Asymchem holds inauguration ceremony for new innovation centers
On June 24th Asymchem held a joint inauguration ceremony for the Institute for Advanced Pharmaceutical Materials (IAPM), Center of Drug Delivery and Formulation (CDDF), Center of Biological Technology and Innovation (CBTI), and Center for Clinical Research Technology Innovation (CTRI). The launch of the new technology innovation centers, combined with previously established technology centers (CBST, CEPS, CFCT, CIMT), make up eight technology centers dedicated to the development of cutting-edge and crucial future technologies. The centers support Asymchem’s strategy supporting a new GXP one-stop service engine of “GMP-GLP-GCP”.
The first Science and Technology Advisory Committee of Clin-nov Medical formed
In order to better integrate resources in the industry and further enhance the strength of the one-stop service, Clin-nov Medical initiated the establishment of the “Clin-nov Science and Technology Advisory Committee”. The committee is comprised of experts, scholars, and entrepreneurs within the pharmaceutical industry. The goal is to utiliz the professional guidance and advice of the experts to promote long-term development. Additional goals are to provide comprehensive clinical research services and solutions for global pharmaceutical innovation enterprises, in order to reduce R&D risks, shorten R&D cycles and save R&D costs.
Summit Dialogue: Survival Strategies for Biotech Companies During a Capital Winter
On June 17, the sixth online forum of “China New Drug – Biotech Companies’ Survival Strategies in a Capital Winter” was successfully held. The forum was hosted by Dr. Xinhui Hu, CTO & CBO of Asymchem. Attendees included founders of Biotech companies and senior investors from investment institutions. The participants discussed “The biggest challenges faced by Biotech companies in China today & How can Chinese Biotech companies cope with the upcoming capital winter.”
Liu Jian, Secretary of Shanghai Jinshan District Party Committee along with other officials visited AsymBio
On June 8, Liu Jian, secretary of Shanghai Jinshan District Party Committee, Zhai Jinguo, Vice Mayor of Shanghai Jinshan District, and other top officials, visited AsymBio in Shanghai. They carried out a study on “epidemic prevention, economic stability and safety security” along with the situation of epidemic prevention and control. Dr. Gao Kai, Chief Technical Officer of AsymBio, attended the meeting and presented a detailed report on related issues.
Highly Efficient Production of Optically Active (R)-Tetrahydrothiophene-3-ol in Batch and Continuous Flow by Using Immobilized Ketoreductase
Recently, Asymchem published the paper “Highly Efficient Production of Optically Active (R)-Tetrahydrothiophene-3-ol in Batch and Continuous Flow by Using Immobilized Ketoreductase” in the American Chemical Society Journal Org. Process Res. Dev. The results of this study were independently completed by the enzyme immobilization team at the Center for Biosynthesis Technology (CBST). The immobilized ketoreductase developed for the enzymatic synthesis of (R)-Tetrahydrothiophene-3-ol can be reused multiple times and successfully applied to continuous flow reactions, significantly improving production efficiency and demonstrating the company’s outstanding strength and leadership in enzyme engineering and enzyme immobilization technology.
The Continuous Flow Synthesis System and Method of Trimethylsilyl Acetylene Developed by Asymchem Receives Patent Authorization
The continuous flow system developed by Asymchem includes Grignard reagent continuous preparation unit, acetylene Grignard reagent continuous synthesis unit and the trimethylsilyl acetylene continuous preparation device. The use of these methods and continuous flow synthesis system for the preparation of trimethylsilyl acetylene not only reduces the production cost and shortens the cycle time, but also improves the safety of the entire process.
Asymchem TJ Sites Construction Project
R&D center, comprehensive building, power station and warehouse supporting works are expected to be delivered in August
R&D center and power station have been topped out
TJ3 North site
design is 90% completed
the R&D center’s fifth, sixth and seventh floor laboratories and analytical room areas were completed.
The installation of laboratory fume hoods and central duct on the fourth floor, the exterior wall coating of the power station, equipment piping such as air conditioning chillers in the power station, and the electrical installation are all complete.
20% complete along with the main body of R&D center and comprehensive building has been sealed.
