Incident: On January 11, Hehuang Pharmaceutical announced that the marketing application for solepinib for the treatment of adult patients with primary immune thrombocytopenia has been accepted and given priority approval by the China National Drug Administration (“China Drug Administration”).
Solepinib has shown BIC potential in treating ITP. Solepinib is a novel, highly selective oral spleen tyrosine kinase (“Syk”) inhibitor developed to treat hematologic malignancies and autoimmune diseases. ESLIM-01 is a randomized, double-blind, placebo-controlled phase III clinical trial of solepinib in China that included 188 patients with chronic adult primary immune thrombocytopenia who had received at least one previous treatment. In August 2023, Chi-Med announced that the study had successfully reached its main end.
Results of the phase I/II study of solepinib showed that 40% of patients with RP2D showed a sustained response. Compared to the 18% sustained response of fortantinib, the first syk inhibitor on the market, solepinib showed BIC potential.
Fruquintinib is marketed in the US, and second-line gastric cancer is about to be marketed. Fruquintinib was approved for marketing by the FDA on November 9, 2023, more than 20 days earlier than the original target review date for the Prescription Drug User Payment Act (PDUFA) on November 30, 2023. The marketing license application for furoquintinib in Europe was confirmed by EMA in June 2023, and a listing application was submitted to Japan's Ministry of Health, Labor, and Welfare in September. The marketing application for furoquintinib for second-line gastric cancer indications was accepted by the National Drug Administration in April 2023, and is expected to be approved for listing in the first half of 2024.
The US critical phase II data for savortinib is expected to be read in 2024. The second-line MET+ phase II phase of gastric cancer in China has already started. Servotinib is a highly selective oral MET inhibitor. The results of the US critical phase II study (SAVANNAH) of savortinib combined with ositinib to treat abnormal MET and ositinib refractory non-small cell lung cancer (SAVANNAH) are expected to be read out in 2024. In 2023AACR, cevotinib disclosed second-line MET amplification phase I data for advanced gastric cancer, with an ORR of 45%. After communicating with the State Drug Administration, registration of the phase II study of this indication in China has already started.
Profit forecasting and investment advice. With the gradual implementation of fruquintinib, cevotinib, surufatinib, and solepinib indications and the expansion of the global market, we expect the company's 2023-2025 revenue to be US$8.7, 7.8, and US$92 billion, respectively, corresponding to EPS of $0.16, -0.03, and 0.13, maintaining a “buy” rating.
Risk warning: R&D falls short of expected risks, commercialization falls short of expected risks, market competition increases risks, and drug price reduction risks.