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Chinese NMPA Grants License to MicroPort Endovascular MedTech’s Venous Stent for Treating Vascular Conditions
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Shanghai MicroPort Endovascular MedTech Co., Ltd, a Chinese endovascular device manufacturer listed on the Shanghai Stock Exchange (SHA: 688016), has received a Category III medical device license from China’s National Medical Products Administration (NMPA) for its venous stent system. This product was granted special review status as an innovative medical…
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Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
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Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
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Allgens Medical Technology’s BonGold Receives Marketing Approval from Malaysia’s MDA
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Allgens Medical Technology Co., Ltd, a Beijing-based innovator in regenerative medicine materials and implantable devices listed on the Shanghai Stock Exchange (SHA: 688613), has secured marketing approval from the Medical Device Authority (MDA) of Malaysia for its flagship product, BonGold, an artificial bone repair material. BonGold is a biomimetic mineralized…
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Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
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Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this…
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Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
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Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
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Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…
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J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
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Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
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NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
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MicroPort MedTech’s ReeAmber Catheter Wins NMPA Nod for Peripheral Artery Treatments
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SHANGHAI—Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading player in the medical device industry, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its ReeAmber peripheral balloon dilation catheter. This next-generation device is designed to address a broad spectrum of vascular…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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China’s NMPA Grants Medical Device License to DaAn Gene’s Monkeypox Detection Kit
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GUANGZHOU—DaAn Gene Co., Ltd, a subsidiary of Sun Yat-sen University based in China (SHE: 002030), has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its Monkeypox virus nucleic acid detection kit, which utilizes the fluorescence PCR method. This development is significant…
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Changchun High & New Technology Secures NMPA Approval for Turner Syndrome Treatment
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CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin. This long-acting somatropin is now approved for use in growth disorders…
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AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
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BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ: AZN, LON: AZN) ‘s Fasenra (benralizumab) as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above. This decision follows the positive outcomes of the MIRACLE Phase III clinical…
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Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
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COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
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Lepu Medical Secures Approval for RECATCHOR Catheter, Enhancing Cardiovascular Procedures
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has secured marketing approval from the National Medical Products Administration for its innovative RECATCHOR device. This anchored balloon dilation catheter is designed to facilitate the anchoring of guidewires and assist in the exchange…
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Robotrak Secures NMPA License for China’s First Smart Ophthalmic Navigation Laser
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Robotrak, a Nanjing-based ophthalmic innovation platform, has secured a Category III medical device license from the National Medical Products Administration (NMPA) for its cutting-edge smart ophthalmic navigation laser. This marks the first such device of its kind in China. The all-solid-state laser photocoagulation device offers a suite of advanced features,…
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Lepu Scientech Secures NMPA Approval for MemoSORB Biodegradable Atrial Septal Defect Occluder
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd. (HKG: 2291) has announced that it has received a medical device license from China’s National Medical Products Administration (NMPA) for its innovative MemoSORB biodegradable atrial septal defect occluder. This cutting-edge device offers significant advantages over traditional nitinol occluders by markedly reducing inflammatory responses,…
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Sino Medical Secures Moroccan Approvals for NC Rockstar Catheter and HT Supreme Stent System
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Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in China’s medical device sector, has secured marketing approvals in Morocco for its NC Rockstar non-compliant coronary artery balloon dilation catheter and the HT Supreme drug-eluting stent system. The NC Rockstar catheter is designed for balloon dilation of autologous coronary…
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Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
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Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
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Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
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Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced that their Alzheimer’s disease therapy, Leqembi (lecanemab), has received approval in the United Arab Emirates (UAE) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and/or mild AD dementia.…
