Incident: The company released its 2023 annual report, with a net loss of 750 million yuan, a decrease of 140 million yuan compared to 890 million yuan in 2022. As of December 31, 2023, cash and cash equivalents amounted to $1.85 billion.
The core product Saikaize was approved for listing. Sekaize (Zewokie Orense injection, CT053) was approved and marketed by the State Drug Administration on March 1, 2024. It is used to treat adult patients with recurrent or refractory multiple myeloma, which progressed after at least 3 lines of treatment (at least one proteasome inhibitor and immunomodulator had been used); the R/R MM phase 2 trial (NCT03915184) conducted in North America has enrolled more than 100 patients. 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.
CT041 is undergoing clinical research on gastric cancer and pancreatic cancer. CT041 is a potential global first-of-its-kind autologous CAR-T candidate targeting CLDN 18.2. is being developed for clinical treatment of CLDN 18.2 positive solid tumors such as gastric cancer/gastroesophageal junction cancer and pancreatic cancer. CT041 is undergoing phase Ib trials in China for advanced gastric cancer/esophagastric junction adenocarcinoma and PC, and in confirmatory phase II clinical trials for advanced GC/GEJ. In April 2023, CT041 received IND approval from the National Drug Administration for adjuvant treatment of pancreatic cancer (PC) with positive Claudin 18.2 expression (CT041-ST-05, NCT05911217); CT041 initiated phase II clinical trials in the US in May 2023 to treat GC/GEJ patients with positive Claudin 18.2 expression who failed at least second-line treatment. Due to CMC-related problems in RTP production plants, this study was conducted by FDA Request a moratorium on clinical trials.
Global production capacity continues to expand, and vertically integrated production capacity has been established at three key stages of manufacturing. The company has established internal vertically integrated production capacity for the three key stages of CAR-T manufacturing, including plasmid production, lentiviral vector production, and CAR-T cell production, and continues to expand global production capacity in China and the US.
Through a clinical production plant in Xuhui, Shanghai, and a commercial GMP manufacturing plant in Jinshan, Shanghai, we can independently produce CAR-T cell products to support clinical trials in China. The Triangular Research Park CGMP manufacturing plant in Durham, North Carolina has begun GMP production of autologous CAR-T cell products. Additional production capacity for autologous CAR-T cell products can be produced for 700 patients each year, which will be used to support clinical research and early commercialization in the US, Canada and Europe.
Profit forecast: With the approval of the company's core products CT053 and CT041 for listing, we expect the company's revenue for 2024-2026 to be 100 million yuan, 300 million yuan, and 700 million yuan, respectively.
Risk warning: R&D progress falls short of expectations, commercialization of core varieties falls short of expectations, policy risks.