EX-99.6 9 sinovactestrpts.txt SINOVAC BIOTECH 6K, TEST REPORTS EXHIBIT 99.6 ------------ (2002) Liangren (Guo) No.S0599 No.L0001 National Institute for the Control of Pharmaceutical & Biological Products -------------------------------------------------------------------------- TEST REPORT ----------- Report No.SH200301297 Name of test sample: SARS virus strain Sino1. Sample supplier: Beijing Sinovac Biotech Co. Ltd. Test purpose: Contract test. Basis for test: {{Main Technical Points for SARS Vaccine Inactivated Pre-Clinical Research}} {{Regulations for Biological Products of China>>2000 Edition}}
TEST REPORT FROM NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS [Seal for test reports of National Institute for the Control of Pharmaceutical and Biological Products] Report No. SH200301297 Page 1 of 1 ---------------------------------------------------------------------------------------------------- Name of Test Sample SARS virus strain Sino1 Test Sample Number SHBE200300674 Sample Supplier Beijing Sinovac Biotech Sample Series/Type / Co. Ltd. Sample Source / Test Sample State Liquid Test Purpose Contract test Test Sample Quantity 20ml Test Items Complete test Sample Reception Date October 8, 2003 Basis for test {{Main Technical Points for SARS Vaccine Inactivated Pre-Clinical Research}} {{Regulations for Biological Products of China}} 2000 Edition ---------------------------------------------------------------------------------------------------- Test Item Standard Requirement Test Result --------- -------------------- ----------- Virus titre (Cytopathy method) 7.0logCCID50/ml Virus titre (Plaque titration method) 6.48logPFU/ml Sterility test There should no growth of Satisfies the requirement bacteria and fungi Mycoplasma examination There should be no growth of Satisfies the requirement (Cultivation method) mycoplasmas Exogenous factor examination Blood absorption test No blood absorption Satisfies the requirement Non-blood absorption test No cytopathy Satisfies the requirement Exogenous factor examination on All animals should be alive Satisfies the requirement animals and healthy, chick embryo allantoic fluid agglutination test negative END ---------------------------------------------------------------------------------------------------- Test Conclusion This sample was tested according to the {{Main Technical Points for SARS Vaccine Inactivated Pre-Clinical Research}} and the {{Regulations for Biological Products of China}} 2000 Edition and the results satisfy the requirements. Technology Officer [Signature] Date of Issue October 16, 2003 ----------------------------------------------------------------------------------------------------
(2002) Liangren (Guo) No.S0599 No.L0001 National Institute for the Control of Pharmaceutical & Biological Products -------------------------------------------------------------------------- TEST REPORT ----------- Report No.SH200301298 Name of test sample: SARS virus strain Sino3. Sample supplier: Beijing Sinovac Biotech Co. Ltd. Purpose of certification: Contract test. Basis for test: {{Main Technical Points for SARS Vaccine Inactivated Pre-Clinical Research}} {{Regulations for Biological Products of China}} 2000 Edition
TEST REPORT FROM NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS [Seal for test reports of National Institute for the Control of Pharmaceutical and Biological Products] Report No. SH200301298 Page 1 of 1 ---------------------------------------------------------------------------------------------------- Name of Test Sample SARS virus strain Sino3 Test Sample Number SHBE200300675 Sample Supplier Beijing Sinovac Biotech Sample Series/Type / Co. Ltd. Sample Source / Test Sample State Liquid Test Purpose Contract test Test Sample Quantity 20ml Test Items Complete test Sample Reception Date October 8, 2003 Basis for test {{Main Technical Points for SARS Vaccine Inactivated Pre-Clinical Research}} {{Regulations for Biological Products of China}} 2000 Edition ---------------------------------------------------------------------------------------------------- Test Item Standard Requirement Test Result --------- -------------------- ----------- Virus titre (Plaque titration method) 6.95logPFU/ml Sterility test There should be no growth of Satisfies the requirement bacteria and fungi Mycoplasma examination There should be no growth of Satisfies the requirement (Cultivation method) mycoplasmas Exogenous factor examination