Luye Pharma Group Ltd.

36 articles about Luye Pharma Group Ltd.

• FDA Approves Luye Pharma's Rykindo® for the Treatment of Schizophrenia and Bipolar 1 Disorder

  1/15/2023

  Luye Pharma Group announced that the U.S. Food and Drug Administration has approved Rykindo® 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.

• Luye Pharma Releases Top-Line Results from a Phase II Clinical Trial of Its New Antidepressant Ansofaxine Hydrochloride Extended-Release Tablets

  12/23/2021

  Luye Pharma Group released the encouraging top-line results from a Phase II clinical trial of its new antidepressant, Ansofaxine Hydrochloride Extended-Release Tablets, at the 19th National Psychiatry Conference of the Chinese Medical Association.

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  China Puts Renewed Focus on Monoclonal Antibodies in COVID-19 Fight

  12/9/2021

  Researchers in China are busy developing several treatments, combining vaccines and drugs for COVID-19, and also working on monoclonal antibodies treatment.

• Boan Biotech to Present the Pre-clinical Data of Its Proprietary CD3+ T-cell Engager Platform and CEA/CD3 Bispecific Antibody at World Bispecific Summit

  9/26/2021

  Boan Biotech, a subsidiary of Luye Pharma Group, will orally present the pre-clinical data of its proprietary CD3+ T-cell engager platform and CEA/CD3 bispecific antibody at World Bispecific Summit 2021.

• Italfarmaco Group Enters Into an Agreement with Luye Pharma to Commercialize Alzheimer’s Disease Treatment Rivastigmine Multi-Day Transdermal Patch in Four European Countries

  3/16/2021

  Italfarmaco Group adds innovative Alzheimer’s disease therapy to its neurology-based product portfolio

• Luye Pharma Group Selects LifeSphere® Signal and Risk Management to Automate Drug Safety Signal Detection

  4/23/2020

  ArisGlobal, the leading provider of life sciences software that automates core drug development functions for over 250 life sciences companies, announced Luye Pharma Group, an international pharmaceutical company dedicated to the R&D, manufacturing, and sale of innovative medications has selected LifeSphere® Signal and Risk Management as its next-generation signal detection tool.

• Luye Pharma Continues to Deliver Strong Growth in 2019

  3/27/2020

  Luye Pharma Group (02186.HK) reported its financial results for 2019 on March 27, 2020 . According to the results, the company has achieved a total revenue of RMB 6.358 billion , up 22.9% year-on-year. EBITDA was RMB 2.488 billion , up 26.9% year-on-year; and normalized profit attributed to shareholders was RMB 1.592 billion , up 19.4

• NDA Filing for Luye Pharma's Antidepressant Drug LY03005 Accepted by the U.S. FDA

  3/4/2020

  Luye Pharma Group has announced that the U.S. Food and Drug Administration (FDA) has reviewed and accepted the filing of a New Drug Application (NDA) for LY03005, a new chemical drug for the treatment of major depressive disorder. LY03005 is the company's second drug in the central nervous system (CNS) therapeutic area currently in the U.S.

• Luye Pharma Grants Cipla Medpro Exclusive Distribution and Marketing Rights for Seroquel® and Seroquel XR® in South Africa and Certain Neighbouring Countries

  2/11/2020

  Luye Pharma Group has announced that it has entered into an exclusive distribution and marketing service agreement with Cipla Medpro South Africa Limited, for Seroquel® and Seroquel XR® in South Africa, Namibia and Botswana.

• The First Asia Pacific Psychiatry Symposium Takes Place

  9/3/2019

  Developments in the Frontiers of Diagnosis and Treatment for Bipolar Disorder and Schizophrenia Receive Extensive Attention

• Luye Pharma First Half of 2019 Results: Strong Revenue Growth and Substantial Development of R&D Product Pipelines

  8/29/2019

  Luye Pharma Group released its financial results for the first half of 2019 on August 28.

• Luye Pharma's Rykindo® NDA Filing Accepted by the U.S. FDA

  5/30/2019

  Rykindo®, Luye Pharma's innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market.

• Luye Pharma's Rykindo® Expected to Be the First Chinese Innovative Drug to Receive U.S. FDA Approval

  3/29/2019

  Luye Pharma Group has announced submission of a new drug application to the U.S. Food and Drug Administration for Rykindo®, completed on March 28.

• Luye Pharma Reaches Strategic Partnership with AstraZeneca, Strengthens Commitment to Cardiovascular Therapeutic Field

  1/16/2019

  Luye Pharma grants AstraZeneca exclusives rights to promote Xuezhikang Capsules in mainland China

• Luye Pharma Announces Innovative Drug - Risperidone Extended Release Microspheres for Injection has Reached Final Stage of NDA Process

  12/31/2018

  Luye Pharma Group today announced that it has entered the final stage of New Drug Application (NDA) submissions for the innovative drug, Risperidone Extended Release Microspheres for Injection ('LY03004), after previous positive pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and subsequent related procedures.

• Luye Pharma's Goserelin Acetate Extended-release Microspheres Start Phase III Clinical Trials in China, Paralleling Smooth Progress with U.S. Regulators

  9/7/2018

  Luye Pharma announced that its independently developed drug, Goserelin Acetate Extended-release Microspheres for Injection (LY01005), has entered phase III clinical trials for prostate cancer in China.

• 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

  8/29/2018

  Luye Pharma Group 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.

• Luye Pharma Well Positioned for CNS Market with the Approval of A New Indication for Seroquel XR in China

  7/22/2018

  Luye Pharma Group has announced that its Central Nervous System (CNS) drug, Seroquel XR (Quetiapine Fumarate XR), has received approval from the official Chinese medical authorities for a new indication in the treatment of depression arising from bipolar disorder.

• Luye Pharma Bolsters Its Global Analgesics Portfolio with China Class 1.1 New Compound LY03012 to Start Phase I Clinical Trials

  6/19/2018

  Luye Pharma Group announced that clinical applications of the company's new compound candidate have been formally accepted by the China Food and Drug Administration.

• Seroquel Stepping Stone: How Luye Will Use Seroquel to Expand in Emerging Markets

  6/7/2018

  The $538 million acquisition by Luye Pharma Group Ltd. (HKSE:2186) of Seroquel quetiapine fumarate from AstraZeneca plc (LSE:AZN; NYSE:AZN) will lay the commercial groundwork in new emerging markets for the Chinese pharma's internal CNS pipeline.