Amgen Targets China's 290 Million Cardiovascular Patients with Repatha (Evolocumab) Launch and Expanded Indications

Amgen China Announces the Official Launch of Its Cholesterol-Lowering Drug Repatha (Evolocumab) Injection in China

Repatha was approved in China in July 2018, becoming the first PCSK9 inhibitor approved by the National Medical Products Administration (NMPA) and the first product from Amgen to receive approval in China. It is indicated for the treatment of homozygous familial hypercholesterolemia (HoFH) in adults or adolescents aged 12 years and older. In January this year, Repatha received approval for a broader indication, allowing its use in adult patients with atherosclerotic cardiovascular disease (ASCVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization.

“Cardiovascular disease has become the ‘leading killer’ among Chinese residents, and atherosclerosis caused by high levels of low-density lipoprotein cholesterol (LDL-C) in the serum is an important cause of cardiovascular disease. If not effectively intervened, atherosclerosis will progress”Exhibitionwhich can lead to myocardial infarction and stroke.” Professor Ma Changsheng from Beijing Anzhen Hospital, Capital Medical University, stated that the approval of the new indication for evolocumab injection provides a new treatment option for a significant proportion of patients with atherosclerotic cardiovascular disease who have failed to effectively control their LDL-C levels through existing lipid-lowering therapies to prevent recurrent cardiovascular events.

Cardiovascular disease is a leading cause of death worldwide, with nearly half of these deaths occurring in Asia. Currently, China is experiencing a rapid acceleration in population aging, and the elderly population is at high risk for cardiovascular disease.

Data show that there are up to 290 million patients with cardiovascular disease in China, including approximately 13 million stroke survivors and 11 million patients with coronary heart disease. The overall mortality rate from acute myocardial infarction (AMI) is on the rise. Cardiovascular diseases account for more than 40% of all disease-related deaths among residents, representing one of the most significant health challenges facing the Chinese population. The annual economic burden attributable to cardiovascular diseases, whether direct or indirect, on patients, their families, and public finances reaches as high as $21.7 billion. Furthermore, stroke remains one of the primary causes of household poverty in rural areas of China.

In the current macro environment, the continuous expansion of cardiovascular disease management and pharmaceuticals is both imperative and urgent.

“Additional indications for evolocumab injection are currently under development,” said Winnie Chen, Head and General Manager of Amgen Asia Pacific.

Greater reduction in disease risk compared to placebo

Repatha is a human monoclonal immunoglobulin G2 (IgG2) antibody targeting human 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 LDLR to recycle back to the hepatocyte surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the bloodstream, thus reducing LDL-C levels.

Wen Chen Peixi told a reporter from The Economic Observer that, as an innovative biologic target mechanism, the efficacy of evolocumab injection (Repatha) in effectively reducing the risk of cardiovascular disease has been extensively validated in patients with atherosclerotic cardiovascular disease.

Reporters learned from clinical study data that the approval of the new indication for Repatha was based on data from a cardiovascular study (FOURIER) conducted in 27,564 patients. The data showed that, compared with patients receiving placebo plus statin therapy, those receiving Repatha plus statin therapy had a 27% relative risk reduction in myocardial infarction events, a 21% relative risk reduction in stroke, and a 22% relative risk reduction in coronary revascularization procedures.

Meanwhile, Wen Chen Peixi told reporters that Repatha reduced LDL-C levels in patients with HoFH by 31% compared with placebo.

Reporters learned that monoclonal antibody drugs are widely used in clinical practice due to their high specificity and advantages. Their market share in the global biopharmaceutical industry has been increasing year by year. However, the high cost of monoclonal antibody drugs remains a prominent issue, posing varying degrees of challenges to patient accessibility.

“Launched last September by the China Charity Federation and supported by Amgen, the Repatha Charitable Assistance Program serves as a bridge to provide free access to Repatha for patients with homozygous familial hypercholesterolemia (HoFH),” Wen Chen Peixi told reporters. Amgen has been actively advocating for the inclusion of Repatha in the national medical insurance scheme, which would enable broader support for patients’ medication needs. Given that cardiovascular disease management is not a one-time intervention but requires continuous monitoring and control of low-density lipoprotein cholesterol (LDL-C), companies must consider whether patients can effectively receive treatment and follow-up care within the healthcare system.

We will increase our investment in China in the future.

Industry experts pointed out at the forum that the approval and launch of Repatha heralds a new era in the treatment of cardiovascular diseases in China.

Wen Chen Peixi stated at the forum that the approval and market launch of Repatha also represent an important milestone in Amgen’s commitment to providing high-quality innovative medicines for Chinese patients and in predicting and preventing diseases, while Amgen is also committed to its long-term development in China.

“In the field of cardiovascular disease, in addition to Repatha (evolocumab injection), Amgen will have other product candidates and new therapeutic approaches, including those for heart failure, in the future,” stated Wen Chen Peixi. Beyond cardiovascular disease, Amgen will also focus its investments and strategic layout in China on orthopedics and oncology. Furthermore, regarding orthopedic conditions such as osteoporosis, several of Amgen’s effective therapies have already been launched overseas to serve patients. The company hopes to bring these successful treatments to China as quickly as possible.

Beyond its investment in product introductions, Amgen will also drive the introduction of its drug pipeline, striving to synchronize clinical trials of innovative medicines in the Chinese market with those in global markets. The company aims to accelerate the launch of innovative drugs and effective therapeutic options in China, with the broader ambition of establishing China as a leading market for certain specific indications.

Amgen is strengthening its partnerships with local Chinese entities while increasing its investment in the Chinese market.

“The top priority in introducing new drugs is to ensure they reach patients as quickly as possible; we are rapidly serving patients through collaborations with domestic pharmaceutical companies Simcere Pharmaceutical and Beta Pharma,” Wen Chen Peixi told reporters. Amgen will continue to partner with academic, research, and industrial institutions in China to establish extensive, long-term, and diversified strategic collaborations in the fields of pharmaceutical research and clinical practice, exploring more innovative and effective solutions for the prevention and treatment of cardiovascular diseases. Meanwhile, Amgen is also exploring and focusing on high-incidence cancer areas, such as gastric cancer, and considering how to enhance R&D efficiency through collaborations with local Chinese partners.

“Amgen is well aligned with China’s macro environment, demographic structure, and healthcare-related challenges. We remain committed to serving Chinese patients and contributing to the ‘Healthy China 2030’ strategy.”

“China is currently undergoing an accelerated aging process, with the elderly population projected to reach 34.9% by 2050. How to age healthily, stay away from the risks of cardiovascular diseases, continuously improve people's quality of life, and reduce the economic and social burdens caused by aging is not only the responsibility of the government but also that of every individual dedicated to...”Healthcare“...the shared mission of industry professionals,” Wen Chen Peixi told reporters. She stated that Amgen’s advocated health management philosophy, which combines prediction with prevention, can be succinctly summarized as addressing not only existing diseases but also preventing future ones—a approach that aligns perfectly with the national goals and policy directions for comprehensive public health. In the current environment, Amgen will have substantial opportunities for research and development as well as collaboration.

Source: Economic Observer Network Author: Shi Kai