First quarter overview of the vaccine industry in China Securities Co., Ltd.: Product batch approvals increase year-on-year, multiple products and new indications approved.

China Securities Co., Ltd. released a research report stating that the total number of vaccine batch approvals in the vaccine industry in Q1 2026 was 875 batches, an increase of 14.1% compared to the same period last year, mainly due to a significant increase in the number of batches approved for products such as polio vaccines, MMR vaccines, and hepatitis B vaccines. In terms of research and development, in Q1 2026, Liaoning Chengda Biotechnology's human diploid rabies vaccine, CanSino Biologics Inc.'s MCV4 age expansion and component pertussis vaccine, and Shenzhen Kangtai Biological Products' quadrivalent influenza split vaccine were approved for new indications. Several other products are currently in the process of market approval. In 2026, the vaccine industry should pay attention to: 1) the follow-up research and development milestones of innovative vaccine pipelines and expectations for external authorization. 2) Product sales improvement, combined with the contribution of new product launches to revenue growth. 3) Follow-up developments after equity changes. Key points from China Securities Co., Ltd. include: Vaccine research and development pipeline: human diploid rabies vaccines, MCV4 age expansion, and others have been approved, with multiple pipelines in the process of market application. 1) RSV vaccine: domestic companies are racing to develop, with the NME pipeline entering Phase II clinical trials. 2) Herpes zoster vaccine: multiple products are in the process of market application, with a rich pipeline of research. 3) Pneumonia vaccine: Chongqing Zhifei Biological Products' PCV15 is in the process of market approval, with a rich pipeline of iterative products. 4) Rabies vaccine: Liaoning Chengda Biotechnology's human diploid rabies vaccine has been approved for market, with many products in the research pipeline. 5) Meningitis vaccine: focus is on MCV4, with CanSino Biologics Inc.'s 4-6 year age group expansion vaccine approved. 6) Influenza vaccine: many domestic vaccines are on the market, with a large number of clinical stage pipelines. 8) Multivalent vaccines: few varieties are on the market, with various companies pursuing differentiated positioning. Batch approvals in the industry: in Q1, the number of batch approvals increased by 14%, with rapid growth in polio vaccines and others. Overall situation: In Q1 2026, the total number of batch approvals in the vaccine industry was 875 batches, a year-on-year increase of 14.1%, mainly due to a significant increase in the number of batches approved for products such as polio vaccines, MMR vaccines, and hepatitis B vaccines. Product category structure: 1) Pneumonia vaccine: a decrease in batch approvals in Q1, with a significant decrease in PCV13. 2) HPV vaccine: an 11% increase in batch approvals in Q1, with rapid growth in the 2-valent HPV vaccine. 3) Rabies vaccine: batch approvals in Q1 remained stable, with an increase in the proportion of human diploid rabies vaccines. 4) Meningitis vaccine: a decrease in batch approvals in Q1, with a growth in the 2-valent and 4-valent combined vaccines. 5) Pertussis-like vaccines: a decrease in batch approvals in Q1 for pertussis vaccines, with steady growth in tetanus vaccines. 6) Varicella vaccines: batch approvals in Q1 remained stable, with BioKang and BaiKe leading the market share. 7) Herpes zoster vaccine: 9 batches were approved in Q1 (+50%), all manufactured by GSK. Risk factors Product safety and operational compliance risks: Vaccines have special biological characteristics, requiring stricter regulatory requirements and wider management scope. If there are safety issues with vaccine products, or if vaccine companies violate operational compliance requirements, it could not only negatively impact the companies' own operations and production, but also cause fluctuations in the overall vaccine industry. Product research and development and market progress falling below expectations: Currently, many products are in the research and development phase or market application phase. If the progress in research and development and market approval falls below expectations, or even if research and development or market approval fails, it will affect the future revenue and profit expectations and valuation levels of related vaccine companies. Industry policy change risks: Vaccine companies are subject to strict policy regulations and restrictions from research and development to sales, and changes in policies could lead to new competitive pressures or risks for companies, affecting business operations. Batch approval data only represent the number of samples approved by the Chinese inspection agency, not actual sales figures, and are for reference purposes only.