Luye Pharma Releases its Financial Results for the First Half of 2018: Double-Digit Growth in Core Product Sales, Exceeded Expectations in Sales, R&D and M&As

HONG KONG,Aug. 29,2018 -- Luye Pharma Group(02186.HK) released its financial results for the first half of 2018 on August 26,with the financial report showing the company has maintained strong business performance and double-digit growth in the sale of its established products - significantly higher than the industry average. Meanwhile,the company has been accelerating the development of both its product pipeline and commercialization in global markets,further enhancing its abilities in the realm of international operations.

In the first half of 2018,Luye Pharma recorded a revenue of RMB 2.204 billion,up 19.1% year on year. Profits attributable to shareholders reached RMB 563 million,up 46.1% year on year.

A senior management spokesperson at Luye Pharma commented: "With the combined efforts of our employees around the world,Luye Pharma's financial results for the first half of 2018 exceeded market expectations. Not only have the existing products continued to experience strong growth in sales,we have also been able to take advantage of policy opportunities to accelerate registration of our pipeline products in major markets,such as China and the United States. Furthermore,through acquisitions and partnerships,we have taken additional steps towards realizing our global development strategy with our ever-increasing competitiveness in product offerings and commercialization. We believe that the company will maintain this momentum of rapid growth and continue to make breakthroughs in sales,R&D,and M&A in the future."

First Half of 2018 Highlights:

Products-- Luye Pharma achieved double-digit growth in product sales,becoming a Top 15 Chinese pharmaceutical company.

In the first half of 2018,the company's core products registered double-digit growth in sales. Among these core products,sales of Lipusu continued to grow rapidly,and thanks to the reimbursement policy,Beixi,Xuezhikang and CMNa also performed strongly,contributing more to the company's overall sales than they have in the past.

According to IQVIA (formerly known as IMS) data,the overall growth rate for China's pharmaceutical industry in the first half of 2018 was 2.84%. This is compared to Luye Pharma's rate of 12.14%,which significantly outperformed the industry average. In terms of total sales,Luye Pharma's ranking has jumped from within the top 20 Chinese pharmaceutical companies at the end of 2017,to within the top 15 currently.

The company expects its market share will continue to grow in the second half of 2018,given the strength of its products' competitiveness.

R&D-- Time to market was reduced,with a rich product pipeline being developed across a variety of therapeutic areas

In the first half of 2018,Luye Pharma's R&D expenditure increased by 57.7% year-on-year. Through independent R&D and external partnerships,the company has been able to integrate global R&D resources to accelerate the development and launch of new drugs. As of now,significant results have been achieved in areas of new drug delivery systems (NDDS),new chemical entities (NCE),and biological antibodies.

With respect to NDDS,Risperidone Extended Release Microspheres (LY03004) for the treatment of schizophrenia and bipolar disorder has entered its final stage of NDA (new drug application) in China and the United States; Rotigotine Extended Release Microspheres (LY03003) for the treatment of Parkinson's disease has been exempted from Phase II clinical trials in China and the United States,and has moved into the Phase III trials stage. Additionally,Rivastigmine Multi-day Transdermal Patches for the treatment of mild to moderate Alzheimer's disease has reached a critical stage of clinical development.

Among the NCEs,Ansofaxine Hydrochloride Extended Release Tablets (LY03005),a new Class 1.1 drug for the treatment of depression,has shown positive results in phase II clinical trials in China. The new immuno-oncology drug LY01013,an IDO/TDO dual target inhibitor,was approved for clinical trials,while the application for LY03012,a new class 1.1 analgesic drug,has been put forward for clinical trials.

In terms of biological antibodies,Recombinant anti-VEGF humanized monoclonal antibody injection (LY01008),for the treatment of colorectal cancer and non-small cell lung cancer,as well as the Recombinant anti-RANKL whole human monoclonal antibody injection (LY06006),indicated for postmenopausal women with osteoporosis,are both progressing well in their phase III and phase I studies respectively.

In addition,the company has been actively seeking opportunities in fields such as cell and gene therapies and immune-oncology through a series of collaborative projects. In the first half of this year,Luye Pharma entered into strategic partnerships with two U.S. biotech companies,Excel Biopharm LLC and ELPIS Biopharm,to jointly develop the next generation of therapeutic antibodies for use in immuno-oncology and CAR-T therapy respectively.

M&A -- Global operations capability further enhanced with increased synergy

Luye Pharma acquired the assets of AstraZeneca's Seroquel and Seroquel XR in 51 countries and regions around the world. This move strengthens Luye Pharma's ability for commercialized access to the global central nervous system therapeutics market. Further,it establishes a solid foundation for Luye Pharma's pipeline products to become available to the world's major markets.

In addition to the above,the transdermal patch business acquired by Luye Pharma at the end of 2016 is also running well,driven by increased synergy. This year,Luye Pharma's two subsidiaries in Germany and Switzerland closed a deal with Bayer on the acquisition of the global rights to Apleek,Bayer's contraceptive transdermal patch product. Moreover,Luye Pharma has launched a number of transdermal patch products in major markets around the world,including Japan,Israel,Thailand,South Korea,Switzerland,etc. The company has also set up local manufacturing and will start new drug applications for Buprenorphine transdermal patches and Rivastigmine transdermal patches to accelerate their entry into China.

Looking forward to the future,Luye Pharma's management team is full of confidence,with a senior management spokesperson adding: "Driven by innovation and our development strategy,we will continue to enhance our capabilities in global R&D,global manufacturing and global marketing. We will increase our R&D investment in areas that work with our competitive advantages and strategic focus,allowing us to bring our global pipelines to global markets sooner to meet the needs of patients worldwide."

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