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Luye Pharma’s LY01005 Meets Phase III Trial Goals in Breast Cancer Treatment
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China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for LY01005 in breast cancer treatment has successfully met pre-set endpoints. The study demonstrated that LY01005 effectively controls serum estradiol to postmenenopausal levels, with clinical efficacy comparable to a control drug, achieving a non-inferiority standard. Study DetailsThe…
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Fidia Farmaceutici’s Hyalubrix 60 Shows Promise in Treating Arthropathy at Hainan Hospital
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Italy-based Fidia Farmaceutici S.p.A announced that its Hyalubrix 60, a prefilled syringe with sodium hyaluronate solution for intra-articular injection, has successfully completed treatment in four patients at Hainan General Hospital’s Lecheng branch. Product ProfileHyalubrix 60 is designed to restore the viscoelastic properties of knee and hip synovial fluid. It serves…
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Ascentage Pharma’s Olverembatinib Receives Health Canada Approval for Phase Ib Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from Health Canada to conduct a Phase Ib clinical study of its third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), olverembatinib (HQP1351), for drug-resistant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Study DetailsThe open-label, multi-center, randomized, global…
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Junshi Biosciences’ Toripalimab Receives EC Orphan Drug Designation for NPC
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that its PD-1 inhibitor Toripalimab (trade name: Tuoyi) has received orphan drug designation (ODD) from the European Committee (EC) for the treatment of nasopharyngeal carcinoma (NPC). This marks the sixth ODD for Toripalimab in the US and Europe, following previous designations for…
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Ji Xing Pharmaceuticals Enrolls First Patient in OC-01 Phase III Study for Dry Eye
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that the first patient has been enrolled in a Phase III clinical study for its OC-01 (varenicline) nasal spray in China. The study aims to evaluate the efficacy and safety of OC-01 in treating dry eye and neurotrophic keratopathy. Drug ProfileOC-01…
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Gan & Lee Pharmaceuticals Doses First Patient in GZR18 Phase II Study for Diabetes and Obesity
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that the first patient has been dosed in a Phase II clinical study for its Category 1 biologic product GZR18, a novel glucagon-like peptide-1 (GLP-1) receptor agonist designed for once-weekly administration. Study DetailsThe Phase Ib/IIb study will evaluate the safety, tolerability, pharmacokinetics,…
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Sinopep-Allsino Biopharm’s SPN0103-009 Receives NMPA Approval for Diabetes and Obesity Clinical Study
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China-based Jiangsu Sinopep-Allsino Biopharmaceutical Co., Ltd announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its injectable SPN0103-009 for the treatment of type 2 diabetes and obesity. Drug ProfileSPN0103-009 is a novel, long-acting GLP-1 peptide analog designed for improved stability,…
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Lepu Biopharma’s Pucotenlimab Receives Conditional NMPA Approval for MSI-H/dMMR Tumors
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The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co., Ltd’s pucotenlimab (HX008), a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug is indicated for microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) expressing tumors in two patient groups: (1) those with advanced colorectal…
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Tris Pharma and Pediatrix’s Methylphenidate Tablet, Ipsen’s Triptorelin Injection Awarded Priority Review by CDE
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The Center for Drug Evaluation (CDE) website shows that US-based Tris Pharma and Pediatrix Therapeutics’ methylphenidate hydrochloride sustained release chewable tablets, along with Ipsen Pharma’s injectable pamoic acid triptorelin injection, have been granted priority review status. The drugs are recognized for aligning with new pediatric drug varieties, dosage forms, and…
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InnoCare’s Tafasitamab Receives First Prescription in China’s Bo’Ao Lecheng Pilot Zone
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China-based InnoCare (HKG: 9969) announced that the first prescription for its pipeline candidate tafasitamab (trade name: Monjuvi) has been issued in the Bo’Ao Lecheng Medical Tourism Pilot Zone. The drug is intended for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) in patients not eligible for…
