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China-based HighTide Therapeutics Inc. (HKG: 2511) has announced that its Phase II study for the drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) as a treatment for type 2 diabetes (T2DM) has achieved its primary endpoint and several important secondary endpoints. The study demonstrated that treatment with HTD1801 resulted in a superior…
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Zhejiang Conba Pharmaceutical Co., Ltd (SHA: 600572) has announced that its modified version of US firm Marnac’s pirfenidone, in the form of an inhalable solution, has been approved for clinical trials in China. The drug is aimed at treating idiopathic pulmonary fibrosis (IPF), a progressive lung disease characterized by diffuse…
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has separately announced clinical trial approvals from the National Medical Product Administration (NMPA) for two of its drug candidates, SHR-1654 and SHR-2001. These molecules are set for assessment as potential treatments for rheumatoid arthritis and systemic lupus erythematosus, respectively. SHR-1654: A Novel Treatment for…
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Sino-US Laekna has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its LAE102 antibody. The drug is set to be assessed as a potential treatment for non-small cell lung cancer (NSCLC). This achievement marks LAE102 as Laekna’s first internally-discovered drug candidate…
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US-based Cabaletta Bio, Inc. (NASDAQ: CABA) has announced that the US Food and Drug Administration (FDA) has cleared the company’s second Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. The clearance is for a Phase I/II study in patients with active idiopathic…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) and its US partner X4 Pharmaceuticals Inc. have announced positive top-line data from a pivotal Phase III clinical study for the once-daily, oral CXCR4 antagonist mavorixafor. The trial is assessing the molecule as a treatment for WHIM syndrome (warts, hypogammaglobulinemia, infections, and…
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US-based FibroGen Inc. (NASDAQ: FGEN) has announced positive topline data from a Phase III trial for roxadustat, a treatment for anemia in patients receiving chemotherapy. The study, which focused on 153 patients in China (NCT05301517), showed that detailed results will be presented at a future industry conference. Roxadustat’s Efficacy and…
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China’s Betta Pharmaceuticals (SHE: 300558) has announced the enrollment of the first patient in a Phase I/II clinical study for its first-in-class bispecific antibody (BsAb), BPB-101. The molecule is currently being assessed for the treatment of advanced malignant solid tumors. BPB-101: A Trifunctional IgG1 Subtype Humanized AntibodyBPB-101 is a trifunctional…
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Antengene Corp., Ltd (HKG: 6996) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its first-in-class CD24 monoclonal antibody (mAb), ATG-031. The Phase I PERFORM study is designed to assess the safety, tolerability, pharmacological properties, immunogenicity,…
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BioRay Pharmaceutical Co., Ltd has announced that its drug zuberitamab has been approved by the National Medical Products Administration (NMPA) to treat CD20 positive diffuse large B-cell lymphoma, non-specific (DLBCL, NOS) in adults. The approval is for the use of zuberitamab in combination with standard cyclophosphamide, doxorubicin, vincristine, and prednisone…
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Chengdu-based WestVac Biopharma Co., Ltd has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for two COVID-19 protein vaccines co-developed in collaboration with West China Hospital, Sichuan University. These vaccines are specifically targeting the XBB variant and other emerging strains, including the recombinant bivalent COVID-19 protein…
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China-based chimeric antigen receptor (CAR)-T cell specialist CARSgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of patient enrollment for a Phase II clinical study of its CT041 in advanced gastric cancer/esophageal gastric junction adenocarcinoma (GC/GEJ) with positive CLDN18.2 expression that has previously failed at least second-line treatment. CT041:…
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The Center for Drug Evaluation (CDE) website has indicated that three home-grown drugs are on track to obtain priority review statuses. These include Shenyang Sinqi Pharmaceutical Co. Ltd.’s atropine for arresting the progression of myopia in children, Zhuhai Jinzhidun Pharmaceutical Technology Co., Ltd.’s trientine for hepatolenticular degeneration that cannot tolerate…
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China-based biotech BeiGene (NASDAQ: BGNE) has formed a collaboration with US-based non-profit organization The Max Foundation (Max) to improve access to the Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) for patients with chronic lymphocytic leukemia (CLL) in 29 low- and middle-income countries. The three-year collaboration aims to enhance access to…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its small molecule drug HDM1002, intended for the treatment of adult type 2 diabetes. This follows closely on the heels of the drug’s approval to enter clinical trials in…
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Everest Medicines (HKG: 1952), a China-based biopharmaceutical company, has declared the successful completion of patient enrollment in a multi-center Phase III clinical trial for etrasimod in Asia, specifically targeting the treatment of moderate-severe active ulcerative colitis (UC). This development follows Everest’s acquisition of development rights to etrasimod in Greater China…
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced the receipt of another clinical trial approval for its drug candidate SHR0302, which is intended for the treatment of graft versus host disease (GVHD). SHR0302: A Selective JAK1 Inhibitor with Oral Solution PotentialSHR0302 is recognized as a highly…
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its tetravalent influenza virus split vaccine, VaxigripTetra, has been granted market approval by the National Medical Products Administration (NMPA) in China. This approval extends the vaccine’s usage to include individuals aged three years and above, building on the earlier approval for…
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The Center for Drug Evaluation (CDE) website in China indicates that AstraZeneca’s (AZ, NASDAQ: AZN) Beyfortus (nirsevimab) is on course to be awarded priority review status for its use in preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants who are about to enter…