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Huadong Medicine Seeks Regular Approval for Elahere in Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its application for converting conditional to regular approval for Elahere (mirvetuximab soravtansine) has been accepted by the National Medical Products Administration (NMPA). This antibody drug conjugate (ADC) targets folate receptor α (FRα) and represents a significant step forward in the treatment…
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Huadong Medicine’s V30 Optical Radiofrequency Device Receives NMPA Review Approval
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has accepted a market filing for it’s subsidiary Viora Ltd.’s V30 optical radiofrequency therapy device. The Category III medical device is used for various medical aesthetics procedures, including skin tightening, hair removal, and treating vascular…
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Boehringer Ingelheim Appeals CNIPA’s Invalidation of Jardiance Patents
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The Intellectual Property Court of the Supreme People’s Court of China issued a notice, holding a hearing on the case of administrative dispute over the invalidity of invention patent between the appellant Boehringer Ingelheim and the appellee China National Intellectual Property Administration (CNIPA), as well as third parties of first…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HDM1005, a long-acting agonist targeting the GLP-1 receptor and GIP receptor. The drug is set for development to treat adult patients with heart failure with preserved…
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Huadong Medicine’s ADC HDM2005 Granted FDA Orphan Drug Designation for MCL
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL). Drug Mechanism and Preclinical ResultsPreclinical studies have shown that after HDM2005 enters the…
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SMPA Suspends Indobufen Procurement After Patent Infringement Verdict
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Shanghai’s Sunshine Medical Procurement All-In-One (SMPA) announced the suspension of procurement for indobufen, manufactured by Hunan Jiudian Pharmaceutical and Zhejiang Tongwu Biomedical, following a patent infringement verdict by the Hangzhou Intellectual Property Office. The decision highlights ongoing disputes over the drug’s patent status in China. BackgroundIndobufen, an isoindolylphenylbutyric acid derivative…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for OSA Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its HDM1005, a long-acting GLP-1/GIP receptor agonist, has received clinical trial approval from the National Medical Products Administration (NMPA) for obstructive sleep apnea (OSA) combined with obesity or overweight. The drug previously received nods for type 2 diabetes, weight loss, and…
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Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Denmark-based Novo Nordisk A/S’s (NYSE: NVO) Tresiba (insulin degludec) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is adult type 2 diabetes. Drug ProfileInsulin degludec, a…
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Huadong Medicine’s MediBeacon TGFR System Approved by NMPA for GFR Measurement
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for the MediBeacon Transdermal GFR System (TGFR), a Category III medical device licensed from US firm MediBeacon Inc. The device is designed to assess the glomerular filtration rate (GFR)…
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Huadong Medicine’s HDM1005 Shows Positive Results in Phase Ia/Ib Study
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced positive results from the Phase Ia/Ib study of HDM1005, a long-acting agonist targeting the GLP-1 and GIP receptors, in China. Study Details Safety ResultsThe most common adverse reactions were decreased appetite and gastrointestinal issues (nausea, vomiting, bloating), which were mild to moderate…
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Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
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Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin, a biosimilar version of Johnson & Johnson (J&J)’s auto-immune disease drug Stelara (ustekinumab), has been accepted for review by the National Medical Products Administration (NMPA). The Chinese firm is seeking approval for its use in…
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Huadong Medicine’s Ellansé M Filing Accepted by China’s NMPA
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that its market filing for the injectable polycaprolactone-based dermal filler Ellansé M has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company as it seeks to expand its presence in the…
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Huadong Medicine’s MediBeacon TGFR System Receives FDA Marketing Clearance
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing clearance from the US Food and Drug Administration (FDA) for its MediBeacon Transdermal GFR System (TGFR), a medical device co-developed with US partner MediBeacon Inc. The system is designed to evaluate renal function in adult patients with both impaired…
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Impact Therapeutics’ Senaparib Cleared by NMPA for Ovarian Cancer Therapy
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China-based Impact Therapeutics has announced receiving marketing clearance from the National Medical Products Administration (NMPA) for its senaparib to be used as maintenance therapy in adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The clearance is for patients who have achieved complete or partial…
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Huadong Medicine Gets FDA Nod for Phase I Study of HDM2006 in Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its Category 1 chemical drug, HDM2006, in patients with advanced solid tumors. This marks a significant step forward in…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for MAFLD/MASH Clinical Trial
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Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 receptor and GIP receptor and will be tested in metabolic associated fatty liver disease (MAFLD) and…
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Huadong Medicine Partners with SynerK PharmaTech for Hypertension siRNA Drug Development
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced a strategic partnership agreement with SynerK PharmaTech (Suzhou) Co., Ltd., an RNA-targeted therapies developer with operations in Boston, US, and Suzhou and Beijing, China. The collaboration aims to develop an angiotensinogen (AGT)-targeted small nucleic acid (siRNA) drug for the treatment of…
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Huadong Medicine’s HDM1005 Receives FDA Clearance for Heart Failure and Obesity Clinical Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, HDM1005. The drug will now proceed to clinical trials involving patients with heart failure with preserved ejection fraction (HFpEF) and obesity. HDM1005:…
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Huadong Medicine’s Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Arcalyst (rilonacept), a treatment for recurrent pericarditis (RP). This marks an expansion of the drug’s application in addressing autoimmune diseases. Rilonacept’s Mechanism and Global ApprovalsRilonacept is a recombinant…
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Huadong Medicine’s SaiYueXin Biosimilar Accepted for Review by NMPA for Pediatric Psoriasis
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Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted its filing for an additional indication for SaiYueXin, a biosimilar to Johnson & Johnson (J&J, NYSE: JNJ)’s Stelara (ustekinumab). The Chinese pharmaceutical company is now seeking approval for the use of SaiYueXin in…
