Research and development of innovative drugs involves the intersection of multiple disciplines. Our R&D team members have professional/cross-disciplinary backgrounds in medicine, pharmacy, chemistry, and biology. Our core R&D management team consists of professionals with extensive experience in pharmaceutical R&D and management in the United States and China. They possess a wealth of management and R&D experience in international pharmaceutical/biotechnology companies, and are familiar with the technical regulations and patent strategies for global drug management. Our senior R&D team has expertise in the fields of target validation, exploratory research, molecular simulation and design, high-throughput and high-content screening, and biomarkers in translational medicine. This expertise is backed by core competencies in the early screening and evaluation of innovative drugs, in clinical trials and development, and in other various procedures required for lab-to-market development, including preclinical research, pilot testing, quality control, and production. Together, talent, technology, and R&D management offer powerful support for our innovative drug development.
Early Research & Development Centers
The engine of Chipscreen’s work as a pioneer in R&D of innovative drugs in China is the early R&D center. Grounded in science and dedicated to innovation, our early R&D centers have always focused on unmet clinical needs and the development of novel drugs with significant clinical differentiation advantages as well as commercial potential.
From the very beginning, the early R&D centers have worked to establish and gradually refine our core technology platform, the integrated drug discovery and early evaluation platform based on chemical genomics. This platform combines the so-called “omics” techniques of modern molecular biology with molecular pathology data derived from clinical research, medicinal chemistry molecular structure and bioactivity data, and an integrated data analysis system. This enables prediction and early evaluation of the possible molecular pharmacology and toxicology of new chemical entities, and supports the identification of lead compounds with a continuously optimized structure that may be progressed to the next stage of development. Thanks to our platform we are able to effectively control the risks of innovative drug development.
We have two Small Molecule Early R&D centers located in Shenzhen and Chengdu respectively. Through comprehensively managing two Centers focused on different therapeutic areas, we could optimize the allocation of human resources and research focus, to speed up product discovery and technology innovation, which will strongly support the development and commercialization of further new products.
Early Research & Development Center of macro-molecule (Chengdu Chipscreen NewWay Biosciences) is a newly established innovative biotech company under Chipscreen Biosciences. It is committed to the development of all innovative therapeutic measures except small molecules, currently focusing on discovery and development of macro-molecule products, to further enriching our innovative drugs pipeline.
Clinical Development System
The clinical development strategies and practices for innovative drugs with novel mechanisms are significantly different from “fast-follow” or generic drugs. In the past decades, Chipscreen has explored and put into practice strategies and models that work for innovative drug development. Our success stories cover the full gamut from early phase clinical trials to registered clinical trials, from new drug approval to post-marketing real-world observations, and from clinical research in China to global clinical development. Our strength in every aspect of clinical drug development is guaranteed by a fully equipped development team across the country, specializing in clinical trial management, medicine, registration, operations, data management, statistics, pharmacokinetics, and drug safety.
Clinical pharmacological research is conducted to comprehensively understand the pharmacokinetic and pharmacodynamic characteristics of innovative drugs in humans, so as to provide scientific basis for clinical development protocols. At the same time, the clinical pharmacological research team is working with the other teams such as early research & development centers, clinical development, product development, and pharmaceutical affairs aiming for approval and marketing of innovative drugs.
Product development is an important supporting for manufacture technology transition from early development to industrialization of innovative drugs, ensuring both drug quality and drug safety.
During the process of innovative drug development, as we learn more about a new drug, our R&D team are constantly optimizing their pharmaceutical research work based on the requirements for clinical studies and scale-up production. This includes the manufacturing process and control for innovative drugs (selection of synthesis routes, formulation development, control of critical steps and intermediates, etc.), impurity profiling (organic impurities, process impurities, and genotoxic impurities, etc.), and quality control (determination of inspection items, evaluation of critical quality attributes (CQA), formulation of quality standards, establishment of analytical methods, methodological validation, and stability research, etc.). All this ensures that the drug is safe and effective with controllable quality, further guaranteeing development success. Today, our product development system has benefited from experience accumulated during the development of Chidamide, Chiglitazar and Chiauranib, and is well placed to handle the challenges of developing safe and effective drugs.
Intellectual Property Rights
The patent application and maintenance bound up with our products during their lifecycle provide legal protection for the core interests of the company, including the commercial value and social value of innovative drugs.