Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd.(hereinafter referred to as “Lewwin Pharm”), adhering to the tenet that “discovering a drug may be serendipitous, but delivering high-quality drugs is imperative,” has successfully established an international innovative“research-oriented”non-clinical drug evaluation technology platform that complies with international and domestic GLP standards, AAALAC International requirements, FDA regulations, and ICH guidelines. Lewwin Pharm has obtained multiple authoritative international and domestic certifications, including full GLP certification (covering all ten non-clinical safety evaluation items) from the NMPA (National Medical Products Administration) of China, FDA GLP recognition/inspection, OECD GLP certification, AAALAC International accreditation, CNAS CNCA GLP accreditation (China National Accreditation Service for Conformity Assessment, National Certification and Accreditation Administration), national CMA accreditation (China Metrology Accreditation), CNAS laboratory accreditation, and Animal Biosafety Level 2 (ABSL-2) laboratory registration for animal studies. It is the first drug evaluation GLP Institute in South China to pass FDA GLP inspection and the first in China to pass FDA “Unannounced Inspections”. The non-clinical evaluation data provided by Lewwin Pharm have been recognized by regulatory authorities in multiple developed countries and regions, including the United States and the European Union, and can support global regulatory submissions.Lewwin Pharm offers comprehensive, one-stop non-clinicaltechnical services throughout the entire drug development chainfor pharmaceutical R&D institutions, enterprises, and universities. These services cover proof-of-concept studies, druggability evaluation, pharmacology and pharmacodynamics studies, drug safety evaluation, preclinical and clinical pharmacokinetic and toxicokinetic studies, in vivo fate studies of drugs, bioanalysis, in vivo and in vitro biosafety studies, laboratory animal pathology and clinical testinganimal medical examination and testing, international registration and regulatory submission support, as well as efficacy,toxicology, and other testing services in fields such as veterinary drugs,health foods, cosmetics, chemicals, and high-end medical devices.The non-clinical evaluation data provided by Lewwin Pharm have been recognized by regulatory authorities in multiple developed countries and regions, including the United States and the European Union, and can support global regulatory submissions.

As GLP leading enterprise in South China,LEWWIN PHARMA has been repeatedlyrecognized with prestigious honors, including: China’s First National Key Specialized, Sophisticated, Distinctive and Innovative “Little Giant”Enterprise in the field of GLPNational Key Specialized, Sophisticated, Distinctive and Innovative "Little Giant" Enterprise, the first GLP-certified pharmaceutical research institute that has won the “Excellent Enterprise” award in the China Innovation and Entrepreneurship Competition, First Prize of Guangdong Provincial Science and Technology Progress Award, and Guangzhou Anchor Entity for Advanced Pharmaceutical and Medical Device Evaluation Research and the CRO Chain. AsaGLPleading enterprise in non-clinical evaluation research for drugs in Southern China,LEWWINPHARMhas established more than ten national and provincial R&D platforms, such asOphthalmic Drug Non-Clinical Evaluation and Research Center of the State Key Laboratory of Ophthalmology, High-level New-type R&D Institute in Guangdong Province, Guangdong Provincial Key Laboratory of Drug Non-Clinical Evaluation and Research,Guangdong Engineering Research Center for Innovative Drug Evaluation and Research, Innovation Center for Basic Research in Inflammation and Immune-Related Diseases, Ministry of Education, TCM Non-Clinical Evaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine,Provincial Enterprise Technology Center, and Guangdong Engineering Technology Research Center covering drug evaluation, cell and gene therapy, ophthalmic drugs, and other fields.Lewwinhasoperatedapostdoctoral research station with independent enrollment authorityandhasestablished multiple high-end cooperative innovation platforms, including theGuangzhou-Hong Kong-MacaoOverseas ChineseDiabetes Innovation Institute.the only GLP-certified pharmaceutical research institute that has won the “Excellent Enterprise” award in the China Innovation and Entrepreneurship Competition, First Prize of Sci-tech Innovation Services Professional Competition of 12th China Innovation & Entrepreneurship Competition,Provincial-level Single Champion Manufacturing Enterprise in Guangdong Province, First Prize of Guangdong Provincial Science and Technology Progress Award, Guangdong Provincial Service-oriented Manufacturing Demonstration Platform,Guangzhou Anchor Entity for Advanced Pharmaceutical and Medical Device Evaluation Research and the CRO Chain, etc. ForR&D platform establishment, LEWWIN has established more than ten national and provincial R&D platforms, such asHigh-level New-type R&D Institute in Guangdong Province,State Key Laboratory of Ophthalmology(GLP Center of Ophthalmic Drugs), Provincial Key Laboratory, Guangdong Engineering Research Center, Provincial Enterprise Technology Center, Guangdong Engineering Technology Research Center covering drug evaluation, cell and gene therapy, ophthalmic drugs, and other fields. Additionally,LEWWIN actively builds an industry-university-research collaborative innovation system and has established multiple high-end cooperative innovation platforms, including the Diabetes Innovation Institute of Guangzhou, Hong Kong, Macao and Overseas Chinese.

LEWWIN PHARMA specializes in non-clinical pharmaceutical evaluation and research, having established a distinctive research system with remarkable achievements in its key fields such as ophthalmic drugs, traditional Chinese medicine and natural products, cell and gene therapy drugs, vaccines and anti-infectives, topical formulations, and pediatric drugs. Multiple research initiatives represent world-first successful studies that have gained regulatory approval; We have not only applied for and obtained numerous patents for models and critical evaluation technologies but has also supported a series of blockbuster drugs in securing international and domestic clinical approvals. These milestones include the world’s first cell-based drug for graft-versus-host disease ocular application, which received FDA Orphan Drug designation along with clinical approvals from both the FDA and China; the world’s first Class 1 eye drops capable of reversing cataracts; the world’s first multi-target cell therapy product for solid tumors; the internationally pioneering DRIP inhibitor novel anti-tumor drug; and the first new drug marketed to delay the progression of myopia in children. These contributions have actively supported the development of the biopharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area.