Undergo inspection

From March 24 to 26, 2020, the Changchun Inspection Sub-bureau of the Jilin Provincial Drug Administration conducted routine supervisory inspections of our company’s live attenuated varicella vaccine and lyophilized live attenuated influenza vaccine for nasal spray.

From May 25 to 29, June 1, and June 2, 2020, on-site supervisory inspectors conducted GMP follow-up inspections of our company’s live attenuated varicella vaccine.

On July 27, 2020, an inspection team from the Changchun Inspection Sub-bureau of the Jilin Provincial Drug Administration conducted a follow-up inspection of our company’s corrective actions regarding defects in the live attenuated varicella vaccine and the lyophilized intranasal live attenuated influenza vaccine.

From October 10 to 13, 2020, an inspection team from the Inspection and Verification Center of the National Medical Products Administration conducted a routine inspection of our company’s lyophilized live attenuated influenza vaccine for nasal spray.

From October 10 to 13, 2020, an inspection team from the Jilin Provincial Drug Administration conducted a supervisory inspection of our company’s live attenuated varicella vaccine and lyophilized live attenuated influenza vaccine for intranasal administration.

On October 12, 2020, an inspection team from the Changchun Inspection Sub-bureau of the Jilin Provincial Drug Administration conducted an inspection of our company’s adverse drug reaction monitoring practices.

From December 10 to 11, 2020, an inspection team from the Changchun Inspection Sub-bureau of the Jilin Provincial Drug Administration conducted an inspection of our company’s corrective actions for identified deficiencies.

From May 11 to May 13, 2021, an inspection team from the Center for Drug and Food Review and Inspection of the National Medical Products Administration conducted a routine inspection of our company’s live attenuated varicella vaccine.

From May 11 to May 15, 2021, upon assignment by the Center for Drug and Food Review and Inspection of the National Medical Products Administration, a verification team from the Jilin Provincial Medical Products Administration conducted an on-site registration inspection of our company’s application for a live attenuated varicella vaccine (specification: 0.5 mL per vial; acceptance numbers: CYSB2000337 [National] and CYSB2000395 [National]). During the on-site registration inspection of the manufacturing facility, the Jilin Provincial Center for Drug Review and Inspection also carried out a concurrent Good Manufacturing Practice compliance inspection of our company’s application for the same live attenuated varicella vaccine (specification: 0.5 mL per vial) from May 11 to May 15, 2021.

On July 13, 2021, the Production Supervision Division of the Jilin Provincial Drug Administration conducted a verification inspection to confirm the implementation of corrective measures for deficiencies identified during an inspection of our company’s live attenuated varicella vaccine.

From October 23 to October 26, 2021, the Jilin Provincial Drug Review and Inspection Center conducted a GMP compliance inspection of our company’s live attenuated varicella vaccine and lyophilized live attenuated influenza vaccine for nasal spray.

From February 16 to February 18, 2022, the Changchun Inspection Sub-bureau of the Jilin Provincial Drug Administration conducted a special inspection of our company’s lyophilized live attenuated influenza vaccine for nasal spray.

From June 17 to June 22, 2022, upon assignment by the Center for Drug and Food Review and Inspection of the National Medical Products Administration, a verification team from the Jilin Provincial Medical Products Administration conducted an on-site inspection for drug registration of our company’s application for a live attenuated herpes zoster vaccine (specification: 0.5 mL per vial; acceptance number: CXSS2200036[National]). During the period of the on-site drug registration inspection, the Jilin Provincial Center for Drug Review and Inspection also carried out a concurrent Good Manufacturing Practice compliance inspection of our company’s application for the same live attenuated herpes zoster vaccine (specification: 0.5 mL per vial) from June 17 to June 22, 2022.

From November 8 to November 10, 2022, the Changchun Inspection Sub-bureau of the Jilin Provincial Drug Administration conducted a follow-up inspection to address the deficiencies identified during its special inspection of our company’s lyophilized live attenuated influenza vaccine for nasal spray, which was carried out from February 16 to February 18, 2022.

