Henlius and Accord Healthcare Receive European Approval for Biosimilar Trastuzumab

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The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

Shanghai Henlius Biotech (Henlius) and partner Accord Healthcare have received approval from the European Commission for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab), that was developed and manufactured by Henlius. The approval covers the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer, the companies announced in a July 29, 2020 press release. Roche’s Herceptin is one of the company’s blockbuster drugs, reaching over CHF 6 billion (US$6.5 billion) in 2019 sales (1).

Henlius stated in its press release that Zercepac (HLX02) is the first monoclonal antibody (mAb) biosimilar developed in China that has successfully entered the market in the European Union (EU). The development and manufacturing process of Zercepac (HLX02) is in line with international standards, the company stated in the press release. The company’s manufacturing facility in Xuhui, China, and quality management system have been certified by the EU as being good manufacturing practices (GMP) compliant.

"I’m very glad to see that an international drug regulatory authority has acknowledged the efficacy and safety of Henliu’s self-developed biosimilar, which also means our clinical trial is of international standard. I’m looking forward to seeing more HER2 positive breast cancer and gastric cancer patients benefiting from China-developed trastuzumab in more countries and regions,” said Binghe Xu, principal investigator of an international multi-center Phase III clinical study of Zercepac (HLX02), in the press release.

"The approval of Zercepac in the EU is a significant milestone of our global strategy. This achievement announces that our capability in the development and manufacturing of biologics has reached international standards. In the future, Henlius will provide more high-quality biologics as new treatment options to benefit patients worldwide,” said Scott Liu, co-founder and CEO of Henlius, in the press release.


“With Zercepac, our first mAb, we firmly establish our expertise in bringing high quality complex medicines to market—to ensure improved patient access and to provide cost effective alternatives to overstretched health systems,” Paul Tredwell, vice-president, Speciality Brands, Europe, Middle East, and North Africa, Accord Healthcare, added in the press release.


1. Roche, “Finance Report 2019,” roche.com/investors, March 2020.

Source: Shanghai Henlius Biotech