- China’s First Trastuzumab Biosimilar 汉曲优®Approved by NMPA
- Release Time: Aug 14, 2020
Shanghai, China, 14th August, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the trastuzumab biosimilar 汉曲优® (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 汉曲优® 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 汉曲优®(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 汉曲优®, Henlius strictly followed the NMPA and European Medicines Agency (EMA) biosimilar guidelines and has taken multiple head-to-head comparisons between 汉曲优® 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 汉曲优® 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 汉曲优® and has adopted single-use technology for its manufacturing, leading to decreased risk of contamination and increased production efficiency. Manufacturing site of 汉曲优® 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 汉曲优®, Henlius has built a professional and efficient international commercial team and established an innovative commercial model. With the launch of 汉曲优®, 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 汉曲优®, said, "汉曲优® 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 汉曲优® and reference trastuzumab. The approval of 汉曲优® 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, “汉曲优® 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 汉曲优®. We hope that 汉曲优® 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 汉利康® was approved by the NMPA in 2019, making it the first biosimilar in China. Now we are proud that 汉曲优® can benefit Chinese patients. The recognition of 汉曲优® 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 innovaton and 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.
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monocolonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. After 汉利康®(HLX01, rituximab) was launched commercially, 汉曲优® (HLX02, trastuzumab, EU brand name: Zercepac®) also has been approved in the EU and China, becoming the first China-developed mAb biosimilar approved both in the EU and China. Up to date, in addition to 2 products launched successfully and 1 product (HLX03 adalimumab) to be potentially launched within 2020, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions.