The board of directors of Luye Pharma Group Ltd. announced the first batch of RYKINDO (risperidone) for extended-release injectable suspension for export to the United States has been successfully shipped, which means that the product has officially entered the commercialization stage in the U.S. market. The Group developed RYKINDO® on its proprietary microsphere technology platform. In January 2023, RYKINDO ® has received marketing approval from the U.S. Food and Drug Administration (the ``FDA'') as a treatment for schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

The drug is administered bi-weekly by intramuscular injection and delivers the active ingredient, risperidone, via long-acting and extended-release microsphere technology. The most common adverse reactions in patients with schizophrenia (5%) were headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremity, and dry mouth. The most common adverse reactions in patients with bipolar disorder were (5% in monotherapy trial) weight increased and (10% in adjunctive therapy trial) tremor and parkinsonism.

Schizophrenia and bipolar disorder are both severe mental disorders, and according to recent figures, affecting an estimated 24 million and 40 million people worldwide, respectively. In the U.S., the estimated prevalence of schizophrenia and related psychotic disorders ranges between 0.25% and 0.64%, while an estimated 4.4% of U.S. adults experience bipolar disorder at some point in their lives. The two diseases both have high relapse rates, with poor treatment adherence known to be one of the key associated risk factors.

Data from the IQVIA has shown that long-acting antipsychotics generated sales of approximately USD 7.5 billion in the global market and USD 5.0 billion in the U.S. market in 2022. The Group will continue to promote the commercialization of RYKINDO® in the U.S. market, so that the product can serve the unmet clinical needs of adult patients with schizophrenia and bipolar 1 disorder as soon as possible.