A Phase I Randomized, Double-blind, Placebo-controlled and Dose Escalation Study to Evaluate the Safety and Immunogenicity of a Viral Vector-based Tuberculosis (TB) Vaccine Ad5-105K Against TB Disease in Adults Aged 18 to 49 Years

This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine (Dose A or Dose B of Ad5-105K) or a placebo in a ratio of 2:1. The distribution of participant's gender and age should be balanced in each group.

开始日期2025-02-01

申办/合作机构

康希诺生物股份公司

[+1]

NCT06708286

/ Recruiting临床2/3期

A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)

This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.

开始日期2024-12-20

申办/合作机构

康希诺生物股份公司

CTR20244440

/ Active, not recruiting临床2期

评价吸附无细胞百（五组分）白破联合疫苗免疫原性和安全性的随机、盲法、对照Ⅱ期临床试验

主要目的：各年龄层接种1剂吸附无细胞百（五组分）白破联合疫苗安全性

开始日期2024-12-20

申办/合作机构

康希诺生物股份公司

100 项与康希诺生物股份公司相关的临床结果

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0 项与康希诺生物股份公司相关的专利（医药）

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项与康希诺生物股份公司相关的文献（医药）

2024-12-31·Emerging microbes & infections

Safety and immunogenicity of heterologous boosting with orally administered aerosolized bivalent adenovirus type-5 vectored COVID-19 vaccine and B.1.1.529 variant adenovirus type-5 vectored COVID-19 vaccine in adults 18 years and older: a randomized, double blinded, parallel controlled trial

Article

作者: Xu, Jia-Wei ; Yu, Lin-Ling ; Wang, Fei-Yu ; Wang, Rui-Jie ; Gou, Jin-Bo ; Zhu, Tao ; Gao, Ping ; Xu, Yu ; Wang, Bu-Sen ; Huang, Hai-Tao ; Qiu, Wei ; Liu, Xuan ; Hou, Li-Hua ; Wang, Qing- ; Zhang, Yuan-Yuan

Vaccination strategies that can induce a broad spectrum immune response are important to enhance protection against SARS-CoV-2 variants. We conducted a randomized, double-blind and parallel controlled trial to evaluate the safety and immunogenicity of the bivalent (5×10¹⁰viral particles) and B.1.1.529 variant (5×10¹⁰viral particles) adenovirus type-5 (Ad5) vectored COVID-19 vaccines administrated via inhalation. 451 eligible subjects aged 18 years and older who had been vaccinated with three doses inactivated COVID-19 vaccines were randomly assigned to inhale one dose of either B.1.1.529 variant Ad5 vectored COVID-19 vaccine (Ad5-nCoVO-IH group, N=150), bivalent Ad5 vectored COVID-19 vaccine (Ad5-nCoV/O-IH group, N=151), or Ad5 vectored COVID-19 vaccine (5×10¹⁰viral particles; Ad5-nCoV-IH group, N=150). Adverse reactions reported by 37 (24.67%) participants in the Ad5-nCoVO-IH group, 28 (18.54%) in the Ad5-nCoV/O-IH group, and 26 (17.33%) in the Ad5-nCoV-IH group with mainly mild to moderate dry mouth, oropharyngeal pain, headache, myalgia, cough, fever and fatigue. No serious adverse events related to the vaccine were reported. Investigational vaccines were immunogenic, with significant difference in the GMTs of neutralizing antibodies against Omicron BA.1 between Ad5-nCoV/O-IH (43.70) and Ad5-nCoV-IH (29.25) at 28 days after vaccination (P=0.0238). The seroconversion rates of neutralizing antibodies against BA.1 in Ad5-nCoVO-IH, Ad5-nCoV/O-IH, and Ad5-nCoV-IH groups were 56.00%, 59.60% and 48.67% with no significant difference among the groups. Overall, the investigational vaccines were demonstrated to be safe and well tolerated in adults, and was highly effective in inducing mucosal immunities in addition to humoral and cellular immune responses defending against SARS-CoV-2 variants.Trial registration: Chictr.org identifier: ChiCTR2200063996.

