On April 19, 2020, Sanofi announced that Alisijuumab injection (trade name: Polyda®, Praluent®) was launched in China! As a PCSK9 inhibitor lipid-lowering drug, the launch of Polyida® provides an important new treatment option for a large number of patients with unsatisfactory anti-atherosclerosis treatment in China, especially to reduce the risk of major adverse cardiovascular events (MACE) and Reducing the risk of all-cause death. At the same time, the "Caring Rieter-Polyida Patient Assistance Project" was officially launched to help patients with acute coronary syndrome (ACS) to better manage disease and related risks.
Going on the "hot wheels" to go public 2 months in advance, helping Chinese ACS patients reduce the risk of cardiovascular events
Polyida® can be said to have stepped into the "hot wheels" of accelerated approval and entered China. In December 2019, it was approved by the China National Drug Administration (NMPA) for the heart of patients with atherosclerotic cardiovascular disease. Prevention of vascular events and treatment of low-density lipoprotein cholesterol levels in primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. In addition, China is the first country to receive two major indications for Polydyne® and was successfully launched in China 2 months ahead of schedule.
"Acute coronary syndrome (ACS) has had a high mortality rate in recent years, bringing a heavy burden of disease. Even after ACS patients have received evidence-based preventive treatment, there will still be a high residual risk. LDL-C level is related, so reducing LDL-C is the core of secondary prevention for ACS patients. "Academician Ge Junbo from Zhongshan Hospital Affiliated to Fudan University introduced. Polydyne not only has evidence-based evidence that significantly reduces cardiovascular events in ACS patients, but it is currently the only PCSK9 inhibitor that has been shown to be associated with a 15% reduction in all-cause death1. It significantly reduces LDL in recent ACS patients who have been treated with statins. -C level reached 61%. In addition, the long-term follow-up of Chinese patients with ACS is very unsatisfactory, and the patient's long-term medication compliance is poor, and Polydat® injected subcutaneously every two weeks brings a new option for lipid-lowering therapy, which is convenient to use and beneficial to improve patient compliance. .
Dr. Pius S. Hornstein PhD, General Manager of SanofiPharm Global Business Unit China and President of China, said: "Sanofi has over 60 years of experience in cardiovascular disease management and we are very pleased with this breakthrough Sex Drugs-Polyida® has been successfully launched in China in the most digital way. As one of the five new drugs planned to be launched this year, its launch will open Sanofi's new journey in China. It is expected that by 2025, we will China brings more than 25 new drugs and vaccines to help Chinese patients bloom. "
"Polyda is a potent, evidence-based medical evidence of PCSK9 inhibitors, and it is really needed for patients with acute coronary syndrome. Because only 10% of patients with acute coronary syndrome in China are able to Reaching the standard of blood lipids 70mg / dL, even when discharged, only 30% of patients can meet the standard. So there is still a lot of room for us to work hard. At present, there are more than 4,400 hospitals in the country to establish chest pain centers, of which 1372 hospitals passed Certification of the Chest Pain Center. We should use the construction of the Chest Pain Center as a starting point to promote the construction of the disease prevention system. "Professor Huo Yong, director of the Department of Cardiology, Peking University First Hospital, introduced.
Speech by Professor Huo Yong, Chief Physician of Cardiology, Peking University First Hospital
The first domestic prescription was issued, and Polyda® officially entered clinical application
Professor Chen Jiyan, director of the Department of Cardiology, Guangdong Provincial People's Hospital, said: "PCSK9 inhibitor-like lipid-lowering drugs have opened a new era of cardiovascular therapy. Its emergence has made cholesterol become 'younger', reflecting the advancement of technology. Such new drugs The listing of the product can lower cholesterol and bring more benefits to patients. "
Aunt Huang (pseudonym), 65 years old, received PCI treatment in an outpatient hospital due to a sudden acute inferior myocardial infarction and also implanted a stent. Aunt Huang has a long history of hypercholesterolemia and regularly takes statins after discharge from hospital. A month later, the blood lipid and liver biochemical examination found that the LDL-C level was still at a relatively high level. The doctor considered that her intensive statin treatment or the combination of ezetimibe was difficult to achieve the guideline control goals, so it was recommended to use more powerful Alixiu monoclonal antibody injection, so Zhongshan Hospital affiliated to Fudan University issued the first domestic prescription. Subcutaneous injection of lipid-lowering is a new attempt for Aunt Huang and many patients with ACS. She also looks forward to Pollida® to achieve strong lipid-lowering, live more at ease, and do not want to be hospitalized due to cardiovascular events.
Professor Qian Juying, deputy dean of Zhongshan Hospital affiliated to Fudan University, Department of Cardiology, pointed out that alixiuzumab injection as a new class of powerful lipid-lowering drugs can reduce LDL-C by 50% to 60% at baseline , Or even higher. For very high-risk ACS patients with high baseline cholesterol levels, combined with familial hypercholesterolemia, or repeated atherosclerosis events, LDL-C has not yet reached the treatment goal after applying the maximum tolerated dose of statin and ezetimibe . In response to this situation, alixiuzumab injection provides clinicians with a new treatment option. It can be said that the advent of these innovative drugs provides a new strategy for lipid-lowering management in ACS patients.
In order to help adult patients diagnosed with primary hypercholesterolemia or mixed dyslipidemia, and patients with atherosclerotic cardiovascular disease get more care, reduce the financial burden of patients, prevent patients from recurring cardiovascular events, prolong For the life of patients, Sanofi and China Primary Health Care Foundation launched the “Caring Rieter Patient Assistance Project” in the country in April 2020. Applications are now open to provide medical assistance to patients who meet the application requirements.