On November 18, 2019, Asymchem Laboratories (Tianjin) Co., Ltd. (SHE: 002821. SZ, “Asymchem”) officially opened its Center for Early Phase Pharmaceutical Development (“Center”) to provide more flexible and efficient one-stop solutions for innovative drug development worldwide. The Center will help improve the capability and provide one stop service for CMC. In addition, the Center’s service to the early phase projects may eventually bring more commercial projects and optimize the service supply chain for innovative drugs. This is one of the drivers which shows that Asymchem continues to grow the innovative drug development market.
Official launch of the Center for Early Phase Pharmaceutical Development
Dr. Hao Hong, Chairman&CEO of Asymchem, COO Ms. Rui Yang, CFO Da Zhang, SVP Yi Hsiao and other executives attended the launching ceremony on November 18.
Then Dr. Yihui Chen, Vice President of the center stated that its establishment will comprehensively improve Asymchem’s pharmaceutical development capability for early phase projects; characterized by large project quantity, tight schedule, immature process quality, and analysis method. The center includes research/development, manufacturing, quality assurance/quality control, drug registration/filing, procurement, materials, and formulation. This will provide efficient and flexible solutions at one facility, and guarantees that projects will run smoothly through technology and process optimization.
Improve early phase pharmaceutical development for innovative drugs
With the improvementsin novel drug research and development, along with innovation to discover newtargets, new molecules, and new treatments; drug candidates will increase and have breakthroughs. In mid-April, 2019, there are 16,181 drug candidates worldwide, up from 5,995 in 2001. The candidate number grows at aCAGR of around 11% during 2013-2018. Currently the domestic review system is being updated with implementation of the MAH related policies, which will acceleratereview and potential acceptance of domestic innovative drugs.
Asymchem has had the ability to provide services for the full life cycle of drugs, from preclinical to market, and has received several early phase clinical projects. Asymchem’s continued efforts, to improve the clinical service capacity, are shown with the launch of the Center for Clinical Phase Pharmaceutical Development.
Equipped with professional analysis team and advanced equipment, the center covers a floor area of 1,500m2 in Stage I and will expand to 5,000m2. This will enhance Asymchem’s ability and capacity to provide early phase pharmaceutical development services. The center focuses on preclinical development to IND then further to Phase I for novel drug development projects. Asymchem will enact a rapid response mechanism to help clients speed up the process for IND submission and clinical trials. The center offers services regarding process safety evaluation, screening for salts or crystal forms, crystallization process development, analytical method development/validation, and formulation development. In addition, it will also coordinate with the company’s Department of Regulatory Affairs and Tianjin Innovation Center for Clinical Research to provide comprehensive services for IND submission and clinical research.
Experienced talent team, well-structured management process
Home to over one hundred of professionals experienced in pharmaceutical development, analysis, and production; the center is expected to grow even more in the next few years. The center has highly educated employees proficient in novel drug research and development, among them 70% hold a master’s degree or higher.
Professional teams with project managers will be designated for each client to provide integrated services from development to registration and filing. This contributes to the coordination of all activities and communication during the process, to guarantee the project’s success in a timely manner.
Quality management system in line with international standards
Scientifically designed and equipped with HVAC (heating, ventilation and air-conditioning) systems, Asymchem’s facilities comply with GMP (Good Manufacturing Practices) and cGMP regulations set forth by the US FDA (U.S. Food and Drug Administration). Due to strict compliance with all required quality management regulations, Asymchem’s sites have successfully passed the inspection of US FDA, Australian TGA (Therapeutic Goods Administration), Chinese FDA and Korean MFDS (Ministry of Food and Drug Safety). Related laws and regulations have been applied throughout the quality assurance system from staff, equipment, material, method, to environment and other aspects. This ensures a smooth transition from development and analysis, to production.
The Center for Early Phase Pharmaceutical Development allows Asymchem to expand its capacities from early phase pharmaceutical development to late phase clinical development and even commercialization. It marks another step that Asymchem has improved clients’ services and accelerating production for more innovative drugs to market.