Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Hepalink"), which is listed in Shenzhen and Hong Kong, today announced the preliminary results of a clinical trial in Italy in which the company's enoxaparin sodium preparation Inhixa participated in, INHIXA COVID19.
According to preliminary data released at the 20th SIMIT conference in Milan, the timely use of enoxaparin higher than the prophylactic dose or moderate dose of COVID-19 patients can shorten the length of hospital stay by 20% or more and alleviate symptoms in more than 65% of cases. This is the first clinical trial approved by the Italian Medicines Agency (AIFA) in 2020 for the use of heparin in COVID-19 patients, and the only clinical trial completed so far. The full report will be released in the near future.
Enoxaparin sodium is a drug for the prevention and treatment of venous and arterial thromboembolism. After the outbreak of the new crown epidemic, scientists found that changes in coagulation function and thrombosis are closely related to the mortality rate of new crown pneumonia. The World Health Organization1 recommended in January 2020 that intravenous thromboembolism (VTE) in COVID-19 patients should be prevented by giving heparin, especially low-molecular-weight heparin.
As early as the beginning of the outbreak, in vitro tests showed that the SARS-CoV-2 virus appeared to disappear after exposure to high concentrations of enoxaparin sodium. Therefore, Italian doctors and Hepalink's grandson company Techdow Pharma Italy S.R.L. (Tiandao Pharmaceutical) have joined forces to conduct a study on inhixa, a enoxa, a sodium enoxa preparation widely recognized in Europe, to evaluate the safety and efficacy of enoxaparin administered in new doses in improving the course of COVID-19.
The study enrolled more than 300 patients with moderate to severe COVID-19, with participation from 13 trial centers in Italy2. The trial was designed as a Phase II one-arm intervention prospective study. Each patient is followed up for at least 90 days after the diagnosis of COVID-19. Patients enrolled in the interventional study were given subcutaneous injections of enoxaparin of 60 mg, 80 mg, and 100 mg once daily, depending on> body weight, at 45 to 60 kg, 61 to 100 kg, or 100 kg, respectively, for 14 days, and adjusted according to anti-Xa factor activity monitoring; patients in the observational cohort were given subcutaneous injections of enoxaparin at a standard thromboprophylaxid dose of 40 mg per day.
Preliminary data show that 64% of patients in the intervention cohort and 57.8% of patients in the observational cohort observed an improvement in clinical status between enrollment and day 14. In terms of length of stay, the length of stay in the intervention cohort was 8-16 days and the observational cohort was 11-22 days. In addition, the dose increase in enoxaparin was safe, with only 1 major bleeding event in the intervention cohort, which did not cause significant harm to the patient after treatment.
Pierluigi Viale, Professor of Infectious Diseases at the University of Bologna, Head of Infectious Diseases and Research Coordinator at the Santa Osorla-Malpigi Complex, said: "The reduction in the clinical course and length of hospital stay is encouraging and encouraging. The preliminary results of the trial provide the basis for the subsequent widespread promotion of large-sample trials. ”
Zhai Zhenguo
Professor, Department of Respiratory Medicine, Chunichi Clinic, China National Respiratory Medicine Center
Professor Zhai Zhenguo from the National Respiratory Medicine Center of China, the Respiratory Center of China-Japan Hospital, and the Department of Respiratory and Critical Care Medicine said: "The merger of new crown pneumonia with VTE has always been concerned by scholars at home and abroad. In clinical practice, nearly 20% of patients with new coronary pneumonia will have abnormal coagulation function, and almost all severe and critically ill patients have significant coagulation disorders. Patients with COVID-19 with VTE, especially pulmonary embolism (PE), may be an important cause of worsening or even death in infected people. In addition, some patients have a pronounced hypercoagulable state early on, and if left unimported, may be secondary to extensive microthrombosis, eventually leading to disseminated intravascular coagulation (DIC), which can seriously affect the prognosis of patients. ”
In order to help clinicians around the world treat patients at risk of COVID-19 and VTE to provide effective intervention strategies, Professor Zhai Zhenguo's team co-authored the "Expert Consensus on the Prevention and Treatment of COVID-19 Complicated VTE" with European experts as early as the early stage of the epidemic in 2020, based on the practical experience of anti-epidemic in mainland China and comprehensive literature search, providing clinicians with recommendations for the prevention and treatment of venous thromboembolism in patients with new coronary pneumonia, and on the severity of the disease, the risk of thrombosis, Detailed diagnosis and treatment is provided for specific conditions such as bleeding risk.
Professor Zhai Zhenguo said: "The risk assessment and prevention of VTE is an important part of the comprehensive comprehensive treatment of COVID-19. Based on the current evidence-based medical evidence and clinical experience, low molecular weight heparin is recommended for preventive treatment of hospitalized patients with COVID-19 who are at risk of complicated VTE. It is gratifying to see that the study on the application of Chinese enoxaparin in italy with severe covid-19 patients has reached a good conclusion, and further gives recommendations for dosage application. Clinicians need to pay attention to changes in the risk of thrombosis and bleeding dynamics caused by repeated illness in some patients. Treatment strategies must be repeatedly evaluated and optimized to reduce the incidence of deep vein thrombosis (DVT) and fatal PE. ”
Li Li, Chairman and President of Hepalink, said: "Enoxaparin sodium is a classic drug that has lasted for a long time. When Tendo Italy was founded four years ago, no one expected that today, enoxaparin sodium will play an important role in preventing complications associated with COVID-19 infections. Preliminary results from the INHIXA COVID19 trial suggest that the potential of enoxaparin sodium is never exhausted. Hepalink is very pleased and honored to be able to make a modest contribution to this pandemic affecting global health. “
Since 2016, the sodium enoxaparin formulation produced by Shenzhen Tiandao under Hepalink has landed on the European market, and has been sold in 43 countries around the world and incorporated into the medical insurance payment system of many countries, which marks that China's production of high-quality low molecular weight heparin has reached international standards and strength. Hepalink also looks forward to bringing the gospel to patients with thromboembolic diseases in China and making positive contributions to the national strategic reserve of therapeutic drugs.
About Inhixa
Heparin's enoxaparin sodium preparation is sold in the Chinese market under the proxine brand, in the non-Polish market in the European Union under the Inhixa brand, and in the Polish market under the Neoparrin brand. Proclotin is the first and only enoxaparin sodium injection preparation in China that has passed the consistency evaluation of generic drugs in all available specifications (0.2ml/0.4ml/0.6ml/0.8ml/1.0ml), the first generic drug approved by the China Food and Drug Administration for enoxaparin sodium injection, and the first biosimilar drug licensed by the European Medicines Agency for sales, with a cumulative sales of more than 200 million units in Europe. At present, Hepalink's enoxaparin sodium preparation is sold in 43 countries and regions around the world.
About Hepalink
Founded in Shenzhen in 1998, Hepalink is a leading multinational pharmaceutical company with an A+H dual financing platform, with its main business covering the investment, development and commercialization of the whole heparin industry chain, biomacromolecular CDMO and innovative drugs. The company's three segments of business are synergistic and driven by unmet clinical needs, and are committed to providing high-quality safe and effective drugs and services to patients around the world and protecting their health.
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