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Cabaletta Bio’s CABA-201 Clears FDA for Phase I/II Study in Idiopathic Inflammatory Myopathy
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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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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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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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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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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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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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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…
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Zelgen Biopharmaceuticals’ ZG0895 Receives FDA Approval for Clinical Trials in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate ZG0895, which targets advanced solid tumors. ZG0895 is a highly selective toll-like receptor (TLR8) agonist developed in-house, designed to offer a new…
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Skyline Therapeutics Initiates Clinical Study with First Patient Dosing of SKG0106 for wAMD
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Skyline Therapeutics has reached a significant milestone with the completion of the first patient dosing in its clinical study for SKG0106 intraocular injection solution. This in-house developed ophthalmology gene therapy was approved for clinical trials in China in December 2022. The open, dosage escalation study is designed to evaluate the…
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Gracell Biotechnologies Initiates Trial for GC012F in Refractory SLE with Dual-Target FasTCAR Therapy
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Gracell Biotechnologies Inc., (Nasdaq: GRCL), a China-based biopharmaceutical company, has announced the start of an investigator-initiated trial (IIT) in China for its therapeutic candidate GC012F. This candidate is an autologous FasTCAR therapy aimed at treating refractory systemic lupus erythematosus (SLE). The therapy is distinctive as a dual B cell maturation…
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Huadong Medicine’s HDM1002 Receives FDA Approval for Clinical Trials
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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1002. This small molecule is a complete agonist of the GLP-1 receptor with oral activity, known for its…
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Mabwell Bioscience’s 9MW3911 Receives NMPA Approval for Clinical Trial in Advanced Tumors
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical trial approval in China for its 9MW3911, a non-IL-2 blocking CD25 monoclonal antibody (mAb). The National Medical Products Administration (NMPA) has given the go-ahead for the drug to be assessed as a treatment for advanced…
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Akeso Biopharma Initiates Phase III Study for Ivonescimab in Non-Small Cell Lung Cancer
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China-based Akeso Biopharma (HKG: 9926) has announced the initiation of a Phase III clinical study for its bispecific antibody (BsAb) ivonescimab (AK112), which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF) in non-small cell lung cancer (NSCLC). Global Phase III HARMONi Study Design and Patient DosingThe global,…
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RemeGen Ltd Receives Approval for Phase I Clinical Study of RC198 in Solid Tumors
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RemeGen Ltd (HKG: 9995) has announced that it has received approval from the Human Research Ethics Committees of Australia to conduct a Phase I clinical study for its investigational drug RC198. The study will focus on patients with locally advanced unresectable or metastatic solid tumors. RC198: An Fc Fusion Protein…
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Grand Pharmaceutical Group Completes Enrollment in Phase III Study for Ryaltris Nasal Spray
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the completion of all subject enrollment in a multi-center Phase III clinical study for its Ryaltris compound nasal spray (GSP301). This compound is under evaluation as a potential treatment for seasonal allergic rhinitis (SAR) in patients aged 12 years and older.…
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Alphamab Oncology and CSPC Pharma Get Green Light for KN026 Phase III Study in Breast Cancer
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China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced receiving approval in China to conduct a registrational study for KN026 combined with docetaxel (albumin bound) in first-line HER2 positive recurrent and metastatic breast cancer. Design and Objectives of the Phase III StudyThe randomized, controlled, open,…
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Jiangsu Hengrui Pharmaceuticals Advances SHR-1819, SHR-2002, and Adebrelimab into New Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced receiving clinical trial approvals for its drug candidates SHR-1819, SHR-2002, and adebrelimab (SHR-1316). SHR-1819 is now cleared to enter Phase II clinical trials for chronic sinusitis with nasal polyps, and SHR-2002 will proceed to a Phase I clinical study in advanced…
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Ascletis Pharma Receives Approval for Phase IIa Study of ASC10 for RSV Infection
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving the green light to conduct a Phase IIa study for its ASC10 in the treatment of respiratory syncytial virus (RSV) infection. This follows the company’s previous approval from the US FDA in January 2023 to carry out a similar Phase IIa…
