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Jingxin Pharmaceutical’s Didaxini Gains NMPA Approval as Category 1 Drug
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Jingxin Pharmaceutical Co., Ltd (SHE: 002020), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Category 1 drug, Didaxini. This drug is a partial agonist of GABAA (γ-aminobutyric acid A) receptors and selectively targets the α1 subtype of…
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Sino Medical Secures Market Approval in Taiwan for NC Rockstar Coronary Catheter
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Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that its NC Rockstar non-compliant coronary artery balloon dilation catheter has received market approval in Taiwan, China. This innovative device, which includes a TIP head, balloon protective sheath, balloon, and inner tube, is designed for balloon catheter dilation of autologous coronary…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy. The approval is…
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Tonghua Dongbao Pharmaceuticals Secures NMPA Approval for Biosimilar Liraglutide
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese 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 (NYSE: NVO) GLP-1 receptor agonist Victoza (liraglutide), which is indicated for blood sugar control in type 2 diabetes patients.…
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Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
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Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) for its generic budesonide nasal spray. The product is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis, and for the prevention of nasal…
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Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
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The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory…
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Valgen Secures NMPA Approval for China’s First Transcatheter Mitral Valve Clamp System
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Hangzhou-based Valgen Holding Corporation has received market approval from the National Medical Products Administration (NMPA) for its innovative DragonFly transcatheter mitral valve clamp system, marking it as the first of its kind in China. The DragonFly system is designed for use in transcatheter mitral valve edge-to-edge repair (TEER) procedures and…
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Ambio Gains FDA Approval for Generic Forteo, Challenging Eli Lilly’s Osteoporosis Market
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Ambio has secured regulatory approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly’s (NYSE: LLY) recombinant peptide Forteo (teriparatide), both of which are indicated for the treatment of osteoporosis. The subcutaneous injection will be marketed in partnership with Apotex. According to the public…
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Chinese Firms Secure EUAs for Omicron XBB Vaccines Amid Dominant Variant Surge
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A wave of Chinese pharmaceutical companies has announced the receipt of Emergency Use Authorizations (EUAs) for their COVID-19 vaccines targeting the Omicron XBB variant. Among the notable developments are Lizhu Pharmaceutical’s (HKG: 1513) recombinant bivalent vaccine, which combines the prototype strain with the Omicron XBB variant, and CanSino Biologics’ (SHA:…
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NMPA Approves TINGSN Technology’s Disposable Intracardiac Ultrasound Diagnostic Catheter
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The National Medical Products Administration (NMPA) has granted market approval to TINGSN Technology, a China-based firm, for its disposable intracardiac ultrasound diagnostic catheter. This approval is the 239th for an official innovative medical device by the NMPA. The product comprises a catheter body, an operating handle, and a connector, and…
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Lee’s Pharmaceutical Secures NMPA Approval for Adasuve, Pioneering Loxapine Inhaler for Agitation
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured marketing approval from China’s National Medical Products Administration (NMPA) for Adasuve, a loxapine inhaler designed to treat acute agitation in adults with schizophrenia or bipolar I disorder. This approval is supported by a series of clinical studies conducted across the United States,…
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AK Medical Holdings Receives NMPA Approval for Hip Surgery Navigation System iBot
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AK Medical Holdings Ltd (HKG: 1789), a Chinese medical technology company, has announced that it has received Category III medical device approval from the National Medical Products Administration (NMPA) for its iBot, a navigation and positioning system designed for hip joint surgery. The iBot system, which includes a robotic arm,…
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Everest Medicines’ Nefecon for IgAN Receives NMPA Approval in China
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for Nefecon (targeted-release formulation budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression has been approved by the National Medical Products Administration (NMPA). Nefecon is a…
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Takeda’s Takecab Receives NMPA Approval for Helicobacter pylori Eradication in China
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Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Takecab (vonoprazan) to eradicate Helicobacter pylori (HP) when combined with appropriate antibiotics. The vonoprazan-based quadruple regimen, which includes bismuth, is the first of its…
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Fujian Cosunter’s Oral COVID-19 Therapy Receives Conditional Approval in China
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has received conditional marketing approval in China. GST-HG171 is a 3CL protease (3CLpro) inhibitor, characterized as having broad-spectrum anti-COVID-19 activity. 3CL protease is an essential protease for…
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Jiangxi Jemincare Group Secures NMPA Approval for Generic Ibrance Capsules
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Jiangxi Jemincare Group, a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s (NYSE: PFE) Ibrance (palbociclib). This follows the company’s earlier approval for its active pharmaceutical ingredients (APIs) of palbociclib in China. Palbociclib, initially…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Receives NMPA Approval for CKD Treatment
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced that their SGLT2 inhibitor, Jardiance (empagliflozin), has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of adult chronic kidney disease (CKD). This development expands the drug’s therapeutic applications in China. EMPA-KIDNEY Study Outcomes The approval…
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Boehringer Ingelheim and Eli Lilly Secure NMPA Approval for Jardiance in Chronic Kidney Disease
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced the receipt of marketing approval from the National Medical Products Administration (NMPA) for their SGLT2 inhibitor Jardiance (empagliflozin) aimed at treating adult chronic kidney disease (CKD). This pivotal approval marks a significant advancement in the management of CKD, further establishing…
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RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving…
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Sumitomo Pharma Receives Chinese Approval for Xenleta to Treat Pneumonia
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Japan-based Sumitomo Pharma Co., Ltd (OTCMKTS: DNPUF) has secured market approval in China for Xenleta (lefamulin acetate), a drug indicated for the treatment of community-acquired pneumonia in adults. The approval was obtained through Sumitomo’s Suzhou-based subsidiary, which already has Mepem (meropenem), a carbapenem antibiotic, in its Chinese market portfolio, and…
