IKAIDA has been approved for listing in China, favoring the overall development of the CAR-T cell therapy industry
On June 22, 21, 21, the National Drug Administration officially approved a new drug marketing application for Fosun Kate's CD19-targeting CD19 CAR-T cell therapy product iKaida (Achilenexide injection) to treat adult patients with recurrent or refractory large B-cell lymphoma (r/r LBCL) after receiving second-line or higher systemic treatment. According to reports, the price of iKaida is about 1.2 million yuan (or 200,000 US dollars) per bag, which is lower than the US (about 370,000 US dollars) and Japan (about 310,000 US dollars). Although the unit price of CAR-T is high as a customized product, we believe that the approval of IKAIDA this time reflects the FDA's support for innovative therapies and drugs in response to unmet medical needs. The CAR-T cell treatment pipeline currently being carried out in China includes: 1) JWCAR029 (accepted by the Drug Administration's BLA in the first half of '21); 2) CT053 by Kozimei (phase 2/3 clinical trials in progress, or submitted BLA in China and the US separately in 22/23); and 3) Cinda Biotech's IBI326 (critical phase 2 clinical trials in progress for the treatment of recurrent refractory multiple myeloma). Promoting differentiated CAR-T pipelines to clinical stages The company's first CAR-T cell therapy pipeline, LY007, was clinically approved by the National Drug Evaluation Center on January 21. LY007 is a differentiated CAR-T cell therapy. Clinical research on recurrent and hard-to-treat B-cell non-Hodgkin lymphoma will commence. According to research published in “Scientific Translational Medicine” in the US, LY007 targets CD20 and uses a full fragment OX40 co-stimulation signal design to enhance cytotoxicity to tumors and maintain therapeutic function in immunosuppressed tumor microenvironments. Based on its unique mechanism of action, the company believes that LY007 has the potential to obtain positive signals in solid tumors, and the vast majority of existing CAR-T cell treatments have no significant curative effect on solid tumors.
COVID-19 testing continued to drive performance growth in the first quarter of '21
Revenue in the first quarter increased about 11 times year over year and recorded a net profit of HK$27 million (compared with a net loss of HK$25 million in the same period last year), mainly driven by Hong Kong's COVID-19 testing business, such as rapid testing at airports.
Comparable company valuations and catalysts
The company currently has a market capitalization of about 200 million US dollars, while the market capitalization range of clinical-stage CAR-T comparable companies listed on the main board of the Hong Kong Stock Exchange is 1.2 billion to 2.2 billion US dollars. Comparable to the Nasdaq-listed Chinese company, the current market capitalization of CAR-T is about 5.6 billion US dollars. Future key catalysts include phase 1 clinical results of LY007.