Amgen's Evolocumab (Repatha) Officially Launched in China, Offering Innovative Biologic Therapy for High-Risk Cardiovascular Patients

On March 23, 2019, Amgen China held the 2019 China Lipid Management Summit in Beijing, marking the official launch of Repatha (generic name: evolocumab) in the Chinese market. The summit brought together top healthcare professionals and leading cardiovascular experts in China to discuss the current state of cardiovascular disease management in the country, with a particular focus on lipid management and related issues. A reporter from Arterial New Medicine (WeChat ID: biobeat1) attended the event and conducted an interview with Ms. Wen Chen Peixi, Head of Amgen Asia Pacific and General Manager, at the media roundtable.

Amgen’s cholesterol-lowering drug Repatha was approved in China in July 2018, becoming the first PCSK9 inhibitor approved by the China National Medical Products Administration (NMPA) for the treatment of homozygous familial hypercholesterolemia (HoFH) in adults and adolescents aged 12 years or older. It was also Amgen’s first product to gain marketing approval in China. In January 2019, Repatha received approval for a broader indication, enabling its use in adult patients with atherosclerotic cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.

China is rapidly transitioning into an aging society. It is projected that by 2050, the elderly population will account for 34.9% of the total population in China, and this demographic is particularly susceptible to cardiovascular diseases.

According to the "Report on Cardiovascular Diseases in China 2017," there are up to 290 million patients with cardiovascular diseases in China, including approximately 13 million stroke survivors and 11 million patients with coronary heart disease. From 2002 to 2015, the mortality rate of acute myocardial infarction showed an overall upward trend. Cardiovascular diseases account for more than 40% of all disease-related deaths among residents, making them one of the most significant health challenges facing Chinese citizens today.

Professor Ma Changsheng of Beijing Anzhen Hospital, Capital Medical University, stated, “Cardiovascular disease has become the leading cause of death among Chinese residents. Atherosclerosis induced by high levels of low-density lipoprotein cholesterol (LDL-C) is a major contributor to cardiovascular events. Without effective intervention, the progression of atherosclerosis can lead to myocardial infarction and stroke. However, a significant proportion of patients with atherosclerotic cardiovascular disease fail to achieve adequate control of serum LDL-C levels through existing lipid-lowering therapies, thereby remaining at risk for recurrent cardiovascular events. The approval of the new indication for evolocumab brings hope to a broad patient population, effectively lowering lipid levels while also improving patients’ quality of life.”

Repatha (generic name: evolocumab) is a human monoclonal immunoglobulin G2 (IgG2) antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9, inhibiting the interaction between circulating PCSK9 and low-density lipoprotein (LDL) receptors (LDLR), thereby preventing PCSK9-mediated LDLR degradation and allowing LDLRs to recycle back to the surface of hepatocytes. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the bloodstream, thus reducing LDL cholesterol (LDL-C) levels. Elevated LDL-C levels are identified as a significant risk factor for cardiovascular disease (CVD).

Repatha can be used in combination with dietary therapy and other low-density lipoprotein cholesterol (LDL-C) lowering treatments (such as statins, ezetimibe, and LDL apheresis) to further reduce LDL-C levels. Repatha has been approved in more than 60 countries and regions, including the United States, Japan, Canada, and all 28 member states of the European Union. Applications in other countries are currently underway.

Clinical study data demonstrate that Repatha can significantly reduce LDL-C levels in patients with homozygous familial hypercholesterolemia (HoFH) that remain elevated despite dietary management and lipid-lowering pharmacotherapy. Compared with placebo, Repatha reduced LDL-C levels by 31% in patients with HoFH. Its significant efficacy and favorable safety profile were further confirmed in a long-term (1-year) study of patients with HoFH.

The approval of this new indication is based on data from the FOURIER cardiovascular study, which involved 27,564 patients. The study results demonstrated that, compared with patients receiving placebo plus statin therapy, those treated with Repatha (evolocumab) in combination with statins experienced a 27% relative risk reduction in myocardial infarction, a 21% relative risk reduction in stroke, and a 22% relative risk reduction in coronary revascularization procedures.

Data from the Asian population in the FOURIER study also demonstrated that Repatha was equally effective in reducing the risk of cardiovascular events in Asians compared with other populations, with a comparable safety profile.

A significant proportion of patients undergoing lipid-lowering therapy still fail to achieve optimal LDL-C levels. The approval of Repatha for broader indications provides a new treatment option for these patients whose LDL-C levels are not adequately controlled with existing lipid-lowering therapies, helping them reduce the risk of life-threatening myocardial infarction and stroke.

Ms. Wen Chen Peixi has served as Vice President and General Manager of the Asia-Pacific region at Amgen since 2014, responsible for leading and driving Amgen’s business development in the Asia-Pacific region, including 14 key emerging Asian markets such as China, Japan, Australia, and Southeast Asia. Ms. Wen Chen Peixi has over 20 years of experience in the pharmaceutical industry.

Amgen aims to introduce more innovative medicines to China, with its novel drugs in orthopedics and oncology being key targets for introduction. Amgen is committed to bringing more innovative therapies to Chinese patients and contributing to the Healthy China 2030 strategy.

Meanwhile, Amgen is also accelerating its localization efforts in China. Since 2012, Amgen has begun establishing branches in China, aiming to bring more of Amgen's innovative drugs to the vast number of patients in China. After setting up an office in Beijing to handle registration and clinical-related matters, Amgen established its China headquarters in Shanghai and set up an Asia-Pacific R&D center. The company has conducted multiple clinical studies domestically and plans to introduce innovative drugs for the treatment of major diseases such as cancer and cardiovascular conditions. Amgen has also partnered with Beta Pharma and Simcere Pharmaceutical to jointly promote the introduction of Amgen’s innovative drugs and the development of biosimilars.

Ms. Wen Chen Peixi, Head of Amgen Asia Pacific and General Manager, stated, “As the first PCSK9 inhibitor approved in China, Repatha brings hope to patients with homozygous familial hypercholesterolemia and adult patients with atherosclerotic cardiovascular disease. We will also provide new treatment options for high-risk patients whose LDL-C levels cannot be adequately lowered by statins alone, thereby reducing the risk of myocardial infarction and stroke. Amgen will continue to invest in the fields of serious and chronic diseases, providing efficient ways to introduce innovative biologics into the Chinese market, fulfilling Amgen’s mission to serve Chinese patients and contributing to the Healthy China 2030 initiative.”

The approval and market launch of Repatha is merely the beginning. It not only heralds the dawn of a new era in the treatment of cardiovascular diseases in China, but also marks a significant milestone in Amgen’s commitment to providing high-quality innovative medicines to Chinese patients and advancing disease prediction and prevention.