-up transformation, preclinical pharmacological and toxicological research, drug registration and submission, and batch manufacturing processes.

 2. Guangdong-Hong Kong-Macao Greater Bay Area Anti-Tumor Drug R&D and Evaluation Center

In collaboration with the Cancer Research Center of The Hong Kong University of Science and Technology (HKUST) and the laboratory of Professor Liang Chun from the Division of Life Science at HKUST, by integrating the comprehensive advantages of both parties’ key technology platforms in anti-tumor target research, anti-tumor mechanism research, anti-tumor drug screening, non-clinical pharmacology evaluation of anti-tumor drugs, pharmacokinetic studies, safety evaluation, and pharmaceutical research, LEWWIN PHARM jointly established the “Guangdong-Hong Kong-Macao Greater Bay Area Anti-Tumor Drug R&D and Evaluation Center”. This aims to enhance the capabilities of both parties in anti-tumor drug R&D and innovation, improve their innovation capacity, R&D capability, and comprehensive drug creation ability in the field of anti-tumor drug research, promote the transformation of scientific research achievements from the Division of Life Science/Cancer Research Center of HKUST, and facilitate the transformation of “innovative ideas” into “innovative products”.

◆ Team Introduction

LEWWIN PHARM has an independent “Cellular and Anti-Infective Drug Research Center” and a relatively independent professional team dedicated to the non-clinical evaluation and research of cell and anti-infective drugs. The team consists of nearly 80 members, including over 10 high-end experts. The proportion of team members with Master’s or PhD degrees exceeds 40%. The frontline personnel performing the work are senior technicians with over 7 years of experience. Currently, it co-establishes the Guangdong Engineering Research Center for Cellular and Genetic Therapy Innovative Drugs and the One-stop Public Service Platform for R&D and Evaluation of Cellular and Genetic Therapy Products in the Guangdong-Hong Kong-Macao Greater Bay Area, holding a leading position domestically.

◆ Administration Techniques

Proficient in various special administration techniques for cell and gene therapy drugs.

◆ Detection Methods

Successfully established and validated various common detection methods for cell and gene therapy drugs, such as immunofluorescence/histochemistry, in vivo imaging technology, qPCR, flow cytometry, etc., enabling the investigation of biodistribution, cell migration, homing, differentiation, biological behavior, and other aspects.

◆ Instruments & Equipment

◆ Project Experience

Has conducted systematic non-clinical evaluation studies for immunocytes such as stem cells, CAR-T cells, TCR-T cells, CAR-NK cells, DC, CTL, CIK, TIL, and various gene therapy drugs, with extensive project research and submission experience!

● Gene Therapy Drugs

• Nucleic Acid Drugs: Plasmid DNA drugs, mRNA drugs, ASO, siRNA, etc.;

• Viral Vector Drugs: Adenoviral vectors, Adeno-associated viral vectors, Lentiviral vectors, etc.;

• Oncolytic Microorganism Drugs: Oncolytic virus drugs, oncolytic bacteria drugs, etc.;

• Gene Editing Drugs: CRISPR-Cas9 ex vivo editing drugs, CRISPR-Cas9 in vivo editing drugs, etc.