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China: NMPA Approves New Therapies | 2026
Rexobin Approved for Pustular Psoriasis Flares July 29, 2026 The NMPA has authorized Rexobin injection, submitted by Shanghai Huatai Biological Pharmacy, through the priority review pathway. The treatment is intended for adults weighing at least 40 kilograms who experience flare-ups of generalized pustular psoriasis. The approval introduces an additional therapy for patients affected by this rare and severe inflammatory skin condition. The authorization was announced on July
Takeda Secures Landmark Approval for Orzeyful in China | iPharmaCenter
Takeda China has received approval from the National Medical Products Administration (NMPA) for Orzeyful (oveporexton) as a treatment for Narcolepsy Type 1 (NT1). Also read: Germany Enacts 2026 Healthcare Reform to Curb Statutory Insurance Spending This authorization establishes Orzeyful as the first oral orexin receptor 2 (OX2R)-selective agonist in the Chinese market and represents the first therapy approved specifically to address the underlying physiological cause of the
Orpathys wins conditional NMPA approval for MET‑amplified gastric cancer in China | iPharmaCenter
HUTCHMED has secured conditional approval from China’s National Medical Products Administration for savolitinib, marketed as Orpathys, in a new gastric cancer indication. The decision allows oncologists to use Orpathys in adults with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma whose tumours harbor MET amplification and who have already been through at least two systemic treatment regimens. Also read: CVS Pharmacy Joins Medicare
China Clears Vanflyta for FLT3-ITD Positive AML, Marking a New Option in Targeted Leukemia Care | iPharmaCenter
China’s regulatory authority has approved Vanflyta (quizartinib) for adults with newly diagnosed acute myeloid leukemia (AML) harboring FLT3-ITD mutations, introducing a targeted therapy option into frontline treatment. The drug is to be used alongside standard induction and consolidation chemotherapy, followed by maintenance therapy. Also read: EULAR Annual Meeting in London, UK | 2026 The decision is supported by data from the phase 3 QuANTUM-First study, which showed that


Exdensur (depemokimab) wins NMPA approval in China for severe eosinophilic asthma
China’s National Medical Products Administration (NMPA) has authorised Exdensur (depemokimab) as an add-on maintenance therapy for severe asthma with an eosinophilic phenotype in adults and adolescents aged 12 years and older. This decision makes Exdensur the first ultra-long-acting biologic available in China for this patient population, offering a new option for those whose disease remains uncontrolled despite standard treatment. Details of Phase III SWIFT-1 and SWIFT-2 tri
China Approves Myqorzo and Redemplo, Expanding Options in Hypertrophic Cardiomyopathy and Familial Chylomicronaemia Syndrome | iPharmaCenter
China’s National Medical Products Administration has authorised two innovative therapies licensed by Sanofi, strengthening treatment options in serious cardiovascular and lipid disorders. Myqorzo (aficamten) has been approved for adults with obstructive hypertrophic cardiomyopathy, while Redemplo (plozasiran) has been cleared to reduce triglyceride levels in adults with familial chylomicronaemia syndrome who require dietary management. iPharmaCenter Consulting: Find services
China Grants Approval to Nucala for COPD Management | iPharmaCenter
China’s National Medical Products Administration has officially cleared Nucala (mepolizumab) as a supplemental maintenance therapy for adults suffering from chronic obstructive pulmonary disease (COPD). This authorization specifically targets patients whose condition remains poorly managed and is linked to elevated levels of eosinophils in the blood. Nucala: A Milestone in Biological Respiratory Care Nucala stands as the inaugural monthly biological treatment in China indic
Enhertu approved in China for HER2‑low or HER2‑ultralow metastatic breast cancer | iPharmaCenter
Enhertu (trastuzumab deruxtecan) has received marketing authorization in China as the first HER2‑targeting therapy for people with HER2‑low or HER2‑ultralow metastatic breast cancer whose disease has worsened after at least one endocrine treatment in the metastatic setting. The decision is supported by phase 3 DESTINY‑Breast06 data showing clinically meaningful improvements in progression‑free survival versus standard chemotherapy. New indication in China The National Medic
China NMPA Approves Pfizer’s Matazisimab (You Ruiting) for Routine Prophylaxis in Hemophilia Patients with Inhibitors | iPharmaCenter
China’s NMPA has approved Pfizer’s matazisimab (You Ruiting) for routine prophylaxis in hemophilia A or B patients with inhibitors, backed by pivotal BASIS data
Vyloytm (zolbetuximab) Gains Approval in China for First-Line Treatment of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma | iPharmaCenter
China’s National Medical Products Administration (NMPA) has approved Vyloytm (zolbetuximab) for use alongside fluoropyrimidine- and...
China Approves GSK’s Nucala for Chronic Rhinosinusitis with Nasal Polyps in Adults | iPharmaCenter
Nucala has become the first anti-interleukin-5 therapy approved in China for treating adults with chronic rhinosinusitis with nasal...
HUTCHMED and Innovent Announce Conditional Approval of Fruquintinib and Sintilimab Combination for Advanced Endometrial Cancer in China | iPharmaCenter
HUTCHMED and Innovent Biologics have announced that the China National Medical Products Administration (NMPA) has conditionally approved...
HUTCHMED Announces Continued Inclusion of Savolitinib in China’s National Reimbursement Drug List at Current Terms | China NRDL 2024 | iPharmaCenter
HUTCHMED has announced that the China National Healthcare Security Administration (NHSA) has renewed the inclusion of savolitinib in the...