From November 16 to November 18, 2022, the Jilin Provincial Drug Review and Inspection Center conducted a GMP compliance inspection and a review of licensed items under the Drug Production License for the newly added No. 1 pre-filled syringe diluent filling line in our Company’s Secondary Filling Department.

From December 19, 2022, to December 22, 2022, the Center for Drug and Food Review and Inspection of the National Medical Products Administration conducted an inspection of our company’s lyophilized live attenuated influenza vaccine for nasal spray.

From December 19, 2022, to December 22, 2022, the Jilin Provincial Drug Review and Inspection Center conducted a GMP compliance inspection of our company’s live attenuated varicella vaccine and lyophilized live attenuated influenza vaccine for nasal spray.

On April 4, April 6, and April 7, 2023, the Changchun Inspection Sub-bureau of the Jilin Provincial Drug Administration conducted routine supervisory inspections of our company’s live attenuated zoster vaccine.

From May 17 to May 20, 2023, the Jilin Provincial Drug Review and Inspection Center conducted a regulatory GMP on-site inspection of our company’s live attenuated zoster vaccine.

From May 17 to May 20, 2023, the Jilin Provincial Drug Review and Inspection Center conducted a special inspection of our company’s live attenuated zoster vaccine and lyophilized live attenuated influenza vaccine for nasal spray at the manufacturing facility where these vaccines are produced.

From May 24 to May 27, 2023, the National Medical Products Administration conducted an inspection of our company’s live attenuated zoster vaccine.

On October 9, 2023, the Changchun Inspection Branch of the Jilin Provincial Drug Administration, acting on behalf of the Jilin Provincial Drug Administration, conducted a routine inspection of our company’s pharmacovigilance activities.

June 3, 2024 to June 7, 2024 ， The Jilin Provincial Drug Review and Inspection Center conducted a regulatory GMP compliance inspection of our company’s lyophilized live attenuated influenza vaccine for nasal spray.

June 17, 2024 To June 20, 2024 ， The Changchun Municipal Inspection Sub-Bureau conducted a special inspection of our company’s lyophilized live attenuated influenza nasal spray vaccine, as well as special inspections for product changes and routine supervisory inspections.

June 17, 2024 To June 20, 2024 ， The Changchun Municipal Inspection Branch conducted a special supervisory inspection of our company’s lyophilized live attenuated influenza vaccine for nasal spray, live attenuated varicella vaccine, and live attenuated zoster vaccine.

July 25, 2024 To July 28, 2024 ， The Vaccine Inspection Center of the National Medical Products Administration conducted a routine inspection of our company’s live attenuated varicella vaccine.

August 12, 2024 To On August 16, 2024, the Jilin Provincial Drug Review and Inspection Center conducted an on-site inspection of our company’s marketing authorization application for the intranasal live attenuated influenza vaccine (Acceptance Number: CXSS2400043), and concurrently carried out a GMP compliance inspection of the same application.

August 12, 2024 To On August 16, 2024, the Jilin Provincial Drug Review and Inspection Center conducted a regulatory GMP compliance inspection of our company’s lyophilized live attenuated influenza vaccine for intranasal administration (diluent).

September 19, 2024 To On September 25, 2024, the Production Division of the Jilin Provincial Drug Administration conducted a routine inspection and follow-up inspection of our company’s live attenuated varicella vaccine.

October 15, 2024 To On October 17, 2024, the Production Division of the Jilin Provincial Drug Administration conducted a special inspection of our company’s live attenuated varicella vaccine.

November 11, 2024 To On November 15, 2024, Russian authorities conducted an audit of our company’s live attenuated varicella vaccine in Russia.

November 21, 2024 To On November 22, 2024, the Production Division of the Jilin Provincial Drug Administration conducted a special inspection of our company’s live attenuated varicella vaccine.

From May 19, 2025, to May 22, 2025, the National Vaccine Inspection Center conducted AEFI monitoring inspections and an inspection of the lyophilized live attenuated influenza vaccine for nasal spray at our company.

From September 16 to September 19, 2025, the Jilin Provincial Drug Review and Inspection Center will conduct a GMP compliance inspection of our company’s live attenuated varicella vaccine and live attenuated herpes zoster vaccine.