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Shanghai Fosun Pharmaceutical’s SBK010 Stroke Treatment Accepted for NMPA Review
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its chemical drug SBK010 for review. SBK010, which is licensed from Chengdu Shibekang Biomedical Technology Co., Ltd, another…
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Jacobio Pharma Receives NMPA Approval for Pan-KRAS Inhibitor JAB-23E73 Clinical Trial
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug JAB-23E73, a pan-KRAS inhibitor developed in-house. This follows prior clearance from U.S. authorities to initiate a Phase I/IIa study for…
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AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
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AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
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FDA Panel Weighs in on Narrowing Use of PD-1 Inhibitors in Stomach and Esophageal Cancers
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The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
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2seventy bio and BMS Discontinue Phase III Trial for Multiple Myeloma Therapy Abecma
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2seventy bio Inc. (NASDAQ: TSVT), a U.S.-based biotechnology company partnered with Bristol-Myers Squibb (BMS, NYSE: BMY) on the development of the chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel; ide-cel), has announced the discontinuation of enrollment in a Phase III clinical trial. The trial, known as KarMMa-9, was investigating…
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Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for Generic Vizamyl Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of GE Healthcare’s Vizamyl (flutemetamol F-18). This trial aims to evaluate the positron emission tomography (PET)…
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Sino Biopharmaceutical Receives NMPA Approval for Rivastigmine Patch for Mild-to-Moderate Alzheimer’s
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its rivastigmine transdermal patch. This new treatment is intended for the management of symptoms associated with mild-to-moderate Alzheimer’s disease (AD). Rivastigmine, classified…
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Innovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China’s CDE
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted a market approval filing to the Center for Drug Evaluation (CDE) for its investigational drug picankibart (IBI112), intended for the treatment of moderate to severe plaque psoriasis. Picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody…
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Shanghai Haihe Pharmaceutical’s Oral Paclitaxel RMX3001 Wins NMPA Nod for Advanced Gastric Cancer
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Shanghai Haihe Pharmaceutical Co., Ltd from China and its South Korean partner Daehwa Pharmaceutical have received approval from the National Medical Products Administration (NMPA) for their co-developed paclitaxel oral solution RMX3001. This new drug is intended for use in patients with advanced gastric cancer who have experienced disease progression during…
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Eli Lilly’s Kisunla Secures Market Approval in Japan for Early Symptomatic Alzheimer’s
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Eli Lilly & Co. (NYSE: LLY) has announced that its Alzheimer’s disease (AD) treatment, Kisunla (donanemab), has been granted market approval in Japan. The drug is indicated for adults with early symptomatic AD, including those with mild cognitive impairment (MCI) and/or mild dementia stage, who have confirmed amyloid pathology. Kisunla…
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Amgen’s Tepezza Receives Approval in Japan for Treating Thyroid Eye Disease
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Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye…
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Elevation Oncology’s Claudin 18.2 Targeting ADC Earns FDA Fast Track Designation for Gastric Cancer
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Elevation Oncology, Inc. (NASDAQ: ELEV), a biopharmaceutical company based in the U.S., has announced that it has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy EO-3021 (SYSA1801). This antibody-drug conjugate (ADC) targets Claudin 18.2 and is being developed for the treatment…
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China Medical System’s Opzelura Cream Filing for Vitiligo Accepted by NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA). Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in…
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Junshi Biosciences’ Toripalimab Secures EC Nod for Two Cancer Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
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Allist Pharma’s Partner Abbisko Receives NMPA Green Light for NSCLC Drug Trial
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for ABK3376, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This drug is co-developed with Allist Pharmaceuticals Inc., (SHA: 688578), and is intended…
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UCB’s Bimzelx Gains FDA Approval for Three Additional Autoimmune Indications
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Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic…
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HBOW Bio’s First-in-Class Tumor Imaging Drug NC527-X Receives NMPA Clinical Trial Approval
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HBOW Bio, a precision oncology company supported by Sherpa Healthcare Partners, has secured clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate NC527-X. This first-in-class near-infrared fluorescence (NIRF) tumor imaging agent is recognized as the world’s first drug to harness low oxygen pathways for…
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CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
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The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in U.S. Phase II Study for Port Wine Stain Treatment
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505), a leading biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its hemoporfin photo-dynamic therapy (PDT) in the United States. The study is focused on treating port wine stain (PWS),…
