Break through the "ninety-nine percent bottleneck"
——The domestic cervical cancer vaccine won the international "passport"
October 14, 2021 is a memorable day. The first domestic cervical cancer vaccine "Xinkening" jointly developed by the Xiamen University Xia Ningshao team and Xiamen Wantai Canghai Biotechnology Co., Ltd., a subsidiary of Yangshengtang Wantai Biotechnology Co., Ltd., passed the world The Health Organization PQ certification has become China's first cervical cancer vaccine certified by the World Health Organization PQ. This is also the first cervical cancer vaccine that is internationally recognized by a developing country with completely independent intellectual property rights.
In 19 years, with hundreds of thousands of experiments and the efforts of thousands of people, the "Xinkening" made by "Wisdom" of Xiamen University has taken an important step on the road to protect more women from cervical cancer and protect the health of people in the world. .
The World Health Organization PQ certification is a United Nations action plan launched in 2001. It includes a set of review procedures. The goal is to ensure the quality, efficacy and safety of drugs purchased by international funds and non-governmental organizations, and to serve the health of people in developing countries. need.
The scope of PQ certification was initially only for anti-AIDS drugs, anti-malarial drugs, and anti-tuberculosis drugs. Later, the scope of PQ certification was gradually increased for reproductive health drugs, zinc agents, influenza drugs, antiviral drugs, antibacterial drugs, raw materials (API), The scope and variety of products accepted for certification of vaccines and testing reagents (RDT) are gradually expanding.
Passing PQ certification is a milestone.
Generally speaking, only products that have passed the PQ certification can participate in the United Nations bulk public procurement.
Buyers such as UNICEF, Global Fund to Fight AIDS, Tuberculosis and Malaria, UNAIDS, World Bank, Asian Development Bank and other international organizations and institutions.
In addition, for drugs that have passed PQ certification, many countries allow exemption from local registration or simplified registration procedures, which means that when drugs are exported to these countries, there is no need to repeat the complicated and lengthy marketing registration process, and they can be directly sold and used in that country. .
Passing the PQ certification means that this domestic cervical cancer vaccine has an internationally recognized “passport”, which is undoubtedly great news for promoting the prevention and elimination of cervical cancer worldwide.
Of course, certification is a full stop, but also a beginning.
In the Wantai factory in Haicang, Xiamen, the bivalent cervical cancer vaccine production line is working non-stop.
Li Shicheng, Chairman of Xiamen Wantai Canghai Biotechnology Co., Ltd. said: "At present, we are working hard to rapidly expand production capacity to meet the growing demand."
Zhang Jun, a key member of the vaccine research team and deputy director of the National Center for Infectious Disease Diagnostics and Vaccine Engineering Technology of Xiamen University, said: "Benefiting more women and facing people's lives and health is the significance of our vaccine research and development. Passing PQ certification means vaccines. Not only can it benefit Chinese women, but it can also benefit more women in other low-income countries."
It is understood that the research and development of the domestic cervical cancer vaccine originated from a visit.
During their visit to the United States in 2002, Xia Ningshao and Zhang Jun accidentally learned that foreign companies had invested a lot of money to advance the Phase III clinical trials of genetically engineered cervical cancer vaccines.
At that time, Xia Ningshao's team was developing the world's first hepatitis E vaccine based on the self-developed E. coli technology platform, and a major breakthrough had been achieved.
Inspired by this, they decided to continue to rely on the E. coli technology platform to start the cervical cancer vaccine project.
Is it feasible?
Questioning voices came from all directions, this is destined to be a long and tortuous road.
In 1997, Zhang Jun joined Xia Ningshao's team and began research on infectious disease prevention and control technology.
"In those years, ninety-nine percent of our research and development process was a bottleneck. We used 100% hard work and persistence to fight against the bottleneck every day." Zhang Jun said, "Of course, we Persistence is not blindness, it is self-confidence based on experimental data obtained by full demonstration."
Li Shaowei, the leader of the vaccine team, still remembers that the road to vaccine research and development is full of various hardships.
In the beginning, it took several months for the doctoral student Gu Ying (now still engaged in vaccine research in Xia Ning Shao's team) to clone the human papillomavirus (HPV) from a patient with cervical lesions in a hospital in Xiamen for vaccine development. The L1 gene of E. coli was subsequently expressed in E. coli to obtain HPV-like virus particles, which made key progress. In the process of vaccine technology development, once in order to solve one of the "price" production process problems, the team members collapsed. cry.
"Difficult, it's really hard, it's so hard to doubt life. But you can only wipe away your tears, continue to persist, the breakthrough will be the next corner." Li Shaowei said with emotion.
Over the past 19 years, with hundreds of thousands of experiments, from students to professors, from dozens of people to thousands of people, working together 100%, Xia Ningshao's team has finally broken through the "100%" with a solid foundation and excellent ability. "The ninety-nine bottleneck".
(Our reporter Ma Yuehua, our correspondent Ouyang Guilian)