March 9, 2023 PAO-02-23-CL-07
As a technology-driven CDMO, Asymchem is differentiated from most of our peers and competitors in that the company invests in technology development on a continual basis and views that technological evolution as central to what we offer our customers, today and into the future. R&D spending is higher at Asymchem than most other CDMOs in China and elsewhere. The investments in technology are essential to attracting clients with projects that require specialized capabilities, not just basic outsourcing services, and these are the kinds of customers that we view as key to our continuing growth, particularly as the fraction of programs that require specialized support services continues to increase. As labor costs climb in China, Asymchem will leverage advanced technologies and specialized technical capabilities as key differentiators, because, for many drug candidates today, the best and most cost-effective solutions can only be provided through the use of advanced technologies.
Currently, two key technology areas for the company are enzymatic transformations and flow chemistry for small molecule manufacturing. Going forward, additional advanced technologies will be integrated into our offering to address evolving customer needs for support for both small molecules and biologics development and manufacturing. Synthetic biology is one area for which we are currently exploring customer demand and the ways in which it could be most effectively incorporated into our offerings. Before technologies are selected for further development at Asymchem, significant research is conducted to assess their application potential and technical feasibility. As a result, while there is no certainty that the technologies will be chosen for use in the future, the company is reasonably confident that they will be valuable to clients and will continue to monitor closely.
This forward-looking philosophy at Asymchem is not limited to technology development. The company has become more diversified over the past 20 years, particularly with respect to the number of international customers that we work with. In addition, while we initially focused on small molecule production on behalf of large pharma customers, Asymchem’s services have expanded to small biotech companies and new modalities, including peptides, oligonucleotides, and other biologics, for which significant growth is anticipated in the coming years.
These changes have created the need for Asymchem to establish a truly global footprint. A large number of emerging biotech and biopharma firms that have limited internal resources and need the support of technically advanced and savvy CDMO partners are located in the United States, increasingly in a relatively small number of active biotech hubs. These potential customers require significant support, ideally locally given their limited resources. That led Asymchem to consider options for establishing a foothold in a biotech hub in America — initially evaluating a few major hubs, including San Francisco and San Diego, California, or Boston, Massachusetts.
The decision to establish the R&D center in the Boston area — specifically in Woburn, Massachusetts — was a clear one. There are more biotech companies within this hub pursuing a wide range of modalities, including oligonucleotides, peptides, mRNA, gene editing, and so on. This type of lively and interactive hub represents one of the primary sources of innovation in the industry and presents Asymchem with significant opportunities to interact with potential clients and attract their attention. Access to a highly trained talent pool and the ability to attract skilled workers to the vibrant Boston area were other factors.
Asymchem initially started as a contract manufacturing organization (CMO) offering large-scale and commercial production services. Clinical-stage development capacities and capabilities were added later. With the new Boston-based R&D Center, the company is expanding into early-stage projects, performing process chemistry and preformulation development work to support preclinical animal studies and first-in-human (FIH) clinical studies.
The location of the site will enable close collaboration with U.S.-based clients, within the Boston biotech hub and beyond, and the ultimate offering will be a small but comprehensive chemistry manufacturing and controls (CMC) package. The goal is to support emerging, largely virtual biotech companies that do not have many employees but have innovative ideas that can offer new therapeutic options and help the industry to advance. These firms can leverage Asymchem’s expertise, lab facilities, and technologies at the Woburn site to bring those ideas to fruition.
For successful candidates progressing to clinical-stage development, the large-scale GMP manufacturing can then be cost-effectively implemented at the main facilities in China. As such, one role for the Boston site will be to liaison between U.S. biotech companies and the headquarters in Tianjin, introducing new clients to our network and simplifying tech transfers as programs scale.
Opening the R&D Center in the Boston area is just one step on Asymchem’s planned globalization journey. After this site is operational for a year or two and the company has gained a greater understanding of the potential in the U.S. biotech market and the opportunities available to Asymchem, an additional, larger space for GMP production will be established. That facility may be obtained through acquisition, but it could also be a greenfield plant built to suit. The specific location has yet to be selected. The United States is the current focus, particularly the Boston biotech hub, but Asymchem is not ruling out options in Europe, as the company hopes to expand its presence in that region as well in the coming years.
Dr. Steven Hu serves as CTO and CBO of Asymchem and is responsible for new technology development and business development. Before joining Asymchem, Dr. Hu was the CTO of Everest Medicines, where he was responsible for CMC, supply chain, and technical operations. He grew the team from inception and was responsible for the in-license of eight drugs. Before joining Everest, he was the senior director and head of CMC at Roche Pharm Research and Development Shanghai, heading process research and synthesis, analytical, preformulation, and formulation development. Prior to Roche, he was the director of new product development of GSK China R&D, overseeing the management of the entire drug product development life cycle from formulation development and optimization, process development, and scale-up to technology transfer and commercial manufacturing. Dr. Hu obtained his Ph.D. in chemical engineering from Brown University and conducted postdoctoral research at MIT.