Author：Luye Life Sciences
Luye Pharma has announced it has entered an agreement with AstraZeneca China, the terms of which grant AstraZeneca China exclusive rights to promote Luye Pharma’s Xuezhikang Capsules in mainland China. This is the first time that a multinational pharmaceutical company has gained exclusive authorization in China to promote an innovative drug independently developed by a Chinese pharmaceutical company.
According to the agreement, AstraZeneca will be responsible for the exclusive promotion of Xuezhikang Capsules in mainland China, while Luye Pharma will retain asset rights, commercial sales rights, the registration permit, all intellectual property rights and other product-related rights aside from product promotion.
As a widely acknowledged product both at home and abroad, Xuezhikang is the only natural lipid-regulating drug with proven benefits in clinical endpoints, and has completed phase II clinical trials in compliance with U.S. FDA regulations. Large-scale and evidence-based clinical studies, including the China Coronary Secondary Prevention Study (CCSPS) have confirmed that Xuezhikang, with comparatively few adverse reactions, can inhibit cholesterol synthesis and significantly reduce total mortality, coronary heart disease mortality and the incidence of cardiovascular events in patients with coronary heart disease. Clinical trials results of Xuezhikang combined with Ezetimibe also revealed that Xuezhikang, whether in monotherapy or used in combination with Ezetimibe, can significantly reduce low-density lipoprotein cholesterol (LDL-C), with a 45% reduction in LDL-C observed in combination treatment. Xuezhikang also demonstrated a strong safety profile with no serious liver and muscle-related adverse events and no increased risk of new-onset diabetes reported in clinical use. Additionally, it was learned Xuezhikang contains a variety of beneficial components that can also reduce blood lipid levels and protect cardiovascular health, and is therefore safe for long-term use.
Given their proven efficacy and safety in lipid-regulation, Xuezhikang Capsules have been recommended as a first-line blood lipid management drug by the Chinese Guidelines for the Prevention and Treatment of Adults with Dyslipidemia (2016 Revision), and included in the latest edition of China's National Drug Catalog for Basic Medical Insurance and Work-Related Injury Insurance, as well as the country’s National Essential Drugs List.
Under the partnership, Luye Pharma will leverage AstraZeneca's long-term expertise in the cardiovascular therapeutic field, both in terms of its excellent academic promotion and extensive distribution network, further expanding the accessibility of Xuezhikang Capsules in China for the benefit of more patients with cardiovascular diseases. It is expected that Xuezhikang Capsules will maintain a double-digit compound annual growth rate in sales over the next 10 years, significantly higher than the industry average.
On top of this, the two parties are discussing the possibility of expanding Xuezhikang to the U.S. and Europe, as well as other emerging markets, leveraging AstraZeneca’s advantages in cardiovascular therapy to further promote Xuezhikang Capsules to more countries and regions across the world. In addition to the Chinese mainland, Xuezhikang is currently accessible in Taiwan, Hong Kong, Singapore, Malaysia, and other markets.
Yang Rongbing, President of Luye Pharma Group, is confident in the partnership: “Xuezhikang Capsules are one of our key independently-developed medicines. Doctors and patients have widely recognized Xuezhikang’s lipid-regulating efficacy during long-term clinical use. The partnership with AstraZeneca will enable this highly trusted and naturally made medicine to reach more Chinese patients in need. The deal will also help accelerate the promotion of Xuezhikang capsules in international markets, and further strengthen Luye Pharma’s competitive advantage in the cardiovascular field.”
“Since entering the Chinese market 25 years ago, AstraZeneca has always been committed to its ‘patient-centric’ philosophy. We have always focused on addressing the most urgent unmet medical needs and providing patients with high-quality, innovative medical solutions. Cardiovascular therapy is one of our key business areas in China, and we hope to expand the accessibility of Xuezhikang further to bring benefits to more Chinese patients,” said Leon Wang, Executive Vice President, International, and China President of AstraZeneca. “AstraZeneca will spare no effort in deepening cooperation with local Chinese partners to make high-quality, innovative drugs available to more patients. Building on this partnership, we will further integrate the resources of the two sides, and apply international medical management practices to promote locally developed innovative drugs in the world markets.”
About Xuezhikang Capsule
Developed by Luye Pharma Group, Xuezhikang is a natural lipid-regulating medicine made by fermenting special red yeast rice with modern technology. Xuezhikang Capsule can regulate abnormal blood lipids, by reducing total blood cholesterol, triglycerides, low-density lipoprotein cholesterol and by improving high-density lipoprotein cholesterol, inhibit the formation of atherosclerotic plaque, protect vascular endothelial cells and inhibit lipid deposition in the liver.
Xuezhikang has been on the market for over 20 years. Large-scale and evidence-based clinical studies including China Coronary Secondary Prevention Study (CCSPS) have confirmed that Xuezhikang, with comparatively few adverse reactions, can inhibit cholesterol synthesis and significantly reduce the total mortality, coronary heart disease mortality and the incidence of cardiovascular events in patients with coronary heart disease. The clinical trial results of Xuezhikang combined with Ezetimibe also showed that Xuezhikang, whether used alone or used in combination with Ezetimibe, can significantly reduce low-density lipoprotein cholesterol (LDL-C), with 45% reduction in LDL-C observed in the combination treatment. Xuezhikang also demonstrates good safety profile with no serious liver and muscle-related adverse events and no increased risk of newly-onset diabetes reported in its clinical use. Also, it contains a variety of beneficial components that can also reduce blood lipid levels and protect cardiovascular health and therefore is safe for long-term use.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has a robust pipeline of more than 30 drug candidates in China and more than 10 drug candidates overseas. The company currently has a number of new drugs and new formulations in the central nervous system and oncology therapeutic areas under study in the U.S. and Europe. Luye Pharma has set up 7 manufacturing sites with over 30 production lines in total, establishing GMP quality management and international standard control systems. The company offers more than 30 products covering the four largest and fastest growing therapeutic areas — oncology, cardiovascular, metabolism and central nervous system, with business conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as fast growing emerging markets.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in therapeutic areas including Oncology, Respiratory and Cardiovascular & Metabolic Diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
About AstraZeneca in China
Since entering China in 1993, AstraZeneca has been committed to meeting China’s increasing healthcare needs by continuously following the science and focusing on innovation, becoming China’s most trusted healthcare partner bringing forth innovative solutions to improve the lives of Chinese patients. AstraZeneca’s China headquarters are based in Shanghai, and we’ve established manufacturing sites in Wuxi and Taizhou, as well as a China Distribution Centre in Wuxi. In China, AstraZeneca focuses on therapeutic areas that local patients need most: respiratory, cardiovascular, metabolic, oncology, gastrointestinal and renal disease. In 2017, AstraZeneca China Commercial Innovation Centre was established in Wuxi, with the aim to explore innovative IoT-based integrated diagnosis and treatment solutions. In the same year, AstraZeneca cooperated with SDIC Fund in establishing Dizal Pharmaceutical to accelerate local development of innovative medicines for patients in China.