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 Abstract Immune escape of emerging SARS-CoV-2 variants of concern (VOCs) and waning immunity over time following the primary series suggest the importance and necessity of booster shot of COVID-19 vaccines. With the aim to preliminarily evaluate the potential of heterologous boosting, we conducted two pilot studies to evaluate the safety and immunogenicity of the V-01 or a bivalent V-01D-351 (targeting Delta and Beta strain) booster after 5–7 months of the primary series of inactivated COVID-9 vaccine (ICV). A total of 77 participants were enrolled, with 20 participants in the V-01D-351 booster study, and 27, 30 participants in the age stratified participants of V-01 booster study. The safety results showed that V-01 or V-01D-351 was safe and well-tolerated as a heterologous booster shot, with overall adverse reactions predominantly being absent or mild in severity.
How to improve the resistance against the Omicron variant on the basis of existing COVID-19 vaccines? Sequential booster immunization (also known as "heterologous booster vaccination") is regarded as one of the important exploration directions.
Innovation, openness, integration, win-win partnership Guangzhou Lab led by Zhong Nanshan signed a cooperation agreement with Microbio (Shanghai), Livzon Pharmaceutical, and other four pharmaceutical companies for COVID-19 drug development   In the morning of June 10, the 14th China Bioindustry Convention opened on Guangzhou International Bio Island. At the high-level forum, Zhong Nanshan, chairman of the convention, winner of the Medal of the Republic, and academician of the Chinese Academy of Engineering, delivered a speech themed "scientific pandemic control for public health and sound economic development". In his speech, Zhong Nanshan discussed hot issues and development trends in global public health, human health, and China's national biosafety risk control and governance system. In addition, he introduced the representative COVID-19 vaccines and drugs developed by the Chinese companies participating in the signing ceremony. Zhong said that representative COVID-19 drugs under development in China included 3CLpro inhibitor, siRNA, Chinese herbal monomer, and antibody-based drugs. Guangzhou Lab under his leadership was working on five new COVID-19 drugs, some of which were jointly developed with other institutes and leading the industry in terms of development progress. He also made objective comments on achievements of some well-known research institutes and enterprises in this field.  
In recent years, SMEs in China are trying to become specialized and sophisticated enterprises that produce new and unique products. Some of SMEs have developed into "little giants" focusing on a market niche and master key technologies with a strong innovation capacity. These "little giants" are in the vanguard of manufacturing upgrading and high-quality economic development, and lay a solid foundation for innovation in Shenzhen. Shenzhen Haibin Pharmaceutical Co., Ltd. (Haibin Pharmaceutical for short), was established in Yantian District in 1989 and officially put into operation in 1992. It is now a listed high-tech pharmaceutical company dedicated to independent development and production of carbapenem antibiotics, and a "little giant" company in Guangdong province. ▲ Exterior view of the company   Extend the industrial chain via innovation to become the world's largest supplier of Meropenem raw materials In early summer, "little giant" companies in Yantian District are striving for innovation. In the corporate lab of Haibin Pharmaceutical, researchers are discussing about technical approaches for product development. Since its establishment, Haibin Pharmaceutical has been making persistent efforts in innovation. The company began with antibiotics and started development and marketing of carbapenem antibiotics the earliest in China. In addition, it is the first Chinese company that independently produces Meropenem raw materials and preparations. Now, Meropenem trihydrate and preparations have been exported to more than 30 countries in Asia, Africa, Europe, and North America. The company owns multiple GMP-compliant production lines. ▲ Working lab staff member   Innovation injects new impetus into the company, stimulates new markets, and boosts high-quality economic development. In 2018, the company started to adjust the carbapenem product lines, extend the industrial chain, and optimize production techniques. In recent years, Haibin Pharmaceutical sees a rapid increase in exports of Meropenem raw materials, and has become the largest supplier of Meropenem raw materials in the world. The company owns multiple invention patents regarding Meropenem production techniques. "From 2018 to 2021, exports of Meropenem raw materials increased 4-fold," said Sun Wanpeng, a senior manager of Haibin Pharmaceutical. As the main product line of the company, the carbapenem series of antibiotics includes imipenem and cilastatin sodium and biapenem apart from Meropenem. All these are first-line medicines against moderate-to-severe infections. ▲ Facilities in a sterile workshop     Supportive policies and services energize SMEs in Yantian District After years of efforts, Haibin Pharmaceutical has been appraised as "National High-Tech Enterprise", "Shenzhen High-Tech Enterprise", "Guangdong Independent Innovation Demonstration Enterprise", and "Guangdong Intellectual Property Demonstration Enterprise". As an industry-leading enterprise rooted in Yantian District, Haibin Pharmaceutical has benefited a lot from the district in its journey of marketing products globally. ▲ Facilities in an R&D laboratory   "Yantian District's efforts to improve the urban environment and its beneficial policies for talents have helped to attract a large number of talents to our company," Sun Wanpeng said. The government's talent housing policy has addressed the needs of some middle- and high-level talents for accommodation over nearly three years. "The livable environment, convenient transport system, and improved housing conditions make our core employees more satisfied and happier to work here." He said frankly that over the past 20 years, he had grown from a front-line manager to a leadership team member, and witnessed the vigorous economic development in Yantian District. Thanks to the support from the government, including the funding to production line and corporate projects and other incentive policies, talent recruiting training provided at irregular intervals, and upgraded supporting facilities, Haibin Pharmaceutical is embracing new opportunities for development. The company is improving the production capacity and efficiency, and the growth rate of value added meets the its expectation. In Sun's view, Yantian District is enhancing its support for local enterprises in recent years. The government has issued many supportive policies, taken solid measures such as precise services and improvement of the development environment, and upgraded supporting facilities continuously to support innovation and transformation of enterprises. All these have energized SMEs in Yantian District.        