Blood absorption test No blood absorption Satisfies the requirement Non-blood absorption test No cytopathy Satisfies the requirement Exogenous factor examination on All animals should be alive Satisfies the requirement animals and healthy, chick embryo allantoic fluid agglutination test negative END ---------------------------------------------------------------------------------------------------- Test Conclusion This sample was tested according to the {{Main Technical Points for SARS Vaccine Inactivated Pre-Clinical Research}} and the {{Regulations for Biological Products of China}} 2000 Edition and the results satisfy the requirements. Technology Officer [Signature] Date of Issue October 16, 2003 ----------------------------------------------------------------------------------------------------
(2002) Liangren (Guo) No.S0599 No.L0001 National Institute for the Control of Pharmaceutical & Biological Products -------------------------------------------------------------------------- TEST REPORT ----------- Report No.SZ200303628 Name of test sample: SARS Vaccine Inactivated. Sample supplier: Beijing Sinovac Biotech Co. Ltd. Purpose of certification: Registration testing. (Application for new drug clinical research) Basis for test: Regulations for Business Declaration. [Seal for Test Reports of National Institute for the Control of Pharmaceutical & -------------------------------------------------------------------------------- Biological Products] --------------------
TEST REPORT FROM NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS [Seal for test reports of National Institute for the Control of Pharmaceutical and Biological Products] Report No. SZ200303628 Page 1 of 2 ---------------------------------------------------------------------------------------------------------- Name of Test Sample SARS Vaccine Test Sample Number SZBE200305345 Inactivated Manufacturer Beijing Sinovac Biotech Lot Number 20030904 Co. Ltd. Sample Supplier Beijing Sinovac Biotech Specification 1.0ml/vial Co. Ltd. Test Purpose Registration test (New Dosage Form Liquid (water drug application for injection) clinical research) Test Items Complete test Packaging Specification / Sample Reception Date Oct. 20, 2003 Expiry Date August 2004 Test Quantity 55 vials Signed and Sealed Quantity / Basis for test Regulations for Business Declaration ---------------------------------------------------------------------------------------------------------- Test Item Standard Requirement Test Result --------- -------------------- ----------- Stock solution assay Protein content assay <=50ug/ml 5ug/ml Vero cell residual NDA content <=10ng/dosage <10ng/dosage assay Residual bovine serum protein content assay <=50ng/dosage <6ng/dosage Inactivation test Three generations of [one Satisfies the requirement character illegible] passage; fluorescence detection for each generation is negative Finished product assay Identification test Appearance Same effectiveness test Same effectiveness test No colour or light cream white Satisfies the requirement liquid with no foreign object pH value 6.5~8.0 7.3 Examination of toxin within less than 100EU/ml =>6<13EU/ml bacteria Sterility test There should be no growth of Satisfies the requirement bacteria or fungi Effectiveness test (Immune mouse To be determined Sino1 Strain - 1:275.9 method) (Original time vaccine); 1:240.0 (1:4 times vaccine); 1:105.4 (1:16 times vaccine); 1:45.4 (1:64 times vaccine) GZ01 Strain - =>1:495.2 (Original time vaccine); =>1:519.9 (1:4 times vaccine); 1:450.1 (1:16 times vaccine); 1:192.0 (1:64 times vaccine To be continued on the next page ----------------------------------------------------------------------------------------------------------
No.L0001 National Institute for the Control of Pharmaceutical & Biological Products -------------------------------------------------------------------------- TEST REPORT ----------- Report No.SH200301357 Name of test sample: Vero Cell (Generation 143) Sample supplier: Beijing Sinovac Biotech Co. Ltd. Purpose of certification: Contract test. Basis for test: {{Regulations for Biological Products of China}} 2000 Edition [Seal for Test Reports of National Institute for the Control of Pharmaceutical & -------------------------------------------------------------------------------- Biological Products] --------------------
