Henlius Hanlin obtained the EU GMP certificate

Henlius announced on April 23 that the company ’s Shanghai Xuhui production site has successfully passed the EU GMP on-site verification of HLX02 Trastuzumab Antigen Solution (DS) and Preparation (DP) lines, and was officially awarded the Polish Health Inspection Agency Chief Pharmaceutical Inspector Two EU GMP certificates issued (Certificate of GMP Compliance of a Manufacturer).

This is also the second domestic manufacturing base to obtain EU GMP certified biopharmaceutical enterprises after WuXi Biologics, andHenlius Xuhui Base has also become the first GMP factory in China to obtain EU GMP certification for the production of self-developed antibody biopharmaceuticals HLX02 trastuzumab has also become the first domestic biosimilar drug that has obtained the European Union GMP certification.

Trastuzumab antigen is researched as Herceptin of Gene Tek & Roche, mainly used to treat HER2-positive breast cancer patients test. The results of clinical studies prove that in patients with HER2-positive relapsed or metastatic breast cancer, HLX02 and original trastuzumab have similar efficacy and safety.

The EU is the earliest region in the world to formulate guidelines for biosimilar drugs, and it is also the major global market for biosimilar drugs. After obtaining the EU GMP certification, HLX02 can be mutually recognized and shared among nearly 30 member countries, and it can also share the verification results with countries such as the United States and Canada that have signed a mutual recognition agreement (MRA).

However, it still takes some time until HLX02 is officially approved for listing in the EU. In June 2019,Henlius and Accord jointly promoted HLX02 to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA). The interface reporter said that after completing the EU GMP certification, HLX02 will need to submit some additional information in the follow-up to the market. At that time, HLX02 trastuzumab will be the first self-developed domestic biopharmaceutical to be approved for listing in the EU.

In terms of sales in overseas markets, Fuhong Hanlin has also made a good layout in advance. It has successively reached cooperation with foreign biopharmaceutical companies such as Accord, Cipla, Mabxience and Jacobson Pharmaceutical to promote HLX02 in more than 100 countries The commercialization of the region. The EU market will be promoted by Accord, which has the exclusive commercial rights of HLX02 in more than 70 countries and regions.

In November 2019, BeiGene's Zebutinib was approved in the United States and became the first domestically made new anti-cancer drug "out to sea". The number of "out to sea" is still zero on the more difficult macromolecular biological drugs. However, innovative pharmaceutical companies includingHenlius, Beiji China, and Junshi Biology have already made arrangements, on the one hand to carry out global clinical trial research, on the other hand to find overseas partners for rights and interests licensing. Just recently, Hengrui Pharmaceutical licensed its Carrilizumab commercial rights in South Korea to South Korean CG Company.