In the evening of April 13, Joincare Pharmaceutical Group Industry Co., Ltd. announced that the Livzon Test for SARS-CoV-2 Antigen (Latex Method) independently developed by Livzon Diagnostics, a company affiliated to its subsidiary Livzon Pharmaceutical Group, was approved by China Food and Drug Administration for marketing. This kit is applicable to nasopharyngeal swabs, oropharyngeal swabs, and nasal swabs. It is easy to use and can provide a clear, easy-to-interpret test result in 15 minutes, without the need for a professional lab. Therefore, the kit can be used for self-testing.
On June 10, a paper about the recombinant SARS-CoV-2 fusion protein vaccine (V-01) was published in the Emerging Microbes & Infections (EMI). In the latest phase III clinical trial, a dramatic increase of neutralizing antibody titers was measured in the V-01 group primed with inactivated vaccines 14 days after boosting. The trial results proved that, as a heterologous booster, V-01 was safe, efficacious, and could elicit robust humoral immunity during the pandemic of the Omicron variant.     This double-blind, placebo-controlled, and randomized phase III clinical trial was conducted in Pakistan and Malaysia, aimed to assess the efficacy, immunogenicity, and safety of heterologous boosting with one dose of V-01 within 3-6 months after the completion of primary vaccination. The study was registered with ClinicalTrials.gov (number: NCT05096832).   It is well known that heterologous boosters can be more immunogenic than homologous boosters, and can increase the intensity, sustainability, and breadth of immune responses. As expected, heterologous V-01 booster in participants elicited a robust virus-neutralizing antibody response, with a geometric mean titer (GMT) of 1452.8 at 14 days after boosting. It was also proven to be significantly safer than mRNA vaccines and the adenovirus vaccine of Oxford/AstraZeneca (AZ).   Findings from this heterologous booster trial should be considered to further optimize the immunization schedule and strategy for the control of COVID-19.   According to previous press reports, V-01 is the world's first COVID-19 vaccine that has demonstrated the efficacy of heterologous boosting in a randomized, double-blind phase III clinical trial conducted in more than one healthcare center against epidemic strains including Omicron, and that has obtained data about the protective efficacy against mild or severer Omicron infections. The V-01 vaccine can elicit protection quickly after administration, and it provides as good efficacy of heterologous boosting and primary immunization as mRNA vaccines and AZ adenovirus vaccine for at-risk populations.   EMI is a peer-reviewed open access journal committed to publishing best and latest research results on emerging infectious diseases. The journal has academician Wen Yumei from Fudan University and professor Hans-Dieter Klenk from the University of Marburg as the co-editors-in-chief, and professor Lu Shan from University of Massachusetts Medical School as the executive editor. Associate editors of this journal include academician Xu Jianguo from Chinese Center for Disease Control and Prevention, professor Yuan Zhenghong from Fudan University, professor Tang Yiwei from Memorial Sloan-Kettering Cancer Center, Cornell University, professor Zhang Wenhong from Huashan Hospital affiliated to Fudan University, and professor Lorne A. Babiuk from the University of Alberta.   References: 1. Xuan-Yi Wang, Syed Faisal Mahmood, Fang Jin, Wee Kooi Cheah, Muhammad Ahmad, Mian Amjad Sohail, Waheed Ahmad, Vijaya K Suppan, Muneeba Ahsan Sayeed, Shobha Luxmi, Aik-Howe Teo, Li Yuan Lee, Yang-Yang Qi, Rong-Juan Pei, Wei Deng, Zhong-Hui Xu, Jia-Ming Yang, Yan Zhang, Wu-Xiang Guan & Xiong Yu (2022) Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial, Emerging Microbes & Infections, DOI: 10.1080/22221751.2022.2088406   Link: https://doi.org/10.1080/22221751.2022.2088406 Keywords: V-01, efficacy, heterologous boosting, subunit vaccine, phase III clinical trial   Source: Cailian Press
The Omicron variant is highly infectious and spreads very quickly. Elderly people with underlying medical conditions or unvaccinated are at higher risk of severe illness after Omicron infection. Experts say that COVID-19 vaccination is particularly important for elderly people in addition to necessary personal protection. Livzon V-01 vaccine is proven to be able to protect this at-risk population effectively: In a phase III heterologous booster trial, V-01 demonstrated a protective efficacy of 71.83% for at-risk populations with underlying medical conditions.     