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Ascletis Pharma Doses First Patient in Phase II Study of ASC41 for NASH
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Ascletis Pharma Inc. (HKG: 1672), a China-based biopharmaceutical company, has announced that the first patient has been dosed in a 52-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41. The study is targeting patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). Phase II Clinical Trial DesignThe…
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Transcenta’s TST004 Receives FDA IND Clearance for IgAN Treatment
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China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for TST004, a best-in-class, humanized monoclonal antibody targeting MASP2. The drug is set to be evaluated as a potential treatment for immunoglobulin A nephropathy (IgAN).…
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Connect Biopharma’s CBP-201 Shows Positive Results in Atopic Dermatitis Study
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China-based Connect Biopharmaceuticals Ltd has announced the topline results of a pivotal clinical study for its monoclonal antibody (mAb) candidate, CBP-201, targeting allergic inflammation in moderate-to-severe atopic dermatitis (AD). The study was conducted across multiple centers in China and evaluated the efficacy and safety of CBP-201, as well as the…
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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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Humanwell Healthcare’s Remimazolam Receives NMPA Approval for Bronchoscopy Use
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its remimazolam (benzenesulfonate), a Category 1 chemical injectable. The drug is now approved for use as a sedative in support of bronchoscopy procedures. Drug Overview…
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Biosyngen’s First-in-Class Drug Candidate BRG01 Accepted for IND Review
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Biosyngen has announced that its investigational new drug (IND) filing for the first-in-class (FIC) drug candidate BRG01 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BRG01, an innovative therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC).…
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Alphamab Oncology’s KN019 Achieves Primary Endpoint in Phase II RA Study
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Suzhou-based biotech Alphamab Oncology (HKG: 9966) has announced that its China-based Phase II KN019-201 study, assessing the safety and efficacy of its cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immunosuppressive fusion protein KN019 in active rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX), has reached its primary endpoint. Study Design…
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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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Zelgen Files NDA for Jacktinib to Treat Myelofibrosis in China
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has filed a New Drug Application (NDA) with the National Medical Products Administration (NMPA) for its JAK inhibitor, jacktinib, to treat medium to high risk myelofibrosis (MF). This includes primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post PV MF), and…
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Lepu Biotechnology’s MRG003 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation for its core product MRG003 in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The epidermal growth factor receptor (EGFR) targeted antibody drug conjugate (ADC) had previously obtained Orphan Drug…
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Lepu Biotechnology’s PD-1 Inhibitor HX008 Gains New Indication Approval
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its HX008, a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug, which was first approved in China in July this year for…
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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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Legend Biotech’s Carvykti Approved in Japan for Relapsed Multiple Myeloma
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma. The approval is limited to…
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NMPA Releases 59th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 59th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 67 new specifications, among which 15 are injectables. The update aims to further standardize and improve the quality of generic drugs in the…
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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…
