Taiwan's major biotech manufacturing service provider Mycenax Biotech plans to buy some new drug testing platforms and a small cell strain supplier primarily in the US and Japan in 2019.
Mycenax is also actively looking for global partners as it aims to expand overseas in the next two years.
Mycenax, which is focused on developing and manufacturing new biologic entities and biosimilars, also announced the positive results from a Phase I PK clinical trial of LusiNEX (Mycenax tocilizumab biosimilar).
Results show that LusiNEX matches the profiles of originator products marketed in the European Union as RoActemra, and the USA as Actemra by Swiss pharma giant Roche.
“We are planning to apply for the scientific advises to European Medicines Agency and Japan Pharmaceuticals and Medical Devices Agency in the first quarter of 2019 to finalize the multinational Phase III study design with the goal of being granted for both intravenous and subcutaneous dosage forms,” said Karen Wen, president at Mycenax Biotech.
There are currently no tocilizumab biosimilars approved, the company said, adding that LusiNEX can become a new affordable alternative for patients suffering from lots of immunology and musculoskeletal disorders including rheumatoid arthritis.
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