HONG KONG, June 25, 2018 /PRNewswire/ — On June 22nd in Hong Kong, Luye Pharma Group hosted a conference to unveil their Global Collaboration Strategy. Liu Dianbo, Chairman of Luye Pharma Group, said at the event, "Starting in 2019, Luye Pharma will gradually begin to enter into a period of harvest, with past work coming to fruition, the company plans to launch at least one new drug every year. At the same time, we are also making comprehensive plans for the company’s development over the next five to ten years. We will pursue global partnerships in three strategic areas – global R&D, global manufacturing and global marketing, to ensure the company’s goal of becoming one of the world’s top fifty pharmaceutical companies by 2025."
The focus of the conference was on Luye Pharma’s "Whole Value Chain Global Collaboration" strategy, proposed by Liu Dianbo. This is the first time that Luye Pharma has released their official global collaboration strategy to the public:
From innovation, R&D and manufacturing to marketing and distribution, Luye Pharma is committed to close collaboration with global business partners to best leverage the resource advantage of every party in the entire industry value chain, to better serve patients worldwide.
Jiang Hua, Vice President, Strategy & Business Development at Luye Pharma Group, also discussed the strategic thinking behind the company’s recent acquisition of AstraZeneca’s Central Nervous System (CNS) products, Seroquel (quetiapine fumarate, immediate release, IR) and Seroquel XR (extended release formulation) in 51 countries and regions. Mr. Simon Mellon, Consul for Trade and Investment at the British Consulate General in Guangzhou and Assistant Director for Life Sciences, Health and Social Care for South China at the Department for International Trade, as well as Mr. Chen Bing, Vice President of Alliances & Business Development at AstraZeneca also attended the conference.
Global R&D: Strengthen the advantages of four innovative technology platforms and make comprehensive plans for development of new tech areas
Luye Pharma has always been focused on the development and manufacturing of innovative drugs, and has set up R&D centers in Europe, the United States and China. To integrate its global R&D resources, Luye Pharma follows a strategy of independent R&D augmented by external collaboration. The company to date has developed four innovative technology platforms; advanced drug delivery systems, new antibodies, structurally optimized small molecules, and cell & gene therapy, in addition to multiple existing collaborative agreements with leading biotechnology companies.
Luye Pharma’ s "advanced drug delivery systems" represent the company’s unique competitive advantage in the R&D field, an area Luye has been relentlessly pursuing for many years. The company’s microspheres, liposomes and transdermal drug delivery technologies are at an advanced international standard. Risperidone Extended Release Microspheres (LY03004), which was developed by Luye Pharma for the treatment of schizophrenia and bipolar disorder, has reached the NDA (new drug application) stage in the United States. Rotigotine Extended Release Microspheres (LY03003), indicated for Parkinson’s disease, have begun Phase III clinical trials. "These new drugs will go on the market one by one, starting from 2019, in countries and regions around the world, something of a harvest period for Luye" said Jiang Hua. "In addition to independent research and development, we will also seek external collaboration to strengthen the four major existing innovative technology platforms and to facilitate our forward-looking deployment for the next generation of innovative drugs."
Since last year, Luye Pharma has been deploying its resources in multiple areas through a number of R&D collaboration projects, including novel target antibodies, protein drugs, immuno-oncology, cell therapy, and smart precision drug delivery systems. In August 2017, Luye Pharma acquired two monoclonal antibody drugs from Shandong Bo’an Biotechnology Co., Ltd. (LY01008 and LY06006), and obtained a "biological antibody technology" R&D platform. The two drugs have already started Phase III and Phase I clinical studies, respectively. At the end of 2017, Luye Pharma made an equity investment in Exicure Inc., a US-based biotechnology company. Exicure’s SNA technology will synergize with Luye Pharma’s established liposome and microsphere delivery technologies in discovering novel nucleic acid drugs for use in oncology and other areas of unmet needs. In the field of immuno-oncology, Luye Pharma has successively built strategic collaborations with three leading U.S. biotechnology companies – ABPRO, Excel Biopharm LLC and ELPIS BIOPHARM, to jointly develop novel bispecific antibodies, therapeutic antibodies for the next generation of immuno-oncology and CAR-T therapy, among others.