TEST REPORT FROM NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS [Seal for test reports of National Institute for the Control of Pharmaceutical and Biological Products] Report No. SH200301357 Page 1 of 1 ---------------------------------------------------------------------------------------------------- Name of Test Sample Vero Cell (Gen. 143) Test Sample Number SHBB200300556 Sample Supplier Beijing Sinovac Biotech Sample Series/Type / Co. Ltd. Sample Source Beijing Sinovac Biotech Test Sample State / Co. Ltd. Test Purpose Contract test Test Sample Quantity 5 bottles Test Items Complete test Sample Reception Date August 26, 2003 Basis for test {{Regulations for Biological Products of China}} 2000 Edition ---------------------------------------------------------------------------------------------------- Test Item Standard Requirement Test Result --------- -------------------- ----------- Sterility test No growth of bacteria Satisfies the requirement Mycoplasma examination Cultivation method Negative Satisfies the requirement DNA staining method Negative Satisfies the requirement Cell culture direct observation Normomorph Satisfies the requirement Examination of passage culture of different cells Monkey originated Vero cells Normomorph Satisfies the requirement Human originated 2B2 cells Normomorph Satisfies the requirement Same type of cells in Normomorph Satisfies the requirement different batches Red cell absorption test Negative Satisfies the requirement Animal and chick embryo examination (survival rate %) Suckling mouse Suckling mouse =>80% Suckling mouse 90% Adult mouse Adult mouse =>80% Adult mouse 100% Guinea pig Guinea pig =>80% Guinea pig 100% Rabbit Rabbit =>80% Rabbit 100% Chick embryo Chick embryo =>80% Chick embryo 100% Chick embryo allantoic fluid red cell Negative Satisfies the requirement agglutination test Oncogenic test No growth of tumour Satisfies the requirement Identification test Isozyme Monkey originated Satisfies the requirement Reverse transcription virus Negative Satisfies the requirement examination ---------------------------------------------------------------------------------------------------- Test Conclusion This sample was tested according to the {{Regulations for Biological Products of China}} 2000 Edition and the results satisfy the requirements. Technology Officer [Signature] Date of Issue November 13, 2003 ----------------------------------------------------------------------------------------------------
(2002) Liangren (Guo) No.S0599 No.L0001 National Institute for the Control of Pharmaceutical & Biological Products -------------------------------------------------------------------------- TEST REPORT ----------- Report No.SH200301352 Name of test sample: Vero Cell (Generation 160) Sample supplier: Beijing Sinovac Biotech Co. Ltd. Purpose of certification: Contract test. Basis for test: {{Regulations for Biological Products of China}} 2000 Edition [Seal for Test Reports of National Institute for the Control of Pharmaceutical & -------------------------------------------------------------------------------- Biological Products] --------------------
TEST REPORT FROM NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS [Seal for test reports of National Institute for the Control of Pharmaceutical and Biological Products] Report No. SH200301352 Page 1 of 1 ---------------------------------------------------------------------------------------------------- Name of Test Sample Vero Cell (Gen. 160) Test Sample Number SHBB200300626 Sample Supplier Beijing Sinovac Biotech Sample Series/Type / Co. Ltd. Sample Source Beijing Sinovac Biotech Test Sample State / Co. Ltd Test Purpose Contract test Test Sample Quantity 4 bottles Test Items Partial test Sample Reception Date September 16, 2003 Basis for test {{Regulations for Biological Products of China}} 2000 Edition ---------------------------------------------------------------------------------------------------- Test Item Standard Requirement Test Result --------- -------------------- ----------- Oncogenic test No growth of tumour Satisfies the requirement END ---------------------------------------------------------------------------------------------------- Test Conclusion This sample was tested according to the {{Regulations for Biological Products of China}} 2000 Edition and the results satisfy the requirements. Technology Officer [Signature] Date of Issue November 12, 2003 ----------------------------------------------------------------------------------------------------