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MicroPort MedTech’s Vepack Filter Retriever Earns NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a prominent medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Vepack filter retriever. The Vepack system, comprising a catcher and a sheath/expander, is designed to percutaneously remove…
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Venus Medtech’s VenusP-Valve Receives Marketing Approval in Venezuela, Expanding Global Reach
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Venus Medtech (Hangzhou) Inc., (HKG: 2500), a leading medical device company, has announced that it has received marketing approval for its VenusP-Valve, a transcatheter pulmonary valve replacement (TPVR) system, in Venezuela. This marks another significant milestone for the company, as VenusP-Valve is the first self-expanding TPVR product to be approved…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo (efgartigimod alfa SC) in gMG
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced that China’s National Medical Products Administration (NMPA) has granted Biologic License Application (BLA) approval for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). Vygart Hytrulo is indicated for use in combination with conventional therapy…
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Shanghai Pharmaceuticals Secures NMPA Nod for Roche’s Valcyte Generic
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Roche’s Valcyte (valganciclovir). Valganciclovir is a crucial medication primarily used to treat cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS)…
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Ipsen S.A. Receives NMPA Green Light for Six-Month Diphereline Dosage in Central Precocious Puberty
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Ipsen S.A. (EPA: IPN; OTCMKTS: IPSEY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its six-month dosage form of Diphereline (triptorelin), a treatment for central precocious puberty (CPP), a condition that leads to early sexual development in children. This makes Diphereline the…
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Shanghai HeartCare Medical Secures Taiwan Approval for Homegrown Femoral Artery Occluder
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Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609), a leading player in the Chinese medical device industry, has announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its innovative vascular closure device, the first home-grown femoral artery occluder. The device, which was approved…
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Huadong Medicine’s Partner Arcutis Gets FDA Nod for Roflumilast Cream
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate…
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Eisai and Biogen’s Alzheimer’s Therapy Leqembi Receives Marketing Approval in Hong Kong
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Eisai Co., Ltd, a Japanese pharmaceutical company, along with its co-development partner Biogen Inc. (NASDAQ: BIIB), has announced that they have received marketing approval in Hong Kong for their Alzheimer’s disease (AD) therapy Leqembi (lecanemab). Known as 乐意保 in Chinese, the drug is administered intravenously every two weeks and is…
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Haohai Biotech’s Sodium Hyaluronate Gel Receives NMPA Approval for Aesthetic Treatments
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Shanghai Haohai Biology Science & Technology Co., Ltd (HKG: 6826, SHA: 688366) has announced that it has received Medical Device Registration Approval from the National Medical Products Administration for its innovative amino acid cross-linked sodium hyaluronate gel. The product is indicated for injection into the middle to deep layers of…
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Johnson & Johnson’s Opsumit Faces Generic Competition with Qilu Pharmaceutical’s Entry
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Johnson & Johnson (J&J, NYSE: JNJ)’s pulmonary hypertension treatment, Opsumit (macitentan), is set to encounter intensified competition in China following the approval of a generic version by local pharmaceutical company Qilu Pharmaceutical last month. Macitentan, classified as an endothelin receptor antagonist (ERA), initially received marketing approval in the US in…
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China Isotope & Radiation Corporation Secures NMPA License for Innovative Radiotherapy System
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China Isotope & Radiation Corporation (CIRC; HKG: 1763) has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its innovative gamma beam stereotactic radiotherapy system. This new system represents a significant advancement in the field of radiation therapy. The product streamlines the…
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Boston Scientific’s FARAPULSE Pulse Field Ablation System Earns NMPA Approval
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Boston Scientific Corporation (NYSE: BSX), a leading medical device company in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FARAPULSE pulse field ablation system. This system includes the FARAWAVE disposable cardiac pulse field ablation catheter and the FARASTAR cardiac…
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Ascentage Pharma’s Olverembatinib Receives Marketing Approval from Macau SAR for CML Treatment
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Macau Special Administrative Region (SAR) of China for its drug olverembatinib. This novel BCR-ABL1 tyrosine kinase inhibitor (TKI) is indicated for the treatment of adult patients with chronic-phase chronic myeloid…
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Allist Pharmaceuticals Receives NMPA Approval for Phase III Trial of Furmonertinib in EGFR Mutated NSCLC
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Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study. The study will assess the efficacy and safety of Allist’s furmonertinib in combination with chemotherapy compared to osimertinib (Tagrisso) in…
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Yantai Dongcheng Pharmaceutical Gets NMPA Approval for ⁹⁹ᵐTc Tetrofosmin Imaging Agent
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ⁹⁹ᵐTc tetrofosmin, a SPECT myocardial perfusion imaging agent. This radiopharmaceutical drug, which is utilized for myocardial perfusion imaging in…
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Shenzhen Salubris Pharmaceuticals’ Fotagliptin Receives NMPA Approval for Type 2 Diabetes Treatment
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug, fotagliptin. This drug is intended to improve blood sugar control in adult patients with type 2 diabetes,…
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Roche’s Alecensa Secures NMPA Approval as Adjuvant Therapy for Early-Stage NSCLC
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
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Novo Nordisk’s Esperoct Receives NMPA Approval, First Long-Acting Factor VIII for Hemophilia A in China
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The National Medical Products Administration (NMPA) has granted approval to Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical giant, for its drug Esperoct (turoctocog alfa pegol). This marks Esperoct as the first and only long-acting recombinant coagulation factor VIII approved in China for on-demand treatment and control of bleeding events, as…
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PharmaEssentia’s Besremi Receives Approval for Polycythemia Vera Treatment in China
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PharmaEssentia Corporation (TPE: 6446, FRA: 8Z1), a biopharmaceutical company based in Taiwan, has announced that its drug Besremi (ropeginterferon alfa-2b) has been approved by the National Medical Products Administration (NMPA) to treat adult polycythemia vera (PV) in China. This ultra-long-acting interferon, developed in-house, is already registered in the European Union,…
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Haisco Pharmaceutical’s Crisugabalin Gains NMPA Approval for Post-Herpes Neuralgia Treatment
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved an additional market approval filing for its drug candidate crisugabalin (HSK16149). This latest approval expands the drug’s indication to include the treatment of post-herpetic neuralgia…
