Recently, Chengdu Olymvax Biopharmaceuticals Inc. (hereinafter referred to as “Olymvax”) successfully held the Kick-off Meeting & Investigator Training for Phase IIIa Clinical Trials of Quadrivalent Influenza Virus Split Vaccine (MDCK Cell) in Weiyuan County, Neijiang City, Sichuan Province and Jiangjin District, Chongqing Municipality. The meeting was hosted by Sichuan Provincial Center for Disease Control and Prevention and Chongqing Municipal Center for Disease Control and Prevention, and relevant leaders from Sichuan Province, Chongqing Municipality and other units attended and delivered speeches. Mr. Fan Shaowen, Chairman and General Manager of Olymvax, Mr. Qi Jianliang, Vice President of Public Affairs of Chengdu Bonacius Pharmaceutical Technology Co., Ltd. (the CRO), and Dr. Li Rongcheng, Chief Scientist of Chongqing Mildmed Biopharmaceutical Co., Ltd., delivered speeches.
Based on the results of Phase I clinical trials of this vaccine, all parties attending the meeting fully recognized its safety, product quality and market potential. For the upcoming Phase IIIa clinical trials, all leaders unanimously emphasized strict quality control and the strengthening of risk prevention and control, requiring investigators to earnestly fulfill their responsibilities, strictly abide by regulations, and effectively protect the rights and interests of subjects. Mr. Fan Shaowen stated that as the sponsor, Olymvax will adhere to the principle of “Quality First, Authentic Data”, strictly abide by the Good Clinical Practice, ensure the trials are conducted in a compliant and scientific manner, establish and improve a monitoring and handling mechanism for adverse events, and fully protect the rights and interests of subjects. The Company expects to closely cooperate with Sichuan Provincial CDC, Chongqing Municipal CDC and relevant partners to efficiently advance Phase III clinical trials, promote the product to the market at an early date, and contribute to influenza prevention and control and people’s health in China.
In the training session, the attending experts provided detailed training on GCP, relevant regulations on vaccine clinical trials, and the protection of subjects’ rights and interests, and elaborated on the clinical trial protocol, operational procedures and quality control. Operational process drills and first aid drills were also organized at the meeting to ensure that all participants master the standardized procedures and effectively implement the protection of subjects’ rights and interests.
This Phase IIIa clinical trial is jointly promoted by Sichuan Provincial Center for Disease Control and Prevention as the leading unit and Chongqing Municipal Center for Disease Control and Prevention as a sub-center, marking a key step forward for the Company in the field of influenza vaccine R&D.
This vaccine adopts MDCK suspension cell culture technology, which is the first quadrivalent influenza vaccine project of the same kind in China to enter the efficacy evaluation stage. It is expected to fill the gap in this technical route in China and provide an important reference for the upgrading of influenza vaccine production technology. Compared with the traditional chicken embryo culture process, this technology can effectively shorten the production cycle, has potential advantages such as good safety, easy scale-up of production, and wide applicable population, and can achieve higher production yield, more stable product quality and lower production cost, thus expected to provide a better immune solution for influenza prevention and control. The previous Phase I clinical trial data showed that the vaccine exhibited good safety and immunogenicity in healthy people aged 6 months and above, laying a solid foundation for the conduct of Phase III clinical trials.
Olymvax focuses on the R&D, production and sales of human vaccines, has built an orderly product pipeline, and possesses significant capabilities in the transformation of R&D achievements. Influenza series vaccines are important achievements of the Company’s expansion from bacterial vaccines to viral vaccines. The Company will continue to advance relevant clinical trials of influenza series vaccines, strive to complete relevant research at an early date, further expand the Company’s R&D pipeline and enhance market competitiveness.