Trastuzumab biosimilar HLX02 approved by NMPA

China-developed mAb biosimilar first to be approved by both NMPA and EC

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SHANGHAI—Shanghai Henlius Biotech, Inc. announced recently that the trastuzumab biosimilar HLX02, which was independently developed and manufactured by Henlius, has been approved by the National Medical Products Administration (NMPA). HLX02 — which will go by the brand name Zercepac in the EU — was approved by the European Commission in late July. HLX02 is the first China-developed mAb biosimilar to be approved in both China and the EU.
HLX02 is a trastuzumab injection (150mg/vial, without preservative) indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer. Trastuzumab was included in China’s National Reimbursement Drug List (NRDL) in 2017. According to “Interim Measures for the Administration of Drugs in the NRDL,” drugs in the NRDL are managed by their common names, and drugs with common names which have been listed in the NRDL will automatically enter the reimbursement list.
“As the leading company in the biologics industry of China, Henlius’ self-developed rituximab biosimilar HLX01 was approved by the NMPA in 2019, making it the first biosimilar in China. Now we are proud that HLX02 can benefit Chinese patients,” said Dr. Scott Liu, co-founder and CEO of Henlius. “The recognition of HLX02 by domestic and international regulatory authorities is the result of insisting [on strict] quality standards … Henlius will continue making efforts in providing affordable and effective therapies for patients worldwide.”
During the development process of HLX02, Henlius says that the company stringently followed the NMPA and European Medicines Agency (EMA) biosimilar guidelines. Henlius has undertaken multiple head-to-head comparisons between HLX02 and the reference drug,  trastuzumab. Results from analytical studies, preclinical studies, a Phase 1 clinical study and a global multi-center Phase 3 clinical study showed that HLX02 is highly similar to trastuzumab in terms of quality, safety and efficacy.
Henlius has implemented the concept of quality by design in process development for HLX02, and has adopted single-use technology for its manufacturing — leading to decreased risk of contamination and increased production efficiency. The manufacturing site of HLX02 and its quality management system has passed multiple on-site inspections and audits by the NMPA, the EMA, EU Qualified Persons and international business partners of Henlius; the site has also obtained both China and EU GMP certificates.
“HLX02 is the second product successfully approved for launch [from] Henlius, and the first product that has received recognition from international drug regulatory agency. We are very grateful to all the physicians, nurses, patients and regulatory authorities that have contributed to or supported the studies of HLX02. We hope that HLX02 will benefit HER2-positive breast cancer and gastric cancer patients both in urban and rural areas in China,” commented Mr. Wenjie Zhang, president of Henlius.

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