Rykindo (risperidone extended release microspheres) / Luye Group - LARVOL DELTA

Pharmacokinetics and Safety of a Novel Extended-Release Microsphere Formulation of Risperidone in Patients with Schizophrenia or Schizoaffective Disorder. (PubMed, J Clin Pharmacol) - "Risperidone extended-release injectable suspension (R-ERIS; marketed as RYKINDO) is a novel immediate-release version of risperidone formulated as extended-release microspheres for biweekly intramuscular injection to treat schizophrenia in adults...Eligible patients (N = 108) 18 to 65 years old were randomized (1:1) to receive IM injections of R-ERIS 25 mg or the comparator, a biweekly risperidone long-acting injectable (BW-RLAI; marketed as RISPERDAL CONSTA) 25 mg for a total of 5 injections...R-ERIS was safe and well tolerated. Overall, R-ERIS exhibited a faster onset and offset than BW-RLAI and statistical analysis of exposure parameters demonstrated bioequivalence at steady state."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Drugs for bipolar disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Population Pharmacokinetic Analysis to Support and Facilitate Switching from Risperidone Formulations to Rykindo in Patients with Schizophrenia. (PubMed, Neurol Ther) - P1 | "This established approach provides guidance to physicians to initiate Rykindo therapy in adult patients with schizophrenia."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

In brief: Three new injectable antipsychotic drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

FDA Approves Luye Pharma's Rykindo for the Treatment of Schizophrenia and Bipolar 1 Disorder (PRNewswire) - "Luye Pharma Group (Luye Pharma)...announced that the U.S. Food and Drug Administration (FDA) has approved Rykindo® (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults."

sNDA • Bipolar Disorder • CNS Disorders • Schizophrenia

A First for China! Rykindo Approved in China, Demonstrating Strength of Luye Pharma’s World-Leading Microspheres Technology Platform (Luye Press Release) - "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."

Non-US regulatory • CNS Disorders • Schizophrenia

Effects of CYP2D6, CYP3A5, and ABCB1 gene polymorphisms on the pharmacokinetics of two risperidone long-acting injection microsphere formulations. (PubMed, Prog Neuropsychopharmacol Biol Psychiatry) - "The pharmacokinetics of risperidone and the ratio of risperidone to 9-OH-R were highly dependent on CYP2D6 activity. However, there was no significant effect in 9-OH-R. A future study involving a larger sample is required to verify whether CYP2D6 IMs have lower risperidone active moiety clearance than CYP2D6 NMs for LAI formulations. In addition, the risperidone active moiety was eliminated faster in ABCB1-G2677T/A and C3435T TT carriers receiving Risperdal Consta®."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia • ABCB1 • CYP3A5 • PCR

LY03004: Launches in EU and Japan for schizophrenia in 2020 (Luye Pharma) - Corporate Presentation: Launches in EU and Japan for bipolar disorder in 2020

Launch Europe • Launch Japan • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Luye Pharma : Voluntary announcement - Luye Pharma received a Complete Response Letter from the U.S. FDA regarding its NDA for LY03004 (Market Screener) - "The board of directors (the 'Board') of Luye Pharma Group Ltd....announces that the Company received a complete response letter (the 'CRL') from the U.S. Food and Drug Administration (the 'FDA') regarding its New Drug Application ('NDA') for LY03004...for the treatment of schizophrenia and bipolar I disorder. The CRL requested additional information and the satisfactory resolution of inspection issues of the active pharmaceutical ingredient ('API') manufacturing facility before this application may be approved. The Company will work closely with its API partners and the FDA to address the issues raised in the letter and move forward the approval process of this NDA promptly."

FDA event

Luye Pharmaceutical (02186-HK): New drug application for schizophrenia is included in the priority review process [Google Translation] (Eastmoney.com) - "Luye Pharmaceutical (02186-HK) announced injectable risperidone release microspheres ( 'LY03004') of the New Drug Application by the Chinese State Drug Administration Bureau Center for Drug Evaluation inclusion in the priority review process....In November 2019, the group's long-acting preparation production base in Yantai, China successfully passed the FDA pre-market approval inspection at zero 483."

