Core views:
Event: Chi-Med released phase III clinical data (ESLIM-01) of solepinib for primary thrombocytopenia (ITP) at the 2024 EHA conference. According to the summary (S316) published by Chi-Med, the study was a randomized, double-blind, placebo-controlled phase III clinical study. The study location was China, and the registration number was NCT05029635.
The continuous response rate is outstanding, and the safety and effectiveness are excellent. According to the summary information, 188 patients enrolled in the study were randomly assigned to solepinib and placebo according to a 2:1 ratio. The median number of treatment lines was 4.0, and 134 patients had previously received TPO/TPO-RA treatment. Results showed that the sustained response rate for solepinib and placebo (primary endpoint, at least 4 platelet counts greater than 50 x 109/L in 6 follow-ups during weeks 14-24) was 48.4% and 0%, respectively, 46.8% and 0% in patients who had previously received TPO/TPO-RA treatment, and the overall response rate for 24 weeks was 70.6% and 16.1%, respectively. Its curative efficacy is in the leading position among the indicated products, especially the sustained response rate. The safety performance was good. The incidence of the two groups ≥3 TEAEs was 25.4% and 24.2%, respectively. Most TEAEs were moderate to mild.
Domestic NDAs have been included in priority review, and overseas clinical INDs have also been approved. According to the company's announcements relating to solepinib issued on January 11 and March 22, 24, the NDA for treating ITP by solepinib was accepted by the FDA in the same month and included in priority review, and its overseas IND was also approved. In addition, its phase II/III study for the treatment of warm-antibody autoimmune hemolytic anemia also entered the registration phase in March '24.
Profit forecasting and investment advice. The company's R&D, commercialization and overseas capabilities have been initially verified, and the differentiated innovation pipeline is sufficient. As each product gradually enters the harvest period, the company is expected to turn a loss into a profit in 25 years. Net profit due to mother for 24-26 is estimated to be -1.16, 100 million US dollars and 115 million US dollars, respectively. The reasonable value of the company was obtained through the DCF Act at HK$40.73 per share, giving it a “buy” rating.
Risk warning. Drug review risks, fee control policy risks, R&D progress falls short of expectations.