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AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
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Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the Phase III DESTINY-Gastric04 study for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody drug conjugate (ADC) has demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) in patients with second-line…
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Boehringer Ingelheim Appeals CNIPA’s Invalidation of Jardiance Patents
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The Intellectual Property Court of the Supreme People’s Court of China issued a notice, holding a hearing on the case of administrative dispute over the invalidity of invention patent between the appellant Boehringer Ingelheim and the appellee China National Intellectual Property Administration (CNIPA), as well as third parties of first…
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Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment
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Genentech, a subsidiary of Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), announced that its thrombolytic agent TNKase (tenecteplase) has been approved by the US Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS) in adults. Drug ProfileTNKase, a tissue plasminogen activator, is administered as a single…
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Eisai’s Lecanemab Rejected by Australia’s TGA for Early Alzheimer’s Treatment
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Japan-based Eisai Co., Ltd (TYO: 4523) announced that the Therapeutic Goods Administration (TGA) of Australia has refused to approve its lecanemab for the treatment of early Alzheimer’s disease (AD), specifically for mild cognitive impairment due to AD and mild AD dementia. Background and PartnershipsEisai entered into a licensing agreement with…
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Boston Scientific to Acquire SoniVie, Boosting Hypertension Treatment Portfolio
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Boston Scientific Corporation (NYSE: BSX) is set to acquire SoniVie Ltd, an Israel-based medical device company known for its TIVUS intravascular ultrasound system. The TIVUS system is designed to treat hypertensive disorders, including renal artery denervation (RDN) for hypertension, by denervating nerves surrounding blood vessels. The product is expected to…
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Fapon Biopharma’s FP008 Receives FDA Approval for Clinical Trials
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China-based Fapon Biopharma announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its FP008, an anti-PD-1 × IL-10M fusion protein designed to target solid tumors refractory to anti-PD-1 therapy. Drug ProfileFP008 is a first-in-class immunocytokine with a unique mechanism of action (MOA).…
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Kyorin Pharmaceutical Licenses KRP-M223 to Novartis for Global Development
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Japan-based Kyorin Pharmaceutical Co., Ltd. announced a licensing agreement with Novartis (NYSE: NVS), granting the Swiss pharmaceutical giant exclusive global development, manufacturing, and commercialization rights to its KRP-M223. Under the agreement, Kyorin retains an option to commercialize the drug in Japan and manufacture it for the Japanese market, while Novartis…
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GSK’s Depemokimab Accepted for FDA Review as Ultra-Long-Acting Biologic
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GSK plc (LON: GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has accepted indication approval filings for its depemokimab, a monoclonal antibody (mAb) targeting IL-5, with a PDUFA target date set for December 16, 2025. The UK-based pharmaceutical giant is seeking FDA approval for the drug’s…
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Juvestar and Raziel Therapeutics Launch Phase III Study for RZL-012 in China
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Juvestar Biotech Co., Ltd., a subsidiary of China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), and Israel-based Raziel Therapeutics jointly announced the initiation of a Phase III study for RZL-012 in submental fat (SMF) reduction in China. Drug ProfileRZL-012, an injectable lipolytic drug developed by Raziel for…
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Waters and Kehua’s LC-MS Systems Gain NMPA Approval for IVD Use
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Two home-grown liquid chromatography with tandem mass spectrometry (LC-MS) systems, the ACQUITY UPLC I-Class PLUS / Xevo TQ-Loong System and the ACQUITY UPLC I-Class PLUS / Xevo TQ-S cronos System, have obtained marketing approvals from the National Medical Products Administration (NMPA). These products, developed jointly by US firm Waters Corporation…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
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Shanghai BioScience Completes RMB 100M Financing Round Led by HUAGAI Capital
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China-based Shanghai BioScience Co., Ltd., a life sciences service platform, announced the completion of a new financing round, raising RMB 100 million (USD 13.73 million). The funding round was solely led by HUAGAI Capital. The proceeds will be used to accelerate the construction of independent brand product lines through mergers…
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Bayer HealthCare and JD Healthcare Partner on Women’s Health Ecosystem
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German pharmaceutical giant Bayer HealthCare (ETR: BAYN) has entered into a new partnership with JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), focusing on women’s health. The collaboration aims to establish a comprehensive health management ecosystem covering the entire life cycle of women, integrating Bayer’s medical expertise…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HDM1005, a long-acting agonist targeting the GLP-1 receptor and GIP receptor. The drug is set for development to treat adult patients with heart failure with preserved…
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Bio-heart’s Iberis RDN System Completes First Commercial Surgery in Germany
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced the successful completion of its first commercial surgery using the Iberis multi-electrode renal radiofrequency denervation (RDN) system in Germany. The procedure was performed by Dr. Saarraaken Kulenthiran at the University Hospital of Saarland, with no complications or adverse events reported.…
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Geneseeq and MGI Tech Form Global Partnership for Oncology Solutions
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Geneseeq Technology Inc., a genetic cancer testing service provider operating in Canada and China, has entered into a global partnership with China-based gene sequencing specialist MGI Tech Co., Ltd (SHA: 688114). The collaboration leverages MGI’s DNBSEQ gene sequencing platform to conduct in-depth cooperation in clinical basic research, product regulatory filing…
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Tonghua Dongbao’s Tongboli Under GMP Inspection in Egypt
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) announced that the on-site Good Manufacturing Practice (GMP) inspection by the Ministry of Health of Egypt for its Tongboli, a biosimilar version of Novo Nordisk’s GLP-1 receptor agonist Victoza (liraglutide), is well underway in the country. Product BackgroundTongboli, the Victoza knockoff, received marketing approval…
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United Laboratories’ UBT251 Receives FDA Green Light for Phase II CKD Study
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that it has received approval from the US Food and Drug Administration (FDA) to assess its Category 1 drug UBT251 in a Phase II study for the treatment of chronic kidney disease (CKD). Drug ProfileUBT251 is a triple agonist targeting…
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CStone Pharmaceuticals Doses First Patient in CS2009 Phase I Study for Solid Tumors
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China-based CStone Pharmaceuticals (HKG: 2616) announced the first patient dosing in a global, multi-center Phase I study for its CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. No infusion reactions or other adverse events were observed, marking a promising start to the clinical evaluation of the drug. Drug ProfileCS2009, an…
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AbbVie Enters Obesity Field with Gubra’s GUB014295 Licensing Deal
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US pharmaceutical giant AbbVie (NYSE: ABBV) announced that it is making significant progress in the obesity treatment field through a licensing agreement with Denmark-based Gubra A/S (CPH: GUBRA). AbbVie has secured exclusive global development and commercialization rights to GUB014295, a potential best-in-class, long-acting amylin analog for the treatment of obesity.…
