Luye Pharma Group announced that its biopharmaceutical drug 博优诺®(Bevacizumab Injection), developed by the Group’s holding subsidiary Boan Biotech, has received marketing authorization from China’s National Medical Products Administration (NMPA), for the treatment of advanced, metastatic or recurrent non-small-cell lung cancer (NSCLC), and metastatic colorectal cancer. 博优诺® is the third biosimilar of Avastin® to enter the market in China, as well as the first product from Boan Biotech’s pipeline to receive marketing authorization.
博优诺®and Avastin® are Equivalent in Efficacy - Bevacizumab is a Standard Therapy for the Treatment of Multiple Cancers
The marketing approval for 博优诺® is based on the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars issued by the NMPA’s China Center for Drug Evaluation in February 2021. 博优诺®and Avastin® were compared head-to-head in two pivotal clinical studies - the first was a pharmacokinetic(PK) study among healthy subjects, and the second was a comparative study of efficacy and safety in metastatic or recurrent non-squamous NSCLC patients. Both studies met primary endpoints, demonstrating that 博优诺® and Avastin® are equivalent in efficacy and highly similar in terms of PK characteristics, safety, and immunogenicity.
As a classic anti-angiogenic oncology drug, Bevacizumab is considered standard therapy and is recommended by a number of guidelines worldwide for treating multiple malignant tumors. The drug is indicated for the treatment of NSCLC, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, and other solid tumors worldwide, with its efficacy and safety widely recognized by physicians and patients through its long-term clinical use. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars, all indications for Avastin® approved in China can also be gradually applied to 博优诺®.
In addition, the combination of Bevacizumab and paclitaxel provides unique advantages in treatment. 博优诺® can be used with Luye Pharma’s core product paclitaxel liposome injection (Lipusu®) to achieve a good synergy effect.
Preparing to Market 博优诺® - Meeting Patient Needs
According to data from the World Health Organization’s International Agency for Research on Cancer, the number of new cancer cases reported in 2020 in China was 4.57 million, the highest in the year and accounting for 23.7% of the total in the world. Lung cancer and colorectal cancer are the two cancers with the highest incidence rate in China, with 820 thousand and 560 thousand new cases each, respectively. Based on the high and ever-increasing number of patients in these two disease areas, the approval of 博优诺® is expected to help patients gain access to high-quality medication and address unmet needs.
Meanwhile, Bevacizumab Injection has been included in China’s National Reimbursement Drug List, further increasing accessibility. As the third biosimilar of Avastin® to enter Chinese market, 博优诺® is expected to have optimistic prospects. According to the data from IQVIA, global sales of Bevacizumab Injection totaled USD 6.09 billion, with sales in China accounting for RMB 3.63 billion in 2020.
Through comprehensive leverage of its expertise along the whole industry value chain, Boan Biotech has been active in the preparation for 博优诺® entering the market, in manufacturing, sales team building, market access channels, and other areas. In addition, Luye Pharma Group's long-term accumulated resources and expansive networks in the field of oncology are also expected to bring synergetic effects to enable the success of 博优诺®.
Boan Biotech’s Rapid R&D Pipeline Development – Efficiency in Innovation
Boan Biotech’s antibody discovery research is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, and ADC Technology. By leveraging its efficient and innovative capabilities, the company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar products including 博优诺®
Jiang Hua, Chief Executive Officer of Boan Biotech, said：We are delighted to see 博优诺®become the first product from Boan Biotech’s pipeline approved for marketing, and hope it will bring benefit to patients in need of high-quality and affordable anti-angiogenic treatment. The approval of 博优诺® is an important milestone for us and validates our efforts in the field with a tangible and substantial payoff.Focusing on the development of biopharmaceuticals, we hope to further accelerate R&D progress with more innovative products, serving more patients in China and around the globe.
In addition to 博优诺®, Boan Biotech has a series of biopharmaceutical products in various stages of clinical development, including LY-CovMab, an innovative antibody for the treatment of COVID-19, which has completed phase I clinical trial in China and is soon to start the phase II clinical trials in China, the U.S. and Europe. Other Boan Biotech biosimilar products are expected to bear fruit in the near future. Phase III clinical trials in China for LY06006 (a biosimilar of Prolia®) are nearing completion, with final administration of the drug completed for all the subjects, and the drug already receiving approval for clinical trials in Europe and the U.S. LY01011 (A biosimilar of Xgeva®) is undergoing phase III clinical trials in China and phase I clinical trials in Europe and the U.S., and LY09004, a biosimilar of Eylea® is also undergoing phase III clinical trials in China.
博优诺®(Bevacizumab Injection) is a recombinant humanized immunoglobulin G1(Ig G1) monoclonal antibody which targets vascular endothelial growth factor (VEGF). The drug inhibits VEGF from binding to VEGF receptor-2(VEGFR-2) by binding VEGF-A, resulting in inhibition of the biological effects of VEGF, including effects on vascular permeability, proliferation, and endothelial cell migration and survival, continuously inhibiting the angiogenesis, growth, and metastasis of tumors.