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Luye Pharma’s Subsidiary Boan Biotech Partners with Haier Biomedical for Pharmaceutical Industry Digitalization
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced a strategic partnership between its controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955), and Haier Biomedical. The collaboration will focus on the integration of digitalization, automation, and artificial intelligence (AI) to enhance the digital and…
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Luye Pharma Group’s 2024H1 Revenue and Net Profits Surge, Driven by Oncology and CNS Therapy Revenues
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Luye Pharma Group, a China-based pharmaceutical company listed in Hong Kong (HKG: 2186), has reported its financial results for the first half of 2024. The company recorded revenues of RMB 3.0746 billion, marking a 6% increase year-on-year (YOY), and a significant surge in net profits, which rose by 201% YOY…
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Luye Pharma’s Subsidiary Boan Bio Reports 2024H1 Revenue Growth and First Full Year of Profitability
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Luye Pharma Group, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2186), has announced its 2024H1 financial report through its controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955). The report reveals a significant year-on-year (YOY) increase in total revenues, which stood at RMB 363 million, a rise of…
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Luye Pharma’s LY03020 Receives NMPA Approval for Schizophrenia and Alzheimer’s Psychosis Treatment
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate LY03020, intended for the treatment of schizophrenia and Alzheimer’s disease psychosis (ADP). LY03020 is developed using Luye’s innovative New Molecular…
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Luye Pharma’s Antipsychotic Erzofri Gains FDA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has achieved a significant milestone with the US Food and Drug Administration’s (FDA) marketing approval of its in-house developed antipsychotic medication, Erzofri (paliperidone palmitate extended-release injectable suspension). The approval grants Erzofri the clearance for treatment of schizophrenia and…
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Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
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Luye Pharma Group Secures RMB 1.6 Billion Investment to Boost Financials and R&D
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has successfully secured RMB 1.6 billion in funding from the Shenzhen Luye Private Equity Investment Fund. This fund is primarily controlled by the Shenzhen Municipal People’s Government State-owned Assets Supervision and Administration Commission. The…
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Luye Pharma’s Oxycodone/Naloxone Product Receives NMPA Approval for Severe Pain Management
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Luye Pharma Group (HKG: 2186), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its oxycodone, naloxone product, LY 021702. The drug is indicated for use in adults requiring opioid analgesics to manage severe pain, including both…
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Luye Pharma’s Manufacturing Facility Passes FDA Inspection for Paliperidone Palmitate Product
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that it has successfully passed the Pre-Approval Inspections (PAI) by the U.S. Food and Drug Administration (FDA) for its manufacturing facility producing paliperidone palmitate extended-release injectable suspension (LY03010). The inspection was completed without any Form 483 Inspectional Observations, indicating…
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Luye Pharma’s Once-Weekly Parkinson’s Disease Treatment Receives NMPA Approval
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Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration for its once-weekly rotigotine extended-release microspheres for injection (LY03003), indicated for the treatment of Parkinson’s disease (PD). Parkinson’s disease is a prevalent neurodegenerative condition among middle-aged and elderly individuals, characterized by…
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Luye Pharma’s Paliperidone Palmitate Injection Wins NMPA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its paliperidone palmitate injection. This second-generation antipsychotic long-acting injection is now approved for the treatment of schizophrenia during both the acute and…
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Luye Pharma Submits Market Approval Application for Rivastigmine Patch in Japan
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced a market approval filing with the Japanese regulatory authorities for its rivastigmine twice-weekly transdermal patch, LY03013. The company is seeking marketing authorization for the drug to treat symptoms of mild-to-moderate Alzheimer’s disease (AD). Developed on Luye’s…
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Luye Pharma’s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group (HKG: 2186), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen’s Xgeva (denosumab). BA1102 is now approved for use in treating giant…
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Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
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Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous…
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Luye Pharma Group Posts 2.7% YOY Revenue Growth in 2023 with Strong Market Performance
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced its financial performance for 2023, along with recent business updates. The group reported a total revenue of RMB 6.143 billion (USD 850 million), marking a 2.7% year-on-year (YOY) growth. Their oncology, cardiovascular, central nervous system (CNS),…
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Luye Pharma Launches Small-Cell Lung Cancer Treatment Zepzelca in Hong Kong and Macau
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the official market launch of Zepzelca (lurbinectedin), a novel drug for the treatment of small-cell lung cancer (SCLC), in Hong Kong and Macau. Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (MCE: PHM), is a selective inhibitor of…
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Luye Pharma Initiates Phase III Clinical Trial for Irinotecan Liposome Injection in Small-Cell Lung Cancer
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its irinotecan liposome injection, LY01610. The Phase III study, which is multi-center, randomized, open-label, and parallel-designed, aims to evaluate the efficacy and safety of LY01610 in…
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Luye Pharma Grants Myung In Pharm Rights to Rivastigmine Patch for Alzheimer’s Treatment in South Korea
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced a licensing agreement with South Korean firm Myung In Pharm. Under the agreement, Myung In Pharm has been granted commercialization rights to Luye’s rivastigmine twice-weekly transdermal patch (LY03013) in South Korea. The drug is indicated for the treatment of…
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Luye Pharma’s Paliperidone Palmitate NDA Avoids Patent Lawsuit, Clears Path for FDA Approval
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) submitted to the US FDA via the 505(b)(2) route for its paliperidone palmitate extended-release injectable suspension (LY03010) has not faced a patent infringement lawsuit in the US. This follows the FDA’s acceptance of…
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Luye Pharma’s Biosimilar Bevacizumab Gets GMP Certification in Brazil
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its biosimilar version of Roche’s blockbuster drug Avastin (bevacizumab). This certification marks a significant step forward in Luye’s efforts…
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Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy. The approval is…
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AstraZeneca Expands China Presence with Over 30 Agreements at CIIE
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At the 6th China International Import Expo (CIIE) in Shanghai, UK-based pharmaceutical giant AstraZeneca plc (AZ; NASDAQ: AZN) has signed over 30 agreements with Chinese provincial governments and other entities, marking a significant expansion in China. The agreements include substantial investments and collaborations aimed at enhancing local production, improving access…
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Luye Pharma Group’s Rivastigmine Patch LY03013 Approved by China’s NMPA for Alzheimer’s Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rivastigmine twice-weekly transdermal patch (LY03013), a treatment for symptoms of mild and moderate Alzheimer’s disease (AD). Product Development and AdvantagesLY03013, a modified version of rivastigmine, was developed…
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Luye Pharma Files NDA for Paliperidone Palmitate Injectable Suspension with US FDA
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China-based Luye Pharma Group (HKG: 2186) has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product, paliperidone palmitate extended-release injectable suspension (LY03010), via the 505(b)(2) regulatory pathway. The drug is under consideration for approval as a treatment for schizophrenia…
