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Hainan Poly Pharm’s Generic ProHance Wins FDA Approval in US
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced that the US Food and Drug Administration (FDA) has approved its generic version of Bracco’s ProHance (gadoteridol), making it the first and currently only ProHance generic available in the US. The approved strengths include 1.3965 g/5 mL, 2.793 g/10 mL, 4.1895…
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Sinopep-Allsino Wins NMPA Approval for Generic Liptruzet in China
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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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Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Shionogi’s Mulpleta (lusutrombopag). This Category 4 chemical drug becomes the first generic Mulpleta in China, marking a significant milestone in the…
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Hybio Pharmaceutical Receives US FDA Approval for Biosimilar Victoza (Liraglutide)
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving official approval from the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of its biosimilar version of Denmark firm Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). Liraglutide: A Crucial Treatment for DiabetesLiraglutide, an analog of human…
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Tasly Pharma Receives NMPA Approval for Generic Lioresal (Baclofen) Oral Solution
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China-based Tasly Pharma Co., Ltd (SHA: 600535) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Swiss pharmaceutical giant Novartis’ (NYSE: NVS) Lioresal (baclofen) in the form of an oral solution. This Category 3 chemical drug is now approved…
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Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
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Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for its generic versions of Incyte Corporation’s Jakavi(ruxolitinib) and Missionpharma’s Urocit-K(potassium citrate), marking a significant milestone for the company. Approval of Generic JakaviJakavi, a JAK inhibitor, is…
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Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
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Jiangxi Jemincare Secures First Generic Approval for GSK’s Requip in China
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Jiangxi Jemincare Group, based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of GSK’s Requip (ropinirole), marking the first generic approval for this medication in China. The drug is indicated for the treatment of Parkinson’s disease (PD) and PD with non-motor…
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Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…
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Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
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Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National Medical Products Administration (NMPA) for its biosimilars of Novo Nordisk (NYSE: NVO)’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart), both of which are indicated for the treatment of type 2 diabetes. These…
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China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first…
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Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version of Pfizer’s Vyndaqel (tafamidis meglumine), marking it as the first generic to pass the generic quality consistency evaluation (GQCE) in China. This development is highlighted on the NMPA’s official website. Tafamidis meglumine is indicated for…
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Joincare Pharmaceutical Receives NMPA Approval for Generic Seretide
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a leading pharmaceutical company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its generic version of GlaxoSmithKline’s (GSK) Seretide (salmeterol, fluticasone). This compound inhalable preparation is now approved for use as…
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Qilu Pharmaceutical Achieves First Approval for Generic Bendamustine in China
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic bendamustine, marking it as the first of its kind in China for the treatment of malignant tumors. Bendamustine, a bifunctional nitrogen mustard derivative, is recognized for its ability to induce cell death through multiple mechanisms, thereby…
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Easton Pharmaceutical Gets NMPA Nod for Generic Version of Merck KGaA’s Concor
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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Concor, which contains bisoprolol and amlodipine, a compound preparation used as an alternative therapy for hypertension. The approval signifies that Easton’s…
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Qilu Pharmaceutical Gets NMPA Green Light for Generic Romiplostim for ITP Treatment
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The National Medical Products Administration (NMPA) in China has granted marketing approval to Qilu Pharmaceutical for its generic version of Amgen’s romiplostim, a treatment for chronic idiopathic thrombocytopenia (ITP) that has not responded well to other treatments such as corticosteroids and immunoglobulins. This marks the first approval of its kind…
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Jiangsu Hengrui’s Generic Version of Tepadina Approved for Transplantation Conditioning in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Tepadina (thiotepa), originally developed by Switzerland-based Adienne S.r.l. The infusion is indicated as a conditioning treatment…
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Aosaikang’s Marketing Approval Filing for Delafloxacin Accepted by China’s NMPA
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the National Medical Product Administration (NMPA) in China has accepted for review its marketing approval filing for the Category III chemical injectable drug delafloxacin. Delafloxacin is a new generation broad-spectrum fluoroquinolone antibiotic indicated for the treatment…
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Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
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Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in Switzerland (SWX: SDZ), has announced the launch of Tyruko (natalizumab), the first biosimilar version of Biogen’s (NASDAQ: BIIB) blockbuster Tysabri, in the German market. This move marks a significant advancement in the treatment options for…
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Hengrui Pharmaceuticals Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
