“Symposium on the Development of Nucleic Acid Drug Innovation and Localization of Core Technologies”
December 4, Beijing – the “Symposium on Development of Nucleic Acid Drug Innovation and Localization of Core Technologies” hosted by the China Society of Drug Regulation and organized by Asymchem was held. The conference took advantages of both online and live opportunities, inviting leaders from NMPA and relevant institutions, academicians from the Chinese Academy of Sciences, as well as experts and scholars from universities, industry associations and biopharmaceutical companies. Attendees of the symposium discussed the development trend of nucleic acid drug innovation and the road to localization of core technologies, including key equipment. Additionally, experts discussed commercialization of domestic pharmaceutical process equipment and how the chinese oligonucleotide synthesizer can rapidly promote the R&D transformation of independent intellectual property rights of nucleic acid drugs.
Asymchem completed its listing on the Hong Kong Stock Exchange
December 10, Hong Kong– Asymchem (stock code: 002821.SZ/6821.HK) was listed on the Main Board of the Hong Kong Stock Exchange for a public offering of H shares. The issue price was HK$388.00 per share, with a total of approximately 18,415,400 shares issued, raising net proceeds of approximately HK$6,850 million. The proceeds from the H-share offering will be used to further strengthen global operations, increase capacity and capability of small molecule CDMO, strengthen emerging services and expand service offerings, invest in R&D projects, and selectively make strategic investments and acquisitions to maintain technology leadership, diversify service types and expand global footprint.
Asymchem successfully passed the US FDA on-site GMP inspection
Recently, an innovative API project of a well-known domestic pharmaceutical company served by Asymchem successfully passed the US FDA on-site GMP inspection. This US FDA review, which was notified just three working days in advance without naming the target product (close to a flight inspection), was triggered by the marketing application in the US of said drug. Asymchem successfully passed this inspection, which further validates Asymchem’s sound quality management system and cGMP production capability in compliance with international standards, and its ability to provide services from clinical to commercial production for US and China dual reporting.
Asymchem Ketone Reductase Mutants Patent Granted
Asymchem’s self-developed ketone reductase was granted a patent (CN 110713992 B). Asymchem has developed a new ketone reductase through enzyme evolution technology, which can efficiently and stably synthesize high purity chiral alcohols (Conv. >99%, ee >99%), which are difficult to synthesize chemically, by the reduction reaction of acetophenone derived compounds.
Asymchem High-efficiency Peptide Biosynthesis Platform Established
Asymchem establishes a biosynthesis platform for DNA recombinant expression and purification of peptides, which enables efficient biosynthesis of a wide range of pharmaceutical peptides. After a simple 2-3 step purification, peptides with >97% purity and yields >3.5mg/g wet cells can be obtained. This technology greatly reduces the cost of purification and increases the yield of peptides at the same time.
Asymchem’s In-house Developed Oligonucleotide Synthesizer Operational
The Asymchem self-developed OS50 (synthesis capacity 0.2mmol~4mmol/column) is now comparable with OP100 in terms of quality, and the synthesis outcome is comparable to that of OP100, which has been applied in laboratory R&D. The OS1000 (synthesis capacity 40mmol/column) has been successfully validated and put into the production of CpG series compounds. The successful application of OS50 and OS1000 synthesizers has opened the pathway of domestic replacement of synthesizers from laboratory R&D to pilot-scale production. Meanwhile, the OSkilo of larger synthesis capacity is also in plan, and the application of this series of synthesizers will greatly enhance Asymchem’s rapid delivery capability in the field of oligonucleotides.
Fixed Assets Investments
Tianjin Site Construction Ongoing
To increase production capacity, improve operational efficiency and meet the growing needs of new business expansion, Asymchem’s TJ sites have been undergoing upgrades and additions. Below is a summary of progress.
90% of new Kg-scale laboratory on the first floor of TJ2 Building 12 is completed
25% of TJ3 north side plot is completed. Building 3, 4 and 5 foundation construction is completed, backfill completed.
10% of TJ West bio-fermentation plant is completed, and the foundation of R&D center and comprehensive building is completed.
10% of Ribo joint venture plant is completed, and the foundation of R&D center is completed, conceptual design of production plant is basically completed.
TJ West CMMD plant is 30% completed.
The completion of the plant will help to increase capacity, improve operational efficiency, and lay a solid foundation for carry out company strategy smoothly.
Renovations and Construction at Asymchem’s DH1, DH2, and DH3 Plants
DH1 8998 project related renovation works are steadily progressing.
the renovation of 2 production lines in Building 5 has been completed.
the renovation of 1 production line in Building 6 has been completed, and 2 new production lines in Building 6 are expected to fully start construction at the beginning of January.
the installation works in the reserved area of Building 7 is 85% completed, and the DCS system SAT has been done.
the installation work of the new Building 5 module 16 is 30% completed.
the construction of the comprehensive building is 79% completed, and the main structure is finished.
Project of 50 vertical tank farm installation completes 99%, PSSR rectification and site detailing completed.
construction of the raw material plant area is 60% completed, the construction of each single unit of the first phase of the project has been completed, and another 2 sets of new incinerators are planned.
The completion of projects above will further enhance production capacity, better meet the internal demand for raw materials, and effectively strengthen the supply chain management and security.