Industry Overview - The overall number of vaccine batch approvals in 2025 is projected to be 3,793, representing a year-on-year decline of 11.3%, primarily due to significant decreases in approvals for polio, meningitis, encephalitis, and measles-mumps-rubella vaccines [2][4] - Key vaccines expected to be approved in 2025 include Consonance's PCV13 and Wantai's 9-valent HPV vaccine, with several others in the review stage [1][4] Vaccine Development Pipeline - The RSV vaccine development is competitive among domestic companies, focusing on mRNA and recombinant protein technologies [1] - The shingles vaccine has four products in the application stage, indicating a rich pipeline [1] - Consonance's PCV13 has been approved, enhancing its product pipeline [1] - Wantai's 9-valent HPV vaccine is the first domestically produced vaccine to be approved [1] - Two human diploid rabies vaccines have been approved, with multiple products submitted for approval [1] - The meningitis vaccine pipeline is concentrated on MCV4, with a five-valent meningococcal vaccine from Sinovac entering clinical phase I [1] - The flu vaccine market has several products approved, with many in clinical stages [1] - Multi-valent vaccines have fewer products on the market, but several companies are pursuing differentiated strategies [1] Company-Specific Insights - Zhifei Biological's vaccine batch approvals are expected to decline, with a significant drop in agency products, while several self-developed products are nearing market launch [4] - Kangtai Biological anticipates a slight decrease in batch approvals, with the varicella vaccine contributing to new growth, and multiple vaccines in the application stage [4] - Watson Biological expects a 16% year-on-year decline in batch approvals, with RSV and shingles mRNA vaccines approved for clinical trials [4] - Wantai Biological has seen a significant increase in 2-valent HPV batch approvals, with the 9-valent HPV vaccine approved for market [4] - Kangxino Biological's MCV4 batch approvals are expected to continue growing, with PCV13 approved for market [4] - Kanghua Biological's human diploid rabies vaccine batch approvals are projected to decline, while the acquisition of Namixin aims to expand its mRNA technology platform [4] - Olin Biological anticipates significant growth in tetanus batch approvals, with data from its pneumococcal vaccine expected in the first half of 2026 [4] - Baike Biological expects a 42% year-on-year decline in vaccine batch approvals, with a liquid nasal spray flu vaccine approved [4] Investment Recommendations - Companies with strong self-research capabilities and innovative vaccine pipelines, such as Kangtai Biological, Kanghua Biological, Kangxino Biological, and Olin Biological, are recommended for investment focus, especially those with products nearing market launch [4]
中信建投:25年疫苗行业产品批签发同比下降 多款重磅产品获批上市