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迈威生物-U(688062):9MW2821亮相ASCO 创新研发顺利

Maiwei Bio-U (688062): 9MW2821 debuted at ASCO, successful in innovative research and development

廣發證券 ·  May 29

9MW2821 was selected for the 2024ASCO oral report focusing on its market potential for various solid tumors. The company issued an announcement (ID: 2024-031) to announce that 9MW2821 will report its phase I/II clinical study data and latest developments for various advanced solid tumors in the 2024 American Society of Clinical Oncology (ASCO) annual meeting: Among 240 patients in the 1.25 mg/kg dose group, 37 patients with urothelial cancer assessed for tumors: ORR was 62.2%, mPFs was 8.8 months, and MoS was 14.2 months; 53 cases of cervical cancer patients with tumor evaluation: ORR of 35.8 %, mPFS was 3.9 months, and MoS was not achieved; 39 patients with esophageal cancer with tumor evaluation: ORR of 23.1%, mPFs of 3.9 months, and MoS of 8.2 months; 20 patients with triple-negative breast cancer with tumor evaluation: ORR of 50.0%, mPFs of 5.9 months, and MoS not yet achieved. In terms of safety, the most common treatment-related adverse events are leukopenia, neutropenia, and anemia.

The R&D pipeline has been successfully promoted, and analogues have entered the harvest period. According to the company's 2023 annual report, 9MW2921 (TROP2) and 7MW3711 (B7-H3) developed based on the novel antibody conjugation technology platform IDDCTM are all in the domestic phase I/II; the marketing application for the next-generation long-acting G-CSF 8MW0511 has been accepted by the NMPA; the TMPRSS6 monoclonal antibody 9MW3011 has obtained FDA fast track certification and orphan drug qualification; ST2 monoclonal antibody 9MW1911 is in the domestic IB/IIa phase; the first domestic IL-11 monoclonal antibody 9MW3811 has completed Phase I in Australia. In terms of analogues, does the company already have Junmaikang? , Milishu? , My Health? Three products were commercialized to continue hematopoietic development for innovative drug development.

Profit forecasting and investment advice. The company's revenue for 2024-2026 is estimated at 2.41/1,07/2.290 billion yuan. It mainly comes from sales revenue from bioanalogs and innovative drugs.

9MW2821 has shown superior therapeutic effects in more indications. The company has achieved a full industry chain layout, and pharma can be expected to grow. Using the DCF valuation method, we maintain our judgment that the reasonable value of the company is 39.20 yuan/share. Maintain a “buy” rating.

Risk warning. Risk of R&D failure, product sales falling short of expectations, market competition exceeding expectations, etc.

The translation is provided by third-party software.


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