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迈威生物(688062):类似物步入收获期 新药开发高效推进

Maiwei Biology (688062): Analogs are entering the harvest period and the development of new drugs is being promoted efficiently

廣發證券 ·  Apr 18

Core views:

9MW2821 is progressing smoothly and is the first drug with the same target to disclose CC and EC efficacy data.

According to the company's 2023 annual report, 9MW2821 has completed the first domestic phase III patient enrollment for locally advanced or metastatic urothelial cancer treated with platinum chemotherapy and anti-PD- (L) 1; as the world's first drug with the same target to disclose efficacy data for cervical cancer and esophageal cancer, its treatment data for cervical cancer appeared at the SGO conference, and the treatment of esophageal squamous cell carcinoma has been recognized by the FDA on the fast track.

There are plenty of innovative products under development, and early pipelines were unveiled at AACR. 9MW2921 (TROP2) and 7MW3711 (B7-H3) developed based on the novel antibody conjugation technology platform IDDCTM are all in the I/II phase. 8MW0511 is a new generation of long-acting G-CSF. The new drug marketing application has been accepted by the NMPA; the first domestic iron steady-state macromolecule modulator TMPRSS6 monoclonal antibody 9MW3011 has obtained FDA fast track certification and orphan drug qualification. The company has reached an exclusive licensing agreement with DISC for the project, with a transaction amount of up to US$412.5 million, and has received a down payment of 10 million US dollars in 2023; the first domestic ST2 monoclonal antibody, 9MW1911, is in the domestic IB/IIa phase; the first domestic IL-11 Monoclonal antibody 9MW3811 has completed Phase I clinical trials in Australia.

Analogs have entered the harvest period, and hematopoiesis continues for innovative research and development. Does the company already have Junmaikang? , Milishu? , My Health? Three bioanalogues were launched. As of December 31, 2023, Milishu had completed the shipment of 84,474 sticks, Junmaikang resumed supply at the end of the first quarter, and completed the shipment of 166,921 units. The company also signed formal agreements or framework agreements with dozens of countries for overseas marketing of Junmaikang, Milishu, and 9MW0321.

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, a reasonable value of 39.20 yuan/share was obtained. 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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