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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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ZAP-X Gyroscopic Radiosurgery Platform Receives NMPA Approval for Brain Tumor Treatment
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US-based Zap Surgical Systems Inc. has announced that it has received market approval in China for its innovative ZAP-X Gyroscopic Radiosurgery Platform. This advanced system is designed for the treatment of brain tumors, lesions, and other head and neck conditions. The ZAP-X system utilizes unique gyroscopic mobility to direct radiosurgical…
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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…
