Highlights
Continuous Flow Technology Partnership with Shanghai Desano Pharmaceuticals
Nov. 5, Shanghai – Asymchem and Shanghai Desano Pharmaceuticals Co., Ltd. signed a partnership agreement to commercialize continuous flow technology. Based on the agreement, Desano will leverage Asymchem’s comprehensive knowledge of continuous flow reaction technology, including process development, quality assessment, equipment manufacturing, and quality attribute studies etc. that may be required in the registration process. Asymchem holds several patents in this area and this agreement is the first of its kind to realize the commercial cooperation model and reach the industrial application.
Asymchem hosts Forum on New China Policies within the Pharmaceutical industry
Nov. 5, Zhangjiang, Shanghai – Asymchem hosted the forum, Discussing the “Opportunities and Challenges of Innovative Pharmaceutical Industry Development under the New Policies”. The forum invited top experts, scholars, key policy leaders, entrepreneurs, and investment leaders from within the industry in China. The forum allowed for discussion and interpretation of the future of innovative drugs from policy-driven high-quality development of China’s pharmaceutical industry. As well as providing a platform for in-depth discussions on how to better promote the development of innovative drugs in China. During the forum, Asymchem signed cooperation agreements with Axtertx and UTC Therapeutics Inc and will provide continuous flow reaction technology services, CMC and clinical trials, mRNA-related assays, and other technology services to accelerate the process of innovative drug launch.
Five year anniversary of Shenzhen Stock Exchange IPO
From 2016-2021, Asymchem has had an impressive five-year post-IPO track record. As of today, Asymchem has 20 business centers, 8 production sites, and more than 7,000 employees, of which 2,600 are scientists and engineers worldwide. The company has had a compound growth rate of over 30% in operating revenue and over 30% in net profit. Over the past five years, Asymchem has maintained high R&D investment, and the four R&D technology platforms （CEPS, CFCT, CBST, and CIMT） have enabled Asymchem to continuously improve business capability. 617 projects have been completed since 2016, and Asymchem continues to contribute to global innovative drugs through its one-stop service platform. In addition, the company has also fulfilled social responsibility and contributed to sustainable development through various methods, such as Green Walk, the fight against COVID-19, and establishing scholarships.
Technology Updates
Transaminase mutant granted patent
Asymchem has developed its synthetic route for the preparation of key intermediates for migraine drugs utilizing the bioenzymatic method. Compared with the traditional chemical process of two-step reductive amination （high pressure, precious metal catalyst, 55% yield）, the transaminase mutant obtained by enzyme engineering modification can catalyze the transamination reaction of the target substrate in one step with high efficiency （yield >81%, de >99.5%） and achieve kilogram-scale scale-up, showing great potential for industrial application. The related synthetic route and mutant sequence have been granted by the China National Intellectual Property Administration （CN112980810A, CN 112980899A ）.
Oligonucleotide Service Platform Capacity Expansion
Asymchem has established a one-stop service platform for CMC of antisense oligonucleotides, siRNA, nucleic acid aptamer, vaccine adjuvant CpG, including process development, analytical method development and validation, GMP pilot production, process validation, etc. The company has achieved stable supply of oligonucleotide APIs and provided CMC services from phase I to phase III clinical and future commercializable production for several customers. Two pilot production lines have been established, which can achieve an annual production capacity of 10~16 Kg of siRNA. Asymchm will further enhance the capacity layout, it is expected that by 2022 4Q, 6~8 pilot production lines (60~100 Kg/year) and 2 commercial production lines (~200 Kg/year) can be realized, to reach the world’s leading oligonucleotide API production capability.
500 L peptide Production Line Operational
Asymchem’s commercial solid-phase peptide production line is now operational with two 500L solid-phase synthesis reactors, DAC600 purification equipment, and a 17.5m2 lyophilizer. The line can meet the demand of 5~10Kg/batch commercial production of peptides.