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MicroPort MedBot’s Dragonfly Eye 3D Endoscopy Earns CE Mark for Intraperitoneal Procedures
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that its in-house developed Dragonfly Eye 3D electronic intraperitoneal endoscopy has received the CE mark, a significant milestone for the company’s innovative medical device. High-Definition Imaging and Surgical PrecisionThe Dragonfly Eye 3D is a state-of-the-art three-dimensional electronic abdominal endoscope designed…
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Qilu Pharmaceutical’s Iruplinalkib Receives NMPA Approval for ALK+ NSCLC Treatment
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China-based Qilu Pharmaceutical has announced that its Category 1 chemical drug, iruplinalkib, an ALK inhibitor, has obtained marketing approval from the National Medical Products Administration (NMPA). This approval allows the use of iruplinalkib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor anaplastic lymphoma…
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Jiangsu Hengrui’s Oteseconazole (SHR8008) Approved by NMPA for Severe Vulvovaginal Candidiasis
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The National Medical Products Administration (NMPA) has granted approval to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) for its drug oteseconazole (SHR8008), which will be used to treat severe vulvovaginal candidiasis (VVC). This marks a significant advancement in the treatment options for patients suffering from VVC. Oteseconazole: A Selective…
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EOC Pharma’s Lusutrombopag Receives NMPA Approval for Chronic Liver Disease Treatment
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China-based EOC Pharma Group has announced that its drug, lusutrombopag, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of chronic liver disease (CLD) patients with thrombocytopenia. The drug is specifically indicated for patients being prepared for surgery, including diagnostic procedures. Lusutrombopag: An Oral TPO-RA…
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Teva Pharmaceutical’s Copaxone Approved by NMPA for Multiple Sclerosis Treatment in China
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The National Medical Products Administration (NMPA) website has indicated that Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) innovative chemical drug Copaxone (glatiramer acetate) has been approved for use as a treatment for multiple sclerosis (MS) in China. This marks the second MS therapy available in China following Bristol-Myers Squibb (BMS, NYSE:…
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AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its fixed dose combination of dapagliflozin and metformin, a treatment for type 2 diabetes. This once-daily compound is now the only sustained-release formulation in China…
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CStone Pharmaceuticals’ Gavreto Approved for First-Line RET Fusion-Positive NSCLC Treatment in China
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) of China has granted approval for a supplemental new drug application (sNDA) for Gavreto (pralsetinib). This approval is for the first-line treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC).…
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Jiangsu Hengrui’s Dalpiciclib Approved for Initial Therapy in HR+, HER2- Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving another indication approval for its drug dalpiciclib (SHR6390). The approval is for use as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor…
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Fosun Kite’s Yescarta Gains NMPA Approval for Refractory Large B-Cell Lymphoma
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China-based Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196; HKG: 2196) and Gilead (NASDAQ: GILD) subsidiary Kite Pharma, has announced that its product Yescarta (axicabtagene ciloleucel) has obtained marketing approval from the National Medical Products Administration (NMPA) for a new indication…
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Sino Medical Sciences Technology Secures FDA Thailand Approval for NC Rockstar Balloon Catheter
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received market approval from the Food and Drug Administration of Thailand for its NC Rockstar noncompliant balloon catheter. This development marks a significant step for the company’s expansion into the Southeast Asian medical device market. Product Composition…
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NMPA Approves XZenith Biopharm’s Anaprazole for Duodenal Ulcer Treatment
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The National Medical Product Administration (NMPA) has granted marketing approval for anaprazole, a proton pump inhibitor (PPI) developed by China-based XZenith Biopharm. This home-grown Category 1 drug is now approved for use in treating duodenal ulcers. Anaprazole’s Mechanism of Action and Clinical AdvantagesAnaprazole, a benzimidazole compound, functions by inhibiting gastric…
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Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer
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Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received an indication extension from China’s National Medical Products Administration (NMPA) for its biologic drug nimotuzumab. This new approval marks an expansion of the drug’s use beyond its original authorization in nasopharyngeal carcinoma (NPC) to now…
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Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
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US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus-based gene therapy co-developed by Roche. This treatment is designed for ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD)…
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Australian Scleral Lens Epicon A Approved by China’s NMPA as 10th Novel Product
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Ruitai Bio’s Epicon A, a scleral lens product from Australia, has been approved by the National Medical Products Administration (NMPA) in China, marking it as the 10th novel product supported by Lecheng’s real-world data. This Category III medical device is set to make a significant impact on the correction of…
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WinHealth Pharma Receives NMPA Approval for Glycerol Phenylbutyrate for Urea Cycle Disorders
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China-based Hong Kong WinHealth Pharma Group Ltd has announced receiving market approval from the National Medical Products Administration (NMPA) for its glycerol phenylbutyrate, a drug used as a long-term treatment for patients with urea cycle disorders (UCDs). This approval specifically targets patients who cannot achieve disease control through protein intake…
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NMPA Approves Suzhou MicroPort Joint Medical Technology’s Zirconium Niobium Alloy Femoral Head for Hip Replacement
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The National Medical Products Administration (NMPA) has granted marketing approval to Suzhou MicroPort Joint Medical Technology Co., Ltd for its zirconium niobium alloy femoral head. This development marks a significant advancement in the field of orthopedic implants, offering a new option for patients undergoing total hip joint replacement surgery. Product…
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Sinocelltech Group Receives NMPA Approval for Biosimilar Version of Humira
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid…
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China Medical System’s Diazepam Nasal Spray Receives NMPA Approval for Cluster Seizures
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China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its diazepam nasal spray. This dosage form is the first of its kind to gain approval in China and is set for use as a…
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AstraZeneca’s Soliris Secures Third Indication for Myasthenia Gravis in China
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that its Soliris (eculizumab), a first-in-class C5 complement inhibitor, has obtained its third indication approval from the National Medical Products Administration (NMPA) in China. This approval allows the use of Soliris to treat adult patients with refractory generalized Myasthenia gravis (gMG)…
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Salubris Pharmaceuticals’ Enarodustat Gains NMPA Approval for Renal Anemia Treatment
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the National Medical Products Administration (NMPA) for enarodustat, a novel drug candidate specifically targeting renal anemia. Enarodustat is a hypoxia-inducible factor proline hydroxylase inhibitor (HIF-PHI) developed for anemia in non-dialysis adult chronic kidney disease (CKD) patients.…