2024-12-01·CARBOHYDRATE POLYMERS

Self-enhanced PTX@HSA-HA loaded functionalized injectable hydrogel for effective local chemo-photothermal therapy in breast cancer

Article

作者: Wang, Yudie ; Li, Hang ; Tan, Lintongqing ; Zhu, Tao ; Gao, Hang ; Zhang, Wen ; Shao, Shuaiqiang ; Li, Dawei ; Liu, Guangchun ; Meng, Xin

Breast cancer is a malignant tumor that poses a significant threat to women's health and single therapy fails to play a good oncological therapeutic effect. Synergistic treatment with multiple strategies may make up for the deficiencies and has gained widespread attention. In this study, sulfhydryl-modified hyaluronic acid (HA-SH) was covalently crosslinked with polydopamine (PDA) via a Michael addition reaction to develop an injectable hydrogel, in which PDA can be used not only as a matrix but also as a photothermal agent. After HSA and paclitaxel were spontaneously organized into nanoparticles via hydrophobic interaction, hyaluronic acid with low molecular weight was covalently linked to HSA, thus conferring effectively delivery. This photothermal injectable hydrogel incorporates PTX@HSA-HA nanoparticles, thereby initiating a thermochemotherapeutic response to target malignancy. Our results demonstrated that this injectable hydrogel possesses consistent drug delivery capability in a murine breast cancer model, collaborating with photothermal therapy to effectively suppress tumor growth, represented by low expression of Ki-67 and increasing apoptosis. Photothermal therapy (PTT) can effectively stimulate immune response by increasing IL-6 and TNF-α. Notably, the treatment did not elicit any indications of toxicity. This injectable hydrogel holds significant promise as a multifaceted therapeutic agent that integrates photothermal and chemotherapeutic modalities.

2024-10-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Chemoenzymatic synthesis of sialyl-α2,3-lactoside–functionalized BSA conjugate inhibits influenza infection

Article

作者: Tan, Lintongqing ; Zhang, Shuai ; Yang, Yang ; Qiao, Ying ; Mi, Xue ; Wang, Jia-Ning ; Si, Weixue ; Meng, Xin ; Lao, Zhiqi ; Xue, Mingming

Influenza remains a global public health threat, and the development of new antivirals is crucial to combat emerging drug-resistant influenza strains. In this study, we report the synthesis and evaluation of a sialyl lactosyl (TS)-bovine serum albumin (BSA) conjugate as a potential multivalent inhibitor of the influenza virus. The key trisaccharide component, TS, was efficiently prepared via a chemoenzymatic approach, followed by conjugation to dibenzocyclooctyne-modified BSA via a strain-promoted azide-alkyne cycloaddition reaction. Biophysical and biochemical assays, including surface plasmon resonance, isothermal titration calorimetry, hemagglutination inhibition, and neuraminidase inhibition, demonstrated the strong binding affinity of TS-BSA to the hemagglutinin (HA) and neuraminidase (NA) proteins of the influenza virus as well as intact virion particles. Notably, TS-BSA exhibited potent inhibitory activity against viral entry and release, preventing cytopathic effects in cell culture. This multivalent presentation strategy highlights the potential of glycocluster-based antivirals for combating influenza and other drug-resistant viral strains.

