China’s first and only CAR-T product with CD20 target approved for registration clinical application
China Biotech Services Holdings Limited (“CH BIOTECH SER” or “Company”, stock code: 8037.HK) non-wholly-owned subsidiary Shanghai Longyao Biotechnology Co., Ltd. ( “Shanghai Longyao”) received an approval letter from the National Medical Products Administration for a clinical trial of the Company’s LY007 Cellular Injection on January 21, 2021, which is registered as a Class I new drug. LY007 Cellular Injection is mainly used for the treatment of non-Hodgkin lymphoma. It is currently the first and only CD20-targeted CAR-T product whose application for a registered clinical trial has been approved in China.
LY007 Cellular Injection is a chimeric antigen receptor T-cell (CAR-T) injection and is mainly used in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and metastatic follicular lymphoma. LY007 Cellular Injection has beenwas developed independently by Shanghai Longyao and incorporates its patented OX40 co-stimulatory signal design. Experiments have proved that the design enhances the efficacy of the Product without compromising safety. According to the clinical trial application of LY007 Cellular Injection, Shanghai Longyao will commence Phase I clinical trial and study of LY007 Cellular Injection based on the submitted proposal.The National Medical Products Administration’s approval of Shanghai Longyao’s clinical trial application for LY007 Cellular Injection demonstrates Shanghai Longyao’s capabilities in the research and development of immunocellular drugs.
According to a research report issued by China Merchants Bank on CH BIOTECH SER on November 20, 2020, the analyst recommended to watch for the results of the LY007 Cellular Injection clinical trial which could enhance the company’s market value. The report also pointed out that the company’s current market capitalization is slightly less than US$200 million while market capitalization of CAR-T comparable companies listed on the main board of the Hong Kong Stock Exchange is between US$600 million and US$1.4 billion. The current market value of CAR-T comparable Chinese companies listed on NASDAQ is approximately US$3.5 billion.