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Samyang Biopharmaceuticals Corporation successfully launched its anti-cancer treatment drug Azacitidine Injection in the EU for the first time as a Korean company Scrap Facebook Scrap Twitter Print
Writer administrator Hits 3838 2021.01.05

- Obtained marketing authorization for its myelodysplastic syndrome (MDS) drug Azacitidine Injection 100 mg and 150 mg
- To begin export to 17 EU countries including Germany in the first quarter of the next year and take strategy differentiating with two doses
- Improved international credibility with authorization from rigorous drug regulatory authorities in Germany to expand globally

 

▲ Samyang Biopharmaceuticals Corporation’s myelodysplastic syndrome (MDS) drug Azacitidine Injection 100 mg (left) and 150 mg (right)

 

Samyang Biopharmaceuticals Corporation, a biomedical affiliate in the Samyang Group, successfully launched its anti-cancer treatment drug Azacitidine Injection in the EU for the first time as a Korean company.

 

Samyang Biopharmaceuticals Corporation (CEO & President Eom Tae-ung) announced on December 28 that the company obtained marketing authorization for two doses of its myelodysplastic syndrome (MDS) drug Azacitidine Injection 100 mg and 150 mg from German drug regulatory authorities. MDS is a type of rare incurable blood cancer caused by abnormalities with the process of producing blood in marrow, which decreases the numbers and functions of blood cells such as red blood cells, white blood cells, and platelets below a normal level.

 

With this authorization, Samyang Biopharmaceuticals Corporation will begin exporting to Germany and expand its exports to 16 countries in Europe in the first quarter of the next year (France, Spain, Italy, Sweden, Austria, Norway, Denmark, Finland, Ireland, Netherlands, Poland, Iceland, Malta, Czech Republic, Bulgaria, and Slovakia). Under the decentralized procedure (DCP), a company is given the authority to export to EU member states after it completes the national phase. The national phase checks whether translation is correct and accurate in the label and package insert.

 

Samyang Biopharmaceuticals Corporation has launched two doses—100 mg and 150 mg—in an effort to differentiate itself from other competitors only currently providing 100 mg in the European market. The dosage of the anti-cancer drug is determined based on the patient’s body surface area, reducing a financial burden for the patient and making it easier for health professionals to prepare the drug.

 

Azacitidine Injection is a MDS drug (local Korean drug name: Vidaza Injection) developed by the multinational pharmaceutical Celgene. According to IQVIA, a global pharmaceutical market research firm, the azacitidine market in the EU last year was about KRW 500 billion. The MDS Foundation also estimates that the world has 87,000 new patients annually.

 

An official from Samyang Biopharmaceuticals Corporation said, “We obtained authorization from drug regulatory authorities in Germany whose authorization process is rigorous even within the EU, and this has improved our international credibility. Samyang Biopharmaceuticals Corporation is recognized in the global market as the only Korean company certified with both EU and Japanese GMP (good manufacturing practice) for cytotoxic anti-cancer injections.”

 

Samyang Biopharmaceuticals Corporation obtained EU GMP for drug substances in 2005 and finished products in 2014 and has maintained the practice up until today. In 2010, the company acquired GMP certification from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Last year, the company received review by the German Ministry of Health and Consumer Protection (Behörde für Gesundheit und Verbraucherschutz; BGV) in Hamburg, Germany, renewed EU GMP for 4 injections—Paclitaxel, Oxaliplatin, Docetaxel, and Pemetrexed—and acquired new authorization for Azacitidine Injection.

 

Meanwhile, Samyang Biopharmaceuticals Corporation began to expand its cytotoxic anti-cancer injection factory last year to boost its global contract development and manufacturing organization (CDMO) business. Currently, a factory whose expected total capacity covers 5 million vials including 4 million liquid injection vials and 1 million lyophilisation vials is being expanded in Daejeon.


 

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