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Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for its drug acoramidis, commercially known as Beyonttra. This near-complete (≥90%) transthyretin (TTR) stabilizer can now be used to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) in the European Union (EU).…
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China-based Lifetech Scientific Corporation (HKG: 1302) announced that it has received market approval from the National Medical Products Administration (NMPA) for its aortic stent graft system, co-developed by Fuwai Hospital. Product OverviewThe aortic stent graft system is the first of its kind in China specifically designed for chimney technology. It…
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced that the National Medical Products Administration (NMPA) has granted market approval for its Toumai single-arm single-hole laparoscopic surgical robot. The device is designed to perform minimally invasive surgeries through a single incision, offering clinical benefits such as reduced scarring and faster…
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US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s National Medical Products Administration (NMPA) for two of its biologics: Rybrevant (amivantamab) for non-small cell lung cancer (NSCLC) and Talvey (talquetamab) for multiple myeloma. The approvals mark J&J’s latest expansion in China’s oncology market. Rybrevant…
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Stason Pharmaceuticals Inc.’s Purinethol (mercaptopurine). The drug, classified as a Category 2.2 chemical drug, is now approved for the treatment of children with…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’ Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). The latest approval is for the treatment of moderate to severe persistent allergic asthma,…
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Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Organon’s (NYSE: OGN) Liptruzet (ezetimibe, atorvastatin), becoming the first such product approved in China. The drug, used to treat hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH), was…
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China-based Nuance Pharma announced that it has received regulatory approval in Macau for its Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD). This approval marks a significant milestone in the company’s efforts to expand the availability of Ohtuvayre in the Greater China region. Innovative Dual-Inhibitor TherapyEnsifentrine…
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab (trade name: Erbitux). The drug, to be traded under the name Datailai, is approved…
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China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its Kangyueda (stapokibart), an anti-IL-4Rα monoclonal antibody (mAb), this time for its use in seasonal allergic rhinitis. Stapokibart previously gained NMPA approval for the treatment of severe atopic…
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US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Emblaveo (aztreonam and avibactam). The drug is the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic approved for use in combination with metronidazole for patients 18…
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its subsidiary Beijing Tide Pharmaceutical Co., Ltd has received marketing approval from the National Medical Products Administration (NMPA) for its tulobuterol patch. This marks the first approval of its kind domestically in China for a transdermal patch designed to relieve respiratory distress…
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Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US Food and Drug Administration (FDA) for another indication of its Susvimo (ranibizumab) 100 mg/mL, this time to treat diabetic macular edema (DME). With this approval, Susvimo becomes the first and only FDA-approved treatment shown to…
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The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow…
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received marketing approval from the Medical Device Authority (MDA) of Malaysia for its NC Rockstar non-compliant coronary artery balloon dilation catheter. The device is designed for balloon catheter dilation of autologous coronary artery or bypass stenosis to improve…
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received FDA approval for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultra-low (IHC 0 with membrane staining) breast…
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its coronary rapamycin drug balloon dilation catheter, Fireliums, for dilation treatment of primary coronary artery bifurcation stenosis. This approval marks a significant milestone in the commercialization of this…
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its TomaHawk intravascular shock wave therapy device, disposable coronary intravascular shock wave catheter (TomaHawk coronary intravascular shock wave catheter system). This approval marks a significant milestone in the…
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has cleared their supplemental Biologics License Application (sBLA) for once every four weeks Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. The drug is approved in the US for the treatment…