Elderly people and those with underlying medical conditions are drawing more attention in the worldwide pandemic prevention and control   Most of elder people have underlying medical conditions and are at higher risk of developing severe illness from COVID-19. COVID-19 vaccination can lower the risk of infection and illness, and significantly reduce the probability of severe illness and death. Experts recommend that elderly people who have no contraindications and are eligible for vaccination should be vaccinated as soon as possible. Compared with young people, elderly people generate fewer neutralizing antibodies after vaccinated, and neutralizing antibody titers in their body decrease more significantly over time. Therefore, elderly people are advised to receive a booster six months after the completion of primary vaccination.     Currently, several hundred million doses of China-made COVID-19 vaccines have been administrated to elderly people globally, with the highest age of 106 in and outside China. Brazil's Ministry of Health announced on March 23 (local time) that people aged 80 years or older should receive the fourth dose of COVID-19 vaccine four months after the third dose. The Ministry will determine whether people of other age ranges need to receive the fourth dose of COVID-19 vaccine and release an announcement when needed.     Livzon Pharmaceutical Group (000513.SZ) announced earlier that it had completed the interim primary data analysis and obtained key data for the phase III heterologous booster trial of the recombinant SARS-CoV-2 fusion protein vaccine (V-01), which was jointly developed by its subsidiary Livzon Mabpharm Inc. and Chinese Academy of Sciences. The Group stressed that heterologous boosting with V-01 provided a high protective efficacy against Omicron.     Improving the immunity of at-risk populations is key to pandemic prevention and control, and recombinant protein vaccines may play a crucial role in improving the immunity as boosters. The schedule of Livzon V-01 vaccine covers two shots, and its phase II clinical trial results have been published in the National Medical Journal of China in July 2021. The results show that V-01 has excellent immunogenicity and safety, and the overall incidence of adverse events is lower in the elder group than the younger adult group in comparison. This indicates the potential of V-01 to be used for people of all ages.       Brilliant performance of V-01: a protective efficacy of 71.83% for at-risk populations     Fudan University published an important study in the BMC Medicine, which compared neutralizing antibody data of several vaccines to assess their long-term neutralizing antibody response kinetics and predict their protective efficacy and immunogenicity. According to the actual efficacy data measured at 28–84 days after heterologous boosting, boosting with Livzon V-01 vaccine after two doses of inactivated vaccines could provide robust protection against Omicron.     Clinical trial data proved that Livzon V-01 vaccine could protect at-risk populations effectively: In a phase III heterologous booster trial, V-01 showed a protective efficacy of 71.83% for at-risk populations with underlying medical conditions.     Heterologous boosting is an immunization strategy that administrates vaccines developed through different technical approaches at specified intervals and doses to further enhance the protection against viruses. Taking COVID-19 vaccines as an example, heterologous boosting can be achieved with a dose of a recombinant protein vaccine following two doses of inactivated vaccines.       V-01 is a new recombinant protein vaccine against COVID-19 jointly developed by Livzon Mabpharm Inc. and Chinese Academy of Sciences since July 2020, with the intellectual property owned by Livzon. Livzon announced that the phase III V-01 heterologous booster trial was the world's first randomized, double-blind phase III clinical trial conducted to study the protective efficacy of heterologous boosting. Compared with phase III trial results of vaccines available in global markets, V-01's absolute efficacy of 61.35% is quite good. This absolute efficacy meets the standard of WHO.     According to the announcement of Livzon, the heterologous boosting protocol used in the trial was two doses of inactivated vaccines plus one dose of booster. Unli
The Guideline for Diagnosis and Management of Chronic Obstructive Pulmonary Disease in 2001 (‘the new guideline’ in the following passages) has been released recently. Lishutong (Levosalbutamol Hydrocloride Nebuliser Solution), a product Joincare Pharmaceutical Group Industry Co., Ltd (Joincare), is the first authorized β2 adrenoceptor agonist. The medicine was recommended as the first-line treatment. All of these is a sign that the high-standard inhale preparation formally join in the market competition.
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