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China-based Luye Pharma Group (HKG: 2186) announced its 2024 financial performance, recording RMB 6.061 billion (USD 836 million) in revenues, a 1.3% year-on-year (YOY) decline. This decrease was primarily due to reduced income from non-product sales, such as research and development (R&D) services. However, product sales showed resilience, growing 1.1%…
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd (HKG: 6955) released its 2024 financial report, showing revenues growing 17.5% year-on-year (YOY) to RMB726.3 million (USD100 million). This growth was primarily driven by BA1101, a biosimilar of Roche’s Avastin (bevacizumab), and BA6101, a version of Amgen’s…
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd (HKG: 6955) has announced receiving orphan drug designation (ODD) from the US FDA for its novel antibody drug conjugate (ADC) BA1302. The designation covers two indications: squamous non-small cell lung cancer and pancreatic cancer. Innovative ADC DevelopmentBA1302,…
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China-based Luye Pharma Group (HKG: 2186) has announced the initiation of commercialization of its in-house developed Erzofri (paliperidone palmitate extended-release injectable suspension) in the United States, with the first batch of products already shipped. This marks a significant milestone in the company’s global expansion strategy. Erzofri: Long-Acting Injection for SchizophreniaErzofri…
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Zepzelca (lurbinectedin) with priority review status. This approval allows the use of Zepzelca to treat adult patients with metastatic small cell lung cancer (SCLC) who are…
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955), has announced a licensing agreement with an unnamed Brazilian partner. The agreement grants the Brazilian company the rights to commercialize Boan Bio’s BA6101 and BA1102 in the local market as their Marketing Authorization Holder (MAH).…
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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, 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 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 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 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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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 (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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I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company, has announced significant changes to its leadership structure. Wei Fu, currently the CEO of venture capital fund CBC Group and I-Mab’s founding shareholder, has been appointed as the chairman of the board. Fu succeeds Dr. Pamela M. Klein, who is stepping down from…
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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 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 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 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 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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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…