From May17, 2022 to May 19, 2022, Dr Hasan A. Irier and Dr Amanda Lewin checked theproject of plasma sample analysis and detection for human bioequivalence (BE)study of voriconazole dry suspension (Study No.: 21BMT005) undertaken by ourcompany through the remote record review mode. This BE study is used to supportthe China US dual reporting generic drug application submitted by Zhejiang PuliPharmaceutical Co., Ltd; Our company will complete the analysis of BE clinicalsamples in July 2021. The three-day remote inspection involves the review ofdocuments, records and electronic data, as well as the verification andconfirmation of the GLP management system of the biological analysislaboratory, the laboratory site and personnel qualifications, facilities andequipment. All departments of our company cooperated with each other andactively cooperated with the inspection through remote video on site. Theresearch team had in-depth communication with the inspectors. The FDA inspectorof the United States affirmed and thanked our company for its positivecooperation and high-quality remote video display throughout the process.

This isthe first time that our biological analysis laboratory has accepted the remoteaudit of FDA. FDA is considered to be the most stringent and highest standardnew drug approval agency in the world, and its management of BA/BE clinicaltrials is recognized by means of post verification. This verification of the BEanalysis and detection project of the dry suspension of voriconazole wassuccessfully passed with no defects, which is another important milestone afterthe BE analysis and detection project of oxcarbazepine tablets inherited by ourbiological analysis laboratory passed the technical review of the NetherlandsDrug Evaluation Commission (CBG) in February 2022, indicating that ourbiological sample analysis of BA/BE clinical trials has officially been in linewith international standards. The successful on-site inspection by FDA not onlyindicates that the quality system of Longcharm Biotech can be routinelyinspected by global regulators, but also confirms that Longcharm Biotech canprovide global pharmaceutical customers with technology outsourcing servicesthat meet international quality regulatory standards. We will scrupulouslyabide by international quality supervision standards and help partners betterachieve the goal of international double reporting of BA/BE research.

As anindependent third-party testing laboratory, the biological analysis laboratoryof Zhejiang Longcharm Biomedical Technology Co., Ltd., which was inspected thistime, has provided a number of Sino European and Sino American double reportingBA/BE testing services for pharmaceutical industry customers. Founded in 2016,the company is a technical service platform that provides professionalthird-party biological analysis and testing and innovative drug development andincubation. It has nearly 5000 square meters of its own laboratories inHangzhou Pharmaceutical Port and Phase IV of Dazhou Pharmaceutical Valley. Thelaboratory is fully equipped to fully support the drug development projectneeds of pharmaceutical enterprises in different stages from pre clinical tocommercialization.