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Simcere Pharmaceutical Group Reports Steady Revenue Amid R&D Investment Shift
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China-based Simcere Pharmaceutical Group (HKG: 2096) has released its 2024 financial performance report, recording RMB 6.6 billion (USD 914 million) in revenues over the 12 months, marking a 0.4% year-on-year (YOY) increase. The profit attributable to equity shareholders rose by 2.6% YOY to RMB 733 million (USD 101 million). Notably,…
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Simcere Pharmaceutical’s ADC189 NDA Accepted for Influenza Treatment
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Simcere Pharmaceutical Group Limited (HKG: 2096) and AnDiConBio announced that the New Drug Application (NDA) for ADC189, their co-developed anti-influenza drug, has been accepted for review by China’s National Medical Products Administration (NMPA). The drug is intended for treating uncomplicated influenza A and B in adults and adolescents. Mechanism and…
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Simcere Licenses Fermion’s AI-Enabled Painkiller FZ002-037
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China-based Simcere Pharmaceutical Group Limited (HKG: 2096) has announced a licensing agreement with compatriot firm Fermion, an artificial intelligence (AI) empowered small-molecule drug developer, relating to an investigational SSTR4-targeted painkiller candidate drug, FZ002-037. This strategic partnership aims to advance the development and commercialization of FZ002-037 in Greater China, including mainland…
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Simcere Zaiming and AbbVie Ink $1.055B License Deal for MM Drug SIM0500
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China-based Simcere Pharmaceutical Group Ltd (HKG: 2096) has announced a significant strategic move through its oncology subsidiary, Simcere Zaiming. The company has entered into a license option agreement with global pharmaceutical giant AbbVie Inc. (NYSE: ABBV) for the development of its promising drug candidate, SIM0500. Deal Structure and FinancialsUnder the…
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Simcere Zaiming’s SIM0505 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SIM0505, which targets CDH6 in advanced solid tumors. Last month, the drug also received clearance for clinical trials…
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Simcere Pharmaceutical’s SIM0508 Reaches First Patient Dosing in Global Clinical Study
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the first patient dosing in a global clinical study for its Pol θ inhibitor, SIM0508, which targets advanced solid tumors. Global Phase I Study Design and ApprovalThe global multi-center, open-label Phase I study is designed to assess the…
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Simcere Zaiming Launches Phase III Trial for SERD Inhibitor SIM0270 in Breast Cancer
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Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the initiation of a Phase III study for SIM0270 (SCR-6852), an oral brain-penetrating selective estrogen receptor down-regulator (SERD) inhibitor. The study includes the first patient dosing and is designed to assess the anti-tumor effect and safety of SIM0270 in…
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Simcere Pharmaceutical’s Edaravone and Borneol Sublingual Tablets Approved for AIS Treatment in China
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China-based Simcere Pharmaceutical Group Limited (HKG: 2096) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its edaravone and borneol sublingual tablets. These tablets are designed to improve neurological symptoms, daily living activities, and functional impairments caused by acute ischemic stroke (AIS). Rapid Dissolution and Absorption…
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3D Medicines’ Envafolimab Earns NMPA Breakthrough Designation for TMB-H Solid Tumors
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3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for an additional indication. The PD-L1 monoclonal antibody (mAb) is now indicated for the treatment of unresectable or metastatic solid tumors…
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Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
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HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its edaravone, borneol sublingual tablet, intended for the treatment of acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral…
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Jiangsu Simcere Acquires Exclusive Rights to TargetRx’s TGRX-326 in Licensing Deal
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SHENZHEN—Shenzhen TargetRx, Inc., a leading developer of small-molecule kinase inhibitors, has entered into a licensing agreement with Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a fellow Chinese pharmaceutical company. The deal concerns TargetRx’s TGRX-326, an ALK/ROS1 dual receptor tyrosine kinase inhibitor currently at the clinical stage. According to the agreement,…
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Jiangsu Simcere and AnDiConBio’s Anti-Influenza Drug ADC189 Doses First Patient in Phase III Study
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JIANGSU—In a significant development for the pharmaceutical industry, Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in collaboration with AnDiConBio, has initiated a Phase III clinical study for their anti-influenza drug, ADC189. This study marks a crucial step in the advancement of pediatric treatment options, with the first patient dosed in…
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Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
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Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
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R&D Investments and Operating Cash Flows Highlight Resilience in Simcere Pharma’s H1 2024 Financial Report
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has reported its financial results for the first half of 2024, with revenues amounting to RMB 3.114 billion, marking a 7.9% year-on-year (YOY) decline. The innovative drug business contributed RMB 2.203 billion, representing approximately 70.7% of total revenues and reflecting an 8.7% YOY…
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Jiangsu Simcere Pharmaceutical’s Quviviq Approval Application Accepted for Review by China’s NMPA
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals Ltd, has achieved a significant milestone with the acceptance of their marketing approval filing for Quviviq (daridorexant) by China’s National Medical Products Administration (NMPA). Quviviq is an innovative anti-insomnia drug that has already gained commercial…
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Simcere Pharmaceutical’s COVID-19 Therapy Xiannuoxin Earns Full Approval in China
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that its small-molecule COVID-19 therapy, Xiannuoxin (simnotrelvir, ritonavir), has received regular approval from the Chinese regulatory authorities, converting from its previous conditional approval status. This makes Xiannuoxin the first COVID-19 therapy of its kind to achieve full…
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Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
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AnDiConBio Secures Over RMB 200 Million in Series A Financing to Advance Respiratory and Pain Therapies
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AnDiConBio, a Zhejiang-based innovative pharmaceutical company specializing in respiratory infections and pain management, has reportedly secured over RMB 200 million in a Series A financing round. The round was led by Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), Huajin Investment, and Huajin Dadao Investment, with participation from Cowin Capital, Wenzhou…
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Simcere Pharma’s Suvemcitug Shows Positive Results in Platinum-Resistant Ovarian Cancer Study
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has presented updated data from the SCORES study for its drug candidate suvemcitug at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Suvemcitug, also known as sevacizumab; APX-003; BD-0801, is being studied in platinum-resistant ovarian cancer. The…
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Simcere Pharma’s Anti-Insomnia Drug Daridorexant Meets Primary Endpoint in Phase III Clinical Trial
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced topline results from a Phase III clinical study for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd, a Swiss pharmaceutical company. The study evaluated the efficacy and safety of daridorexant in Chinese patients with insomnia and successfully met its…
