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Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sjögren’s Disease
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US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sjögren’s disease (SjD). This designation follows the monoclonal antibody’s Breakthrough Therapy Designation (BTD) received from the agency late last year. Mechanism…
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Medbanks Reports 2024 Financial Results Amid Business Reorganization
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Sipai Health Technology Co., Ltd (HKG: 0314), known as Medbanks, released its 2024 financial report. The Chinese online health platform, which debuted in Hong Kong last December, reported annual revenues of RMB4.565 billion (USD631 million), a 3.1% year-on-year decrease. The operating loss narrowed by 12.2% to RMB238 million (USD33 million)…
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AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for its PD-L1 inhibitor Imfinzi (durvalumab) as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Clinical Need and Approval SignificanceSCLC is a highly…
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HutchMed and Innovent Announce Positive Results for Fruquintinib and Sintilimab in Renal Cell Carcinoma Trial
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Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) jointly announced positive results from the Phase II/III FRUSICA-2 study. The trial evaluated the combination of fruquintinib and sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with…
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Celregen Therapeutics Secures RMB100 Million for iPSC Regenerative Medicine Platform
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Hangzhou-based Celregen Therapeutics, a specialist in cell stem regenerative medicine incubated by Fosun Health Capital, announced the completion of an angel+ financing round, raising close to RMB100 million (USD13.8 million). The funding was led by Fosun Health Capital and SciNova Investment, with proceeds allocated to constructing the company’s iPSC regenerative…
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GE Healthcare Launches AltiX AI.i Edition for Enhanced Cardiac Procedures
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) announced the introduction of the AltiX AI.i edition of Mac-Lab, CardioLab, and ComboLab. These advanced systems are designed to enhance the management of various cardiac procedures through integrated solutions and artificial intelligence. Product Integration and InnovationComboLab combines…
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WuXi AppTec Reports Steady Revenue Growth Amid Diversified Business Expansion
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China-based Contract Research Organization (CRO) WuXi AppTec (SHA: 603259, HKG: 2359) released its 2024 financial results. The company reported an annual operating revenue of RMB 39.24 billion (USD 5.42 billion), marking a 5.2% year-on-year increase when excluding COVID-19 commercialized programs. Revenues for the fourth quarter reached RMB 11.54 billion (USD…
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Eisai Launches JPY16 Billion Tender for EcoNaviSta to Expand Dementia Care Ecosystem
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Japan-based Eisai Co., Ltd (TYO: 4523) announced a tender offer valued at JPY16 billion (USD107 million) for all shares of EcoNaviSta Inc. (TYO: 5585), a firm specializing in dementia care solutions. This move follows a partnership forged between the two companies last July to develop an ecosystem for dementia care.…
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Bayer’s Kerendia Gets FDA Priority Review for Heart Failure with Preserved Ejection Fraction
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German pharmaceutical giant Bayer (ETR: BAYN) announced that a supplementary New Drug Application (sNDA) for its Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The targeted indication is adult patients with heart failure (HF)…
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HMZS Biopharmaceutical Blacklisted After Failing to Monitor Production Process
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HMZS Biopharmaceutical, a Chinese company that won a bid for its phloroglucinol in the 10th volume-based procurement (VBP) tender round, has been blacklisted by the National Drug Alliance Procurement Office. The company’s entrusted manufacturer, Taiji Group Sichuan Taiji Pharmaceutical Co. Ltd., was also blacklisted following the incident. Reason for BlacklistingThe…
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IceCure Medical Secures Chinese Patent for Cryogenic System Connector
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Israel-based IceCure Medical Ltd. (NASDAQ: ICCM) announced receiving patent authorization from the China National Intellectual Property Administration for its invention titled “Cryogenic System Connector.” This patent underscores the company’s commitment to advancing its minimally-invasive cryoablation technology. Cryoablation Technology InnovationIceCure’s technology focuses on destroying tumors through freezing, offering a less invasive…
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FibroGen Reports Decline in Sales, Pushes Ahead with Roxadustat and New Drug Development
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US-based biotech FibroGen Inc. (NASDAQ: FGEN) released its Q4 and full-year 2024 financial results, showing a significant decline in global sales. The company reported sales of USD3.14 million in Q4 and USD29.62 million for the entire year, marking a year-on-year decrease of 13.5% and 36.7%, respectively. Net losses from continuing…
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Taiho Pharmaceutical to Acquire Araris Biotech for USD 400 Million, Expanding ADC Portfolio
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Japan-based Taiho Pharmaceutical Co., Ltd. announced plans to fully acquire Araris Biotech AG, a Swiss biotech company specializing in antibody drug conjugates (ADCs). The acquisition, valued at USD 400 million with potential additional milestone payments of up to USD 740 million, is expected to close during the first half of…
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Livzon Pharmaceutical Receives Approval for Clinical Trials of Adjuvanted Influenza Vaccine LZSN2401
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) announced receiving clinical trial approval for its investigational adjuvanted quadrivalent influenza vaccine LZSN2401 in China. This marks a significant step forward in the development of more effective influenza prevention solutions. Vaccine InnovationLZSN2401 is positioned as the world’s first adjuvanted quadrivalent influenza vaccine to…
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Lifetech Scientific’s Aortic Stent System Approved by China’s NMPA
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China-based Lifetech Scientific Corporation (HKG: 1302) announced receiving market approval from the National Medical Products Administration (NMPA) for its aortic branch reconstruction covered stent system (chimney), co-developed with Fuwai Hospital. This innovative product offers a novel treatment option for patients with arch lesions. Product InnovationThe aortic branch covered stent system…
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PomDoctor Files for Nasdaq IPO to Expand Chronic Disease Management Services
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Guangzhou-based PomDoctor Limited, a leading online medical services platform for chronic disease management, has filed for an initial public offering (IPO) with the US Securities and Exchange Commission (SEC). The company aims to list on the Nasdaq under the ticker symbol POM, marking a significant step in its growth strategy.…
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Rona Therapeutics Initiates Phase II Study for RN0361 in Severe Hypertriglyceridemia
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Shanghai-based Rona Therapeutics Inc. announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its RN0361, an APOC3-targeted siRNA therapeutic. The study will assess the drug’s efficacy and safety in patients with severe hypertriglyceridemia (SHTG), mixed dyslipidemia, and familial chylomicronemia syndrome…
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Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-6213 in Solid Tumor Diagnosis
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its HRS-6213. This novel agent is designed for PET imaging to diagnose and evaluate solid tumors, marking a significant step forward in oncology diagnostics. Mechanism and ApplicationHRS-6213…
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Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its JSKN033, a HER2-targeted antibody drug conjugate (ADC) for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. Drug…
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AstraZeneca to Acquire EsoBiotec for Up to $1 Billion to Boost Cell Therapy Portfolio
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On March 17, 2025, EsoBiotec SA announced a definitive acquisition agreement with AstraZeneca (NASDAQ: AZN). Under the terms of the agreement, AstraZeneca will acquire all outstanding shares of EsoBiotec in a cash and debt-free transaction valued at up to $1 billion. This includes an initial payment of $425 million at…
