Incident: The company recently issued an announcement to release two clinical data at the American AACR Annual Meeting.
The OS results of the lung cancer trial were impressive, and clinical data on gastric cancer was released for the first time. The company now released two phase 2 clinical data for lukansastuzumab (previously SKB264): 1) The latest efficacy and safety results of a phase 2 study on patients with advanced non-small cell lung cancer (NSCLC) who have previously been treated. This data is a further update of the data disclosed at the 2023 ASCO Conference. As of the data cutoff date, 22 patients with EGFR mutations had MdOR of 8.7 months, mPFS of 11.5 months, and MoS of 22.7 months. Among 21 EGFR wild-type patients, MdOR was 9.6 months, mPFS 5.3 months, and MoS was 14.1 months. 2) Preliminary efficacy and safety results of a phase 2 study in patients with advanced gastric cancer or esophagogastric junction cancer who had previously been treated. As of the data cutoff date, ORR was 22.0% and DCR was 80.5% in 41 patients with efficacy evaluations. The ORR for 2L and 3L+ patients was 27.3% and 15.8%, respectively. MDor is 7.5 months. In 3L+ patients with long follow-up time (24 patients, 54.2% of whom had previously received at least 4 lines of treatment), mPFS was 3.7 months and MoS was 7.6 months.
Phase 3 clinical trials of 3L+ gastric cancer can be expected globally. According to the announcement, the company is currently planning to conduct a global phase 3 study on lukansastuzumab monotherapy versus standard chemotherapy for patients with 3L+ gastric cancer or esophagastric junction adenocarcinoma. Previously, the company and partner MSD had already started a global phase III clinical trial for multiple lung cancer indications. It is expected that after the phase III clinical trial for gastric cancer begins, the company will receive milestone payments from MSD. The related clinical layout is expected to further expand the global market space for lukansastuzumab.
Profit forecast and rating: The company's revenue for 2024-2026 is estimated to be 1.14 billion yuan, 15.6 billion yuan, and 2.44 billion yuan, respectively. The company's core products can be expected to be launched, and overseas giants will cooperate to escort overseas and maintain the “buy” rating.
Risk warning: R&D progress falls short of expectations, risk of market competition, risk of health insurance fee control exceeding expectations.