Non-US regulatory

Alkermes, Luye settle patent suit on rival schizophrenia drug (Bloomberg Law) - "Alkermes and J&J’s Janssen unit had claimed Luye Pharma’s proposed injectable version of the schizophrenia-treatment drug risperidone infringes a patent for Risperdal Consta, a long-acting injected medication."

Patent

NDA filling for Luye Pharma’s LY03004 accepted in China, U.S. NDA review progressing smoothly (Luye Pharma Press Release) - "Luye Pharma Group has announced that the New Drug Application (NDA) for Risperidone Extended-Release Microspheres for Injection (LY03004)...has been accepted by China Center for Drug Evaluation of National Medical Products Administration. Previously, the NDA for LY03004 had been accepted for filing in the U.S., and the manufacturing site of the drug had successfully passed the U.S. FDA Pre-Approval Inspection (PAI). LY03004 is soon expected to be available in the U.S. and Chinese markets."

NDA • Non-US regulatory

Luye Pharma's LY03004 manufacturing facility successfully passes U.S. FDA pre-approval inspection with zero observation (PRNewswire) - "LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market. The company has announced that it has received the Establishment Inspection Report from the U.S. Food and Drug Administration (FDA), indicating that the company's manufacturing facility located in Yantai, China, where LY03004 is manufactured, successfully passed the Pre-Approval Inspection (PAI), with no FDA-483 Inspectional Observation."

FDA event

Galaxy International: Green Leaf Pharmaceutical's target price of HK$8.34 maintains an overweight rating [Google Translation] (Sina Corp) - "LY03004 (risperidone for schizophrenia) is expected to be launched in the US in the first half of 2020 (NDA was submitted in March 2019 as 505(b)(2) and FDA accepted NDA application in May 2019) . LY03004 is expected to be launched in China by the end of 2020 (management is expected to submit an application to NDA in China in the second half of 2019)."

Launch non-US • Launch US • Non-US regulatory

Luye Pharma first half of 2019 results: Strong revenue growth and substantial development of R&D product pipelines (PRNewswire) - "The U.S. Food and Drug Administration (FDA) has accepted filing of LY03004's (Extended-Release Microspheres for Injection) new drug application (NDA). LY03004 for the treatment of schizophrenia and bi-polar disorder is the first innovative formulation from China to have an NDA accepted by the FDA...The company will file the NDA for LY03004 in China in the second half of this year."

Non-US regulatory

Luye Pharma's Rykindo NDA filing accepted by the U.S. FDA (PRNewswire) - "Rykindo® (LY03004)...is one step closer to going on the U.S. market. The US Food and Drug Administration (FDA) has completed the filing review and accepted the filing of Rykindo®'s new drug application (NDA)."

NDA

not applicable (clinicaltrialsregister.eu) - P3; N=250; Ongoing; Sponsor: Nanjing Luye Pharmaceutical Co., Ltd.

Clinical • New P3 trial

"Luye Pharma Group announced the submission of a NDA for Rykindo for Injectionto the @US_FDA for the treatment of #schizophrenia and #bipolardisorder. https://t.co/kgWq7GO2kn" (@PsychiatryAdv)

NDA

Luye Pharma's Rykindo expected to be the first Chinese innovative drug to receive U.S. FDA approval (PRNewswire) - "Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration ('FDA') for Rykindo®, completed on March 28. Rykindo® (LY03004) Risperidone Extended-release Microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States....According to Luye Pharma, Rykindo® is expected to be launched in the U.S. and China first, during the 2019 - 2020 period. Meanwhile, Rykindo®'s registration process in Europe and other emerging countries is progressing smoothly."

Launch non-US • Launch US • NDA