Japan BCG Laboratory KK

WHO预认证疫苗如何收费？ 提交WHO资格预认证是需要花钱的，有2个收费标准：一是单苗或传统疫苗，二是联合疫苗或创新疫苗，具体疫苗分类见下表： 收费内容分为3个版块：评审费用、评估费用和现场检查费用，如果是对于有紧急公共卫生需求但没有（或非常小）商业市场的产品，评估费用会优惠1/4-3/1左右。 如果是单苗或传统疫苗，则需要收取2500$的评审费、10万$的评估费和3万$的现场检查费，总费用为13.25万美元（约合93万¥）。我国大部分通过该评审的疫苗都为该类疫苗，如科兴的甲肝疫苗、sIPV疫苗和水痘疫苗，华兰的流感疫苗（属于不含佐剂或仅含有铝佐剂）、北生研的bOPV疫苗。 如果是联苗或创新疫苗，则需要收取5000$的评审费、232750$的评估费和3万美元的现场检查费，总费用为26万7750$（约合188万¥），万泰生物和沃森生物的二价HPV疫苗属于该类。 以上只是获得预审资格的费用，除此之外还有年度维护费用。年度维护费是按资格预审疫苗分级使用。首先，根据过去三年内向联合国机构（包括泛美卫生组织PAHO）和全球疫苗免疫联盟（GAVI）的资格预审疫苗总销售总额的滚动平均数来确定制造商等级，以下简称“PQ促成的销售”。其次，疫苗制造商必须在每年6月30日之前提交其等级的声明：I、II、III或IV共4个等级。 也就是说，如果借助PQ认证促成了海外销售单子，则应当按照成交额给予WHO一定的年度“提成”。 比如，假设科兴的甲肝疫苗在2023年向GAVI提供了100万美元（GAVI采购价）的疫苗，则该疫苗制造商应当为III级，需要额外支付41500美元/年的预认证维护费用。如果是万泰生物的二价HPV疫苗2023年向GAVI提供了100万美元（GAVI采购价）的疫苗，则需要额外支付72500美元/年的预认证维护费用。 WHO通过PQ认证的疫苗 WHO从1987年开始通过了首个PQ认证的疫苗，同时通过PQ认证的疫苗有日本BCG实验室的BCG疫苗、GSK的乙肝疫苗和巴斯德的黄热病疫苗。 最新获PQ认证的疫苗为8月2日玉溪泽润的二价HPV疫苗，此外今年获PQ认证的还有巴斯德三价流感疫苗、印度血清所的肺炎结合疫苗和印度E生物公司的OPV（2型）疫苗、Hexasiil的DTP/Hib/IPV五联疫苗，两家韩国公司的霍乱疫苗（Eubiologics）和伤寒疫苗（SK），以及一家荷兰公司Bilthoven Biologicals B.V.生产的IPV疫苗。 而通过PQ认证的新冠疫苗则仅有1家，该新冠疫苗由西班牙海普拉制药公司(Hipra Human Health)生产，于2023年通过WHO的预认证。此前网传的国药、科兴新冠疫苗，均为WHO的EUL清单疫苗，并非PQ认证疫苗。 我们简单罗列比较热门的流感疫苗、HPV疫苗、PCV疫苗、脑膜炎疫苗、轮状疫苗、水痘疫苗信息如下： 流感疫苗是个大家族，常见的季节性流感疫苗（非大流行疫苗）主要由Seqirus、Sanofi、华兰生物和印度血清所主导，包括了三价、四价，鸡胚、细胞，常规、高剂量/佐剂/重组。列表中相同企业相同疫苗不同年份，为更新包装剂型后再次提交预审。 HPV疫苗是WHO列入2026-2030年高优先纳入预认证清单的疫苗，目前全球共6款HPV疫苗，除印度血清所在提交申请外，其他5款均通过认证。 肺炎结合球菌疫苗所预防的肺炎球菌相关侵袭性疾病是影响全球健康的重要问题，肺炎球菌结合疫苗（PCV）是预防相关疾病最有效的措施。目前通过WHO预认证的PCV疫苗为10价和13价，由辉瑞、GSK和SII主导。 脑膜炎疫苗和脑膜炎在近期又重新进入我国公众的视线内，作为最致命的病菌之一，脑膜炎结合疫苗和肺炎结合疫苗一同成为WHO预认证高优先级的产品。 轮状病毒疫苗是预防5岁以下儿童腹泻性疾病和死亡的重要产品，也是WHO预认证目录高优先级的疫苗产品。可能由于轮状病毒是印度儿童健康的高风险因素，因此该疫苗主要由印度企业主导。 水痘疫苗是比较成熟的疫苗品类，但进入WHO预认证清单的时间并不早，也未在WHO的预认证高优先级清单内。在4款通过预认证的疫苗中，我国科兴上榜。 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

In recent developments, ImmunityBio has gained FDA approval for its immunotherapy drug, Anktiva, in combination with Bacillus Calmette-Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). This approval sets the stage for ImmunityBio to directly compete with Merck's heavyweight drug Keytruda and Ferring Pharmaceuticals' gene therapy drug Adstiladrin, both of which are administered without BCG. However, the global shortage of BCG, with Merck being the sole supplier in the United States, poses a significant challenge. The Global BCG Market: According to a research report by GlobalInfoResearch, there are currently seven companies worldwide that produce BCG: Merck, Sanofi Pasteur, Japan BCG Laboratory, China National Biotec Group, Serum Institute of India, Intervax, and GSBPL. Among them, Merck, Japan BCG Laboratory, China National Biotec Group, Serum Institute of India, and GSBPL are the remaining manufacturers of intravesical BCG. After facing production issues in 2012, Sanofi officially exited the market, leaving Merck as the global primary supplier of BCG. Merck's BCG Supply Strategy: Since 2019, Merck has been implementing a controlled supply of BCG, allocating limited quantities to distributors and wholesalers based on historical purchasing patterns rather than directly supplying individual healthcare providers. In October 2020, Merck announced plans to construct a new TICE BCG production facility in North Carolina, with an expected completion date between late 2025 and late 2026. Once operational, Merck anticipates doubling BCG production capacity to meet future demand. ImmunityBio's Alternative Approach: Although ImmunityBio faces direct competition from established rivals, there is a silver lining. The FDA approval for Anktiva does not specify or restrict the type of BCG used in conjunction with the drug. This allows ImmunityBio to explore alternative options to Merck's TICE BCG. The California-based biotechnology company has entered into an exclusive agreement with the Serum Institute of India (SII), the world's largest manufacturer of BCG, to produce BCG globally. The details of the agreement, including pricing and terms, have not been disclosed. SII's BCG Products: SII offers two BCG products for cancer treatment. The first is a traditional BCG known as Onco-BCG, which has already been commercialized outside the United States. The second product is a recombinant BCG currently undergoing mid-term trials in Europe. This version incorporates two gene modifications to enhance its immunogenicity under CD8+ and CD4+ stimulation, while improving safety compared to standard BCG. Future Prospects: Both ImmunityBio and SII are working diligently to expedite the second phase of clinical trials. However, the timeline for commercial supply remains uncertain in both cases. ImmunityBio has expressed confidence that once the trial protocol is submitted to the FDA, a clearer timeline will emerge. The collaboration between ImmunityBio and SII marks a significant step towards addressing the chronic shortage of BCG supply. By diversifying the sources of BCG production, ImmunityBio aims to ensure a long-term solution for the treatment of NMIBC with Anktiva. With SII's expertise and global reach, the partnership holds promise in meeting the demand for BCG and advancing cancer therapies.