Several Construction Projects Completed for the DH Sites
DH1 Building 5, module 16 installation project and the new comprehensive building project have been completed; 8998 project renovation works of DH1 are steadily progressing, 2 new production lines of Building 6 have been delivered, one new production line of Building 2, module 7 has been basically completed. Air conditioning and DCS system verification remain.
DH2 50 vertical tank area installation project is complete.
DH3 raw material site construction project has delivered each single unit of the first phase project, the second phase of construction (No. 4 building), piping installation and reactor piping are 80% complete. HVAC engineering ventilation has overall completion of 85%, electrical, instrumentation engineering bridging are 90% complete.
After the completion of the project, the production capacity of the company will be further enhanced to better meet the internal demand for raw materials and effectively strengthen the supply chain management.
Clin-nov Medical helps cStem’s “Human Umbilical Cord Mesenchymal Stem Cell Injection” enter Clinical Trials
On May 26, the official website of the CDE showed that the new drug “Human Umbilical Cord Mesenchymal Stem Cell Injection” (acceptance number CXSL2200114) submitted by Shanghai cStem for ARDS receives implied permission for clinical trials. As a leading CRO in cellular drug therapy, Clin-nov participated in the project and provided preclinical project support, medical and registration filing services. The new drug is a Class 1 biologic product independently developed by cStem. The team provided important support to the project in solving key problems in the research process and IND registration filing.
Dr. XINHUI (Steven) HU, joined Asymchem in June 2022 as Chief Technology Officer (CTO) and Chief Business Officer (CBO), responsible for Asymchem’s technology and commercial development.
Dr. Hu assists the company’s Chief Executive Officer (CEO) and Co-Chief Executive Officer (Co-CEO) in technology development and US market development and management. Establishing and leading the Boston R&D center, participating and assisting the company in strategic planning and organizational implementation from both technical and business perspectives. He provides support for the development of new layouts and directions for the company. He received his Ph.D. from Brown University in the U.S., followed by a postdoctoral fellowship at MIT. He served as the Chief Technology Officer of Everest Medicines and was fully responsible for the company’s CMC R&D, technical operations, supply chain management and manufacturing base construction; from 2013 to 2018 Dr. HU worked at Roche Shanghai R&D Center as Senior Director of Pharmacology, responsible for Roche’s pharmacological research and new technology development in the field of antiviral. From 2005 to 2013, he worked in innovative drug research and development at GlaxoSmithKline, Merck, Johnson & Johnson, and other well-known multinational pharmaceutical companies. Dr. HU has participated in or led several small molecule and biologic drugs from preclinical to commercial stages of pharmacological research. He has published several papers in core journals such as J.Pharm.Sci, OPR&D, etc.
Ms. Yang Qiang, joined Kainuo Pharmaceuticals on June 13, 2022 as Senior Director of Pharmacovigilance Department.
In this role, Ms. Yang will be responsible for setting up a pharmacovigilance system that is carried out in order in accordance with regulations, procedures and systems; establishing a pharmacovigilance team to provide support in pharmacovigilance strategies, and bidding for project development and manage pharmacovigilance projects in an all-round manner. She will also facilitate the rapid development of Clin-nov Medical’s capabilities in pharmacovigilance management.
She graduated from Huazhong University of Science and Technology with a master’s degree in pharmacology, Ms. Yang has worked for Shanghai Miaoyi Biological Technology Co., Ltd. as the Pharmacovigilance Director. In general, she has nearly 15 years of work experience in pharmaceutical companies, covering a wide range of fields from pharmacovigilance, quality management in clinical trials to drug research & development. Specifically, pharmacovigilance almost accounts for two thirds of her work experience, which mainly includes the establishment of pharmacovigilance system. Moreover, Ms. Yang is familiar with laws and regulations on pharmacovigilance and clinical trials, and has been responsible for more than one hundred global and regional projects. She has led her team in providing clinical trial service and pharmacovigilance service for about two hundred projects at home and abroad, covering oncology, rheumatology and immunology, endocrinology, cardiovasology, pain, infection and many other areas.