全球首个！！！博沃生物广谱HPV疫苗获批进入临床试验
近日，由上海博沃和武汉博沃联合开发的广谱HPV疫苗获得澳大利亚人类研究伦理委员会签发的伦理批件，并已完成澳大利亚药品管理局（TGA）临床试验备案，从而正式获准进入临床试验——这是全球首个进入临床试验的广谱HPV疫苗。
众所周知，人乳头瘤病毒（HPV）的持续感染是引发宫颈癌的首要原因，此外还会诱发肛门癌、阴道癌、口咽癌、外阴癌、阴茎癌、口腔癌、喉癌、头颈癌等各类型的癌症及尖锐湿疣等性传播疾病和寻常疣、扁平疣等皮肤病。目前，几乎所有疫苗企业研发的HPV疫苗都是基于病毒样颗粒（VLP）的设计，且通过增加HPV的价数以期达到更好的保护范围。目前已上市的最高价次HPV疫苗为9价苗，但它仅对覆盖的型别有保护作用，对9价以外的型别无保护效果。事实上，目前已确定的HPV型别有200余种！
我国国家药品监督管理局根据世界卫生组织（World Health Organization，WHO）国际癌症研究机构（International Agency for Research on Cancer，IARC）的建议，将HPV16/18/31/33/35/39/45/51/52/56/58/59/68定义为高危型。国内外已有文献报道，非9价HPV疫苗覆盖的型别（如HPV39/51/53/56/59/68等）高危型仍会导致宫颈癌的发生。The Lancet Oncology 中的一篇文章指出，未被已上市HPV疫苗覆盖的HPV35/39/51/56/59等血清型持续感染引起的CIN2+和CIN3+，分别占CIN2+事件（宫颈上皮内瘤变2级及以上）的41%和CIN3+事件（宫颈上皮内瘤变3级及以上）的41%。这也就意味着市面上现有的最高价数的HPV疫苗的保护能力仍是有限的，而仅靠增加HPV疫苗的价数不仅会提高疫苗的成本，同时还会降低疫苗的可及性，对相关疾病的防控十分不利。
博沃生物开发的广谱HPV疫苗是全球首个进入临床阶段的广谱HPV疫苗，理论上可预防全部200多种型别的HPV感染及宫颈癌等恶性肿瘤，保护范围更广，生产成本更低，是HPV病毒感染及由此导致的恶性肿瘤的“终结者”。我们期待博沃生物的广谱HPV疫苗以高维度的“颠覆性”技术以及产能和价格优势重构全球HPV疫苗市场，为人类最终消除宫颈癌等病患威胁做出非凡贡献！
Recently, the broad-spectrum human papillomavirus (HPV) vaccine developed by BravoBio and BravoVax has secured ethical approval from Human Research Ethics Committee (HREC) and been acknowledged by Therapeutic Goods Administration (TGA) of Australia, thus officially approved for clinical trials. This is the world's first broad-spectrum HPV vaccine that enters the clinical stage.
Human Papilloma Virus (HPV) is the leading cause of cervical cancer, and it also causes anal cancer, vaginal cancer, oropharyngeal cancer, vulvar cancer, penile cancer, oral cancer, laryngeal cancer, and genital warts. Currently, all protective HPV vaccines on the market such as Gardasil®9 and Cervarix® or in clinical trials (e.g., Recombinant Human Papillomavirus Vaccine against serotypes HPV 6/11/16/18/31/33/45/52/58 produced in E. coli) are based on the variable L1 immunogen and thus provide serotype-restricted protection. However, to date, more than 200 distinct types of HPVs have been identified based on their genomic sequences.According to World Health Organization (WHO) and the International Agency for Research on Cancer (IARC), HPV 16/18/31/33/35/39/45/51/52/56/58/59/68 have been listed as high-risk oncogenic serotypes, among which HPV16/18 cause the majority of HPV-related cancers. A study, recently published in The Lancet Oncology, of 7,466 participants on precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent HPV vaccine found that 41% of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and 41% cervical intraepithelial neoplasia grade 3 or worse (CIN3+) were caused by HPV 35/39/51/56/59 infections, all HPV serotypes that are not covered by Gardasil®9. There’s a high demand for HPV vaccines with coverage to more oncogenic HPVs or a broad-spectrum HPV vaccine that can provide a one-stop solution for all HPV infections.
The broad-spectrum HPV vaccine developed by BravoBio and BravoVax can protect against all the types of HPV theoretically, bringing boarder protections with much lower production cost. We expect that the use of this vaccine could benefit human beings with its unique advantages in revolutionary technology, manufacturing capacity and affordable price, contributing to the ultimate elimination of cervical cancer across the world!
References:
1. Trama, J.P., et al. High-Risk HPV Genotype Distribution According to Cervical Cytology and Age. Open Forum Infectious Diseases. 2022.
2. Shing, J.Z., et al., Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol, 2022. 23(7): p. 940-949.
3. Ma, M., et al., The distribution and pathogenic risk of non‐9‐valent vaccine covered HPV subtypes in cervical lesions. Cancer Med, 2022. 11(6): p. 1542-1552.
4. Yunihastuti, E., et al., Incidence, clearance, persistence and factors related with high-risk anal HPV persistence in South-East Asian MSM and transgender women. AIDS, 2020. 34(13): p. 1933-1941.
5. Molina-Pineda, A., et al., High frequency of HPV genotypes 59, 66, 52, 51, 39 and 56 in women from Western Mexico. BMC Infect Dis, 2020. 20(1): p. 889.
关于博沃生物
上海博沃生物科技有限公司（简称博沃生物）2011年3月成立于上海张江高科技园区，2021年10月迁至北上海生物医药园。2012年12月设立了武汉博沃，是国家级高新技术企业、中国疫苗行业协会理事单位。2020年公司被德勤Deloitte评为“中国明日之星”，是内地唯一获奖的生物医药企业。公司具有基因编辑/构建/克隆/检测、细菌大规模培养、细胞/病毒大规模培养、生物活性物质制备（多糖、蛋白质、病毒等）、多糖与蛋白质化学结合、新型佐剂、新型制剂、新型检测等多个先进技术平台，满足各类创新型生物医药特别是疫苗开发的需要。博沃生物以满足中国和世界人民健康生活的美好愿景为己任，致力于通过重磅级创新疫苗的开发和市场化运营，成为全球疾病控制领域的主力军。
Shanghai BravoBio Co., Ltd (BravoBio) was established in Zhangjiang Hi-Tech Park in Shanghai in March 2011 and moved to MediPark in North Shanghai in October 2021. Its subsidiary company, Wuhan BravoVax Co., Ltd (BravoVax), was founded in December 2012. BravoVax is a "state level high-tech enterprise" and a council member of China Association of Vaccines (CAV). It was awarded as "China Rising Star" by Deloitte in 2020, becoming the only biopharmaceutical enterprise in Chinese mainland to win this award. The company boasts a number of advanced technology platforms, including gene editing / construction / cloning / detection, large-scale bacterial / cell / virus culture, preparation of bioactive substances (polysaccharide, protein, virus, etc.), chemical combination of polysaccharide and protein, novel adjuvant, new preparation and analytical assays, etc. to meet the needs of developing innovative biologics, especially vaccines. BravoBio has held the mission to improve the quality of people's lives, aiming for a healthier and happier future. The company is active to be a global supplier of high-quality vaccine through development and commercialization of its innovative and blockbuster vaccines, contributing to the control of global diseases.
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