Highlights

Asymchem to invest in biologics CDMO R&D and commercialization production base in Fengxian, Shanghai

On March 4, 2022, Asymchem signed an investment agreement with Shanghai Industrial Complex Development Zone Co., Ltd. and plans to invest RMB 3 billion to build a biologics CDMO R&D and commercial production base in Fengxian, Shanghai. The agreement signifies Asymchem’s commitment to expand into biologics, further enhancing its biologics CDMO service capability. Read more.

Asymchem and Hillhouse jointly fund the layout of biologic CDMO field, and started a comprehensive, in-depth strategic cooperation

Recently, Asymchem, Hillhouse and Tianjin Haihe Asymchem Biopharmaceutical Industry Innovation Investment Fund reached a consensus to jointly invest RMB 2.5 billion to build Shanghai Asymchem Biotechnology Co., Ltd. into a global leader in the field of CDMO for biologics and advanced therapeutics. The fund will rely on respective resource advantages in the field of industrial ecology as well as the capital market to launch a comprehensive and in-depth strategic cooperation. In the future, AsymBio will leverage the rapidly growing global biologics and advanced therapeutics CDMO market with its high-level one-stop specialized R&D and manufacturing services. Read More.

 

Technology Updates

Asymchem continues to enhance crystallization process research for high quality drug development

Recently, Asymchem’s crystallization engineering lab introduced a series of online equipment, using Easyviewer, Particle Track, and ReactIR to build a crystallization research platform. In one project, the technical staff redeveloped the reaction-coupled crystallization technology by integrating the crystallization with the previous reaction step to achieve the separation of reaction and crystallization in one step. As a result, the product purity was increased to 99.2%; the content of three key impurities was reduced to 0.07%, 0 and 0.20% respectively. The steps were reduced from 3 to 1. The amount of solvent was reduced by 57%, reducing the impurity content, improving the purity, simplifying the process steps and effectively reducing production costs.

Asymchem and Mersana collaborate to realize commercial process development and production of Auristatin F-HPA/TFA

Recently, Asymchem published a paper in the academic journal Org. Process Res. Dev. (Impact Factor 2021: 3.3) – Process Development and GMP Production of a Conjugate Warhead: Auristatin F-HPA-Ala/TFA (XMT-1864/TFA). The work completed in collaboration with Mersana resulted in a high yield, high quality, commercially available process that successfully produced in multiple batches of 1Kg size in the high activity plant (OEB5) of Asymchem. Additionally, commercial production validation was completed. The product with purity >98% and all isomers <0.5% in >60% yield meets the requirements of subsequent registration.

Asymchem successfully develops aminotransferase mutants, receives patent approval

Asymchem successfully developed aminotransferas mutants based on the directed evolution technology platform and obtained the patent (CN110205310B). The modified aminotransferase has not only high activity but also high stability. These characteristics can be applied to synthesize chiral amines with large spatial site resistance under high temperature, high pH and high solvent conditions, and can effectively solve the problem of difficult catalysis caused by poor solubility of substrate, as well as solve the problems of reverse equilibrium and product inhibition during the reaction (Cov.>99%).

 

Fixed Assets Investments

Asymchem TJ sites construction continues on schedule

  • 25% of the TJ west biofermentation plant project has been completed, the R&D center and the comprehensive building have been topped out.
  • The design of TJ CMMD plant has been completed, the site construction team has entered the plant, the completion rate is 5%.
  • 50% of the design of TJ3 north side plot has been completed, the comprehensive building, R&D center and power station have been topped out, the roof of warehouse 3, 4 and 5 have been poured, the design of API 4 module has been completed.
  • 20% of the oligonucleotide joint venture plant project has been completed, the main body of the R&D center and the comprehensive building have been poured, the foundation of the power station and production module have been completed.
  • DH1 8998 reconstruction project is steadily progressing and expected to be delivered in May. The addition of one production chain in module 7 of building 2 and equipment replacement are completed.
  • 60% of the installation work of module 16 of DH1 new building 5 is completed and half of the equipment is expected to be put into operation at the end of April; 84% of the construction of the comprehensive building is completed.
  • The completion of these projects will further enhance Asymchem’s production capacity, better meet the internal demand for raw materials, and effectively strengthen the supply chain management and security.

 

Newly Joined Talent

Mr. Qi Yin joined Clin-nov Medical in March 2022 as CSO (Chief Strategy Officer) and US Head. He is responsible for the strategy and business direction of Clin-nov in China and Boston, and for integrating resources to achieve business goals; he is also responsible for the development planning and team management of Clin-nov’s US business, helping the company business capacity to grow rapidly. Mr. Yin graduated from Peking University Medical Center, majoring in pharmacology, and completed the MBA New Power Program of the International Institute for Management Development and China Europe International Business School in 2012. He worked at Novartis Biomedical Research Center in China and Novartis Biomedical Research Center in Cambridge, Massachusetts, USA, as Head of Clinical Sciences in Asia Pacific and Global Head of Clinical Sciences Infection, Cardiovascular and Metabolism, respectively, as well as Director of Strategic Planning for Translational Medicine. With extensive experience in strategic planning and tactical direction, he has led the development and implementation of a three-year strategic plan for the establishment of a Center of Excellence for Early Development Ecosystems in Asia to drive translational medicine from traditional Western Europe and North America to the emerging Asia-Pacific region. He also worked on cross-functional project teams in neuroscience, cardiovascular, metabolic, and respiratory disease areas on regulatory affairs, participated in design reviews, and provided regulatory strategy on the full lifecycle of project development.

Mr. Jie Tian officially joined Asymchem as Vice General Manager of AsymBio on 1st March, 2022, reporting to AsymBio CEO Mrs Rui Yang (cc AsymBio CTO Dr. Kai Gao). Mr. Jie Tian will be fully responsible for operations management of AsymBio, including promoting the implementation of the strategy from operation management and team building. Recommending top-talents. Promoting organization ability, consummating the management system. Improving management system and insuring daily work orderly. Tracking the implementation of specific work, in charge of daily affairs of Human Resources Administration Department and team management in AsymBio. Mr. Jie Tian, accomplished his bachelor’s degree in electrical engineering of Beijing University of Aeronautics and Astronautics in 2004. He was employed in ManpowerGroup, JNJ(Johnson&Johnson), Tencent as Human Resources Department director. He has also been in executive positions in various entrepreneurial organizations. He has rich experiences in business platform construction, innovation system construction, capacity building and operation management of fast-growing organizations in large companies.