I. Overall situation

Total 2019 Vaccine Lot Issued5.65Billion, year-on-year growth5.27%. One type of vaccine batch issued3.46Billion, year-on-year growth4.99%, Class II vaccine batch issuance2.23Billion, year-on-year growth7.78%Domestic Vaccine5.28Billion, year-on-year growth4.79%Imported vaccines.0.41Billion, year-on-year growth25.72%Class II vaccines and imported vaccines have achieved rapid growth. With the release and implementation of the Vaccine Management Law, China's vaccine market will usher in the vitality of development. Under the background of the strengthening of the regulatory environment, the industry concentration will continue to increase, and vaccine enterprises that attach importance to research and development and innovation are expected to benefit.

2. related regulations

The Vaccine Administration Act

It mainly involves five aspects: encouraging innovation, strengthening responsibility, strict supervision, sound measures, and severe punishment; and it has realized the whole process of non-clinical research, clinical trials, production and operation, post-marketing research, to adverse reaction monitoring and reporting and handling. Supervision, and relevant regulations have been made on the vaccine production access system, vaccine supply chain, and the qualification of vaccination units.

2. Technical Guidelines for Clinical Comparability Studies of Preventive Vaccines

The guidelines issued by the State Food and Drug Administration are used to guide the clinical development and evaluation of non-innovative vaccines. Non-innovative vaccines refer to similar vaccines that have been listed in China, and their quality, safety and effectiveness are comparable to those of similar vaccines on the market.

Third, popular innovative vaccine varieties to maintain high-speed growth.

This year's second-class seedlingsHPVVaccine, quintet vaccine, 13Imported innovative vaccines such as pneumococcal conjugate vaccine and oral rotavirus vaccine continued to grow at a high rate, and influenza vaccines in domestic vaccines also achieved a high growth rate, especially4Influenza Vaccine, Domestic13Valency of pneumococcal conjugate vaccine and2PriceHPVThe vaccine was approved for listing. The market demand for the differentiation of varieties puts forward higher requirements for domestic vaccine enterprises, and innovative vaccine varieties will become the core competitiveness of vaccine enterprises in the future.

HPVVaccines

2 priceHPVQuantity of vaccine batch issued200.75million (growth-4.95%），4PriceHPVQuantity of vaccine batch issued554.37million (growth+45.88%），9PriceHPVQuantity of vaccine batch issued332.42million (growth+173.35%), High PriceHPVVaccine market demand is strong, which9PriceHPVVaccines need to be made by appointment before they can be vaccinated. Wantai Canghai has developed domestic vaccines.2PriceHPVVaccine has been approved for marketing, pricing329Yuan/branch.

13valence pneumococcal conjugate vaccine

Batch Issued Quantity475.45million (growth+23.57%), Pfizer's overall supply is stable, while there is strong demand, Watson Bio's domestic research and development.13The price pneumococcal vaccine has been approved for marketing.

Oral rotavirus vaccine

The number of rotavirus vaccine batches issued is1020.8310,000 units, of which the number of monovalent vaccine batches issued551million (growth+6.99%），5Quantity of Valable Vaccine Lot Issued469.83million (growth+493.37%），5The price vaccine can provide more protection, and the second year of the market has achieved a higher substitution for the monovalent vaccine.

4Valuable influenza vaccine

The number of influenza vaccine batches issued is3078.42million (growth+90.6%), where4The number of influenza vaccine batches issued is971.05million (growth+89.57%), produced by Hualan Biological4The number of influenza vaccine batches issued is836.08Ten thousand, produced by Jiangsu Jindick4The number of influenza vaccine batches issued is134.96Ten thousand,4Valu influenza vaccine can provide more protection and will further replace3Influenza vaccine.