China’s First Trastuzumab Biosimilar Approved by NMPA

Shanghai Henlius Biotech, Inc. (2696.HK) announced on August 14 that the trastuzumab biosimilar HLX02, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). On 27th July, HLX02 (EU(Nyheter) brand name Zercepac®) has also been approved by the Europe(Nyheter)an Commission (EC), making HLX02 the first China-developed mAb biosimilar to be approved both in China and in the EU. The common name of HLX02 is trastuzumab injection (150mg/vial, without preservative) and it is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer. Trastuzumab has been included in China’s National Reimbursement Drug List (NRDL) in 2017. According to the “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 that have been listed in the NRDL will automatically enter the NRDL.

During the development process of HLX02, Henlius strictly followed the NMPA and European Medicines Agency (EMA) biosimilar guidelines and has taken multiple head-to-head comparisons between HLX02 and the reference trastuzumab. Results from analytical studies, preclinical studies, a Phase 1 clinical study and a global multi-centre Phase 3 clinical study showed that HLX02 is highly similar to the reference trastuzumab in terms of quality, safety and efficacy. Henlius has implemented the concept of QbD (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. Manufacturing site of HLX02 and its quality management system have passed multiple on-site inspections and audits by NMPA, EMA, EU Qualified Persons (QP) and international business partners of Henlius, and have obtained China and EU GMP certificates. To accelerate the commercialisation of HLX02, Henlius has built a professional and efficient international commercial team and established an innovative commercial model.

Dr. Scott Liu, co-founder and CEO of Henlius, said, “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. The recognition of HLX02 by domestic and international regulatory authorities is the results of insisting the quality standards of Henlius, and Henlius will continue making efforts in providing affordable and effective therapies for patients worldwide.”

Mr. Wenjie Zhang, President of Henlius, said, “HLX02 is the second product successfully approved for launch of 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.”

Source: Henlius