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Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or…
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Huadong Medicine Gets FDA Nod for Phase I Study of HDM2006 in Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its Category 1 chemical drug, HDM2006, in patients with advanced solid tumors. This marks a significant step forward in…
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Zhaoke Ophthalmology Partners with AFT for Brimochol PF Distribution in ANZ
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China-based Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a strategic distribution and supply agreement with New Zealand-headquartered AFT Pharmaceuticals Limited, a leading healthcare product manufacturer and distributor. The agreement pertains to Brimochol PF, a fixed dose of carbachol and bromonidine tartrate that is preservative free, co-developed by Tenpoint Therapeutics Ltd.…
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Tonghua Dongbao Begins Phase II Trial for GLP-1/GIP Agonist THDBH120 in Weight Loss
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced a significant milestone in its clinical development program with the first patient dosing in the Phase II clinical study of THDBH120. This study is designed to assess the efficacy and safety of the GLP-1/GIP dual-targeted receptor agonist in weight loss applications. THDBH120…
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CSPC’s Prusogliptin Approved in China for Type 2 Diabetes Treatment
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China’s National Medical Products Administration (NMPA) has granted marketing approval to CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) for its drug prusogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The approval is for the drug’s use in improving blood sugar control among adult patients with type 2 diabetes (T2D). Mechanism of ActionPrusogliptin…
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JW Therapeutics’ Carteyva Granted Breakthrough Therapy Designation by CDE
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China-based JW Therapeutics (HKG: 2126) has announced that its Carteyva (relmacabtagene autoleucel injection) has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation recognizes the potential of Carteyva as a second-line treatment for adults with relapsed or refractory…
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CSPC Pharmaceutical’s ADC Pipeline Advances with SYS 6041 Approval
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has reported significant progress in its antibody drug conjugate (ADC) pipeline. The company’s latest product, SYS 6041, has recently been cleared for study in advanced solid tumors in China. This approval marks a crucial step in the development of CSPC’s ADC portfolio,…
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Henlius Biotech Gains NMPA Clearance for HLX43 ADC Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) drug HLX43, combined with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10), in patients with advanced/metastatic solid…
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Gilead Sciences and LEO Pharma Alliance Targets Inflammatory Diseases
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US-based major Gilead Sciences Inc. (NASDAQ: GILD) has formed a strategic alliance with Denmark-based dermatology specialist LEO Pharma A/S. The partnership aims to bolster the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs, targeting the potential treatment of patients with…
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Junshi Biosciences’ Mindewei Receives Full Approval in China
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the conditional approval in China for its COVID-19 therapy Mindewei (deuremidevir) has been converted to full approval by the National Medical Products Administration (NMPA). This approval is for the treatment of adult patients with mild to moderate…
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Ucello Biotech’s UC101 Receives FDA IND Clearance for Anti-CD19 Therapy
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China-based Chengdu Ucello Biotechnology Co., Ltd., a developer of allogeneic universal chimeric antigen receptor (CAR)-T cell therapies, has announced receiving Investigational New Drug (IND) clearance from the US FDA for its anti-CD19 allogeneic universal T-cell therapy UC101. This clearance is a significant milestone in the development of UC101, paving the…
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Hengrui’s Recaticimab Approved for Hypercholesterolemia Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its Category 1 biologic product recaticimab (SHR-1209) has been approved by the National Medical Products Administration (NMPA). The PCSK9-targeted monoclonal antibody (mAb) can now be used in combination with statins or statins plus other lipid-lowering therapies for adult patients…
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Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1819 Phase II Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its investigational drug SHR-1819. This approval is a significant step forward in the development of SHR-1819, which is…
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Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4375 Clinical Trial
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic product SHR-4375. This approval is a significant milestone in the development of SHR-4375, which is designed to treat advanced malignant solid tumors.…
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Bayer Files for Finerenone Approval in US and China for Heart Failure-Fineline Info & Tech
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Bayer AG (ETR: BAYN) has announced market filings with the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its drug finerenone. The German pharmaceutical giant is seeking approvals in both countries for the mineralocorticoid receptor (MR) antagonist…
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Pfizer’s Sasanlimab Shows Positive Results in Phase III CREST Study
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US-based Pfizer Inc. (NYSE: PFE) has reported positive topline results from its pivotal Phase III CREST study. The study evaluated sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).…
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NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
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China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for patients who carry susceptible FGFR3 gene mutations and have undergone at…
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Doma Biopharma Receives FDA Clearance for DM002 Phase I Study-Fineline Info & Tech
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of its Category 1 drug DM002 in multiple solid tumors. This…
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GSK’s Shingrix Prefilled Syringe Accepted for FDA Review
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UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has announced that a market filing for a prefilled syringe presentation of its recombinant zoster vaccine Shingrix has been accepted for review by the US Food and Drug Administration (FDA). This development marks a significant step towards enhancing the convenience and efficiency of vaccine administration.…
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Fosun Pharmaceutical’s FCN-437c Accepted for NMPA Review for Breast Cancer Treatment
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Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval filing for its FCN-437c has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for patients with hormone receptor (HR)…
