China Approves Henlius' Biosimilar Trastuzumab

Shanghai Henlius Biotech reached another regulatory milestone as China’s National Medical Products Administration (NMPA) approved its trastuzumab biosimilar (HLX02; Zercepac [European name]) for marketing.

The product in late July also was approved by the European Commission. These regulatory nods make HLX02 the first monoclonal antibody developed in China to be approved in both China and the European Union.

The biosimilar is indicated for the treatment of HER2-positive early stage breast cancer, HER2-positive metastatic breast cancer, and HER2-postive metastatic gastric cancer. These indications correspond to the approved indications in China for the trastuzumab originator product, which has been included on China’s National Reimbursement Drug List since 2017.

Henlius said that results from analytical studies, preclinical studies, a phase 1 clinical study, and a global multicenter phase 3 clinical study demonstrated that HLX02 “is highly similar to the reference trastuzumab in terms of quality, safety and efficacy.”

“The approval of HLX02 will improve the accessibility of trastuzumab in China and further strengthen the standardized treatment of patients with HER2-positive breast and gastric cancer," said Binghe Xu, principal investigator of the phase 3 study.

Wenjie Zhang, president of Henlius, said HLX02 marks the second of the company’s products approved for launch. The first was a rituximab biosimilar (HLX01), launched in China and marking that country’s first approved biosimilar. The approval for this drug, used in oncology and for autoimmune diseases, came in February 2019.

In April, the company announced that its new drug application for a denosumab biosimilar was accepted for review by the NMPA. The drug is intended for the osteoporosis market.