Chemas, a local pharmaceutical company, said that it has completed its preparation to conduct clinical trials for CM7919, a new cancer treatment candidate, in Germany.
As preparations, the company entered into a contract manufacturing organization (CMO) agreement with a German drug manufacturer and commissioned a global contract research organization (CRO) company to conduct a clinical trial in Germany.
Chemas said that it would apply for a clinical trial with the German Food and Drug Administration, and will select a clinical hospital and recruit patients to conduct the trial in the first half of 2020,
Thirty European countries cross-recognize the results of screenings by the European Medicines Agency (EMA) through a community licensing system, making it easier to enter other European countries after German clinical trials.
In the long term, the company plans to enter the U.S. and China. Clinical results in Germany can also be submitted to the U.S. Food and Drug Administration under the mutual recognition agreement) between the United States and Germany, which allows for a shorter procedure.
“The main raw material of CM7919, an arsenic arsenide (As4O6), is a new polymorphic inorganic compound,” the company said. “We have applied for or registered 80 patents related to the substance in the U.S., EU, China, and Japan.”
The company is pushing the new drug under development as an orphan drug, it added.
Chemas CEO Kim Tae-sik said, “Everything is ready for manufacturing from raw materials to finished products in Europe to advance the candidate substance into a global new drug. As we have already confirmed the anti-cancer effect of CM7919 through various researches, we plan to conduct the clinical trial in 2020 swiftly.”
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