Welcome to this week's FiercePharmaAsia report, which includes stories about an international antibiotic agreement, SK Bioteck's ambition to become a leading CDMO, Japanese firm JSR's acquisition of Swiss cell line developer Selexis, and more.
The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the U.S. FDA have agreed to align their data requirements for clinical development of new antibiotics, with the aim to boost development of new treatments. Antibiotic resistance and a lack of new meds in this area have increasingly become a major concern for governments.
SK Biotek, a unit of South Korea’s third-largest conglomerate SK Holdings, has aspirations of becoming a leading global CDMO. To achieve that, it has purchased an API plant in Ireland from Bristol-Myers Squibb. The company will continue to produce the products currently made there, including the API for Eliquis. SK indicated last year that it was working on several deals to buy API sites in the U.S. and Europe.
The life sciences unit of Japanese conglomerate JSR Corporation is acquiring mammalian cell line developer Selexis. Switzerland-based Selexis excels in CHO-K1 cell line generation and has a comprehensive cell line development program called SUREtechnology Platform. JSR will combine its operations with CDMO KIB Biopharma, which it bought in 2015.
Korean biotech Orum Therapeutics has raised $8 million in series A to advance its cell-penetrating antibody technology and its monoclonal antibody. The company said in Nature last month that systemic administration of the mutant RAS protein had selective anti-tumor activity in early-stage animal models for human colorectal cancer and fibrosarcoma.
Rare disease genetic diagnostic specialist Centogene has raised $28 million to expand its presence in the U.S. and China. The company has also talked up its plans to secure FDA 510(k) clearance for its CentoMD database of rare disease genotypes and phenotypes. Centogene picked up a CE mark for the database in 2015. Management boasts of having analyzed samples from 110 countries.