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AstraZeneca’s Soliris Secures Third Indication for Myasthenia Gravis in China
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that its Soliris (eculizumab), a first-in-class C5 complement inhibitor, has obtained its third indication approval from the National Medical Products Administration (NMPA) in China. This approval allows the use of Soliris to treat adult patients with refractory generalized Myasthenia gravis (gMG)…
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Abbisko Therapeutics Initiates Phase II Study for Pimicotinib in Chronic Graft-Versus-Host Disease
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib), which is aimed at treating chronic graft versus host disease (cGVHD). Understanding cGVHD and the Role of CSF-1R InhibitionThe pathological and physiological…
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NHSA Launches 2023 NRDL Update Process with New Work Plan and Public Feedback Period
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The National Healthcare Security Administration (NHSA) has commenced the process for the annual update of the National Reimbursement Drug List (NRDL) by releasing the “NRDL Adjustment 2023 Work Plan” and associated documents. These documents are open for public feedback until June 15, ensuring transparency and stakeholder engagement in the update…
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Genor Biopharma’s Geptanolimab NDA for PTCL Rejected by China’s NMPA
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has declined its New Drug Application (NDA) for geptanolimab, a programmed-death 1 (PD-1) inhibitor, for the treatment of recurrent/refractory peripheral T-cell lymphoma (PTCL). The drug, which was under development to treat a range of…
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CSPC Pharmaceutical’s CPO301 Earns Fast-Track Status for EGFR Mutant NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC), CPO301, has received fast-track status for the treatment of recurrent/refractory (R/R) or EGFR targeted therapy ineffective metastatic EGFR mutant non-small cell lung cancer (NSCLC). Preclinical Efficacy and Safety of CPO301Preclinical studies have demonstrated that…
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Salubris Pharmaceuticals’ Enarodustat Gains NMPA Approval for Renal Anemia Treatment
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the National Medical Products Administration (NMPA) for enarodustat, a novel drug candidate specifically targeting renal anemia. Enarodustat is a hypoxia-inducible factor proline hydroxylase inhibitor (HIF-PHI) developed for anemia in non-dialysis adult chronic kidney disease (CKD) patients.…
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Baheal Pharmaceutical Partners with RabPharma for Commercialization of RAB001 in China
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China-based health services and distribution giant Baheal Pharmaceutical Group has announced a strategic partnership with compatriot firm RabPharma. The collaboration focuses on the commercialization of RabPharma’s peptide-drug conjugate (PDC), RAB001, which targets osteonecrosis in mainland China. Financial details of the agreement have not been disclosed. RAB001: A Promising Treatment for…
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CDE Releases 71st Batch of Generic Reference Preparations with Updates and New Injecables
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The Center for Drug Evaluation (CDE) has released the 71st batch of chemical generic reference preparations, marking a significant update in the generic drug sector. This batch includes 24 new specifications, of which 7 are injectables. Additionally, 33 previously published specifications have been updated, with information on 10 injectables being…
