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Abbisko Therapeutics and X4 Pharmaceuticals Announce Positive Phase III Results for Mavorixafor in WHIM Syndrome
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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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FibroGen’s Roxadustat Shows Positive Results in Phase III Chemotherapy-Induced Anemia Trial
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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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Betta Pharmaceuticals Initiates Phase I/II Study for First-In-Class BsAb BPB-101
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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’s First-in-Class CD24 mAb ATG-031 Gets US FDA Approval for Phase I Study
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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’s Zuberitamab Approved by NMPA for CD20 Positive DLBCL Treatment
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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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WestVac Biopharma Receives FDA Approval for COVID-19 Protein Vaccines Targeting XBB Variants
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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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CARSgen Therapeutics Initiates Phase II Study for CT041 in Advanced Gastric Cancer
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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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CDE Lists Three Home-Grown Drugs for Priority Review, Including Myopia Treatment
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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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BeiGene and The Max Foundation Collaborate to Expand Access to Brukinsa for CLL Patients
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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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Huadong Medicine’s HDM1002 Receives NMPA Approval for Type 2 Diabetes Clinical Trial
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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 Completes Patient Enrollment in Etrasimod Phase III UC Trial
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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’s SHR0302 Secures Clinical Trial Approval for GVHD Treatment
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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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Sanofi’s VaxigripTetra Expands Influenza Vaccine Access to All Ages in China
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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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AstraZeneca’s Nirsevimab on Track for Priority Review for RSV Prevention in Infants
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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…
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Antengene Submits Market Approval Filing for Xpovio in Indonesia for Multiple Myeloma and Lymphoma
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Antengene Corp., Ltd (HKG: 6996) has announced a market approval filing in Indonesia for its drug Xpovio (selinexor). The company is seeking approval for the treatment of relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Background on Xpovio and Its ApprovalsDiscovered…
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TYK Medicines Receives CDE Approval for CDK7 Inhibitor TY-2699a Clinical Study
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Shanghai-based TYK Medicines has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its small molecule drug candidate, TY-2699a. This oral, selective CDK7 inhibitor is under development for the treatment of various cancers, including breast, ovarian, prostate, pancreatic, and small…
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Transcenta Holdings’ TST002 Shows Positive Phase I Results for Bone Density in China
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) has announced encouraging Phase I clinical study results for TST002, a drug designed to address decreased bone density in Chinese patients. Phase I Study Design and FindingsThe randomized, double-blind, placebo-controlled, dosage escalation Phase I study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity…
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BeiGene’s Tislelizumab Secures First Approvals Outside China Mainland in Macau
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in Macau for 9 indications. This marks the first time tislelizumab has received approvals outside of the China mainland market, with the Macau drug regulator’s decisions based on those issued by…
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Yizun Biomedicine’s CNK-UT Cell Therapy Initiates Patient Enrollment for Solid Tumor Trial
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Hangzhou-based cell therapy specialist Yizun Biomedicine Co., Ltd has announced the completion of first patient enrollment and reinfusion in an investigator-initiated trial (ITT) for its CNK-UT cell therapy, targeting advanced solid tumors at Shulan Hangzhou Hospital. CNK-UT Cell Therapy: A Universal Cell Technology for Tumor TreatmentCNK-UT is a groundbreaking universal…