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Livzon’s V-01 and V-01D-351 Vaccines Show Strong Safety, Immunity as COVID Boosters
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China-based Livzon Pharmaceutical Group (HKG: 1513) released clinical data for its recombinant novel coronavirus fusion protein vaccine V-01 and bivalent vaccine V-01D-351, showing strong safety and immunogenicity as sequential booster shots. The vaccines are co-developed by Livzon subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology and the Chinese Academy of Sciences’ Institute…
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CANbridge Pharmaceuticals Doses First Patient in CAN103 Gaucher Disease Trial
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China-based rare disease firm CANbridge Pharmaceuticals announced the dosing of the first patient in a Phase I/II clinical trial for CAN103, its enzyme replacement therapy (ERT) candidate, in treatment-naïve patients with type I and III Gaucher disease. The trial marks progress in CANbridge’s partnership with WuXi Biologics (HKG: 2269) to…
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DAC Biotech’s DXC005 ADC Doses First Patient in Beijing Cancer Hospital Trial
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing of its antibody drug conjugate (ADC) DXC005 in a clinical study at Beijing Cancer Hospital’s gastrointestinal oncology department. The trial marks progress in DAC Bio’s pipeline of oncology-focused ADC candidates. Drug ProfileDXC005 combines a MUC-1 targeting antibody…
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Kexing Pharmaceutical Launches Phase III Influenza Vaccine Study in Chile
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China-based Kexing Pharmaceutical (SHA: 688136) announced the start of a Phase III clinical trial in Chile to evaluate the safety and immunogenicity of its quadrivalent influenza virus split vaccine in individuals aged three and older. The vaccine received market approval in China in June 2020. Study DetailsThe trial will enroll…
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Henlius Biotech’s HLX14 Biosimilar Wins TGA Approval for Global Phase III Osteoporosis Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) received approval from Australia’s Therapeutic Goods Administration (TGA) to conduct a global multi-center Phase III study of HLX14, its biosimilar of Amgen’s Prolia/Xgeva (denosumab), targeting postmenopausal osteoporosis in high-fracture-risk women. Study DetailsThe trial will evaluate the efficacy, safety, tolerability, and immunogenicity of HLX14…
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Luye Pharma’s Rotigotine Microspheres Meet Phase III Goals in Parkinson’s Study
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China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for rotigotine extended-release microspheres for injection (LY03003) in Parkinson’s disease (PD) met all pre-set endpoints. The trial demonstrated the drug’s efficacy and safety in early-stage PD patients. Study DetailsThe multi-center, randomized, double-blind, placebo-controlled study enrolled 294 early…
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Eli Lilly’s Retevmo Wins Special Approval in China’s Lecheng Medical Pilot Zone
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Eli Lilly & Co. (NYSE: LLY) has secured special approval for its RET kinase inhibitor Retevmo (selpercatinib) in China’s Bo’Ao Lecheng Medical Tourism Pilot Zone. The drug will be available at the Boao Super Hospital to treat RET gene fusion-positive non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and…
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Innovent Biologics’ Mazdutide Meets Phase II Goals in Type 2 Diabetes Study
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China-based Innovent Biologics Inc. (HKG: 1801) announced that its Phase II study of mazdutide (IBI362/OXM3) in Chinese patients with type 2 diabetes met primary endpoints. The multi-center, randomized trial compared mazdutide with placebo and dulaglutide in patients with inadequate glucose control despite lifestyle interventions and/or stable metformin doses (NCT04965506). Study…
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Sihuan Pharma’s Fourth-Gen Insulin Degludec NDA Accepted by NMPA for Review
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its New Drug Application (NDA) for a fourth-generation insulin degludec analog has been accepted by the National Medical Products Administration (NMPA) for review. The drug is the first insulin degludec analog to enter the marketing review stage after the originator…
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Sihuan Pharma’s Anaprazole Enters Phase II Study for Reflux Esophagitis
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its subsidiary Xuanzhu Biopharmaceutical Co., Ltd has received approval to proceed with a Phase II clinical study of anaprazole for the treatment of reflux esophagitis (RE) and associated symptoms, including acid reflux, heartburn, and retrosternal pain. Drug ProfileAnaprazole, the only…
