occurrences
Recently, the company held a conference in Shanghai to share the latest R&D progress and broadcast it live on the Internet.
At the conference, the company's senior management team shared the company's R&D strategy and vision, as well as some of the projects in the company's rich and innovative drug candidate pipeline, including the latest developments in products such as surufatinib, solepinib, and HMPL-306.
Comment:
Recently, the company has made rapid progress in R&D, showing excellent clinical data and competitive patterns, and continuously promoting product globalization. It is expected that it will continue to catalyze the improvement of the company's fundamental value.
Fruquintinib: Approved for advanced colorectal cancer in China in 2018. It maintains a leading position in the third-tier colorectal cancer market in China. The market sales volume exceeded 0.1 billion US dollars in 2023. Both 2L gastric cancer and 2L endometrial cancer are in the marketing phase, and it is expected that 2L kidney cancer marketing applications will be submitted before the end of the year. Multiple indications will drive domestic sales growth of fruquintinib. At the same time, the company is actively promoting global sales of fruquintinib. At the end of last year, it cooperated with Takeda to achieve a US listing. Sales in the US market exceeded 0.05 billion US dollars in the first quarter of 2024, and it has already been approved for listing in the European Union. It is expected that it will continue to be released overseas during the review of the Japanese listing application.
Sevotinib: Marketed in China in 2021 to treat non-small cell lung cancer with MET exon 14 transitions, and is expected to expand to first-line indications. Research on various indications such as lung cancer and gastric cancer is progressing in an orderly manner. It is expected that a marketing application will be submitted to the US FDA by the end of 2024 for second-line treatment of non-small cell lung cancer with excessive MET expression. It is expected to become another overseas product for the company and an important step in product globalization.
Surufatinib: Launched in China in 2021 for the treatment of advanced neuroendocrine tumors, the prescription share in 2023 was 21%, gradually becoming the preferred treatment for patients. Furthermore, the investigator-initiated clinical trial for pancreatic ductal adenocarcinoma achieved encouraging results. MoS reached 13.3 months (MoS is about 7-11 months with the current chemotherapy regimen), and phase II/III studies on pancreatic ductal adenocarcinoma have been initiated in China.
Solepinib: A new drug marketing application for immune thrombocytopenia (ITP) in China was accepted and included in priority review. It is a potential first Syk inhibitor in China. Brilliant clinical data were published at the recent EHA conference. Compared with the placebo group, the solepinib group significantly improved the sustained response rate (48.4% vs. 0%). The Chinese phase III study of warm-antibody autoimmune hemolytic anemia (waIHa) has been initiated, while the ITP global phase I study is being enrolled.
Tazepastat: The first EZH2 methyltransferase inhibitor introduced in the world has been approved for marketing in the US. The marketing application for a new Chinese drug for the treatment of recurrent or refractory follicular lymphoma has been accepted and included in priority review.
Profit forecast and investment suggestions: The company has abundant pipeline reserves, broad product market space, and continuous overseas sales. We expect the company to achieve revenue of $0.729/0.866/1 billion in 24-26, with earnings per share of -0.06/0.05/0.18, maintaining the company's “buy” rating.
Risk warning: risk of R&D falling short of expectations, risk of sales falling short of expectations, policy risk, etc.