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迈威生物-U(688062):创新管线稳步推进 价值洼地积极布局

Maiwei Bio-U (688062): Innovation Pipeline Steadily Promotes Active Layout of Value Deposits

huaxi securities ·  Nov 2

The company released a report for the third quarter of 2024: the company's total revenue was 0.141 billion yuan, up 41.79% year on year, and net profit to mother was -0.694 billion yuan, down 3.09% year on year. According to single-quarter data, total revenue for the third quarter was 25.5679 million yuan, up 167.73% year on year, and net profit to mother for the third quarter was -0.249 billion yuan, up 4.1% year on year.

Analytical judgment:

The increase in the company's revenue over the same period last year was mainly due to drug sales revenue of 90.715 million yuan from the beginning of the year to the end of the reporting period, an increase of 287.12% over 23.4333 million yuan in the same period last year. By the end of the reporting period, the company already had Milishu? , My Health? And Junmai Kang? Three products on the market. Among them, Malishu? It was approved for listing in March 2023, and achieved sales revenue of 23.5624 million yuan in the third quarter of 2024. By the end of the reporting period, a total of 30 provincial tenders had been completed, and all provinces had completed medical insurance connections. A total of 1,336 hospitals were admitted, covering 2,632 pharmacies. My Health? It was approved for listing in March 2024 and achieved sales revenue of 1.4876 million yuan in the third quarter of 2024; by the end of the reporting period, a total of 25 provincial tenders had been completed, and all 25 provinces had completed medical insurance connections; 42 hospitals had been admitted, covering 653 pharmacies. Jun Maikang? It was approved for listing in March 2022. As of the reporting period, a total of 27 provincial tenders and health insurance connections have been completed; 270 hospitals have been admitted in the third quarter of 2024. In the third quarter of 2024, the company continued to focus on the field of tumor-related and age-related diseases and rapidly promoted various clinical trials. As of the disclosure date of this report, the company has 15 core varieties in the clinical or marketing stage, including 11 innovative drugs and 4 biosimilar drugs, covering the treatment of many major diseases such as tumors, immunity, bone diseases, ophthalmology, and hematology. Among them, there are 3 marketed varieties, 1 in the marketing license review stage, 3 in phase III key registered clinical stage, and 8 other varieties in different clinical research stages.

The company continues to advance research and development of various innovative varieties. In July 2024, the recombinant anti-Nectin-4 antibody conjugate drug (9MW2821) developed by the company was granted fast-track certification by the FDA for the treatment of locally advanced or metastatic Nectin-4 positive triple-negative breast cancer; it was also approved by the National Drug Administration (NMPA) to conduct phase II clinical trials of single drugs or combined PD-1 inhibitors to treat triple-negative breast cancer.

Clinical studies carried out by this pipeline since 2024 have successively included patients with cervical cancer (CC), esophageal cancer (EC), and triple-negative breast cancer (TNBC) and have accumulated certain clinical data, and obtained multiple qualifications, providing the possibility for subsequent accelerated approval; as of the disclosure date of this report, 9MW2821 has been granted 3 “fast track certifications” by the FDA (treatment for advanced, recurrent, or metastatic esophageal squamous cell carcinoma, and locally advanced nectin-metastatic nects that have previously been treated unsuccessfully with platinum-containing chemotherapy regimens 4 Positive triple-negative breast cancer) and 1 “orphan drug qualification” (treatment of esophageal cancer); and in August 2024, it was included in the list of breakthrough treatment types by the Drug Evaluation Center (CDE) of the China Drug Administration to treat locally advanced or metastatic urothelial cancer that has failed previous platinum chemotherapy and PD- (L) 1 inhibitors. During the reporting period, 9MW2821 was approved to launch two phase III key registered clinical studies, which were used to treat cervical cancer and first-line treatment with PD-1 monoclonal antibodies for urothelial cancer, respectively. They are currently in the enrollment stage.

Investment advice

Considering the company's product sales pace and optimistic about the company's strong target research and development capabilities, clinical execution and commercialization promotion capabilities, adjust early profit expectations: that is, we predict that the company's revenue for 2024-2026 will be 0.21/0.81/1.43 billion yuan (previous value 0.4/1.49/2.829 billion yuan), up 64%, 286%, and 76% year-on-year respectively; net profit to mother is -0.94/-0.7/-0.28 billion yuan (previous value -0.971/-) 0.578/-0.068 billion yuan), EPS was -2.34/ -1.75/ -0.69 yuan (previous value -2.43/-1.45/-0.17 yuan), respectively. Using a free cash flow discount valuation method, the company's valuation was 14.8 billion yuan (previous value 18.6 billion yuan), corresponding to a stock price of 36.9 yuan (previous value 46.66 yuan), maintaining a “buy” rating.

Risk warning

The commercialization performance of the product fell short of expectations after launch, and the clinical performance of innovative products fell short of expectations

The translation is provided by third-party software.


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