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AffaMed Technologies’ EDOF Intraocular Lenses Receive FDA Approval in Taiwan
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AffaMed Technologies, a joint venture between AffaMed Therapeutics and SIFI S.p.A., has announced that it has received market approvals from the Taiwan Food and Drug Administration for its MINI WELL, MINI WELL PROXA, and MINI WELL TORIC intraocular lenses, as well as the monofocal intraocular lens MINI 4 Ready. These…
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Everest Medicines’ Xerava Receives NMPA Approval for Complicated Intra-Abdominal Infections
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China-based Everest Medicines Limited (HKG: 1952) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in China, with plans to commercialize the product during the…
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Fosun Pharma’s Generic Remodulin Gains NMPA Approval for Pulmonary Arterial Hypertension
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its generic version of Remodulin (treprostinil) has been approved by the National Medical Products Administration (NMPA) for the treatment of pulmonary arterial hypertension (PAH). The drug is marketed to alleviate symptoms caused by exercise. Understanding PAH and…
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Agena Bioscience’s CYP2C19 Genotyping Kit Gains NMPA Approval for Cardiovascular Applications
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Shanghai-based Agena Bioscience announced that its human CYP2C19 genotyping test kit, co-developed with Simcere Pharmaceutical Group’s subsidiary Simcere Diagnostics, has been approved by the National Medical Products Administration (NMPA) as a Category III product. The kit is designed for the qualitative detection of CYP2C19 gene polymorphism in peripheral blood samples…
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Chipscreen’s Epidaza Receives TFDA Approval for Breast Cancer Treatment in Taiwan
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Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen. Indication and Target Patient…
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Lifetech’s IBS Angel Stent System Gains EU CE MDR Certification
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received CE MDR certification in the European Union (EU) for its in-house developed IBS Angel iron-based absorbable stent system. This marks the world’s first commercialization of such a stent system in the EU, targeting the minimally invasive surgical treatment…
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Lifetech Scientific’s IBS Angel Stent Receives CE MDR Certification in EU
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received CE MDR certification in the European Union (EU) for its in-house developed IBS Angel iron-based absorbable stent system. This marks the world’s first commercialization of such a product in the EU. The first-in-class product is designed for minimally…
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Haihe Pharma’s Glumetinib Gains Conditional NMPA Approval for NSCLC
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has received conditional market approval from the National Medical Products Administration (NMPA). This small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping, marking a significant advancement in…
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Haihe Pharma’s Glumetinib Receives Conditional Approval for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has obtained conditional market approval from the National Medical Products Administration (NMPA). The small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping. Development and Clinical FindingsGlumetinib, co-developed…
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BrightGene’s Generic Halaven Approved for Marketing in China
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Eisai’s (TYO: 4523) cancer therapy Halaven (eribulin). The approval signifies that BrightGene’s product, trade-named BoLiNing, has passed the generic quality consistency evaluation (GQCE). BoLiNing is…
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Hengrui’s Adebrelimab Receives NMPA Approval for Lung Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its adebrelimab (SHR-1316), a programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb). The molecule is now approved for use in combination with chemotherapy to treat first-line extensive stage small-cell lung…
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Sino Biopharmaceutical’s Bevacizumab Biosimilar Approved by NMPA
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. The approved indications for the biosimilar include the treatment of metastatic colorectal cancer (CRC), recurrent glioblastoma, and advanced metastatic or recurrent non-small cell lung cancer (NSCLC).…
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CanSino Biologics’ Inhalable COVID-19 Vaccine Gets EUA in Indonesia
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use authorization (EUA) for its inhalable recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Indonesia. This marks a significant milestone in the global fight against COVID-19, as the company expands its vaccine’s availability to another…
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Sanofi’s VaxigripTetra Approved for Pediatric Influenza Vaccination in China
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced receiving market approval from the National Medical Products Administration (NMPA) for its VaxigripTetra, a tetravalent influenza virus split vaccine, for use in children aged 6 to 35 months. This approval is significant as children are a primary susceptible population to influenza, with…
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Enhertu Approved in China for HER2-Positive Breast Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been approved by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs.…
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Novartis’ Revolade Approved for Severe Aplastic Anemia in China
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Revolade (eltrombopag olamine tablets). The oral thrombopoietin receptor agonist can now be used to treat severe aplastic anemia (SAA) in patients with inadequate previous remission following immunosuppressive therapy. Revolade:…
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BeiGene’s Tislelizumab Approved for Gastric Tumors in China
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that its programmed death-1 (PD-1) inhibitor tislelizumab has been approved in China as a first-line therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) tumors where PD-L1 is overexpressed. Specifically, tislelizumab is approved for use in combination with fluorouracil plus…
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Johnson & Johnson MedTech’s QDOT Catheter Approved in China for Atrial Fibrillation
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Johnson & Johnson MedTech’s next-generation QDOT micro diagnostic/ablation deflectable tip catheter, a disposable pressure monitoring radiofrequency catheter, has been approved for marketing in China. This innovative device is set to serve as a novel solution for the treatment of atrial fibrillation, marking a significant advancement in the field of electrophysiology.…
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MicroPort CardioFlow’s TAVI Product Approved in Thailand
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China-based MicroPort Scientific Corp’s (HKG: 0853) spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has announced receiving marketing approval in Thailand for its in-house developed next-generation transcatheter aortic valve implantation (TAVI) product, the VitaFlow Liberty transcatheter aortic valve implantation system, and the Alwide Plus balloon catheter. This approval expands the…