China's 2024 National Reimbursement Drug List Expands Access to 91 New Drugs | iPharmaCenter
The 2024 National Reimbursement Drug List (NRDL) unveiled by China's National Healthcare Security Administration adds 91 new drugs,...
AstraZeneca and Daiichi Sankyo’s drug, Enhertu approved in China for HER2-mutant mNSCLC | iPharmaCenter
AstraZeneca and Daiichi Sankyo’s drug, Enhertu (trastuzumab deruxtecan), have been granted conditional approval in China as a treatment...
China's NMPA Grants Approval for Padcev (Enfortumab Vedotin) for Advanced Urothelial Cancer | iPharmaCenter
China’s National Medical Products Administration (NMPA) has officially approved Padcev (enfortumab vedotin) for the treatment of adult...
Enhertu Receives Conditional Approval in China for Advanced HER2-Positive Gastric Cancer | iPharmaCenter
Enhertu, developed by AstraZeneca and Daiichi Sankyo, has gained conditional approval in China for use in patients with advanced or...
HUTCHMED's NDA for Tazemetostat in China Receives Priority Review for Relapsed/Refractory Follicular Lymphoma | iPharmaCenter
HUTCHMED (China) Limited has announced that the New Drug Application (NDA) for tazemetostat, aimed at treating adult patients with...


Leqembi Launched in China for Treating Alzheimer's Disease | 2024 | iPharmaCenter
Eisai and Biogen announced that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, Leqembi (ecanemab) (known in...


China Approves Tagrisso Combined with Chemotherapy as First-Line Treatment for Advanced EGFR-Mutated Lung Cancer | 2024 | iPharmaCenter
China’s National Medical Products Administration (NMPA) has granted approval for AstraZeneca’s Tagrisso (osimertinib), combined with...


China Drug Approvals | 2024 | iPharmaCenter
May 13, 2024 Eisai's Fycompa was approved for generalized tonic-clonic seizures Approved in China for the supplementary management of...


China Drug Approvals | 2023 | NMPA Drug Approvals | Pharma | Healthcare | China | iPharmaCenter
December 21, 2023 Takeda's Livtencity was approved in China for CMV infections Takeda declares the approval from China NMPA for...


China Drug Approvals | 2022 | NMPA Drug Approvals | Pharma | Healthcare | China | iPharmaCenter
Takeda announced that the National Medical Products Administration (NMPA) of China approved Exkivity (mobocertinib) for treating adults...


China Healthcare News | Drug News | iPharmaCenter
December 23, 2022 Eisai initiated data submission for BLA of lecanemab in China for Alzheimer's Eisai and Biogen announced that they have...
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