Company events. Takeda released its fiscal year 2023 annual report. Among them, FRUZAQLA (fruquintinib) was listed in November 2023. As of March 31, 2024, sales revenue in the US reached 10.1 billion yen, equivalent to 65 million US dollars, sales of 15.1 million US dollars in 2023, and 2024Q1 sales of nearly 50 million US dollars. The volume was strong and exceeded expectations.
Fruquintinib has remarkable efficacy advantages. Overseas space is large, and major domestic indications are about to be approved.
1) In January 2023, Hehuang Pharmaceutical entered into an exclusive license agreement with Takeda Pharmaceuticals to authorize its overseas rights in furoquintinib. Transactions can total up to $1.13 billion in payments, including a $400 million down payment, plus potential milestone payments plus royalties based on net sales. In November 2023, the FDA approved its listing in the US. A marketing license application was submitted to the European Medicines Agency (EMA) in June 2023, and approved with positive feedback from the European Medicines Agency Committee for Human Medicines (CHMP) in April 2024. A listing application was submitted to the Japan Pharmaceuticals and Medical Devices Administration (PMDA) in September 2023.
2) Colorectal cancer is the third most common cancer in the world, according to Hewang Pharmaceutical's official WeChat account. It is estimated that more than 935,000 people died in 2020. Colorectal cancer is the second most common cancer in Europe, with around 520,000 new cases and 245,000 deaths in 2020. In the US, an estimated 153,000 new cases of colorectal cancer and 53,000 new deaths will occur in 2024. Colorectal cancer is the most common cancer in Japan, with an estimated 148,000 new cases and 60,000 deaths in 2020. Although early stage colorectal cancer can be removed through surgery, treatment results for metastatic colorectal cancer are currently poor and treatment options are limited, and there are still many unmet medical needs.
3) Many domestic indications are being expanded, and major indications are expected to be approved. Fruquintinib was approved for the treatment of third-line colorectal cancer in China in 2018. Currently, multiple indications are being developed domestically. In April 2023, a supplementary application for new indications for second-line gastric cancer was accepted; in April 2024, the marketing application for a new Chinese drug with cindilizumab for the treatment of advanced endometrial cancer was accepted and included in priority review; registered clinical registration with PD-1 for second-line renal cell cancer was completed.
The company's catalytic events are intense, and the innovation pipeline ushered in a harvest period.
1) Sevotinib (c-Met inhibitor): In March 2024, the marketing application for a new indication for the treatment of primary treatment and treatment of MET exon 14 non-small cell lung cancer was accepted in China. Domestic and overseas marketing applications are expected to be submitted in 24 for second-line MET amplifying EGFR-TKI resistance in NSCLC.
2) Solepinib (SYK inhibitor): The marketing application for a new Chinese drug for primary immune thrombocytopenia has been accepted and included in priority review. It is expected to be approved this year. At the same time, it is planned to launch dose exploration studies in the US/Europe in the middle of the year.
3) Tazepastat (EZH2 inhibitor): In March 2023, it was approved for marketing in Macau, China. It is planned to submit a marketing application for a new Chinese drug for third-line or higher treatment of recurrent or refractory follicular lymphoma in mid-2024.
Profit forecast: Overseas sales expectations for fruquintinib were raised. The company's 24-26 sales revenue is expected to be US$7.09, 9.12, and 11.31 billion, with growth rates of -15%, 29%, and 24%; maintaining a “buy” rating risk warning: risk of clinical research and development failure, risk of worsening competitive landscape, risk of falling short of expectations, industry policies, etc.