R&D (Research and development)
Strengths of GNI Group
GNI Group established its research origins on cancer and inflammation therapies by utilizing the genetic information and analysis technology created by the scientists who initially established our organization. The search for new drugs and clinical development are conducted mainly in China. The high-quality and cost effective drug discovery and clinical trials platform in China is one of GNI Group’s main strengths.
Validation and drug design of drug discovery targets
To demonstrate the effectiveness of genes in the computer-calculated drug discovery targets for treatment of diseases, we conducted experiments to confirm the actual effect on human cellular tissue and organs. After demonstrating the functions of the genes in vivo, the most suitable disease treatment model is designed.
These validation steps make up the screening process for identifying the most valuable candidate genes as drug discovery targets. These genes are identified through genetic analysis or from among a great number of gene groups generated by various other methods.
The majority of drugs that are currently available and successfully sold on the market are low molecular compounds. Thus, at GNI Group we design low molecular compounds that can activate or inhibit the functions of the validated drug discovery targets. We also focus on the discovery of cell cycles, proliferation control, cell death, apoptosis (a type of cell death), immune signal transmission (process that occurs when cells respond to outside substances), and lead compounds that inhibit the transmission of inflammatory signals. (Compounds that exhibit bioactivity in drug development. The chemical structure is used as a starting point for improving the efficacy, selectivity, and pharmacokinetic parameters). The target compounds are optimized before filing an investigational new drug application.
Preclinical study and clinical development
The high-quality and promising drug discovery targets developed through our comprehensive drug discovery program have exhibited outstanding efficacy in clinical trials. The team at our subsidiary company Shanghai Genomics, Inc. responsible for preclinical studies is composed of experience experts, and together they have filed numerous investigational new drug applications. They are highly skilled in fields such as physicochemical properties and manufacturing (CMC), pharmacokinetics and toxicity testing (ADMA/Tox). The team is highly regarded for its outstanding level of efficiency and productivity, and has contributed to achieving CFDA approval for our IPF therapy drug ETUARY®(艾思瑞® in Chinese) and our milestone drug F351, moving lead targets to target compounds to clinical trials within a short period of time.
If the clinical trials of the drug targets produce good results, the regulatory agency issues it approval. It is then that the drugs finally reach our intended drug market. To guarantee the quality and efficiency of the clinical trials, which are divided into a total of three phases, GNI Group has a dedicated clinical trial team in-house lead by a medical director, who has a wealth of experience in clinical trials, and a clinical research associate (CRA). We have also established a network of hospitals and KOLs (key opinion leaders) through China.
Our strategy is to develop drugs by first conducting cost effective yet stringent and broad ranging clinical trials in China. These trials enable us to ensure safety and efficacy of the drug targets. It also helps us to expand the indications of drug targets, compare them with other forms of treatment and their concomitant uses, and combine them at various dosages. Based on the phase II POC (proof-of-concept) clinical trial data obtained in China, we evaluate the potential of each drug, and move forward if appropriate with development in the U.S., Japan, EU and other international markets.