Zhongtai: The global Phase III clinical trial of Pimientinib has achieved success, maintaining a "Buy" rating for ABBISKO-B (02256).

Zhongtai released a research report, maintaining the "buy" rating for ABBISKO-B (02256), predicting that the company's total revenue, other income, and income for the years 2024-2026 will be 560 million yuan, 640 million yuan, and 690 million yuan respectively, with net profits of 2 million yuan, 30 million yuan, and 60 million yuan. The company plans to launch a listing application for pimicotinib for treating TGCT in key regions in 2025. Based on the high proportion of European and American patients in the MANEUVER study, the achievement of major endpoints, and the product competitiveness shown in clinical research results, Merck's exercise of overseas selection rights for pimicotinib is expected. This will further open up the overseas market for pimicotinib while improving the company's cash flow. Zhongtai's main points are as follows: Event: On November 12, 2024, the company announced that the MANEUVER pivotal Phase 3 study of the company's self-developed CSF-1R small molecule inhibitor pimicotinib for the treatment of Tenosynovial Giant Cell Tumor (TGCT) patients achieved top-line results, as well as the latest results of a Phase 1 study of pimicotinib for treating TGCT. The MANEUVER study met its primary endpoint, and the submission of pimicotinib for listing is imminent, with the exercise of overseas selection rights by partners expected. Zhongtai pointed out that the key Phase III MANEUVER study is a randomized, double-blind, placebo-controlled clinical trial, divided into three stages, aimed at evaluating the efficacy and safety of pimicotinib in TGCT patients who meet systemic treatment conditions and have not received anti-CSF-1/CSF-1R therapy. The study is being conducted in China (n=45), Europe (n=28), and the United States and Canada (n=21), with the primary endpoint being the 25-week ORR of the first stage. The data showed: at 25 weeks, pimicotinib's objective response rate (ORR) was 54.0%, while the placebo group was 3.2% (p<0.0001). Compared to the placebo group, the study also showed statistically and clinically significant improvements in all key secondary endpoints evaluated at the 25-week mark, including ORR based on tumor volume scores, active joint mobility, stiffness, pain levels, and functional status. The tolerability of once daily oral pimicotinib treatment is good, with a very low rate of treatment discontinuation due to treatment-related adverse events. Compared with non-head-to-head clinical study results, pimicotinib demonstrates therapeutic advantages over similar products already marketed in the United States, such as Pexidartinib, and similar products like Vimseltinib in the FDA marketing approval stage for TGCT (the ORR in the registration clinical studies for TGCT for both products is 39% and 40%, respectively). The company plans to launch a listing application for pimicotinib for TGCT in key regions in 2025. In addition, on December 4, 2023, the company and Merck announced a licensing agreement for pimicotinib, granting Merck the commercialization license for Pimicotinib in mainland China, Taiwan, Hong Kong, and Macau, with the right to select all other global markets. Based on the high proportion of European and American patients in the MANEUVER study, the achievement of major endpoints, and the product competitiveness shown in clinical research results, Merck's exercise of overseas selection rights for pimicotinib is expected. This will further open up the overseas market for pimicotinib while improving the company's cash flow. Updated data from the Phase 1b pimicotinib trial show further improvements in ORR, and with the advantage of tolerability, it is expected to greatly meet the clinical needs of patients through long-term use. CSF1R inhibitors approved or expected to be approved globally for TGCT currently include Pexidartinib and Vimseltinib. Compared to Pexidartinib and Vimseltinib, pimicotinib demonstrated the best potential for efficacy in Phase 1b clinical studies (25-week ORR reached 68%) while significantly improving safety (the "black box warning" for severe hepatotoxicity limits the commercialization of Pexidartinib, while no reports of hair color changes or serious liver damage were reported for pimicotinib in clinical studies, with no serious adverse reactions, and a significant decrease in the incidence of grade 3 or higher treatment-related adverse reactions). The company updated the long-term follow-up data from the Phase 1b clinical study in this announcement: best ORR=85.0%, with a median treatment duration of 20 months, further improving from the previous 25-week data. Clinical studies for pimicotinib targeting cGVHD and solid tumors are steadily progressing, with expectations for multiple achievements. The Phase II clinical study of pimicotinib for cGVHD is ongoing, with POC data to be presented at ASH 2024; the Phase II clinical study for first-line pancreatic cancer is also progressing in an orderly manner. Risk factors: Risks of delayed progress in the authorization of investigational drugs; risks of delays in clinical development progress; risks of information lag or untimely updates in the public data used in research reports.