Biomedical unicorn gets access to overseas market

2020-04-28 Browse times: 116

Shanghai biomedical unicorn Henlius announced recently its Xuhui base has obtained two EU GMP certificates issued by the Polish Health Supervision Agency after it passed the on-site GMP inspection of HLX02 trtozumab raw solution (DS) and the preparation line (DP).

Insiders said this is another major breakthrough in China's biomedical industry to get the Certificate of GMP Compliance of a Manufacturer.

A source with Henlius said the certification marks the base has become China's first GMP factory to obtain the certificate for production of the independently developed antibody biological drug.

The source said the HLX02 trautuzumab has also become the first domestic biological similar drug which has obtained the EU GMP certificate.

It means that Henlius has possessed a commercial production base and a quality management system in line with EU standards, breaking the GMP barrier for the overseas sale of domestic monoclonal antibody biological drugs, the source added.

HLX02 has gone through the phase three clinical trials and is expected to be used to treat HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

Early February 2019, Henlius' first product of Rituximab injection was approved by China's State Food and Drug Administration to become the first biosimilar drug to be marketed in China.

The source said the HLX02 trastuzumab has entered into the new drug marketing application priority review process and is expected to be launched this year.

Liu Shigao, co-founder and CEO of Henlius, said the company will fully promote the global commercialization process of HLX02, playing the “world cup”on behalf of China to compete with the world's top biopharmaceutical companies from Europe, the United States and South Korea.

Liu said Henlius has carried out the international commercialization layout for HLX02 by cooperating with the world's first-class biopharmaceutical enterprises to promote the commercialization process of HLX02 in more than 80 countries and regions.