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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)…
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Hengrui’s SHR4640 Accepted for NMPA Review for Gout and Hyperuricemia Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that a market filing for its SHR4640 as a long-term treatment for primary gout with hyperuricemia has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment…
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Sinogen’s SalMet-Vec Receives FDA Orphan Drug Designation for Pancreatic Cancer
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China’s oncology specialist Guangzhou Sinogen Pharmaceutical Co., Ltd. has announced receiving Orphan Drug Designation (ODD) from the US FDA for its SalMet-Vec in pancreatic cancer. This oncolytic bacteria drug has previously earned ODD statuses from the agency for osteosarcoma, hepatocellular carcinoma, and small cell lung cancer. Drug Profile and MechanismSalMet-Vec…
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Sanofi’s Sarclisa Meets Co-Primary Endpoints in Phase III IRAKLIA Study for Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY, EPA: SAN) has announced that the Phase III IRAKLIA study for its Sarclisa (isatuximab) met its co-primary endpoints when administered subcutaneously (SC) via an on-body delivery system (OBDS) in patients with multiple myeloma (MM). This marks a significant step forward in the treatment of…
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FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted priority review status to the Biologics License Application (BLA) for its portfolio drug nipocalimab. This priority status is based on results from the Phase III Vivacity-MG3 study and is awarded for the product’s potential use…
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Bayer’s Elinzanetant Meets All Primary Endpoints in Phase III OASIS 4 Study
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Germany-based Bayer AG (ETR: BAYN) has announced that the Phase III OASIS 4 study for its non-hormonal treatment elinzanetant has reached all primary endpoints. The study focused on moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing…
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Inmagene Biopharmaceuticals Posts Positive Results for IMG-007 in Atopic Dermatitis
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Inmagene Biopharmaceuticals, a Sino-US biotech that recently merged with US-based Ikena Oncology, Inc. (NASDAQ: IKNA), has posted additional positive topline results from the Phase IIa study for IMG-007 in patients with moderate-to-severe atopic dermatitis (AD). The company also released results from a Phase I trial of IMG-007’s subcutaneous (SC) formulation.…
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GSK Launches Cabotegravir Injection in China for HIV Pre-Exposure Prophylaxis
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UK-based GlaxoSmithKline (GSK; NYSE: GSK) has announced the official commercial launch of its cabotegravir injection in China. The integrase strand transfer inhibitor (INSTI) was approved in May of last year for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents (weighing ≥ 35kg) at risk of infection, to reduce the…