项与康希诺生物股份公司相关的新闻（医药）

2025-02-17

·PRNewswire

CanSinoBIO to Showcase China's Vaccine Innovation at 2025 World Government Summit in Dubai

DUBAI, UAE, Feb. 17, 2025 /PRNewswire/ -- CanSino Biologics Inc. (CanSinoBIO or the Company), a leading Chinese vaccine innovator, has been invited to the 2025 World Government Summit in Dubai from February 11-13. Dr Yu Xuefeng, Chairman and Chief Executive Officer , along with Ms Wang Jing, Chief Commercial Officer and Executive Director, showcased the Company's pioneering technologies and public health strategies during this prestigious event. Continue Reading The 12th edition of the World Government Summit (WGS 2025) brings together influential leaders, heads of state, and tech visionaries from 140 countries to collaborate on global progress over the next decade. The summit focuses on addressing rapid changes, evaluating humanity's progress, identifying improvement opportunities, and empowering future generations through effective governance and sustainability. CanSinoBIO's participation in the summit represents a significant milestone in its global expansion, highlighting its commitment to global public health. By engaging with global leaders, the Company aims to showcase its growing influence, strengthen its biopharma position, and drive innovation and collaboration for a positive global impact. Driving Global Health Solutions CanSinoBIO positions itself as a global vaccine provider rooted in China, dedicated to offering innovative, high-quality, and affordable vaccines worldwide. Over the past sixteen years, CanSinoBIO has established an industry system that meet international standards, and leveraged five advanced technology platforms to develop dozens of innovative vaccine products targeting over ten infectious diseases. "CanSinoBIO is honored to stand as the exclusive representative of Chinese biotechnology companies at the conference," said Dr. Yu Xuefeng. "Our participation in this global platform underscores our dedication to advancing public health solutions and engaging with our partners worldwide to build a healthier and more sustainable future. Moving forward, we will persist in developing a globally competitive pipeline for novel vaccines, such as inhaled tuberculosis vaccine, PBPV and VLP-Polio vaccine." Enhance Global Partnerships for Improved Global Health CanSinoBIO actively builds global partnerships to boost local vaccine production and reduce vaccine disparities. Since 2019, it has expanded its international presence by strengthening its commercial team, increasing production capacity, and partnering with countries in the Middle East, Southeast Asia, and Latin America. Additionally, Menhycia®, the Company's quadrivalent meningococcal conjugate vaccine, has been granted Halal Decree by the Assessment Institute for Foods, Drugs and Cosmetics of Majelis Ulama Indonesia, which is a good reference for the Muslim world. CanSinoBIO has also secured Halal Decree for multiple vaccine products, making vaccines more accessible and affordable for people in the MENA region and beyond. This initiative contributes positively to the global public health system. CanSinoBIO has developed five advanced technological platforms and established a rich portfolio of pipeline products that prevent more than ten diseases, including meningitis, pneumonia, pertussis, diphtheria, tetanus, COVID-19, tuberculosis, shingles, Ebola virus disease etc. Additionally, the Company has multiple globally innovative vaccine products in clinical trial stage, such as its protein-based pneumococcal vaccine (PBPV) and recombinant polio vaccine (VLP-Polio). The PBPV is not serotype-dependent and has broader coverage (at lease 98% coverage of pnemococcal strains), highlighting the potential public health value of this vaccine.. Furthermore, VLP-Polio, a non-infectious polio vaccine that does not rely on live viruses, has secured $19 million in project funding from the Bill & Melinda Gates Foundation and is endorsed by the World Health Organization as a preferred vaccine for the future eradication of polio. Moving forward, CanSinoBIO looks forward to continuing its collaboration with global partners to address the challenges posed by infectious diseases, fulfilling its social and international responsibilities, and contributing to the advancement of global public health. SOURCE CanSinoBIO WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

