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迈威生物(688062):ADC研发稳步推进 销售持续放量

Maiwei Biotech (688062): ADC R&D is steadily promoting continuous sales volume

國聯證券 ·  Sep 4

occurrences

The company released its 2024 semi-annual report, with operating income of 0.116 billion yuan (YoY +28.42%), net profit to mother of 0.445 billion yuan, net profit after deducting non-return to mother of 0.461 billion yuan.

9MW2821 research and development is progressing steadily, and a number of phase III clinical trials have been established

Nectin-4 ADC 9MW2821 has received multiple certifications from FDA regulators, and three phase III clinical trials have been established. In April 2024, 9MW2821 was granted “orphan drug qualification” by the FDA for the treatment of esophageal cancer; in May 2024, 9MW2821 was granted FDA fast-track certification to treat recurrent or metastatic cervical cancer after failure of platinum-containing chemotherapy; in July 2024, 9MW2821 was recognized by the FDA as a fast track to treat Nectin-4 positive triple-negative breast cancer. Currently, 9MW2821 has established three phase III clinical trials: 1) treatment of recurrent or metastatic cervical cancer with monotherapy; 2) treatment of urothelial cancer with treprilizumab; 3) treatment of urothelial carcinoma with monotherapy.

Sales volume continues, and G-CSF is expected to be approved for marketing 2024H1 in 2025, with drug sales revenue of 65.665 million yuan, an increase of 371.85%; during the reporting period, Milishu added 0.117 million new shipments, 487 new hospitals were admitted, and a total of 0.201 million units were completed; a total of 30 provincial tenders were completed, and each province has completed medical insurance connections; a total of 1,092 hospitals have been admitted, covering 2,382 pharmacies; MaiWeijian has completed a total of 9940 shipments A total of 20 provincial tenders have been registered, and 19 provinces have completed provincial medical insurance connections; a total of 14 hospitals have been admitted, covering 522 pharmacies. 8MW0511 (Long-Term G-CSF) is in the NDA stage and is currently under review and approval. It is expected that it will be approved for listing in 2025 to contribute to new sales growth.

Profit Forecasts, Valuations, and Ratings

We expect the company's revenue for 2024-2026 to be 0.714/1.704/2.967 billion yuan, respectively, with year-on-year growth rates of 458.42%/138.64%/74.14%, and net profit of -1.025/ -0.888/-0.539 billion yuan, respectively, with year-on-year growth rates of 2.70%/13.38%/39.33%, EPS of -2.57/-2.22/ -1.35 yuan/share, respectively. Maintain a “buy” rating.

Risk warning: the risk that drug development falls short of expectations, industry competition intensifies, and drug sales fall short of expectations

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