China's First Trastuzumab Biosimilar Han Quyou Approved By NMPA

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the trastuzumab biosimilar Han Quyou (HLX02, EU brand name: Zercepac), developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). On 27th July, Zercepac has also been approved by the European Commission (EC), making HLX02 the first China-developed mAb biosimilar to be approved both in China and in the EU. The common name of Han Quyou 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, which corresponds to all the indications approved in China of the trastuzumab originator. 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.

Under the leadership of Henlius’ co-founders Dr. Scott Liu and Dr. Weidong Jiang, the development and manufacturing process of Han Quyou (HLX02, EU brand name: Zercepac) is also in line with international standards to ensure it meet the requirements to serve patients around the globe. During the development process of Han Quyou, Henlius strictly followed the NMPA and European Medicines Agency (EMA) biosimilar guidelines and has taken multiple head-to-head comparisons between Han Quyou 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 Han Quyou 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 Han Quyou and has adopted single-use technology for its manufacturing, leading to decreased risk of contamination and increased production efficiency. Manufacturing site of Han Quyou 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 Han Quyou, Henlius has built a professional and efficient international commercial team and established an innovative commercial model. With the launch of Han Quyou, Henlius will always put patients in the first place and continue cooperating with various partners to improve the diagnosis and treatment of HER2-positive patients, to gradually approach the goal of leaving no HER2 positive patient behind.

Professor Binghe Xu, principal investigator of the international multi-centre Phase 3 clinical study of Han Quyou, said, "Han Quyou is the first China-developed biosimilar that has been evaluated in an international multi-centre Phase 3 clinical study. The Phase 3 study confirmed that there is no clinically meaningful difference between Han Quyou and reference trastuzumab. The approval of Han Quyou will improve the accessibility of trastuzumab in China and further strengthen the standardised treatment of patients with HER2-positive breast and gastric cancer."

Mr. Wenjie Zhang, President of Henlius, said, “Han Quyou 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 Han Quyou. We hope that Han Quyou will benefit HER2-positive breast cancer and gastric cancer patients both in urban and rural areas in China, and bring patients new hope and additional treatment options.”

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 Han Quyou was approved by NMPA in 2019, making it the first biosimilar in China. Now we are proud that Han Quyou can benefit Chinese patients. The recognition of Han Quyou 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 and taking corporate responsibility to benefit our society.”

Mr. Qiyu Chen, co-CEO of Fosun International, Chairman of Fosun Pharma and Chairman of Henlius, said, "The approval of HLX02 both in China and in the EU is the result of ten-year's hardworking of Henlius. We sincerely appreciate the great contributions made by Henlius team and the trust and support from our society. We will value quality as our core competency and bring quality products to more patients, and we will also keep pushing forward the development of the biopharmaceutical industry."

Looking forward, with its core values of “Affordable Innovation · Reliable Quality”, Henlius will actively accelerate the R&D and commercialisation of more biosimilars and innovative biologics that are developed and made in China and are of international quality, highlighting the company’s vision of becoming the most trusted and admired biotech company in the world.