疫苗

2025-02-10

·药时空

康希诺生物交流纪要20250206

1、公司2024年的业绩预告显示全年实现营业收入8.25亿元到8.65亿元,较上年同期增长131%-142%,请问业绩增长的主要驱动力有哪些? 随着流脑结合疫苗商业化进程的快速推进,以及经营受全球公共卫生事件的影响已经基本消除,公司发布业绩预告,2024年度营业收入实现了快速增长。公司的四价脑膜炎球菌多糖结合疫苗MCV4曼海欣？目前处于独家竞品地位,受益于公司在学术推广和市场教育方面投入的资源,以及产品品牌建设、市场开拓等活动,产品的市场占有率进一步提升。作为定位于中高端婴幼儿疫苗市场的产品,公司坚持采用学术营销的模式,从营收结果也得到了正向反馈。预计2025年全年MCV4曼海欣？仍为独家竞品,公司将紧抓该窗口期,以终端的选择带动产品渗透率的进一步提升。同时,2024年11月,公司提交了MCV4的适用人群年龄扩大至3月龄至6周岁儿童的补充申请,获批后可覆盖国家免疫规划的脑膜炎疫苗全程免疫程序。 2、公司2024年的业绩预告显示,2024年归母净亏损较上年同期大幅度收窄约74-77%,请问主要原因是什么? 公司营业收入的大幅增长及经营效率的提升,以及资产减值损失的大幅减少,使得2024年归属于母公司所有者的净亏损大幅收窄。从三费角度来看,公司持续进行研发投入,优化资源分配,聚焦推进核心管线的研发工作,优化研发支出使用;随着流脑结合疫苗的商业化推进,销售费用率下降,同时,流脑结合疫苗仍处于销售爬坡阶段,后续随着更多产品的获批上市,预计可以起到进一步的规模效应,提高销售费用的使用效率;公司继续推动降本增效,加强管理费用相关发生额的管控,提高各职能部门经营效率。未来公司也将持续优化运营,提升经营效率,以期取得更佳的经营成果。 3、公司近期是否考虑实施回购以增强市场信心? 公司密切关注股价的波动情况,现阶段始终在加速推进流脑产品的商业化进程,以及在研管线的研发进展,并根据公司产品的竞争优势及特点推动对外合作及国际化,以期更好的经营成果及业绩表现。在业务不断发展的基础之上,会综合市场情况,考虑包括回购在内的增强市场信心的一系列举措。 4、公司的MCV4曼海欣？获得了印尼的上市许可,预计何时能产生相关海外收入? 公司预期2025年启动曼海欣？在印尼的上市销售,此外,该产品正于当地进行在18-55岁人群中接种后的安全性和免疫原性的临床试验,以期扩大适用人群。公司也正在积极拓展该产品在其他国家和地区的准入工作,以期进一步扩大公司优质产品在海外区域的影响力,受惠更广阔的人群。关于公司海外业务进展及对外合作情况等,如有阶段性进展,公司将及时分享。 5、公司下一个临近商业化阶段的品种十三价肺炎结合疫苗PCV13i目前NDA的审评进度如何? 截止目前,公司的PCV13i已完成了临床现场检查及生产现场检查相关工作,按照评审要求进行了发补工作,将继续与药监保持积极沟通,保障审评审批工作的顺利进行。公司PCV13i相关临床结果显示,在国内相对流行的血清型中免疫原性表现良好,优于对照苗,具备较强竞争力;并且采用了CRM197和TT的双载体技术路径,减少大量使用同一种载体蛋白而导致的潜在免疫抑制作用。公司对该产品进行竞争优势分析及市场定位,已开展商业化的前期准备工作,以期获批后快速进行市场推广并形成终端需求。此外,对于该产品,公司也正在进行海外市场的布局,使用无动物源培养基,未来进入需清真认证的国家将更具有优势。该品种在国内及海外均具有可观的市场潜力。 6、目前暂无国产组分百白破疫苗获批,公司婴幼儿用组分百白破疫苗DTcP药品注册申请获得受理,预期何时获批上市? 相较于当前中国百白破疫苗市场主要使用的百日咳抗原共纯化DTaP疫苗,公司DTcP疫苗的每种百日咳抗原采用单独纯化技术,以确定的比例配制,从而确保质量稳定以及批间一致性。鉴于百日咳抗原生产对百白破疫苗的重要性,公司已研发出专有百日咳菌株,可提升各种抗原的完整性和质量,并设计生产工艺以提高百日咳抗原的产量。公司拥有DTcP疫苗生产工艺的核心专利,增加了公司在生产方面的竞争优势。根据《药品注册管理办法》和《国家药监局关于发布<突破性治疗药物审评工作程序(试行)>等个文件的公告》(2020年第82号)中优先审评范围的“(三)疾病预防、控制急需的疫苗和创新疫苗”和“(六)国家药品监督管理局规定其他优先审评审批的情形”的相关要求,公司已申请婴幼儿用DTcP纳入优先审评审批程序。公司的婴幼儿用DTcP的基础免疫从2月龄开始,接种3剂,每剂之间间隔1或2个月,加强免疫于18~24月龄进行,每人接种1剂。截止目前,婴幼儿用DTcP的III期临床仍在进行中,已完成了基础免疫的接种及数据收集工作并取得了基础免疫的临床试验总结报告,进行了NDA申报,后续将向监管机构适时提交婴幼儿用DTcP加强免疫相关数据。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

