On March 28, 2024, the phase I clinical trial of "recombinant 15-valent human tumor virus vaccine (Escherichia coli)" jointly developed by Liaoning Chengda Biological Co., Ltd. and Beijing Kangle Guardian Biotechnology Co., Ltd. was officially launched. Relevant project personnel from Chengda Biology, Recreation Guardian, Clinical Trial Agency and CRO Company attended the kick-off meeting.

Cervical cancer, as a major threat to women's health, its prevention and treatment has been the focus of global public health.AccordingCervical cancer is the fourth most common cancer in women worldwide, WHO data shows, human tumor virus (HPV) is directly related to cervical cancer, and the vast majority of cervical cancer cases are related to persistent infection of high-risk HPV. Preventive HPV vaccination and screening and treatment of precancerous lesions are an effective way to prevent cervical cancer.

The initiation of clinical trialsThe 15-valent HPV vaccine was developed by Chengda Bio in cooperation with Recreation Guardian, who is responsible for the early research and preclinical research of the vaccine, and Chengda Bio is responsible for the clinical development, production and commercialization of the vaccine. The 15-valent HPV vaccine is the highest-priced HPV vaccine that has been marketed or approved by IND worldwide so far, covering all high-risk HPV types defined by IARC, it is used to prevent persistent infection caused by HPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68, and diseases such as CIN, VIN, VaIN, AIN, cervical cancer, vaginal cancer, vulvar cancer, anal cancer and genital warts (condyloma acuminatum) caused by the above types of HPV infection can increase the protection rate of cervical cancer to more than 96%.

At the kick-off meeting, the R & D director of Liaoning Chengda Biological Co., Ltd. delivered a speech on behalf of the sponsor. He saidThe 15-valent HPV vaccine is a new class of drugs, and it is also the most expensive HPV vaccine in clinical research. The successful development of this variety and the future market will effectively reduce the disease risk caused by the low-cost HPV vaccine not covering the serotype. The start of clinical trials is an important step for this vaccine from the laboratory to the clinic. We hope that with the joint efforts of the institutions in charge of clinical trials and CRO companies, clinical trials will be completed quickly and well, contributing to the localization of high-priced HPV vaccines and bringing good news to the majority of women.

The staff of Chengda Biology Project introducedThe background of HPV disease, the information of vaccine used in this clinical trial, and the research and development process of 15-valent HPV vaccine are introduced from the pharmaceutical research, safety and immunogenicity of non-clinical research.

At the meeting, the relevant leaders of the institutions responsible for clinical trials stressed the high price.The significance of HPV vaccine research and development confirms the company's hard work in the early preparation work. At the same time, it also emphasizes the importance of the safety of the subjects for the success of the project. I hope everyone will strictly follow the regulations and standards to ensure that the safety and rights of the subjects during the project are fully guaranteed, and the clinical trial work is successfully completed.

The official launch of the 15-valent HPV vaccine clinical trial marks a milestone in the cooperative research and development of this variety between Chengda Biology and Kangle Guardian, and realizes the complementary advantages of technology and industry. The two parties are committed to continuously exploring and breaking through new frontiers in the field of biomedicine, promoting research and development and innovation in the vaccine industry to meet the growing global demand for medical prevention, and strive to make greater contributions to the health and well-being of the Chinese people through technological progress. Innovation promotes the high-quality development of the country's new quality productivity!

As a vaccine manufacturer rooted in China, Chengda Bio has always adhered toThe concept of "facing life, only responsibility,InsistThe core values of "integrity and responsibility" are always committedR & D,Production and promotion of international level, leading domestic biological products. In the future, the company will continue to be driven by technological innovation, guided by clinical value, use advanced scientific research and innovation technology, actively explore industry cooperation opportunities, continuously promote the innovation and development of the vaccine industry, and contribute Chinese wisdom and strength to the cause of human health.