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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…
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Sesen Bio Terminates Vicineum Development After FDA Talks, Citing Phase III Costs
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Sesen Bio Inc. (NASDAQ: SESN) announced the termination of clinical development for Vicineum (VB4-845), its next-generation antibody drug conjugate (ADC) for non-muscle invasive bladder cancer, following discussions with the U.S. FDA. The decision cited costs associated with conducting another Phase III study. Drug Profile and Licensing DealVicineum, developed on Sesen…
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Roche’s Chugai Launches Edirol in China for Postmenopausal Osteoporosis
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Swiss pharma giant Roche’s subsidiary Chugai Pharmaceutical Co Ltd has officially launched Edirol (eldecalcitol), an active Vitamin D3 derivative, in China. The drug, approved in December 2020 for treating osteoporosis in postmenopausal women, will be promoted by Chugai Pharma China Co., Ltd and Roche’s local unit. Drug ProfileEdirol, first approved…
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Humanwell Healthcare’s RFUS-144 Wins NMPA Approval for Pruritus Clinical Study
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that its Category 1 drug RFUS-144 has received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of pruritus. The drug, a selective opioid agonist, was previously approved for pain relief in China. Drug ProfileRFUS-144 is being…
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Hengrui Medicine Launches Revelutamide for Metastatic Prostate Cancer in China
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Hengrui Medicine has launched revelutamide (SHR3680; trade name: Erion), China’s homegrown innovative androgen receptor (AR) inhibitor, for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. The drug received conditional market approval from the National Medical Products Administration (NMPA) in June 2022 and was first prescribed at…
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HutchMed Initiates Phase I Study of CD47 Monoclonal Antibody HMPL-A83 in China
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I clinical study for HMPL-A83, its monoclonal antibody (mAb) targeting CD47, in patients with advanced malignant tumors. The first patient was dosed on July 15, 2022. Study DetailsThe multi-center, open-label Phase I trial (NCT05429008) will evaluate the safety,…
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Kexing Pharmaceutical’s SHEN26 COVID-19 Drug Receives NMPA Approval for Clinical Trials
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China-based Kexing Pharmaceutical (SHA: 688136) announced that its oral small-molecule COVID-19 drug SHEN26, co-developed with Shenzhen Antaiwei Biopharmaceutical Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials. Drug ProfileSHEN26 is a novel coronavirus polymerase (RdRp) inhibitor that blocks viral nucleic acid synthesis.…
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ImmuneOnco’s IMM2902 Receives FDA Fast-Track Designation for CD47/HER2 Targeting
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to its bispecific antibody (BsAb)-receptor recombinant protein IMM2902, targeting human CD47 and HER2. The product is the only CD47/HER2 BsAb to enter clinical trials globally. Drug ProfileIMM2902 inhibits tumor cell growth by…
