Luye Pharma’s Rykindo Approved in the U.S. A “Zero” Breakthrough for China’s Central Nervous System New Drug to Go Overseas

Zhitong Finance APP news, Luye Pharma (02186) announced that Rykindo® (risperidone sustained-release microsphere injection preparation, also known as LY03004) has been approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia For the maintenance treatment of adult patients with bipolar I disorder, as a single agent or as an adjunctive therapy to lithium or valproate.

Rykindo® is independently developed based on the Group’s patented microsphere technology platform. The product is injected intramuscularly once every two weeks, and the active ingredient risperidone is delivered in a long-acting and sustained-release manner through the microsphere formulation to play a role. As far as the company is aware, Rykindo® is the first complex preparation product developed by a pharmaceutical company in mainland China to be approved by the FDA for marketing under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

In addition to the US market, Rykindo® will be approved for marketing in China in 2021. The company is also developing Rykindo® in Europe and plans to expand it to the global market.

Schizophrenia and bipolar disorder are serious mental disorders, affecting about 24 million and 40 million people, respectively, worldwide. In the United States, the prevalence of schizophrenia and related mental disorders is estimated to be 0.25%–0.64%, while approximately 4.4% of adults experience bipolar disorder in their lifetime. Both of these two psychiatric diseases have a high relapse rate, and poor medication compliance is one of the important risk factors leading to relapse in patients.

According to IQVIA data, the sales of long-acting injections of antipsychotic drugs in the world and the United States will reach approximately US$7.1 billion and approximately US$4.4 billion in 2021, respectively.

In addition to Rykindo®, the Group has also commercialized a number of central nervous system (CNS) therapeutic products, including Toludivenlafaxine Hydrochloride Sustained-release Tablets (Ruoxinlin®), Quetiapine Fumarate Tablets (Si Ruikang®) and quetiapine fumarate extended-release tablets, rivastigmine transdermal patch and rivastigmine transdermal patch (twice a week), fentanyl transdermal patch, buprenorphine Transdermal patches cover more than 80 countries and regions around the world, including large pharmaceutical markets including China, the United States, Europe and Japan, as well as fast-growing emerging markets. In addition, the Group is also developing a number of new drugs in the fields of CNS and tumors in the global market.

According to the announcement, Rykindo® meets the current urgent clinical needs and has good market potential. At the same time, this product will further enrich the Group’s product pipeline in the CNS field, and coordinate with the Group’s existing resources and advantages in the CNS field to accelerate the company’s layout and development in this field.

Source: Zhitong Finance Network