News_News_Joincare Pharmaceutical Group Industry Co., Ltd.

Joincare TG-1000 Capsules Achieve Breakthrough Progress; Antiviral Influenza Drugs Sector to Welcome a Significant Product Time Posted：2024-04-18 19:27:16

On the evening of April 17, Joincare(Joincare Pharmaceutical Group Industry Co., Ltd) announced that its innovative drug product, TG-1000 capsules, reached the main research endpoints in a multi-center Phase III clinical trial. The company will soon communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration regarding the marketing application for the drug to treat influenza, advancing the drug's market launch process. TG-1000 is an innovative Class 1 antiviral drug, a new type of cap-dependent endonuclease inhibitor, suitable for patients aged 12 and above with uncomplicated acute infections of influenza A and B. Public information shows that Joincare is an innovative scientific research-based integrated pharmaceutical group, focusing on the development of innovative drugs and high-barrier complex formulations. In recent years, the company has been deeply involved in key therapeutic areas such as respiratory and digestive system diseases, continuously expanding its product line and R&D pipeline in advantageous fields through a development model that combines independent research and development, external introduction, and cooperative development. TG-1000 capsules, introduced by Joincare in March of last year, is a significant innovative drug. Early research data indicate that the drug has the characteristics of rapid onset, long virus suppression time, good tolerance, and is unaffected by food when taken orally, effectively inhibiting both influenza A and B viruses. In September last year, Joincare initiated a Phase III clinical trial for TG-1000 capsules. The Phase III clinical study was a multi-center, randomized, double-blind clinical trial, with the main endpoint being the time to alleviation of all influenza symptoms within 15 days of treatment. Preliminary statistical analysis results show that the drug met the main efficacy indicators with statistical difference (P<0.0001) and no serious adverse reactions related to the drug occurred, demonstrating good clinical performance and higher safety. Influenza, as a common viral infectious disease worldwide, can lead to 300,000-500,000 severe cases and 290,000-650,000 respiratory disease-related deaths globally each year during the seasonal epidemic. Antiviral drugs are one of the important means of treatment and control of influenza. If TG-1000 capsules are successfully approved and launched, they will further strengthen Joincare product layout in the field of influenza and help the company to capture a high ground in the domestic antiviral drug market. In the past two years, the layout of innovative drugs has become one of the main tracks for pharmaceutical companies to compete, especially this year when 'innovative drugs' were written into the government work report for the first time, bringing excellent development opportunities for innovative drugs. Joincare has also made forward-looking arrangements for the layout of innovative drugs in multiple fields. In addition to the smooth progress of the clinical trials for the new antiviral drug TG-1000 capsules, Joincare has also reached several important strategic cooperations in the advantageous respiratory field, achieving multi-dimensional coverage from injectables, inhalation formulations to oral small molecule innovative drugs. Among them, the new drug for asthma treatment DBM-1152A, the oral new drug for asthma N91115, and the oral drug for chronic obstructive pulmonary disease - Bayer's small molecule inhibitor have all entered Phase I clinical trials; the injections QX008N and BA2101 for the treatment of asthma, chronic obstructive pulmonary disease, and other respiratory system diseases have respectively entered Phase Ib and Phase II clinical trials. In addition, Joincare has successfully introduced the analgesic new drug FZ008-145, expanding the company's R&D layout in the field of analgesics. FZ008-145 is the world's second and China's first highly selective second-generation Nav1.8 inhibitor, intended for the treatment of pain, expected to have the advantages of strong efficacy and non-addictive analgesia, and has been approved to start clinical trials.

