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Henlius Biotech’s HLX26 and HaiSiZhuang Combo for NSCLC Gets NMPA Phase II Approval
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will evaluate the combination of HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, with Henlius’s programmed-death 1…
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Yantai Dongcheng Pharma’s 177Lu-LNC1003 Cleared for US FDA Phase I Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its drug 177Lu-LNC1003. This marks a significant milestone for the company as it advances its innovative treatment…
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ABM Therapeutics’ ABM-168 Begins Phase I Dosing in the US for Advanced Solid Tumors
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Shanghai-based ABM Therapeutics, Inc. has announced the commencement of the first patient enrollment and dosing in a Phase I clinical study for its investigational drug ABM-168 in the United States. This open, dosage escalation, dosage expansion study, which received approval in the country in October 2022, is designed to assess…
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CARsgen Therapeutics’ AB011 and Tecentriq Combo Gets NMPA Approval for Gastric Cancer Treatment
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China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 combined with Roche’s programmed death-ligand 1 (PD-L1) therapy Tecentriq (atezolizumab) alongside standard chemotherapy. This treatment is…
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BDgene Technology’s BD111 Receives Tacit Approval for HSV-1 Keratitis Trial
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Shanghai BDgene Technology Co., Ltd has announced that it has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its innovative therapy, BD111. This CRISPR-Cas9 in vivo-based therapy is designed for the treatment of recurrent type 1 herpes simplex virus (HSV-1)-related keratitis (HSK) and is being…
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TYK Medicines’ TY-9591 Gains CDE Green Light for Pivotal Phase II Study in NSCLC with Brain Metastases
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Shanghai-based TYK Medicines has announced that it has received the green light from the Center for Drug Evaluation (CDE) to proceed with a pivotal Phase II clinical study for its drug candidate TY-9591, a novel therapy targeting lung cancer with brain metastases. This trial is strategically designed to support a…
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CMS Receives NMPA Approval for Clinical Study of Tetravalent BsAb for nAMD
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its tetravalent bispecific antibody (BsAb) targeting vascular endothelial growth factor A (VEGFA) and angiopoietin 2 (ANG2) for intravitreal injection in the treatment…
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Sirnaomics’ RV-1730 Receives FDA Clearance for Phase I COVID-19 Vaccine Booster Trial
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Sirnaomics Ltd (HKG: 2257) has announced that it has received clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a Phase I clinical trial of RV-1730, a SARS-CoV-2 vaccine booster candidate. Design of the Phase I Study for RV-1730The Phase I…
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SynerK Achieves Milestone with First Patient Dosing in Phase I siRNA Clinical Trial
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SynerK, a developer of RNA-targeted therapies with operations in Boston, US, and Beijing and Suzhou, China, has announced the completion of first patient dosing in its Phase I clinical study for an investigational small interfering RNA (siRNA). This marks the first time such a therapy has entered the clinical phase…
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Zelgen Biopharmaceuticals’ ZG2001 Receives US FDA Clinical Trial Approval for Pan-KRAS Inhibitor
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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 Category 1 product candidate, ZG2001. ZG2001 is an in-house discovered oral pan-KRAS mutation inhibitor under development for the treatment of KRAS mutant tumors. Prevalence…
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Sichuan Biokin Pharmaceutical Gets NMPA Approval for Two Clinical Studies on Cancer Therapies
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct two clinical studies. One study will investigate the combination of its drug candidate BL-B01D1 with osimertinib (Tagrisso) for the treatment of locally advanced or metastatic non-small…
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Evopoint Biosciences Gets CDE Approval for Phase I/II Study of XNW27011 ADC
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Suzhou Evopoint Biosciences Co., Ltd., a China-based pharmaceutical company, has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/II clinical study for its antibody-drug conjugate (ADC), XNW27011. The study will focus on locally advanced unresectable or metastatic malignant solid tumors expressing Claudin 18.2 (CLDN18.2).…
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Reistone Biopharma’s RSS0343 Receives NMPA Approval for Non-Cystic Fibrosis Bronchiectasis
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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Pharmaceuticals (SHA: 600276) with an investment of USD 100 million in 2018, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RSS0343, intended to treat non-cystic fibrosis bronchiectasis (NCFB). Understanding Non-Cystic Fibrosis Bronchiectasis…
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Neurodawn Pharmaceutical’s Y-1 Receives NMPA Approval for Primary Intracranial Tumor Treatment
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Nanjing-based Neurodawn Pharmaceutical Co., Ltd has announced that its Category 1 drug, injectable Y-1, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of primary intracranial malignant tumors. TRPML1 Inhibitor’s Non-Clinical Study ResultsNon-clinical studies have demonstrated that the TRPML1 inhibitor, Y-1, can effectively inhibit…
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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Four Innovative Drugs
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Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced receiving clinical trial approvals for four category 1 innovative drugs. Three of these approvals were granted by the National Medical Products Administration (NMPA) in China, and one by the US FDA. The drugs are targeted towards treating kidney and cardiovascular diseases.…
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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6010 ADC Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC), SYS6010, which is intended for the treatment of advanced solid tumors. Pre-Clinical Studies and Patent Protection for SYS6010Pre-clinical studies have demonstrated that…
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CARSgen Therapeutics’ CT041 Receives NMPA Approval for Post-Operative Pancreatic Cancer Therapy
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China-based chimeric antigen receptor (CAR)-T cell specialist, CARSgen Therapeutics Holdings Ltd (HKG: 2171), has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate, CT041. The therapy will be assessed as a post-operative adjuvant treatment for Claudin18.2 (CLDN18.2)-positive pancreatic cancer. Potential First-In-Class CAR-T Therapy:…
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Zelgen Biopharmaceuticals’ ZG2001 Receives NMPA Approval for Clinical Trials
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 product candidate, ZG2001. ZG2001: An Oral Pan-KRAS Mutation InhibitorZG2001, an in-house developed oral pan-KRAS mutation inhibitor, is under development for the treatment of…
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Beijing Aosaikang’s ASKG915 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the National Medical Products Administration (NMPA). The study will initially assess the therapy in patients with general advanced solid tumors. ASKG915: A Bifunctional Fusion Protein Targeting PD-1 and IL-15ASKG915…
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Biosyngen Receives US FDA IND Approval for T-Cell Redirection Therapy for EBV-Positive Lymphoma
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Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on…
