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东吴证券:维持和黄医药(00013)“买入”评级 赛沃替尼今年有望美国申报上市

Dongwu Securities: Maintaining Hewang Pharmaceutical's (00013) “buy” rating, and sevolitinib is expected to be listed in the US this year

Zhitong Finance ·  Mar 5 09:09

Dongwu Securities reduced Hewang Pharmaceutical (00013)'s total revenue for 2024-2025 from US$828/992 million to US$665/808 million.

The Zhitong Finance App learned that Dongwu Securities released a research report saying that the Hewang Pharmaceutical (00013) catalyst continues to be implemented, overseas markets are opening up, growth certainty is high, and the “buy” rating is maintained. Based on the uncertainty about the rate of overseas fruquintinib sales volume and the uncertainty of milestone revenue, the total revenue for 2024-2025 was reduced from US$828/992 million to US$665/808 million, and the total revenue for 2026 is expected to be 969 million US dollars. Profitability is expected in 2025.

Incident: The company's revenue in 2023 was US$838 million, +96.52% YoY, in line with the Bank's expectations: comprehensive oncology/immunology revenue was US$529 million (+228% YoY), including: revenue of 164 million US dollars after product sales share (+39% YoY), R&D revenue of 364 million US dollars, and other business revenue of 309 million US dollars, in line with the company's performance guidelines. The 2024 oncology/immunization comprehensive revenue guideline is $3-4 billion, which is expected to be +30-50% compared to the same period last year. Profitability is expected in 2025.

The main views of Dongwu Securities are as follows:

Fruquintinib continues to be released overseas, and it is expected that new indications will be approved domestically.

Fruquintinib is the first and only small-molecule targeted drug against 3-line mCRC approved in the US in 10 years. It has been included in the NCCN guidelines. Europe and Japan are expected to be approved for listing this year. Sales continued to grow, with market sales reaching 107 million US dollars in 2023. Fruquintinib combined with chemotherapy is being approved for second-line gastric cancer and is expected to be approved for domestic marketing this year.

Sevotinib is expected to be listed in the US this year to address the clinical pain points of EGFRTKI resistant NSCLC.

A total of 7 registered clinical trials of sevotinib are underway worldwide: EGFRTKI refractory NSCLC (SACHI study) treating second-line MET amplification in China is expected to complete patient enrollment in 2024H2; domestic phase II clinical enrollment for third-line gastric cancer with MET amplification is in progress. The single drug has the best potential in its class for 2-line EGFRM+met-driven nsCLC, and is expected to be listed in the US by the end of 2024. Overseas clinical trials of solepinib, the best-in-class Syk inhibitor, are about to begin. The number of ITP patients in China is expected to exceed 300,000 in 2027. 67% of patients will enter second-line treatment. Innovative treatments are limited, and the competition pattern is good. The results of Phase III clinical trials registered in China for second-line ITP were impressive. 75% of patients at baseline had frontline TPO drugs, and the sustained response rate was still 40%. The US is about to start clinical phase IB/II, and it is expected that BD will go overseas in the future.

Risk warning: Product registration approval progress falls short of expectations; competition intensifies; commercialization falls short of expectations.

The translation is provided by third-party software.


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