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Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-6209 Clinical Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-6209 in patients with advanced solid tumors. This marks a significant step forward in the development of HRS-6209 as a…
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I-Mab’s Lemzoparlimab Gains CDE Approval for HR-MDS Phase III Trial
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China-based I-Mab (NASDAQ: IMAB) announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) in China and obtained approval to initiate a Phase III registrational trial assessing lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) as a first-line treatment for…
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Takeda’s Modakafusp Alfa and TAK-981 Gain NMPA Clinical Trial Approvals
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The National Medical Products Administration (NMPA) website indicates that Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) modakafusp alfa and subasumstat (TAK-981) have obtained tacit clinical trial approvals. The targeted indications are multiple myeloma (MM) and CD20-positive relapsed/refractory non-Hodgkin’s lymphoma (NHL) combined with rituximab, respectively. TAK-573: A First-in-Class Drug for Relapsed/Refractory…
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Luye Pharma’s LY03015 Receives FDA Approval for Phase I Clinical Study
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China-based Luye Pharma Group (HKG: 2186) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study of its LY03015. The study will assess the safety, tolerability, and pharmacokinetics of the next-generation vesicular monoamine transporter 2 (VMAT2) inhibitor. LY03015 is…
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InnoCare Pharma’s BCL2 Inhibitor ICP-248 Gains NMPA Approval for Clinical Study
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China’s Beijing InnoCare Pharma (HKG: 9969) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed BCL2 inhibitor, ICP-248. This Category 1 innovative drug becomes the company’s fifth drug to reach clinical trials in the blood cancer field…
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Luye Pharma’s BA-CovMab Receives NMPA Approval for COVID-19 Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s BA-CovMab, a broad-spectrum neutralizing antibody against COVID-19, has obtained clinical trial approval from the National Medical Products Administration (NMPA). Mechanism of ActionBA-CovMab is a recombinant fully human monoclonal neutralizing antibody obtained through sequential immunization and…
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CSPC Pharmaceutical’s TG103 Gains NMPA Approval for NASH and Alzheimer’s Trials
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct separate clinical trials for its Category 1 biologic product TG103 in non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease (AD). This marks a significant step forward in the development…
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Jingxin Pharmaceutical Receives NMPA Approval for JBPOS0101 and JX7002 Trials
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Jingxin Pharmaceutical Co., Ltd (SHE: 002020) announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its in-licensed products JBPOS0101 and JX7002. JBPOS0101 is being assessed for focal epilepsy in adults, while JX7002 is under development for hypercholesterolemia and mixed hyperlipidemia. JBPOS0101: A First-in-Class…
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Dizal Pharma’s Sunvozertinib Gains NMPA Approval for EGFR Mutation NSCLC Trial
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) combined with bevacizumab in locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutation. Ongoing…
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Sirnaomics Initiates Phase I Study of STP705 for Abdominal Fat Reduction
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the first subject dosing in a Phase I clinical study for its STP705, targeting adult abdominal fat reduction. The study, expected to report results during the first half of 2023, marks a significant step forward in the development of non-invasive…
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Laekna Therapeutics Doses First Patient in LAE001/LAE002 Study for Prostate Cancer
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China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. The multi-regional clinical trial (MRCT) now spans China, the United States, and South Korea. Study DetailsLAE201INT2101 is a multi-center,…
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Walvax Biotech Enrolls First Subject in Phase III HPV Vaccine Study
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) announced the first subject enrollment for a Phase III clinical study assessing the immunogenicity of its in-house developed nine-valent human papillomavirus (HPV) vaccine compared with Merck Sharp & Dohme’s (MSD) Gardasil 9. The vaccine is designed for the prevention of cervical cancer, vulvar…
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Luye Pharma’s CD25 Monoclonal Antibody BA1106 Gains NMPA Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s in-house developed CD25 monoclonal antibody (mAb) BA1106 has received clinical trial approval from the National Medical Products Administration (NMPA). This makes BA1106 the first CD25-targeted drug to enter clinical trials in China for the treatment…
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Jacobio’s KRAS G12C Inhibitor JAB-21822 Advances to Pivotal Phase II in NSCLC
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has received approval from the National Medical Products Administration (NMPA) to launch a pivotal Phase II trial of its KRAS G12C inhibitor, JAB-21822, for advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. The company plans to file…
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SciClone Pharmaceuticals Doses First Patient in RRx-001 Phase III Study for SCLC
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China-based SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) announced that the first patient has been dosed in the Phase III regulatory REPLATINUM study in China for its RRx-001, a next-generation small-molecule immunotherapy targeting CD47/SIRPα (signal-regulatory protein alpha). The drug, in-licensed from US firm EpicentRx Inc. in July 2020, is being evaluated as…
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Zelgen Biopharmaceuticals’ Jacktinib Wins FDA Approval for Severe Alopecia Areata
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) secured U.S. FDA approval to launch a clinical trial of its JAK inhibitor, jacktinib, for severe alopecia areata, marking the second IND clearance for the drug in the U.S. The therapy targets immune-driven inflammation via JAK/STAT pathway inhibition. Drug Profile and MechanismJacktinib, a…
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Jacobio Pharmaceuticals Doses First Patient in JAB-BX102 Phase I/IIa Trial for CD73-Targeted Cancer Therapy
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a Phase I/IIa trial of its CD73 monoclonal antibody (mAb), JAB-BX102, for advanced solid tumors. The study, cleared by Chinese regulators in March 2022, marks the drug’s global clinical debut after U.S. approval in October 2021.…
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Innovent Biologics Doses First Patient in Higher-Dose Mazdutide Obesity Trial
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China’s Innovent Biologics, Inc. (HKG: 1801) announced that the first participant has been dosed in the higher-dose cohort of a Phase II trial for mazdutide (IBI362), a dual agonist targeting glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR), in Chinese adults with obesity. The study follows positive results from…
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Shanghai Pharma’s CD20 Antibody Advances to Primary Nephropathy Trial After NMPA Approval
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China’s Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to launch a clinical trial for its CD20 monoclonal antibody (mAb) in primary membranous nephropathy, a chronic kidney disorder with limited treatment options. Study DetailsThe drug, developed by Shanghai Jiaolian Drug R&D Co.,…
