Tianjin-based CanSino Biologics
Working On A Vaccine Against The Coronavirus
By Morgan Brady
If one looks at the life science industry, it becomes clear that biotech companies are receiving considerable attention and funding from investors. CanSino is among the top biotech companies in China. Its full name is CanSino Biologics Inc. and it is an emerging biotechnology company, headquartered in China. It manufactures and develops biological vaccine products, and is dedicated to the research and commercialization of vaccine products for human use. The company seeks to address people’s medical needs by marketing and developing leading-edge, high quality vaccines at affordable prices. Currently, it serves customers both in China and other worldwide markets.
CanSino was founded in January 2009 and currently has over 300 employees. It is publicly traded on the Hong Kong stock exchange, and its stock price has been growing. It was founded by Dongxu Qiu, Helen Mao, and Tao Zhu. Xuefeng Yu is now the CEO, executive director, and the co-founder of the company. CanSino discovers quadrivalence meningococcal conjugate, pneumococcal polysaccharide, and adenovirus vector-based tuberculosis vaccines for human use, in addition to DTcP-based combo, among others.
Among a long list of biopharma companies trying to develop a vaccine against the novel coronavirus, CanSino Biologics, and Massachusetts-based Moderna Therapeutics are so far the front-runners.
康希诺生物股份公司于2009年在天津市经济技术开发区(TEDA)成立,建立了强大的疫苗产品线和多种平台技术。致力于开发,生产和商业化高质量的创新疫苗。在国内20余家开展新冠疫苗研发的企业中,康希诺生物股份公司新冠疫苗率先进入临床试验。3月18日,康希诺生物发布公告称,公司与军事科学院军事医学研究院生物工程研究所联合开发的重组新型冠状病毒疫苗获批进入临床试验,这是双方继成功研制埃博拉埃博拉病毒疫苗后的再次合作。
China approves COVID-19 vaccine to enter clinical trials
In the effort to fight the coronavirus outbreak, China has approved the first clinical trial of a vaccine candidate known as Ad5-nCoV, developed by domestic researchers. It is intended to be used to prevent the disease caused by the coronavirus infection. The vaccine was developed by Tianjin-based Cansino Biologics Inc. and the Institute of Biotechnology of the Academy of Military Medical Sciences. The clinical trial will enrol 108 subjects in Wuhan, the epicentre of the pandemic that has spread all over the world, taking the lives of thousands and infecting over 2 million people.
On March 17, CanSino said it has started to prepare for clinical trials of Ad5-nCoV and the pre-screening of healthy volunteers. There are two indicators based on which the company will assess the vaccine. First, the company will determine whether there are adverse reactions after seven days of the injection. Second, it will determine whether adverse reactions are observed 28 days after injection or severe adverse reactions six months after the injection.
“We have completed the necessary preclinical steps for vaccine R&D. The GMP clinical batches have passed quality testing and are ready for the phase I clinical trial,” the company reported.
The existing technology platform can enable faster development of a vaccine, although there are issues to be addressed before administering the vaccine to humans. Usually, models tested on animals should be available before moving any potential vaccines into human trials in order to produce a vaccine that will eventually work without risk. A flu viral vector-based vaccine is now undergoing animal testing to be evaluated for its efficacy and safety. It is scheduled for clinical trial by the end of April.
新冠疫苗入临床 康希诺凭什么拔得头筹
新冠肺炎疫情在全球蔓延,越来越多的药企相继投身新冠肺炎疫苗研发。据不完全统计,目前国内已有超20家药企开展相关疫苗研发工作。3月15日,复星医药宣布,公司控股子公司与BioNTech SE签署协议,复星医药获得许可在中国独家开发、商业化针对新型冠状病毒肺炎的疫苗产品。
另外,还有智飞生物、华兰生物、博雅生物、康众(北京)生物科技有限公司、神州细胞工程有限公司等医药企业正在开展新冠肺炎疫苗的研制工作。不过,上述疫苗研发多处于临床前研究(即动物的有效性、安全性研究)阶段。
疫苗成功研制主要分为前期制备、后期试验验证(动物实验和三期临床试验)、注册、上市、生产以及最终投入使用几个阶段。2020年1月,天津市“新型冠状病毒感染应急防治”科技重大专项首批拟立项项目清单显示,康希诺生物承担 “新型冠状病毒候选疫苗研发”项目;3月4日,康希诺生物市场部人士透露,目前该款疫苗处于临床前研究阶段。康希诺生物新冠疫苗进入临床研究阶段意味着离上市更近了一步。
China is launching clinical trials for a coronavirus vaccine
The Chinese government is doing all that it can to ensure that the coronavirus situation can be put behind us quickly. The Chinese Ministry of Education has called on scientific research institutions, related enterprises, and universities to speed up research on the COVID-19 vaccine. The emphasis is on quality rather than coming up with an ineffective solution quickly. A quick, improperly tested solution may even produce adverse or harmful effects.
Researchers at China’s Academy of Military Medical Sciences have reportedly received approval to launch early-stage clinical trials of a potential coronavirus vaccine.
According to the Chinese clinical trial registration database, "A Phase I test evaluating the safety of the experimental shot in humans intends to recruit 108 healthy people between 16 March and 31 December."
The Phase I study will enrol 45 healthy adults to evaluate the safety and immunogenicity of 25μg, 100μg, 250μg dose levels of mRNA-1273 administered on a two-dose vaccination schedule.
Chinese vaccine approved for human testing
CanSino Biologics Inc. received Chinese regulatory approval to start human trials of a vaccine against the infamous coronavirus. The vaccine was co-developed by China’s Academy of Military Medical Sciences, the Hong Kong-listed company, and will go through clinical trials in Wuhan, China.
CanSino’s trial includes injecting the experimental vaccine into 108 healthy adults between 18 to 60 years of age in three different doses, according to data from the Chinese Clinical Trial Registry. The tests will start this month (March) and continue until the end of 2020. The vaccine has been tested on animals and proven safe and capable of eliciting immunity against the virus, CanSino said in its statement.
Preclinical animal studies of Ad5-nCoV show that the potential vaccine can influence strong immune responses in animal models, and the preclinical animal safety studies demonstrated a good safety profile.
Moreover, CanSino has also started human testing of its recombinant coronavirus vaccine. The collaborators have been trying to develop the vaccine since January. They’ve been working day and night to find a cure for the deadly coronavirus. The company is determined to launch more than one million doses by the end of the year with existing capacity, with no compromises in regard to safety or quality. All the focus is on reaching both good treatment and prevention measures to defeat the virus.
Conclusion
All eyes are currently on pharmaceutical companies as people want to hear good news. CanSino is at the forefront of the fight, and its stock has gained momentum recently, signalling interest and hope from investors. Despite every effort, however, vaccine testing procedures usually take at least one year to culminate in a successful vaccine, and it may be too early to expect a vaccine now. CanSino’s financials are sound, and the support of the government will ensure that it remains solid in the near and medium future.
Investors who want exposure to the healthcare sector might benefit from having CanSino in their portfolio, especially in times of difficult economic conditions as is the case now.
As for the coronavirus, countries will have to maintain their efforts to prevent high infection rates until a vaccine or an antidote can be found.
疫苗开发通常需要一年时间才能最终成功研制,现在期望疫苗还为时过早。想要投资医疗保健行业的投资者可能会从康希诺的投资中受益。至于新冠病毒,各国仍必须继续努力以降低感染率,直到找到疫苗为止。