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Everest Medicines’ Xerava Approved in Hong Kong for Complicated Intra-Abdominal Infections
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Everest Medicines Limited (HKG: 1952), a China-based biopharmaceutical company, has announced that it has received market approval from the Department of Health of the Hong Kong Special Administrative Region for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in the…
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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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BGI Genomics Added to US Defense Department’s Investment Ban List
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BGI Genomics Co., Ltd, a leading Chinese gene sequencing firm, has reportedly been added to the US Defense Department’s list of Chinese companies subject to an investment ban for Americans. The move follows the company’s collaboration with China’s military to develop prenatal tests, as noted by Reuters. Background and ImplicationsThe…
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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).…
