R&D Centers
Our R&D Department is comprised of Drug Discovery, CMC (Chemistry, Manufacturing, and Control), Clinical Development, Medical Affairs, and Regulatory Affairs.
Drug Discovery
During the drug discovery stage, we explore new R&D opportunities, conduct feasibility research and provide evaluation for the opportunities. We also design and prepare new chemical compounds, conduct systematic research related to the manufacturing process and quality management of the new drugs, and develop technology platforms to support, manage and supervise the related technologies. Our R&D centers support a targeted drug discovery and screening platform, which can efficiently complete target identification and validation, compound design, lead optimization and IND approval application.
Chemistry, Manufacture & Controls (“CMC”)
The CMC Group is a critical link between discovery and clinical study. It is responsible for developing chemical and pharmaceutical processes, so that drug substance can be made with the desired physical and chemical properties, and formulated to achieve maximum bio-availability and stability. During the CMC stage, the synthesis of each API molecule is investigated thoroughly to ensure that the drug substance can reach pre-determined quality standards, the manufacturing processes are safe, robust, economical, and environmental friendly, and the drug products have good stability and suitable storage conditions and shelf-life.
Clinical Development
Our clinical development team oversees clinical trials for drug development, sets up the procedural standard of clinical affairs, and handles clinical medicine matters. Our clinical development team also focuses on clinical development strategy development, clinical trial protocol design, clinical trial operation coordination, pharmacovigilance, and clinical trial quality control. Our clinical development team members specialized in management of all stages of our clinical trials, including clinical trial design, implementation, drug supply, and the collection and analysis of trial data. We collaborate with top clinical experts in various areas as our principal investigators, leverage the operational capabilities of industry-leading CROs, and rely on well-known academic medical institutions and clinical trial centers in China and abroad to promote the high-quality and efficient implementation of our clinical trials in China.
Medical Affairs
Our medical affair group focus on the follow-up research on the therapeutic effect of marketed products, collection of patients’ feedback and exploration of the potential indication expansion. Internally, the medical affair team bridges the information gap between our drug R&D team and sales and marketing force, and assists the sales and marketing team to prepare educational materials to accurately describe the differentiation and superiority of our products. Externally, our medical affair team communicate our research data and clinical evidence to KOLs and physicians to support our academic promotion.
Regulatory Affairs
Our regulatory affairs group is responsible for the regulatory approval process of our drug candidates, including, addressing inquiries from relevant authorities and monitoring our R&D projects to ensure their compliance with relevant regulations. Our regulatory affairs team manages the regulatory submission process for our drug candidates, according to the filing and approval requirements by the relevant authorities before clinical trials and commercialization. The regulatory affairs team prepares and manages regulatory filings, addresses regulatory questions and conducts CMC and GMP readiness assessments for our drug candidates. We possess extensive knowledge and experience with regard to regulatory filings in China.