Safety evaluation platform for preventive and therapeutic vaccines
Service items
Pre clinical studies of preventive and therapeutic vaccines can be carried out, including the establishment of the overall methodology, detection of specific indicators, pharmacokinetics, and a full set of pre clinical safety evaluation. At present, the varieties that have been carried out include inactivated vaccine, attenuated vaccine, recombinant vaccine, nucleic acid vaccine, including hand foot mouth disease vaccine, rotavirus vaccine, hepatitis virus vaccine, papillomavirus vaccine, rabies vaccine, AIDS vaccine, DPT vaccine, rubella vaccine, influenza vaccine, respiratory syncytial virus vaccine, coronavirus vaccine, herpes zoster vaccine and other vaccines, as well as the evaluation of new adjuvants.
■ Single dose toxicity test (rodents and non rodents)
■ Repeated dose toxicity test (rodents and non rodents)
■ Safety pharmacology test
■ Pharmacokinetic test (including methodological establishment and validation)
■ Reproductive toxicity test (I, II, III)
■ Local toxicity test
■ Immunogenicity test (including methodological establishment and validation)
■ Single dose toxicity test (rodents and non rodents)
■ Repeated dose toxicity test (rodents and non rodents)
■ Safety pharmacology test
■ Pharmacokinetic test (including methodological establishment and validation)
■ Reproductive toxicity test (I, II, III)
■ Local toxicity test
■ Immunogenicity test (including methodological establishment and validation)
Evaluated varieties
>Preventive vaccine:
It involves inactivated vaccine, attenuated vaccine, recombinant vaccine, nucleic acid vaccine and other types, dosage form design injection, nasal spray, etc., including influenza vaccine, DPT vaccine, rabies vaccine, herpes zoster vaccine, respiratory syncytial virus vaccine, enterovirus vaccine, hepatitis vaccine, rotavirus vaccine, human papilloma virus vaccine, AIDS vaccine, coronavirus vaccine, varicella vaccine, etc.
>Therapeutic vaccine:
It involves a variety of therapeutic vaccines, including DNA vaccine, adenovirus vaccine, etc.
It involves inactivated vaccine, attenuated vaccine, recombinant vaccine, nucleic acid vaccine and other types, dosage form design injection, nasal spray, etc., including influenza vaccine, DPT vaccine, rabies vaccine, herpes zoster vaccine, respiratory syncytial virus vaccine, enterovirus vaccine, hepatitis vaccine, rotavirus vaccine, human papilloma virus vaccine, AIDS vaccine, coronavirus vaccine, varicella vaccine, etc.
>Therapeutic vaccine:
It involves a variety of therapeutic vaccines, including DNA vaccine, adenovirus vaccine, etc.
Cooperative enterprises(Only some cooperative enterprises are displayed)
Institute of Medical Biology, Chinese Academy of Medical Sciences
Company performance - obtaining clinical approval(Only some Company performance are displayed)
| Drug name | Acceptance No | Indication | Class |
| Respiratory Syncytial Virus (RSV) mRNA Vaccine | CXSL2400233 | This product is intended for the prevention of diseases caused by Respiratory Syncytial Virus (RSV) infection. | 1.2 |
| A82/B86 Fully Human Anti-Tetanus Toxin Monoclonal Antibody Injection Combination Formulation | CXSL2300536 | It is primarily used for the prevention of tetanus. | 1 |
| Recombinant Herpes Zoster Vaccine (CHO cells) | CXSL2300518 | This product is intended for the prevention of herpes zoster (shingles). It is not suitable for the prevention of primary varicella (chickenpox). | 3.3 |
| Omicron Variant SARS-CoV-2 mRNA Vaccine | CXSL2300483 | Prevention of SARS-CoV-2. | Prevention of biological products |
| Bivalent Inactivated Vaccine for Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) (Human Diploid Cells) | CXSL2300415 | Prevention of hand, foot, and mouth disease caused by infection with Enterovirus 71 (EV71) and/or Coxsackievirus A16 (CA16). | 1.1 |
| Quadrivalent Influenza Virus Subunit Vaccine (MDCK Cells) | CXSL2300376 | After vaccination, this vaccine stimulates the body to produce immunity against the influenza virus; it is used for the prevention of influenza caused by the vaccine-related strains of the influenza v | 2.2 |
| NMM Therapeutic DNA Vaccine Naked Plasmid Injection | CXSL2200571 | Advanced Solid Tumors and Refractory/Recurrent Lymphomas | 1 |
| Recombinant Human Papillomavirus (HPV) Types 6/11/16/18 Quadrivalent Vaccine (Hansenula polymorpha) | CXSL2200545 | Intended for the prevention of cervical cancer, vaginal cancer, vulvar cancer caused by HPV types 16 and 18 infections; cervical intraepithelial neoplasia grade II and above (CIN2+), adenocarcinoma in | 2.2 |
| EV71-CA16 Bivalent Inactivated Hand, Foot, and Mouth Disease Vaccine (Human Diploid Cells) | CXSL2200357 | After vaccination, this product stimulates the body to produce immunity against Enterovirus 71 (EV71) and Coxsackievirus A16 (CoxA16), and is used for the prevention of hand, foot, and mouth disease a | 1.4 |
| AIDS nucleic acid injection for treatment | CXSL2200115 | Immunotherapy as a supplement to cocktail therapy for HIV/AIDS virus control after discontinuation by inducing and enhancing antigen-specific cellular immune responses. | 1 |
| Component based cell-free pertussis vaccine | CXSL2000386 | Used for preventing pertussis, diphtheria, and tetanus. | Preventive biological products Class 2.2 |
| Nasal spray influenza attenuated live vaccine | CXSL2000343 | Prevention of influenza caused by this virus | Preventive biological products Class 2.2 |
| Recombinant enterovirus 71 virus like particle vaccine (Pichia pastoris) | CXSL1900022 | Vaccination with this product can stimulate the body to develop immunity against EV71 virus and is used to prevent hand, foot, and mouth disease caused by EV71 virus infection. | 9 |
| Adsorbed cell-free pertussis (three component) combined vaccine | CXSL1700134 | After receiving this vaccine, the body can produce an immune response. Used for preventing pertussis, diphtheria, and tetanus. | 6 |
| Recombinant human serum albumin growth hormone fusion protein for injection | CXSL1700106 | Growth disorders in children caused by endogenous growth hormone deficiency | 1 |
| Cell free pertussis Sabin strain poliomyelitis combined vaccine | CXSL1700096 | Stimulate the body to develop immunity against pertussis, diphtheria, tetanus, and poliomyelitis | 1 |
| Rotavirus inactivated vaccine (Vero cells) | CXSL1600129 | After vaccination, this vaccine can stimulate the body to develop anti rotavirus immunity, which is used to prevent diarrhea caused by rotavirus infection. | 1 |
