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On March 14, 2022, The Notice of Approval of Drug Clinical Trial (Notice No. 2022LP00449) approved by the NMMP arrived, approving the IND application for recombinant 15-valent human papillomavirus vaccine (Escherichia coli) co-developed by Liaoning Chengda Biology Co. LTD (Chengda Bio) & Beijing Health Guard Biotechnology INC (BHGB).
Panacro, entrusted by Chengda Bio, has engaged in CRO services such as medical R&D strategy development, medical monitoring, data management and statistical analysis, thus Facilitate the full life cycle management of the project.
Cervical cancer is the second major malignancy in women, with which human papillomavirus (HPV) has a direct correlation. Through screening the dominant gene sequences of the target serotypes, constructing engineered strains of the target serotypes, developing detection kits and optimizing the protein purification process, the recombinant HPV15 (Escherichia coli) co-developed by Chengda Biologics & BHGB can prevent all high-risk HPV viruses and HPV 6/11, which are highly associated with acromegaly.
Panacro has begun to make deployment in vaccine since 2019, and as one of the initiators, we also led the establishment of the Clinical Branch of China Association for Vaccines, serving as the secretary-general unit. By leveraging professional technical capability and perfect vaccine clinical trial quality management and operation system, Panacro team provides high quality and efficient clinical trial services for vaccine development. In 2020, the core vaccine business of Panacro was officially operated independently in Suzhou office, which was highly recognized by the sponsors and partner organizations with its quality expert resources and on-site resources.
“The IND application for recombinant HPV15 (Escherichia coli) co-developed by Chengda Biologics & BHGB was approved, congratulations! Panacro feels proud to have contributed to the clinical trial of HPV15 vaccine, which is the world's vaccine that has been formally submitted and accepted for clinical trial to date. We are all looking f highest-valent HPV orward to the its NDA, which will bring benefits to more women. Panacro will also focus on improving the clinical operations of vaccines and strive to provide better services for vaccine clinical studies in China".