Event: On July 9, Hehuang Pharmaceutical held a R&D day exchange. The management team shared the latest developments in Hewang Pharmaceutical's rich and innovative drug candidate pipeline, including the ESLIM-01 phase III study of solepinib for the treatment of immune thrombocytopenia and the ESLIM-02 phase II/III study for the treatment of warm-antibody autoimmune hemolytic anemia; the phase II/III study of surufatinib for pancreatic duct cancer; and RAPHAEL of HMPL-306 for acute myeloid leukemia Phase III study.
The commercialization of fruquintinib in the US progressed smoothly, and was approved for listing by the EMA. Fruquintinib was approved for marketing by the FDA on November 9, 2023. Since its launch, sales in the US reached 10.1 billion yen (approximately US $65 million) by the end of March. Fruquintinib was approved to treat metastatic colorectal cancer in the European Union in June 2024, and is expected to be approved for treating metastatic colorectal cancer in Japan by the end of 2024. In the regulatory review of fruquintinib second-line gastric cancer indications, the marketing application for second-line treatment of endometrial cancer with cindilizumab was accepted in April 2024 and included in the priority review. It is expected that the top-line results of the renal clear cell carcinoma stage II/III registration study will be announced by the end of 2024.
Sevotinib is expected to communicate the new drug marketing application with the FDA by the end of 2024. Sevotinib submitted marketing applications for first-line and second-line treatment of ME14 jumping mutation non-small cell lung cancer in China in March 2024. Patient recruitment for the SACHI study is expected to be completed by the end of 2024. Patient recruitment has been completed for the critical global Phase II SAVANNAH study, and it is expected that the US FDA will be communicating with the US FDA about the submission of a possible new drug marketing application by the end of 2024.
Solepinib ITP phase III data is impressive, and surufatinib has great potential for pancreatic cancer. The results of the ESLIM-01 Chinese phase III study of solepinib for adult patients with immune thrombocytopenia were published in “The Lancet”. The long-term response rate for treatment was 48.4%, and the placebo was 0. Furthermore, regardless of the number of previous treatment lines or previous TPO/TPO-RA treatment, solepinib provides consistent clinical benefits in ITP patients. A phase II/III study of surufatinib combined with carrilizumab for the treatment of primary pancreatic ductal adenocarcinoma began in May. In 2024 ASCO GI, surufatinib combined with carrilizumab and chemotherapy first-line treatment of PDAC reached 9m and MOs reached 13.3m. The clinical efficacy was significantly higher than that of the AG regimen and the safety was controllable.
Profit forecasting and investment advice. With the gradual implementation of various innovative drugs and the expansion of the global market, we expect the company's revenue in 2024-2026 to be 0.66, 0.8, and 0.96 billion US dollars, respectively, maintaining a “buy” rating.
Risk warning: R&D falls short of expectations, commercialization falls short of expectations, market competition increases risk, drug price reduction risk.