Introduction to this report:
Sikaize was approved for listing. Huadong Pharmaceutical helped it commercialize doses. CT041 is expected to submit an NDA for treatment of at least 3L gastric cancer by the end of this year. It is optimistic about the company's long-term development and maintains an “increase” rating.
Summary:
Maintain an “Overweight” rating. The company released its 2023 annual report, with a net loss of 748 million yuan (loss of 144 million yuan); an adjusted net loss of 733 million yuan (loss of 115 million yuan), due to reduced employee remuneration and R&D expenses through shares; the total amount of cash and its equivalent and term deposits was 1,850 million yuan, a decrease of -18.4% compared to the same period last year (-18.4%) due to payment of R&D expenses, administrative expenses and capital expenses. Taking into account the down payment and milestone income, we adjusted the 2024-2025 revenue to $215/308/million (previously 1.12/4.70), and added a forecast of 2026 revenue of $506 million, maintaining the “incremental” rating.
Seckaize was approved for listing, and Huadong Pharmaceutical helped it commercialize it. On March 1, 2024, Sekaize (Zewokiolense injection, CT053) was approved for marketing to treat ≥3L r/RMM. Huadong Pharmaceutical helped commercialize it. The company has received 200 million payments from the head of state and some milestone payments, and is expected to confirm part of the revenue in this year's statements. The 3-year follow-up data of the phase I clinical trial of CT053 was presented at the 2023 ASH conference. The results showed that CT053 had an ORR of 100%, 92.9% of patients had a survival period of more than 3 years, overall safety was good, and no CRS of grade 3 or higher occurred. More than 100 patients have been enrolled in the phase II clinical trial (LUMMICAR-2) for the treatment of r/r MM in the US and Canada. Since the RTC production plant in North Carolina had CMC-related issues and was requested by the FDA to suspend clinical trials, the company's global factory has sufficient production capacity. As the CMC problem rectification is completed, the RTP plant will further support clinical research and early commercialization in North America and Europe.
CT041 treatment for gastric cancer ≥3L is expected to submit an NDA in China by the end of this year. CT041 treatment for gastric cancer ≥3L is expected to complete phase II enrollment in China in 2024H1, and an NDA will be submitted in China at the end of 2024. IND was approved in April 2023 for post-operative adjuvant treatment of CLDN18.2+ pancreatic cancer patients. In May 2023, a phase II trial began in the US to treat CLDN18.2+ advanced GC/GEJ patients who failed at least 2L, but clinical trials were temporarily suspended due to CMC issues.
Catalyst: CT053 launched, commercial sales exceeded expectations, clinical data disclosure
Risk warning: Uncertain risk of product marketing, risk of uncertainty in new drug development.