4 registered clinical trials of KN04 6 continue to advance, and listing applications are expected to be submitted in 2023: as of August, 4 registered clinical trials continue to progress, (1) Phase 3 clinical trials of squamous NSCLC have completed mid-term analysis, and OS data have been followed up continuously; (2) Phase 3 clinical patients with pancreatic cancer are enrolled in more than 50% of patients, and 90% of patients are expected to complete the group by the end of the year. (3) Phase 2 of PD- (L) 1 NSCLC after treatment is in the dose exploration stage, and the dose exploration phase is expected to be completed by the end of the year. (4) the phase 2 clinical trial of thymic cancer is in progress. In addition, the company expects to apply for phase 3 of KN046 combined with lenvatinib in the treatment of first-line HCC within this year. At the same time, the company plans to submit BTD applications for pancreatic cancer and HCC within this year based on phase 2 clinical results.
The clinical registration of KN026 starts one after another, involving second-line GC, first-line GC and first-line BC:
In January, the registration clinical approval of KN026 monotherapy for second-line GC was approved, and the first patient administration was achieved in April. In August, the registered clinical application of KN026 combined with KN046 without chemotherapy regimen for the treatment of first-line GC was accepted and is expected to be approved in the near future. In addition, the company plans to launch a registered clinical trial of KN026 combined with chemotherapy to treat first-line BC within this year.
In June, the first patient administration was achieved in the first phase of KN052 (PD-L1/OX40). Phase 1 clinical trial of JSKN003 (HER2 double anti-ADC) is underway in Australia. Both molecules are developed based on the company's proprietary technology platform. Follow-up development progress is worth looking forward to.
It has received a considerable amount of revenue based on KN035 sales, and the net loss has narrowed significantly: in the first half of the year, the company has based on KN035 sales of about 53.57 million yuan in sales revenue and franchise use income.
In the first half of the year, R & D expenditure was about 220 million yuan, down about 6.7% from the same period last year, mainly because some existing projects have entered the final stage and some new projects are still in the early stages of start-up. The net loss in the first half of the year was about 147 million yuan, a sharp drop of about 44.9% compared with the same period last year. At present, the cash in the company's account is about 1.709 billion yuan.
Profit forecast and valuation: we predict that the company's revenue from 2022 to 2024 will be about 167.36, 296.51 and 1122.22 yuan respectively, an increase of 14.61%, 77.17% and 278.48% over the same period last year. We maintain our buy rating with a target price of HK $15.11.
Risk tips: research and development and sales of KN046, KN026, KN035 and KN019 are lower than expected, competition in the field of treatment of products intensifies, and excessive R & D investment leads to a shortage of funds.