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C4 Therapeutics’ CFT8919 Earns FDA Approval for Clinical Trials Targeting EGFR L858R Mutations
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US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
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Zai Lab’s Vyvgart Receives NMPA Review for Subcutaneous Injection Form in gMG Treatment
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products Administration (NMPA) has accepted for review a Biologics License Application (BLA) for Vyvgart (efgartigimod alfa) in subcutaneous injection form. The intended indication is for adult patients with generalized myasthenia gravis (gMG). Exclusive Rights and Prior…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-9815 Radiodiagnostic Drug Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug. HRS-9815: A Radiodiagnostic…
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Transcenta Holding Ltd Secures Global Clinical Trial Approvals for Osemitamab in Gastric Cancer
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China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug Evaluation (CDE) and South Korea’s Ministry of Food and Drug Safety (MFDS) for their pipeline candidate osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. Both regulatory bodies have approved the plan for TranStar 301, a global Phase…
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Shanghai BDgene Technology Receives US FDA Approval for HSV-1 Stromal Keratitis Gene Therapy
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Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced receiving approval from the US FDA to conduct a clinical study for its pipeline candidate, BD111, in the treatment of type I herpes simplex virus (HSV-1) stromal keratitis. HSV-1 is a pathogen responsible for a range of diseases, including oral…
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HutchMed Ltd Initiates Phase I Clinical Study for SHP2 Inhibitor HMPL-415 in Solid Tumors
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China-based HutchMed Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of a Phase I clinical study for its investigational novel selective allosteric inhibitor, HMPL-415, which targets Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2). The trial, aimed at assessing the molecule in general solid tumors, marked its first patient dosing…
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Shanghai Fosun Pharmaceutical Submits Daxibotulinumtoxin A (RT002) for NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a China-based pharmaceutical company, has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed daxibotulinumtoxin A for injection (RT002). The drug has been filed for use in adult cervical dystonia, marking a significant step…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-1703 Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its anti-interleukin-5 (IL-5) antibody, SHR-1703. The drug candidate is set to be assessed as a treatment for eosinophilic granulomatous polyangiitis, a rare…
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3SBio Inc. Receives NMPA Approval for Nalfurafine Tablets to Treat Hemodialysis-Related Pruritus
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China-based 3SBio Inc. (HKG: 1530) has announced receiving marketing approval from the National Medical Products Administration (NMPA) in China for its nalfurafine orally disintegrating tablets. The drug is used to improve pruritus in hemodialysis patients in situations where existing treatment efficacy is not ideal. This marks the first and only…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Esflurbiprofen Patch Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its esflurbiprofen patch, a generic version of Japan firm Taisho Pharmaceutical’s Loqoa tape. The intended indication for the patch…
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CSPC Pharmaceutical Group Receives Marketing Approval for Desvenlafaxine in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving marketing approval in China for its Category 3 product, desvenlafaxine, signifying that it has passed the generic quality and consistency evaluation (GQCE). Desvenlafaxine: A Third-Generation Anti-DepressantDesvenlafaxine is a third-generation anti-depressant that functions by inhibiting the reuptake mechanism of 5-hydroxytryptamine norepinephrine,…
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AbbVie’s Rinvoq Receives NMPA Approval for Moderate to Severe Crohn’s Disease Treatment
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US pharmaceutical firm AbbVie (NYSE: ABBV) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Rinvoq (upadacitinib), a selective JAK inhibitor, to treat moderate to severe active Crohn’s disease in adult patients who have a poor or intolerant response or a contraindication to one or…
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Luye Pharma’s Goserelin Acetate Microspheres Approved by NMPA for Prostate Cancer Treatment
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, a treatment for prostate cancer requiring androgen castration therapy. This innovative formulation is designed to provide a smoother drug release during the…
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Huadong Medicine’s Liraglutide Biosimilar Gains NMPA Approval for Weight Loss Indication
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This glucagon-like peptide-1 (GLP-1) receptor agonist is now approved for use in weight loss management. Expanding…
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Abbisko Therapeutics’ EGFR Inhibitor ABSK112 Clears FDA for Global Phase I NSCLC Study
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a global Phase I clinical study for its next-generation EGFR inhibitor, ABSK112, in non-small cell lung cancer (NSCLC). This development highlights the company’s progress…
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Jacobio Pharma’s KRAS Inhibitor Glecirasib Advances to Pivotal Pancreatic Cancer Trial
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a pivotal clinical study for its novel KRAS G12C inhibitor, glecirasib, in pancreatic cancer. This development marks glecirasib as the world’s first KRAS inhibitor to reach the…
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InnoCare Pharma Initiates Clinical Trial for TYK2 Inhibitor ICP-488 in Psoriasis Patients
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced a significant milestone in the clinical development of its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, with the dosing of the first psoriasis patient in China. This marks a progressive step towards addressing the treatment needs for psoriasis and other…
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NMPA Approves Pitolisant for Narcolepsy-Related Excessive Daytime Drowsiness and Cataplexy
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The National Medical Products Administration (NMPA) has approved pitolisant as a treatment for excessive daytime drowsiness (EDS) or cataplexy in adults with narcolepsy. This marks a significant advancement in the therapeutic options available for narcolepsy patients in China. Pitolisant’s Mechanism of Action and International DesignationsPitolisant is a selective histamine 3…
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Ascentage Pharma’s Olverembatinib Gets NMPA Greenlight for Phase III Study in Ph+ ALL
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China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a pivotal regulatory Phase III clinical study. The study will evaluate the combination of its Category 1 drug, olverembatinib, with chemotherapy in newly diagnosed Philadelphia chromosome positive (Ph+) acute…
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Amoytop Biotech’s Pegfilgrastim (Y Shape) Approved for Marketing by NMPA
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has received marketing approval from the National Medical Products Administration (NMPA) for its pegfilgrastim (Y shape) product. This Category 1 biologic is designed for use in patients with non-myeloid malignant tumors to reduce the incidence of infection with febrile neutropenia during treatment with…
