Key points of investment
CT053 has been successfully commercialized, and Phase II of the CT041 is being promoted domestically, and NDA is expected. We are optimistic that the company is a leading global solid tumor CAR-T company, and that commercialization of CT053 and CT041 pipelines one after another will bring growth.
CT053: Domestic commercialization begins, looking forward to expansion
Keji Pharmaceutical received a notice from the State Drug Administration on March 1, 2024 to approve Sikaize with conditions? New drug marketing application (approval date February 23, 2024) for the treatment of adult patients with recurrent or refractory multiple myeloma who have progressed after at least 3 previous treatment lines (at least one proteasome inhibitor and immunomodulator has been used). More than 100 patients have been enrolled in the R/R MM phase 2 trial (NCT03915184) in North America. Due to CMC-related issues at the Research Triangle Park (RTP) production facility in Durham, North Carolina, this study has been requested by the FDA to suspend clinical trials. Based on the analysis of clinical data on the safety and efficacy of CT053 in our in-depth report “Keji Pharmaceutical: The First Tier of Solid Tumors, a CAR-T Leader with Promising Potential”, we are optimistic about the prospects for CT053 cooperation and decentralization between domestic and Huadong Pharmaceuticals.
CT041: The NDA is expected in 2024. It is expected that the US will restart the CT041 trial conducted by Keji in China, including investigator-initiated trials, phase Ib clinical trials for advanced GC/GEJ and PC in China, and confirmatory phase II clinical trials for advanced GC/GEJ, and phase I clinical trials for PC-assisted treatment in China. The company plans to submit an NDA to the NMPA by the end of 2024. In May 2023, the phase 2 portion of the CT041 phase 1b/2 clinical trial began advanced GC/GEJ trials in the US and Canada. Due to CMC-related issues at the RTP manufacturing plant, the study has been requested by the FDA to suspend clinical trials. The company revealed that as of the disclosure date of the annual report, CT041 is the world's first CAR-T cell candidate to enter phase II clinical trials for treating solid tumors. We are optimistic that CT041 domestic confirmatory phase II clinical trials will continue to advance, and look forward to restarting clinical trials after the US CMC issue is resolved.
Profit forecasting and valuation
Considering that CT053 US enrollment progress and CT041 US BLA progress were slightly lower than our previous expectations, we lowered the company's 2024-2025 sales forecast. However, considering that the company's core product CT053 has successfully been commercialized domestically, the CT041 is leading the way in the world, and revenue elasticity after commercialization, we maintain a “buy” rating.
Risk warning
Risk of clinical failure, risk of competition, risk of product sales falling short of expectations, regulatory risk, policy risk.