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迈威生物(688062):BIOPHARMA成长可期 创新初露锋芒

Maiwei Biotech (688062): BIOPHARMA can be expected to grow, innovation is beginning to shine

廣發證券 ·  Dec 10, 2023 00:00

Core views:

Integrated R&D, production and marketing layout, rich product pipeline. Maiwei Biotech is an innovative biopharmaceutical company with a full industry chain layout. The founding team has deep industrial background and R&D experience, and has established four major technology platforms. The products cover fields such as self-immunity, oncology, metabolism, ophthalmology, and infections.

The NECTIN-4 ADC is leading the world in progress and is expected to become a BIC. The company has built IDDCTM, a next-generation ADC fixed-point coupling technology platform, including next-generation coupling technology, connectors, release units, and payloads. Three ADC products have entered clinical trials: (1) 9MW2821 (Nectin-4): the fastest-progressing nectin-4 ADC in China. Pre-clinical data and early data on solid tumors such as UC and CC show that it can obtain a higher objective remission rate, and it has been approved by the CDE to register phase III clinical trials. (2) The company has also developed B7H3 and Trop2 target ADCs based on next-generation fixed-point coupling technology and camptothecin derivative technology, which are in the first tier in China.

Biosimilar drugs have entered the harvest period, developing hematopoiesis for innovative research and development. The bioanalogues developed in the early stages have entered the harvest period. For innovative research and development of blood transfusions: Junmaikan (adalimumab) and Milishu (desalizumab osteosone) have been marketed, and 9MW0321 (desulizumab solid tumor osteoporosis) has been reported for production.

Early differentiated innovation pipeline, leading R&D progress. The company's early pipeline layout has multiple differentiated targets: (1) 9MW1911 (ST2 monoclonal antibody): IL-33/ST2 pathway is a potential treatment signal pathway for respiratory immune inflammation such as COPD, and 9MW1911 is the first in China with the same target and is in the IB/IIIa phase; (2) 9MW3811 (IL-11 antibody): the first in the world, the first in China, to treat malignant tumors and idiopathic fibrosis; (3) 9MW3011: The first tier of global research and development, the first domestic polymer regulating iron homeostasis, is already with DISC Overseas authorization has been reached, and the FDA's fast track certification is expected to achieve global commercialization.

Profit forecasts and investment advice. The company's revenue for 2023-2025 is estimated to be 1.94/4.74/1,043 billion yuan. Mainly from desulizumab sales and confirmation of BD-related milestones (Junmaikang sales are not included in the company's revenue), 9MW2821 is expected to start contributing revenue in 2026. The company has achieved the layout of the entire industry chain, and Pharma can be expected to grow. Using the DCF valuation method, the reasonable value obtained was 43.82 yuan/share. First coverage, giving 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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