A First for China! Rykindo Approved in China, Demonstrating Strength of Luye Pharma’s World-Leading Microspheres Technology Platform

Luye Pharma Group announced today that China's National Medical Products Administration (NMPA) has approved the company's independently developed Risperidone Microspheres for Injection (II) (Rykindo®) for the treatment of acute and chronic schizophrenia, the significant positive and negative symptoms of various other psychotic states, and for the alleviation of the affective symptoms associated with schizophrenia.

Rykindo® is an extended release microspheres injection developed by Luye Pharma on its world-leading R&D platform for long-acting and extended release technology. It is the first innovative microsphere formulation currently undergoing global registration to be independently developed by a Chinese company which also owns all of the drug's related intellectual property.

Major Innovative Breakthrough with Significant Clinical Benefits

Rykindo® is a long-acting drug administered bi-weekly by intramuscular injection. Compared to orally administered antipsychotics, long-acting formulations do not require daily administration, and are thus better received by patients, potentially lowering the sense of self-stigmatization associated with these diseases. Patients are also less likely to skip drug administration, and face a lower risk of drug overdose with long-acting drugs. Patients using long-acting injectables have steady plasma drug levels and will not suffer an immediate relapse when drugs are not administered in a timely manner due to a slower drop in plasma drug levels. Rykindo® can significantly improve the medication compliance issues which are common among patients with schizophrenia in relation to oral antipsychotic drugs, and simplify the treatment regimen.

Rykindo® also has several advantages over another marketed long-acting injectable drug. For example, unlike the reference drug, there is no need for administration of the oral formulation following the first injection of Rykindo®. Furthermore, steady plasma drug levels can be reached much faster with Rykindo® than with the reference product. Thus, patients at the acute phase who are less compliant can benefit from the fast symptom control afforded by Rykindo®. Following the discontinuation of use, the concentration of Rykindo® in human body drops markedly faster than that of the reference drug, making it convenient for doctors to adjust dosage according to patients' conditions. Patients using Rykindo® also have stable clinically effective plasma drug levels and can benefit from more convenient clinical treatment as a result.

Due to its sufficient clinical advantages, Rykindo® was granted priority review by the Center for Drug Evaluation under the National Medical Products Administration (NMPA) in December 2019, making early access possible for Chinese patients suffering from schizophrenia.

Ending Technology Monopoly, Improving Treatment Safety

The research and development of new high-end formulations is regarded by many industry experts as a key strategy for the innovative development of China's pharmaceutical industry, given the clinical advantages and pharmacoeconomic value of high-end formulations as well as the direction of the national strategy for the safe use of medicine.

Firstly, high-end complex formulations such as liposomes and microspheres have more clinical advantages, such as better efficacy and safety, and can address unmet clinical needs. Secondly, injectable microspheres are a complex formulation with high technical barriers; they are difficult to develop and manufacture. The technology lies mostly in the hands of a few foreign companies.

The successful development of Rykindo® by Luye Pharma is the result of the company's efforts to break through technical barriers to build a world-leading new formulation technology platform, as well as its forward-looking strategic planning in this field. Rykindo®'s success once again demonstrates Luye Pharma's outstanding capabilities and superior experience in terms of R&D strategy, mechanisms for innovation, design and development of process equipment and processes, commercial production, quality management of clinical trials and global patent protections. The milestone achievement of the approval of Rykindo® is of great significance to overcoming technology monopolies and improving treatment safety for Chinese patients.

The Guide on the Development Plan for the Medical Product Industry jointly issued in 2016 by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Commerce, the National Health and Family Planning Commission, and the former State Food and Drug Administration sets a clear focus on the development of new injectable drug delivery systems such as microspheres, and on the development of high-end industrialized formulation technology.

Innovative DNA, Going Global

The approval of Rykindo® is seen as a major milestone in the industry and indicates the successful industrialization of Luye Pharma's innovative R&D platform for microsphere formulation after many years of dedicated efforts, giving Luye Pharma a global edge in this field. This is not only a key step in the company's globalization strategy, but also a major step forward for China in innovative microsphere technology on the global stage, drawing extensive attention from all sides.

The decision for global registration of Rykindo® was determined in 2011. The IND filing with the U.S. Food and Drug Administration (FDA) then started at the end of 2012 and the IND application was approved at the beginning of 2013. The NDA filing was submitted in 2015 and the construction of manufacturing workshops was completed in 2018. In 2019, the production site passed Pre-Approval Inspections by the U.S. FDA with zero observations. Following an arduous ten-year journey, the NMPA approval for Rykindo® has finally arrived. Luye Pharma's ten years of effort reflects the spirit of "independent innovation and R&D", which is rooted in the DNA of Luye Pharma, as well as the perseverance and dedication of all the R&D staff at Luye Pharma.

To bring benefits to global patients in the shortest possible time, registration of Rykindo® is being conducted simultaneously in various global markets, with the process entering the new drug application stage in the U.S. and pivotal clinical trials being carried out in Europe. Patent applications for Rykindo® in China, the U.S., Europe, Japan, South Korea, Russia, Canada, and Australia have been granted, with the protection period lasting until 2032.

Focusing on Patient Needs, Embracing a Bright Future for Products

Schizophrenia is a chronic and severe mental disorder affecting more than 20 million people worldwide. The disease is associated with considerable disability, and patients are two to three times more likely than the general population to suffer premature death . Schizophrenia is also a major mental disease in China, with an estimated minimum 10 million patients in the country . A high rate of recurrence resulting from low patient compliance is a major obstacle to effective treatment.

Due to a great number of unmet patient needs, the total market for schizophrenia treatment in China is worth over RMB 6 billion , rising in recent years with a compound annual growth rate significantly higher than the market average. Globally, the market share for long-acting injectables is also increasing year by year.

In addition to the newly approved Rykindo®, Luye Pharma has more than eight innovative pipeline products in various stages of development, all under the innovative microsphere technology platform and targeting major therapeutic areas, such as oncology and central nervous system, to better meet patient needs. Products include Rotigotine Microspheres for Injection (LY03003) for Parkinson's disease, Goserelin Acetate Extended-Release Microspheres for Injection (LY01005) for prostate cancer, breast cancer and other sex hormone dependent diseases, and LY03009 for Parkinson's disease and restless legs syndrome. These microsphere formulations will help simplify treatment regimens for physicians, improve patient compliance and satisfy unmet clinical needs with clinically advantageous dosing cycles ranging from one week to three months. They also offer better efficacy and safety profiles. Once launched, these new drugs will form a rich product portfolio with the company's commercialized products, as well as synergizing with existing resources and advantages to accelerate the company's global strategy for the core therapeutic areas.

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