Author：Luye Life Sciences
Luye Pharma Group announced that the marketing authorization application for the company's oncology product, LY01008 (Bevacizumab injection), has been accepted by the China Center for Drug Evaluation of National Medical Products Administration. LY01008 is a biosimilar of Avastin® indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer.
A leading anti-angiogenic oncology drug, Bevacizumab is a standard therapy recommended by global guidelines for treating multiple malignant cancers and also ranks as one of the top 10 best-selling drugs in the world. According to public financial reports, Avastin® achieved sales of 7.07 billion Swiss francs globally in 2019, while according to IQVIA its 2019 sales in China were RMB2.88 billion.
The application for LY01008 was based on clinical data generated from two clinical comparative studies with Avastin®, the first a pharmacokinetics ("PK") study in healthy subjects, the second a comparative study of efficacy and safety in metastatic or recurrent non-squamous non-small-cell lung cancer patients. Both studies met pre-defined primary endpoints, demonstrating that LY01008 and Avastin® are similar in terms of PK and equivalent in efficacy.
LY01008 is indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer. Patient numbers show that lung cancer and colorectal cancer are the most common and the third most common cancers in China. There were about 774,000 new lung cancer cases in China in 2018. Non-small-cell lung cancer accounts for approximately 85% of all lung cancers. Colorectal cancer is the third most common cancer in China after lung cancer and gastric cancer, with 429,000 estimated new cases and 281,000 deaths in 2018. Due to the huge and rapidly increasing number of patients, medications available to treat this disease rank far short of those required.
LY01008 has stolen a march on the competition by filing the marketing authorization application in China. With an expected increase in market players to come, the size of the market for the biosimilars of Bevacizumab will grow steadily in China—this will also help to alleviate the financial pressure on patients. According to a report by Frost & Sullivan , with the ongoing launch of biosimilars and the use of Bevacizumab in combination with other drugs, the size of the Chinese market for Bevacizumab is expected to reach RMB 17.7 billion by 2030.
As a broad-spectrum monoclonal anticancer drug, Bevacizumab has a unique advantage when being used in combination with other drugs. It can be used in combination with paclitaxel-based chemotherapy drugs including paclitaxel liposome, and multiple related indications have been approved in China and abroad. A Luye Pharma Group management representative said: "We will actively drive the launch and commercialization of LY01008. The company will employ its strength in marketing and its wide market coverage in oncology therapy to support the future launch of LY01008, and build a powerful synergy with existing products."
In addition to LY01008, Luye Pharma also has a series of antibody drugs under development, including both biosimilars and innovative biological drugs. In China, LY06006 (a biosimilar of Prolia®) is under Phase III clinical trials, and both LY09004 (a biosimilar of Eylea®) and LY01011 (a biosimilar of Xgeva®) are under Phase I clinical trials. In addition, Luye Pharma is also using its in-house antibody development platforms such as the "human antibody transgenic mouse" and collaborating with multiple cutting-edge overseas biotech companies to develop the next-generation innovative antibodies in immuno-oncology and increase the pipeline and supply of new biologics. Currently, Luye Pharma has established a complete industry chain covering R&D, manufacturing and commercialization in the biopharmaceutical field.