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Kira Pharmaceuticals Gets FDA Green Light for Phase II Study of KP104 in SLE-TMA
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Kira Pharmaceuticals, a Sino-US biotech company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study of KP104. The study will assess the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with systemic lupus…
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Staidson’s STSP-0601 Receives Clinical Trial Approval for Hemophilia Treatment
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, STSP-0601. The approval is for the on-demand treatment of bleeding in patients with hemophilia A or B…
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Henlius Biotech Gets FDA Nod for HLX07 Clinical Study in CSCC
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its epidermal growth factor receptor (EGFR)-targeted monoclonal antibody (mAb), HLX07, in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). This marks…
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Neurophth Biotechnology Doses First Patient in Phase III Trial for NR082
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that the first patient has been dosed in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01). The study is being conducted in China to evaluate the efficacy and safety of NR082, a recombinant adeno-associated virus serotype 2 (rAAV2), in…
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Bio-Thera Solutions Completes Phase I Study for COVID-19 Antibody BAT2022
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced the completion of all dosage groups (from 100 mg to 1500 mg) in a Phase I clinical study for its BAT2022. The results of the study demonstrated good safety across all dosage groups. BAT2022: Drug OverviewBAT2022 is a bispecific neutralizing antibody against COVID-19…
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Abbisko Therapeutics Doses First Patient in Phase I Study of ABSK043
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that the first patient has been dosed in a Phase I clinical study (ABSK043-101) for its in-house developed oral programmed-death ligand 1 (PD-L1) inhibitor, ABSK043, in patients with advanced solid tumors in China. The drug has previously completed multiple dose…
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Arctic Vision Enrolls First Patient in Phase III Study for ARVN002
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China-based ophthalmology specialist Arctic Vision has announced the enrollment of the first patient in a Phase III clinical study assessing the efficacy and safety of ARVN002 (atropine sulfate) for arresting myopia progression. The study is being conducted in China and marks a significant step forward in the development of this…
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Harbour BioMed Doses First Subject in Phase I Study for HBM9378 in China
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China-based Harbour BioMed (HKG: 2142) has announced the completion of the first subject dosing in a Phase I clinical study for HBM9378 (SKB378), a next-generation fully human antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe asthma. The study is being conducted in China and marks a significant step…
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Telix Pharmaceuticals Gains IND Approval for TLX250-CDx in China
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE). The company will now commence a pivotal Phase III registration study in China for its TLX250-CDx (89Zr-girentuximab), an imaging agent used to support positron emission tomography…
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Angel Pharmaceuticals Gains CDE Approval for Mupadolimab Phase I/Ib Study
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China-based Angel Pharmaceuticals Ltd has announced that it has received approval from the Center for Drug Evaluation (CDE) to initiate a Phase I/Ib clinical study in China for its mupadolimab (formerly CPI-006) in advanced solid tumors. Angel Pharma owns the rights to mupadolimab in Greater China. Drug Overview and MechanismMupadolimab…
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Sino Biopharmaceutical’s TDI01 Receives Clinical Trial Approval for COVID-19
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China’s Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary, Beijing Tide Pharmaceutical Co. Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for its in-house developed Category 1 drug TDI01. The targeted indication for the drug is COVID-19. TDI01: Unique Mechanism and DevelopmentTDI01 stands…
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Fujian Cosunter Receives NMPA Approval for COVID-19 Drug Candidate GST-HG171
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug candidate, GST-HG171, in adult patients with mild/common COVID-19. This marks a significant step forward in the development of…
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Everest Medicines Gains CDE Approval for EVER001 Phase Ib Study
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China-based biotech Everest Medicines (HKG: 1952) has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to conduct a Phase Ib clinical study assessing the safety, efficacy, pharmacokinetics, and pharmacodynamics of its EVER001. The drug candidate, a next-generation covalent reversible Bruton’s tyrosine kinase (BTK)…
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Zelgen Biopharmaceuticals Gains NMPA Approval for Jacktinib Clinical Trial in SLE
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Janus kinase (JAK) inhibitor, jacktinib, in systemic lupus erythematosus (SLE). This marks a significant milestone in the development of this innovative therapy for autoimmune diseases.…
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Joincare’s Modified Drug XYP-001 Gains NMPA Approval for IPF Trial
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its modified drug XYP-001 inhaler. The targeted indication is idiopathic pulmonary fibrosis (IPF). Disease Overview and Current TherapiesIPF is a chronic progressive fibrotic interstitial…
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Sun-Novo’s STC007 Gains NMPA Approval for Postoperative Pain Study
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007 for postoperative pain. This marks a significant milestone in the development of this innovative therapy. Drug Mechanism…
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Tasly Pharmaceuticals Gains NMPA Approval for B1344 Diabetes Study
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human fibroblast growth factor 21 injection B1344 in patients with type 2 diabetes. This marks a significant step in the development of this…
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Alphamab Oncology Doses First Patient in Phase I Study for JSKN003 in Australia
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Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced…
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Transcenta’s First-in-Class Gremlin1 Antibody TST003 Receives FDA IND Clearance
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China-based Transcenta Holding Limited (HKG: 6628) announced that its TST003, a first-in-class, high affinity humanized monoclonal antibody (mAb) targeting Gremlin1, has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA). This milestone allows Transcenta to proceed with clinical trials for this novel cancer treatment. Gremlin1…
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Buchang Pharmaceuticals Gains NMPA Approval for BC008-1A Clinical Study
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China-based Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic product BC008-1A in advanced solid tumors. This marks a significant step forward in the development of BC008-1A as a…