疫苗财报临床研究并购

2024-11-20

·echemi

CanSino Biologics’ PD-1/VEGF New Drug Sparks Revolution in Lung Cancer Treatment!

At the World Congress on Lung Cancer in September 2024, Kangfang Biotics released Evoxil monotherapy (PD-1/VEGF bispecial antibody) and Merck Pabolizumab monotherapy in the first-line treatment of PD-L1 expression positive (PD-L1 Key data from a registered Phase III clinical study (HARMONi-2/AK112-303) of locally advanced or metastatic non-small cell lung cancer (NSCLC) with TPS≥1%. Two months later, Merck also introduced a PD-1/VEGF bisspecific antibody: LM-299. In addition to Merck, many well-known pharmaceutical companies have also invested in the field of PD-(L)1 dual antibody. In recent years, there have been frequent deals in this area, with Chinese biotech companies becoming the main transferers. PD-1 and VEGF are often up-regulated and co-expressed in solid tumors. Anti-vegf drugs have synergistic effects with immune checkpoint inhibitors (ICI) in promoting tumor vascular normalization and stimulating immune activation. Kangfang's remarkable achievements in the HARMONi-2 study confirmed that PD-(L)1/VEGF double antibody has the potential to replace PD-1 monoclonal antibody. Eboxizumab is currently approved in China for use in combination with pemetrexed and carboplatin for the treatment of EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC patients who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI). A marketing application has also been filed for the first-line treatment of ivoximab in patients with PD-L1 positive (TPS≥1%) NSCLC. Other clinically advanced PD-(L)1/VEGF pipelines are almost all from China, which has triggered a rush to authorize domestic PD-(L)1/VEGF drugs to the sea. However, PD-1 monoclonal antibody still faces problems such as low response rate, safety and drug resistance, so the market is full of expectations for the development of a new generation of immunotherapy. At present, PD-1/VEGF double antibody has been the first to achieve a breakthrough, and we look forward to more exciting progress in this field in the future.

免疫疗法临床3期上市批准抗体药物偶联物临床2期

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药物(靶点)	适应症	全球最高研发状态

重组新型冠状病毒疫苗（5型腺病毒载体）（康希诺生物） ( SARS-CoV-2 S protein )	新型冠状病毒感染更多	批准上市
吸入用重组新型冠状病毒疫苗（5型腺病毒载体）（康希诺生物） ( SARS-CoV-2 antigen )	新型冠状病毒感染更多	批准上市
重组埃博拉病毒病 (康希诺生物)	埃博拉病毒性疾病更多	批准上市
ACYW135群脑膜炎球菌多糖结合疫苗（康希诺）	流行性脑脊髓膜炎更多	批准上市
重组新冠病毒XBB.1.5变异株疫苗 (5型腺病毒载体) (康希诺生物) ( SARS-CoV-2 antigen )	新型冠状病毒感染更多	批准上市