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Telix Pharmaceuticals Gains Brazilian Approval for Prostate Cancer Diagnostic Agent TLX591-CDx
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) announced receiving clearance from the Brazilian Health Regulatory Agency for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer. This approval allows the drug to be used in positron emission tomography (PET) for detecting prostate-specific membrane…
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Distinct Healthcare Files for Hong Kong IPO to Expand Integrated Medical Services
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Shenzhen-based Distinct Healthcare Holdings Limited, a comprehensive medical service provider with integrated online and offline offerings, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. This move marks a significant step in the company’s growth strategy and capital market expansion. Company OverviewSince its inception in…
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Pfizer Restructures China Operations to Boost Growth and Innovation
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US-based pharmaceutical giant Pfizer Inc. (NYSE: PFE) announced a significant leadership and organizational restructuring in China, effective March 18, 2025. The move aims to enhance the company’s growth and innovation capabilities in the Chinese market. Organizational ChangesThe restructuring involves merging the retail business team and national bidding team with the…
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CDE’s 2024 Annual Drug Review Report Shows Continued Growth in Regulatory Filings
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The Center for Drug Evaluation (CDE) released its 2024 annual drug review report, highlighting continued growth in drug regulatory filings. The CDE accepted a total of 19,563 filings of various types, marking a 5.73% year-on-year increase. Filings BreakdownThe filings included 17,476 for drug preparations, up 3.42% YOY, and 2,087 for…
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Everest Medicines Initiates Jiashan Plant for Etrasimod Tablet Production
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China-based Everest Medicines (HKG: 1952) announced the start of construction for a manufacturing plant in Jiashan, Zhejiang province, dedicated to producing its S1P receptor modulator etrasimod (formerly known as velsipity). The project, valued at RMB70 million (USD9.7 million), is expected to produce up to 50 million tablets of etrasimod upon…
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GE Healthcare and NVIDIA Expand Partnership to Advance Autonomous X-ray and Ultrasound Technologies
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) announced an expanded partnership with US-based chip giant NVIDIA (NASDAQ: NVDA) focused on the innovative application of autonomous X-ray technologies and ultrasound. This collaboration aims to transform medical imaging through artificial intelligence. Partnership DetailsThe expanded partnership will…
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Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its insulin degludec and liraglutide combination drug, administering the first dose to a patient in China. This marks a significant step forward in the development of this biosimilar version of Novo Nordisk’s Xultophy. Drug Profile and…
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Formosa Pharmaceuticals Inks Licensing Pact with Cipla for APP13007 in 11 Countries
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) announced a licensing agreement with India-headquartered Cipla Limited (BOM: 500087, NSE: CIPLA). Formosa is granting Cipla commercialization rights for its APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in 11 countries, including India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia. Deal…
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AccurEdit Therapeutics Receives FDA Orphan Drug Designation for ATTR Treatment
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China-based AccurEdit Therapeutics (Suzhou) Co., Ltd announced receiving Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug ART001, targeting transthyretin amyloidosis (ATTR). This marks a significant milestone in the development of this innovative gene-editing therapy. Drug Profile and MechanismART001 is the first non-viral…
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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…
