November 20, 2019 - Asymchem Laboratories (Tianjin) Co., Ltd. (SHE: 002821. SZ, “Asymchem”) announced the official opening of its Asymchem Jinshan Biotechnology Development Center (Development Center) as part of Shanghai Asymchem Biotechnology Co., Ltd. (SH Asymchem Biotechnology), a wholly owned subsidiary of Asymchem. SH Asymchem Biotechnology is designed to accelerate the research, development, and production of innovative biological drugs in adherence with Good Manufacturing Practice (GMP). The Development Center facility was built to meet increasing customer demand in Asymchem’s growing CDMO Biologics, CMC and clinical research service offerings.
Opening Ceremony of the Development Center
Opening Ceremony of the Development Center
An opening ceremony was held and attended by: Quanquan Zhang, Deputy Head of Jinshan District of Shanghai and member of the standing committee of the District, Yongchao Zhou, Chairman & Secretary of the party committee of Shanghai New Jinshan Industrial Investment & Development Co., Ltd.(“NJS”), other leaders from Jinshan District’s Development & Reform Commission, Economic Committee, Health Commission, Market Regulation Administration, Investment Promotion Bureau, and the NJS, along with Dr. Hao Hong, Chairman & CEO of Asymchem, COO Ms. Rui Yang of Asymchem, and other executive leaders. Peiren Fan, Chairman of Zhejiang Yangfan Holding Co., Ltd, Chongguang Xu, Jinagsu Kaidi Real Estate (Group) Co., Ltd. also attended the ceremony.
During the ceremony, Dr. Hao Hong shared his appreciation to the Jinshan District Government for their continuous support and cooperation to achieve a mutually beneficial situation. “Asymchem has always put technology development first and expands into innovative biologics business based on service needs in the small molecule CDMO market. Asymchem will continue its plan to explore the use of green pharmaceutical technology to meet increasing clinical needs for the benefit of patients and society as a whole”, stated Dr. Hong.
Dr. Hao Hong, Chairman & CEO of Asymchem, delivers a speech
Quanquan Zhang, on behalf of Jinshan District Committee of the Communist Party of China and Jinshan Government, highlighted Asymchem’s contribution to the development of the biopharmaceutical industry of the Jinshan District. “Both Shanghai Municipality and Jinshan District governments highly uphold the development of biophamaceutical industry. Jinshan government is improving its industry portfolio to offer attractive environments for investment and will seek more opportunities to collaborate with Asymchem to promote the development of the biopharmaceutical industry in Jinshan District.”
Quanquan Zhang, Deputy Head of Jinshan District, delivers a speech
Expansion into Biologics CDMO Field
The global innovative biologics market is experiencing rapid development. Recent years Evaluate Pharma forecasted that the global logistics market will rise to $32.6 billion by 2022 with a CAGR of 8.3%. Frost & Sullivan reported that China’s innovative logistics market will reach 326.9 billion yuan by 2021 with a CAGR of 16.4%. While many well-known innovative drug companies focus heavier on biomacromolecules, there are over 900 types of biologics in the pipeline of the largest 18 pharma companies in the world. The current landscape of biologics promises continued growth for the CDMO industry.
As a leading CDMO, AsymChem is well known to have rich experience in development and production of peptide, nucleotide and other synthetic drugs. Asymchem is now expending expertise to the field of biologics such as Monoclonal Antibody, Bispecific antibody and Fusion proteins. Since 2018, Asymchem has conducted early phase studies of biologics through collaboration between pilot scale production platform in Tianjin and Shanghai Jiao Tong University (The Innovative Biological Technology Laboratory). The establishment of the Development Center marks expansion into biologics CDMO field, which will provide a truly integrated one stop services from CMC to clinical research for our customers.
Guests visit the Development Center
Highly Qualified Staff and Advanced Equipment
Shanghai Asymchem Biotechnology is focused on innovative drug development and GMP production. The development center currently provides services including Cell line construction/Clone screening/Cell banking, Cell culture process development, Downstream purification process development, Formulation development, Drug Product fill/finish process development and Analytical method development. Asymchem Biotechnology owns state-of-the-art equipment including Solentim VIPS ™Automatic Monoclonal Plating Tester, Fortébio Affinity Sensors, Sartorius Stedim Ambr ™ Biolector, GE AKTA Avant150 High-Throughput Purification Screener, Unchianed Labs Uncle High-Throughput Protein Stability Tester, SHIMADZU Q-TOF High-Resolution Mass Spectrometer, ProteinSimple cIEF full-column imaging capillary tubes. With this advanced technology platform, AsymChem Biotechnology is capable of providing true one stop CDMO services for development and GMP production for monoclonal antibody, fusion protein, bispecific antibody and other biologics.
Asymchem has successfully passed the inspection of itsproduction sites more than ten (10) times by the US FDA (Food and DrugAdministration), Australian TGA (Therapeutic Goods Administration), and ChinaNational Medical Product Administration. The International Conference onHarmonisation (ICH) guideline Q9, Q10 and Current Good Manufacturing Practice are/willbe applied to the Development Center and the production platform. Additionally,the highly experienced team will work closely to solve the technology andregulatory challenges to ensure on-time delivery of high-quality drugs.
With the opening of Shanghai Asymchem Biotechnology, Asymchemexpands its service from preclinical research to commercial production of thesmall molecule API, small molecule Drug Product to biologics Drug Substance andDrug Product. Meanwhile, Clinical CRO services of AsymChem’s Tianjin TechnologyInnovation Center for Clinical Research, improve the innovative drug serviceecosystem throughout the period from the IND (Investigational New Drug)application to NDA (new drug application), thus enhancing its capabilities inCMC and Clinical Research. These added capabilities allow Asymchem to remain aleader in the CDMO space and create sustainable business growth while providinghigh quality services.