China Shandong Network - Perception Shandong October 31 news (reporter Lu Weixia correspondent Guo Jian) founded in 1994 Luye Pharmaceutical, is committed to the development, production and sales of innovative drugs. Over the years, the company has taken "innovation" and "internationalization" as the fulcrum of enterprise development, focusing on the three strategic centers of gravity of "global research and development, global manufacturing and global market", focusing on disease fields such as central nervous system and tumors, and has formed a core competitive advantage suitable for its own development.
On the afternoon of the 29th, the media collection group focusing on Yantai biomedical industry walked into Luye Pharmaceutical, which is located in Yantai High-tech Zone.
"After years of unremitting hard work, the company has gradually ushered in a harvest period, and a number of new products have been launched to benefit patients: in June last year, Kingsmin ®, which treats Alzheimer's disease, was approved for listing in China; since this year, the company has ushered in the listing of the first independent research and development in China and global registration for the treatment of schizophrenia, the innovative microsphere preparation Rehinto ®; the company's first anti-tumor biological drug Boyouno ® has been approved for listing in China; the Mingdo day transdermal patch for the treatment of Alzheimer's disease has been licensed in many EUROPEAN countries... The relevant person in charge of Luye Pharmaceutical introduced to reporters.
Under the guidance of "innovation" and "internationalization" development strategies, Luye Pharmaceutical actively promotes R&D and innovation, builds a global supply chain system, and improves the international business operation network, and its existing business has spread to more than 80 countries and regions around the world, gradually highlighting its resource advantages in the whole industry value chain. How local pharmaceutical companies continue to innovate and gain a foothold in the international market, Luye Pharmaceutical is writing its own answer.
Global R&D: Full force around the three major R&D platforms
With China's pharmaceutical innovation entering the "fast lane", more mature local pharmaceutical companies tend to look for opportunities in the biopharmaceutical research and development innovation and market demand in developed countries and regions such as the United States, Europe and Japan, to prepare for the entry of domestic innovative drugs into the international market.
As one of the first Chinese enterprises to carry out new drug registration overseas, Luye Pharmaceutical established the Intellectual Property Department and the International Cooperation Department as early as 1998, and established the Innovation R&D Center in 1999 to clarify its "innovation" and "internationalization" development goals. Today, Luye Pharmaceutical has extended the "tentacles" of innovation to developed countries in Europe, america and Japan, and the company has set up R&D centers in China, the United States and Europe to integrate global R&D resources and improve innovation capabilities.
Focusing on the three major R&D platforms of new preparations, innovative compounds and biological antibodies, the company has more than 10 innovative preparations and innovative drugs in the United States, Europe and Japan to carry out registered clinical research at different stages, many of which have entered the late clinical and new drug market application stage (NDA).
Based on the new formulation platform, the new anti-schizophrenia drug Rehinto ® (Risperidone microspheres (II) for injection) has been approved for marketing in China and is in the application stage of new drugs in the United States; the innovative preparation for the treatment of Alzheimer's disease, Leith's clear skin patch (multi-day patch), has obtained new drug marketing authorization in many european countries; rotigotine sustained-release microspheres for injection for the treatment of Parkinson's disease are in Phase III clinical trials in China and the United States, and Completed Phase I clinical trials in Japan.
Based on the innovative compound platform, the new class I antidepressant drug ansophephaxin hydrochloride extended-release tablets are in the new drug application stage in China and the United States, and the Phase I clinical study has been completed in Japan.
Based on the biological antibody platform, the anti-tumor biological drug Boyounuo ® (bevacizumab injection) developed by Boan Biologics, a holding subsidiary of Luye Pharmaceutical Group, has been approved for marketing in China, and the biological drug disulumab injection for the treatment of osteoporosis has submitted a listing application in China.
Global manufacturing: build a sound global supply chain system
In terms of global manufacturing, the company takes the needs of customers in the global market as the starting point and establishes a supply chain architecture system with advanced concepts. As early as 1999, Luye Pharmaceutical put into use a new plant designed in accordance with European and American GMP standards and passed the world's most stringent GMP inspection.
Luye Pharmaceutical adheres to the international quality standards as the yardstick, and is committed to providing high-quality drugs for patients around the world, and the international high-quality standards have gradually become the "genes" of Luye Pharmaceutical.
The company has gradually established a supply chain architecture system with advanced concepts, extending outward from the 8 major production bases in China and Germany, designing an international product supply layout strategy, and creating a full-coverage supply chain network from the strategic supply of front-end raw materials to the terminal delivery to patients. Its production line has passed the GMP inspection of the United States, the European Union, Japan, Australia, Brazil and other countries, and has reached the international market norms.
Global market: in-depth layout of international business operation system
At the moment of internationalization of industry competition, in addition to making efforts at the R&D and manufacturing ends, domestic pharmaceutical companies are also facing the test of integrating international resources and broadening the international market. Luye Pharmaceutical actively carries out various cooperation with global business partners, through the two-pronged development model of "endogenous growth" and "external cooperation", unites the resource advantages of all parties in the whole industry value chain, taps more new impetus for the company to accelerate development, and continuously enhances its core competitiveness in the global market.
With the help of the international market layout over the years, Luye Pharmaceutical's overseas business operation system has been expanded to more than 80 countries and regions around the world, the company's more than 30 listed products cover the central nervous system, anti-tumor, cardiovascular, digestion and metabolism and other fields, the business covers China, the United States, Europe, Australia, Japan and South Korea and other major global pharmaceutical markets and emerging markets, the company in the United Kingdom, Southeast Asia, the Middle East, North Africa and other regions to form a self-operated sales team, and with dozens of overseas companies to establish partnerships. While continuing to strengthen the international business system and ensuring the sales of existing products, it also lays a good foundation for the subsequent listing of new drugs.
In the past 20 years, Luye Pharmaceutical has been practicing all aspects of corporate management in accordance with international high standards, and has become a pioneer representative of innovation and internationalization of Chinese pharmaceutical companies on the road of internationalization. In the future, Luye Pharmaceutical will continue to base itself in China and face the world, and strengthen its globalization capabilities in all aspects such as innovative research and development, high-quality manufacturing, and market network, enhance its international competitiveness, and benefit more patients.