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Sinovation Medical’s SinoLITT System and Fiber Kit Gain NMPA Approval for Epilepsy Treatment
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Sinovation (Beijing) Medical Technology Co., Ltd has announced that its in-house developed magnetic resonance monitoring semiconductor laser therapy equipment, the SinoLITT System, and disposable laser fiber kit have been approved by the National Medical Products Administration (NMPA) for use in laser treatment of local lesions in patients with drug-resistant epilepsy,…
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Hainan Poly Pharm Wins Health Canada Approval for Generic Cytovene-IV (Ganciclovir)
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a China-based pharmaceutical company, has announced that it has received marketing approval from Health Canada for its generic version of Roche’s Cytovene-IV (ganciclovir). This development marks a significant step for the company as it expands its international footprint in the generic drugs market.…
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Jiangsu Yuyue Medical Secures NMPA Approval for Semi-Automatic External Defibrillator
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Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (SHE: 002223), a China-based medical device company, has announced that it has received medical device marketing approval from the National Medical Products Administration (NMPA) for its semi-automatic external defibrillator (AED). Innovative Features of the AED ProductThe newly approved AED comes equipped with…
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Yifan Pharmaceutical Receives NMPA Approval for Hyruan ONE in Knee Osteoarthritis Treatment
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced receiving market approval from the National Medical Products Administration (NMPA) for its in-licensed Category 5.1 drug Hyruan ONE (sodium hyaluronate), which is indicated for use in knee osteoarthritis. Hyruan ONE: A Single-Dose Preparation for Knee OsteoarthritisHyruan ONE, originally developed by LG…
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AcoStream Second-Generation Receives NMPA Marketing Approval for Peripheral Vascular Use
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its second-generation AcoStream, a product designed to remove blood clots in the peripheral vascular system. Advancement in Blood Clot Removal TechnologyThe first-generation version of AcoStream was approved for marketing in…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Prolia
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving market approval from the National Medical Products Administration (NMPA) for its biosimilar version of US major Amgen’s Prolia (denosumab). This development marks Mabwell’s drug as the world’s second biosimilar of Prolia, which is used to treat osteoporosis in postmenopausal…
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Roche’s Cosentyx 300mg Dosage Approved by NMPA for Ankylosing Spondylitis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the National Medical Products Administration (NMPA) has approved the 300mg dosage regimen of Cosentyx (secukinumab) for use in treating ankylosing spondylitis (AS). This approval represents a significant advancement in the management of this chronic inflammatory disease. Approval Based on MEASURE 3…
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Huadong Medicine Wins NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide). This new biosimilar is intended for use in treating patients with type 2 diabetes. Liraglutide…
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IceCure Medical Gains NMPA Approval for Cryoablation Technology in China
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Israel-based IceCure Medical (NASDAQ: ICCM) has announced that it has obtained regulatory approval from China’s National Medical Product Administration (NMPA) for the commercial launch of its IceSense3 disposable cryoprobes product and its accompanying product console. This minimally-invasive cryoablation technology utilizes liquid nitrogen to freeze and destroy tumors, offering a treatment…
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CSPC Pharmaceutical Receives NMPA Approval for Generic Otezla Equivalent
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its generic version of Celgene’s Otezla (apremilast) has obtained marketing approval from the National Medical Products Administration (NMPA), signifying that it has passed the generic quality and efficacy consistency evaluation. Apremilast’s Background and Clinical Necessity in ChinaApremilast, an oral small…
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Acotec Scientific’s Vericor Receives Marketing Approval from Thailand FDA
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval for its Vericor peripheral support catheter from the Thailand Food and Drug Administration. This development marks a significant step for the company as it expands the reach of its medical devices in the Southeast Asian…
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CSPC Pharmaceutical’s mRNA Vaccine SYS6006 Receives Emergency Use Authorization in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has obtained an Emergency Use Authorization (EUA) for its in-house developed COVID-19 mRNA vaccine, SYS6006, in China. This approval marks a significant milestone as it is the first for a domestically developed mRNA product in the country. Design and…
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CSPC Pharmaceutical’s mRNA Vaccine SYS6006 Receives Emergency Use Authorization in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has revealed that it has obtained an Emergency Use Authorization (EUA) for its in-house developed COVID-19 mRNA vaccine, SYS6006, in China. This approval marks a significant milestone as it is the first for a domestically developed mRNA product in the country. SYS6006 Design…
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Guangdong Zhongsheng’s RAY1216 Receives Conditional Approval for COVID-19 Treatment
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor. The drug is set to be assessed as a treatment for mild to moderate COVID-19. Mechanism…
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AstraZeneca’s Calquence Receives Conditional Approval in China for MCL
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AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received conditional market approval in China for its next-generation Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is approved for the first indication in adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Clinical Trial…
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Jiangsu Recbio’s ReCOV Vaccine Receives Emergency Use Authorization in Mongolia
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced that it has received Emergency Use Authorization (EUA) from Mongolia for its ReCOV, a recombinant COVID-19 vaccine co-developed by the Chinese Academy of Sciences. This authorization marks a significant milestone in the global distribution and accessibility of the…
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Bayer’s Nubeqa Receives Additional NMPA Approval for mHSPC Treatment-Fineline Info & Tech
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German pharmaceutical giant Bayer AG (ETR: BAYN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its drug Nubeqa (darolutamide). The drug, which was previously approved for use in non-metastatic castration-resistant prostate cancer (nmCRPC) in February 2021, can now be used to…
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Hainan Poly Pharm’s Generic Gadovist Receives FDA Approval for MRI Use
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received marketing approval from the US FDA for its generic version of German giant Bayer’s (ETR: BAYN) Gadovist (gadobutrol injection). The drug is approved for use in contrast-enhanced magnetic resonance imaging (CE-MRI) examination of lesions in various…
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Hengrui Pharmaceuticals’ Dexmedetomidine Nasal Spray Approved by NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its dexmedetomidine hydrochloride nasal spray (1ml:500μg). The drug is approved for use as a preoperative sedation in adults. History and Innovation of DexmedetomidineDexmedetomidine was first applied…
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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…