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Government and Enterprise Collaborate to Boost Health and Vitality: Joincare and Livzon Group's Chronic Disease Public Welfare Efforts Support Rural Revitalization in Bomi County, Tibet" Time Posted：2024-03-26 14:25:01

On March 20th, the "Universal Chronic Disease Prevention and Treatment Public Welfare Project" jointly carried out by Joincare and Livzon Group's , in collaboration with the Qizheng Charity Foundation of Tibet, arrived in Bomi County, Linzhi City, Tibet Autonomous Region. A drug donation ceremony was held in front of the Red Building of the County Committee, with the attendance of Deputy County Head Zhuoma Yangjin, Director of the County Health Commission Niu Haiyan, relevant persons in charge from the County People's Hospital and township health centers, volunteers from the Qizheng Charity Foundation of Tibet, and volunteers fromJoincare and Lizhu Group. Bomi County, located in the southeast of Tibet, while focusing on optimizing the rural collective economy, also places a high emphasis on the development of health and well-being, striving to improve the quality of medical services. In recent years, common chronic diseases such as hypertension, hyperlipidemia, and cardiovascular and cerebrovascular diseases have become the main threats to the health of the county's residents. After learning of the county's challenges in chronic disease prevention and treatment, theJoincare & Lizhu Group's chronic disease public welfare project team, in cooperation with the government, organized a donation activity, donating slow-disease treatment drugs worth 1 million yuan to Bomi County. The aim is to alleviate the medication difficulties for low-income people in the county and to support the development of the health sector in Bomi County. Deputy County Head Zhuoma Yangjin expressed sincere gratitude toJoincare and Lizhu Group for the drug donation at the event. She stated, "The donated drugs will greatly replenish our county's medical resources and are of significant importance for improving our medical service level and ensuring the medication needs of the public. We will manage and allocate the donated drugs well, ensuring that this heavy care and concern reach the hands and hearts of the people." In recent years, the issue of medication security at the grassroots level has always been a focus of market attention. With the enhancement of grassroots service capabilities and the advancement of county medical community construction, the development of grassroots medical and health institutions has gradually improved. However, there is still a certain gap in the types and quantities of drugs equipped and used compared to urban hospitals. This year's "Government Work Report" clearly proposed to "expand the types of medication for chronic and common diseases in grassroots medical and health institutions," and the National Health Commission also stated at a recent press conference that in 2024, it will fully build a closely-knit county medical community to further improve the medication security mechanism for grassroots patients and ensure their "access to medication." As an innovative scientific research-based comprehensive pharmaceutical group,Joincare has always adhered to the responsibility of a pharmaceutical company for the country and its people, actively responding to the national policy call and assisting in the construction of basic medical services in rural areas. Since 2018,Joincare , combining its industrial advantages, has launched the "Universal Chronic Disease Prevention and Treatment Public Welfare Project" with Lizhu Group and has continued to carry out a series of public welfare drug donation activities for chronic diseases. By the end of June 2023, the project has covered 8 provinces and 2 autonomous regions nationwide, with a footprint in areas such as Sichuan, Gansu, and Tibet, helping more than 17,700 low-income individuals. In the future,Joincare will continue to adhere to the mission and vision of 'For Health, For Tomorrow, Dedicate to Making Good and New Medicines,' actively practicing social responsibility, combining its industrial advantages to assist in the construction of a healthy rural area, and taking practical actions to provide more help to low-income families with chronic patients in remote areas of our country."

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Joincareand Bayer Reach Exclusive Licensing Agreement for Small Molecule Inhibitor to Strengthen Innovative Drug Strategy and Expand Respiratory Disease Pipeline Time Posted：2024-03-21 19:06:04

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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 Time Posted：2022-06-13 19:10:39

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.

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Haibin Pharmaceutical: A 33-year-old company rooted in Yantian, and a provider of first-line medicines for patients in more than 30 countries Time Posted：2022-06-24 19:42:00

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.

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SARS-CoV-2 antigen test kit of Livzon Diagnostics approved for marketing, enabling quick self-testing in 15 minutes Time Posted：2022-06-20 18:41:11

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.

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A Heterologous V-01 or Variant-Matched Bivalent V-01D-351 Booster following Primary Series of Inactivated Vaccine Enhances the Neutralizing Capacity against SARS-CoV-2 Delta and Omicron Strains Time Posted：2022-07-21 16:45:50

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.

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Phase III trial results of the V-01 vaccine published in EMI showed its superiority in heterologous boosting Time Posted：2022-06-14 21:55:53

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

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