As a clinical-stage biotechnology company with multiple clinical programs initiated in China, US and Australia, GenFleet boasts comprehensive clinical development capabilities with global development experiences in medical science, clinical operation, statistics & data science and regulatory affairs.
With experiences in big pharmas, clinical research organizations and local biotechs, the department integrates various functions and continuously improves the clinical development on the basis of disease biology and translational medicine. The department’s executives used to lead early-stage & late-stage clinical programs and the clinical research platform of translational clinical oncology in multinational enterprises.
GenFleet has been advancing clinical trials targeting multiple indications including solid tumors, liquid tumors and autoimmune diseases. Staff of the department are experienced in conducting trials for treating cancer and autoimmune diseases. By means of macro clinical planning and micro data analysis, the team strives to promote the discovery and development of innovative medicines through excellent execution.
In line with ICH and local regulations of novel drug clinical development, the department sets up a system of clinical research management and quality control through standards of practice for supervision and execution. Diversified experiences in big pharmas, clinical research organizations and local biotechs enable the department to control the risk of clinical development and ensure quality through the team’s precision approaches together with insightful advice from external experts.
Target innovation and drug development driven by biological mechanism research is the starting point of GenFleet's pipeline. Linking cutting-edge technologies and medical needs in a creative manner, we conduct target research, identification of preclinical candidates and clinical transformation by means of in vitro screening, pharmacological research, translation science and other tactics.
GenFleet constructs its R&D platform on the basis of disease biology and translational medicine, and researches into latest biological mechanism of cancer pathways, tumor microenvironment and human immunoregulation.
The newly established DMPK platform contributes to screening and optimization of preclinical candidates through ADME (absorption, distribution, metabolism & excretion) simulation in human body and relevant pharmacokinetic studies, so as to boost success rates of drug discovery and clinical trials from the early stage of R&D programs onwards.
From the screening of preclinical candidates to early-stage process development, we delve into the research and analysis of molecules' structure-activity relationship to prepare good-quality APIs for clinical research and commercial production as GenFleet grows into a clinical-stage biotechnology company developing cutting-edge products with global intellectual property rights.
As a key node linking early discovery and translational medicine, the department integrates advanced models such as SAR (structure-activity relationship)，SPR (structure-property relationship) and CADD (computer-aided drug design) into a grand R&D platform of synthetic chemistry and computing science. Through multi-layered screening, the department is projected to identify preclinical candidates with active physical & chemical characteristics and great PK&PD properties for the development of novel molecules in bringing innovative therapies.
The multi-functional platform of molecular biology and biochemical analysis undertakes high-throughput screening and activity evaluation at enzyme and cytology levels. Besides, the department set up animal models of multiple tumors and autoimmune diseases to identify the in vivo effects and mechanism of molecules. The whole process of in vitro and in vivo analysis methods is capable of supporting the biological research from preclinical studies to clinical transformation.
The new R&D system contains a broad range of functions including antibody discovery, activity screening, drug effects identification, mechanism research and expression & purification of protein. With exclusive screening strategy and antibody engineering, the department is targeted to develop various types of antibody drugs and thus make contributions to GenFleet’s balanced matrix of products.
Deeply understanding molecular mechanism of diseases, we take advantage of the bioinformatics & molecular pathology platform to discover disease-related biomarkers and innovative targets. Bridging between bench and bedside research, our translational studies support model selection and pharmacodynamic index identification in drug discovery.
With reference to molecular pharmacology and potential targets' biological functions, we employ the platform of molecular pathology & multi-omics to search for original biomarkers (including patient screening biomarkers, pharmacodynamic markers, etc.), and establish feasible detection methods in line with regulations of clinical development.
Translational studies span across patient screening, drug resistance mechanism discovery, drug combination strategy and indication selection in clinical development. We strive to identify potential targets according to research data, seek new molecules with full verification through lab tests, and move potential preclinical candidates into clinical trials.
In view of biological mechanism and big data in healthcare, we select most suitable indications to serve unmet clinical needs. Besides, we explore potential mechanisms of drug resistance in translational studies to spot anti-drug resistant compounds and expand indication for novel drugs.
GenFleet's branch in Zhejiang Province of the Yangtze River Delta region is a grand CMC platform of small molecule products. The manufacturing base in Shanghai's Lingang New Town will become GenFleet's R&D and commercialization platform for biological products. The two bases bridging R&D functions, clinical research and manufacturing will play an essential part in the commercialization of our innovative medicines.
Put into operation in 2018, GenFleet's site in Zhejiang site integrates modules of small-molecule API production, process development and pilot scale-up. Its R&D unit of process development extends across 7 labs and has expanded to cover researches into design & development of synthesis routes, scale-up of API & key intermediates, validation of critical process parameters, and transfers & scale-up of pilot process. Dedicated to the API production for toxicology studies, the kilogram laboratory unique to GenFleet supports early-stage non-clinical toxicological tests and presents process development evidences for GMP production. Providing CMC-related data for IND applications, the lab marks a milestone of GenFleet's CMC system building and sets the tone for the company's quality standards of commercial production in future.
GenFleet's site in Shanghai's Lingang New Town is projected to occupy a space of over 33,000 square meters, including a comprehensive R&D and commercialization platform of biologics. The site in Lingang will introduce industry-leading production lines and liquid filling equipment. While diversifying our small molecule products, we also focus on the development of biologics including bispecific antibodies and antibody-drug conjugates by a team of professionals with local and overseas industrial background. Home to numerous high-tech industrial parks, Lingang New Town has attracted over 50 companies from the biopharmaceutical industry including listed companies such as Junshi Pharma, Genor Biopharma, WuXi AppTec. Statistics show the investment and gross production of the healthcare industry in Lingang will top 200 billion yuan in 2035 and the area will see an industrial chain emerging to integrate preclinical research, clinical development, industrial development and R&D enabling platforms.
The department of Pharmaceutical Development strives to prepare multiple solid and liquid dosage forms to increase bioavailability by utilizing conventional and innovative technology in lab scale formulation study, process development, scale-up manufacturing and compatibility study of packaging materials. Moreover, the department features the analytical platform to conduct the development, validation and transfer of analytical methods. It also supports the quality control system and IND & NDA submissions throughout the life cycle management of GenFleet's innovative medicines.
In light of GMP standards and CMC-related regulations in different regions, the department of Pharmaceutical Development aims to build a comprehensive system of CMC regulatory affairs management for R&D process, regulatory submissions and clinical batch supplies. As the ultimate goal of this function, the establishment of a drug supply chain in compliance with global standards greatly facilitates regulatory registrations worldwide.
As the principle of quality management is implemented to different level throughout R&D process, the department of Pharmaceutical Development seeks to build a quality control system based on GMP, ICH and WHO guidance, to ensure all in-house and external R&D performances are in consistency with international regulatory requirements. In addition, it's the mission of the department to continuously improve the overall quality control system at different stages of the company's growth and development.