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和黄医药(00013.HK):呋喹替尼欧洲获批 开启新增量空间

Hehuang Pharmaceutical (00013.HK): Fruquintinib approved in Europe to open space for additional quantities

廣發證券 ·  Jun 24

Chi-Med Announces Takeda Has Received European Commission Approval FRUZAQLA? (Fruquintinib). Chi-Med announced on June 24 that its partner Takeda has obtained approval from the European Commission for furoquintinib as a monotherapy to treat adult metastatic colorectal cancer patients who have previously received existing standard treatments including fluorouracil, oxaliplatin, and irinotecon-based chemotherapy, VEGF treatment, and EGFR treatment, as well as treatment with trifluuridine tipyrimidine or regofinib.

Fruquintinib's overseas expansion has been accelerated. The US and Europe have already been approved, and an application for listing in Japan has also been submitted.

According to the official website of Hutchison Pharmaceuticals, in January '23, Huhuang Pharmaceutical reached an exclusive licensing agreement with a subsidiary of Takeda Pharmaceutical. Takeda has exclusive global licenses to further develop, commercialize, and produce furoquintinib outside of mainland China, Hong Kong, and Macau. Chi-Med will receive payments totaling up to $1.13 billion and royalties based on net sales. According to Takeda's financial report, fruquintinib was approved in the US in November 23, and sales reached 10.1 billion yen (approximately $63 million) as of the end of March '24. Furthermore, a marketing application for fruquintinib in Japan was submitted in September '23.

The commercialization of colorectal cancer in China is progressing smoothly, and NDAs for gastric cancer and endometrial cancer have also been submitted. According to the company's official website, fruquintinib was marketed in China and included in medical insurance in January '20. As of mid-'23, more than 80,000 domestic colorectal cancer patients had been treated with fruquintinib. In addition, marketing applications for furoquintinib combined with paclitaxel for second-line treatment of gastric cancer and cindilizumab for advanced endometrial cancer were also accepted in April 23 and April 24, respectively.

Profit forecasting and investment advice. The company's R&D, commercialization and overseas capabilities have been initially verified, and the differentiated innovation pipeline is sufficient. As each product gradually enters the harvest period, the company is expected to turn a loss into a profit in 25 years. Net profit due to mother for 24-26 is estimated to be -1.16 billion, 100 million US dollars, and 116 million US dollars, respectively. The reasonable value of the company was obtained through the DCF Act of HK$41.16 per share, giving it a “buy” rating.

Risk warning. Drug review risks, fee control policy risks, R&D progress falls short of expectations.

The translation is provided by third-party software.


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