Incident: On February 7, Chu Wong Pharmaceutical published data from the Frutiga Phase III study on the second-line treatment of patients with advanced gastric cancer using fruquintinib combined with paclitaxel in the ASCO Vaccine Series. Patients receiving a combination of fruquintinib and paclitaxel had a median PFS of 5.6 months, while those receiving paclitaxel monotherapy had a median PFS of 2.7 months, showing a statistically significant improvement. In view of FRUTIGA's excellent clinical data, we have increased the probability of fruquintinib being approved for second-line gastric cancer. Considering that furoquintinib submitted a marketing application in April 2023, it is expected that it will be approved for marketing in the first half of 2024.
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.
Solepinib shows BIC potential in treating ITP. Solepinib is a 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.
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 various innovative drug indications and the expansion of the global market, we expect the company's revenue in 2023-2025 to be US$8.7, 7.8, and 9.2 billion US dollars, respectively, with corresponding EPS of 0.16, -0.03, and 0.13 US dollars, 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.