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.”