Global Market: To develop product pipelines with global competitiveness in core therapeutic areas
CNS, oncology, cardiovascular, and metabolism are Luye Pharma’s four core therapeutic areas of long-term focus, with Luye making a series of systematic and sustainable plans aimed at developing these areas. With the acquisition of Acino’s transdermal patch and implants business, as well as a number of new drugs independently developed by the company, Luye Pharma has been able to build a wealth of CNS product pipelines and therapeutic solutions. In addition to Risperidone Extended Release Microspheres (LY03004) and Rotigotine Extended Release Microspheres (LY03003), Ansofaxine Hydrochloride Extended Release Tablets (”LY03005”) for the treatment of depression have also entered into Phase III clinical trials. New drug development projects such as Rivastigmine Multi-day Transdermal Patch (30410) for the treatment of mild-to-moderate Alzheimer’s disease is also progressing smoothly. The recently acquired Seroquel and Seroquel XR from AstraZeneca is another blockbuster added to Luye Pharma’s CNS portfolio.
Seroquel and Seroquel XR are atypical anti-psychotic medicines with antidepressant properties. The main indications for Seroquel are the treatment of schizophrenia and bipolar disorder. Seroquel XR is also approved in some markets for major depressive disorder and generalized anxiety disorder. Because of their fast onset, good tolerability and high patient compliance, Seroquel series products are widely recognized by doctors and patients, and are currently marketed in more than 80 countries around the world, with the total number of prescriptions exceeding 10 million.
In accordance with the acquisition agreement, Luye Pharma will acquire the assets of Seroquel and Seroquel XR in 51 countries and regions including China, the United Kingdom, Brazil, Australia, Saudi Arabia, Mexico, Thailand, Argentina and Malaysia, as well as other countries and regions in Asia, Latin America, Africa, Oceania and Eastern Europe. The assets include marketing authorization, regulatory information, certain patents, relevant business materials and data, manufacturing know-how and sales networks, among others. In addition, AstraZeneca has agreed to grant exclusive, permanent, free and sub-licensable trademark licensing, along with other licensing rights, to Luye Pharma.
"In addition to our optimistic outlook about the business performance and growth potential of the Seroquel products, the deal was made to generate market synergy for Luye and to pave the way for the launch of other CNS products in global markets", said Jiang Hua.
Seroquel and Seroquel XR can complement Risperidone Extended Release Microspheres (LY03004) and Ansofaxine Extended Release Tablets (LY03005) in both domestic and overseas markets, as they can serve the same patient population and there is no exclusive competition when these drugs share channels and promotional resources. Seroquel and Seroquel XR can also contribute, with their readily available domestic and international commercial resources, to the launch and accessibility of new CNS drugs, such as Risperidone Extended Release Microspheres (LY03004) and Rotigotine Extended Release Microspheres (LY03003), as well as comprehensively enhance the global competitiveness of Luye Pharma’s CNS portfolio.
"In the future, we hope to build and expand pipelines featuring global competitiveness in another three core therapeutic areas including oncology and cardiovascular, and we also look forward to continuing our comprehensive and in-depth strategic collaboration with our partners via out-licensing and in-licensing", Jiang Hua added.
Global Supply Chain: Covering upstream raw material procurement right through to patient supply
Luye Pharma is combining its seven global sites into a global manufacturing platform to tap the overseas markets, and hopes to graft the relatively mature local industrial chains into the global advanced supply chain via means including raw materials procurement and CMO partnerships. The goal is to establish a global supply chain network covering everything, from raw materials procurement right through to patient supply.
It is worth mentioning that as a result of the acquisition of Seroquel products, production technology for the two drugs will be transferred to Luye Pharma upon completion of the initial payment to AstraZeneca. The Seroquel series products, especially Seroquel XR, has a very advanced production processes. Luye Pharma plans to introduce these technologies to China shortly after the acquisition, which will also be the first time that the production technology for Seroquel XR comes to China. Shandong Luye Pharmaceutical Co., Ltd. will be the future production base for the global supply of the Seroquel series, not only strengthening the production capacity of new formulations, but also allowing for further alignment with the global production quality system.
"On its path of global development, Luye Pharma has been actively seeking the best M&A opportunities with respect to the different components in the entire value chain, such as R&D, production, and distribution. We look forward to working with our global partners to complement each other and achieve win-win collaborations. We also hope to tap into new and more sustainable growth drivers for the company through a variety of extensive development models and further enhancements to the company’s core competitiveness in the global market," Liu Dianbo concluded.