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Aosaikang’s Generic Livtencity Accepted for Review by China’s NMPA
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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed that a market filing for its generic version of Japan-based Takeda’s (TYO: 4502) Livtencity (maribavir) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the potential introduction of a more accessible…
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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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Livzon Pharmaceutical’s Leuprorelin Acetate Microspheres Passes China’s GQCE
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China’s Livzon Pharmaceutical Group Inc., (HKG: 1513, SHE: 000513) has announced that its leuprorelin acetate microspheres for injection have successfully passed the generic quality consistency evaluation (GQCE) in China. Leuprolide, a gonadotropin-releasing hormone (GnRH) receptor agonist, is utilized in the treatment of prostate cancer and endometriosis. Originally developed by Japan’s…
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BrightGene Bio Receives FDA Clearance for Generic Eribulin APIs, Advancing in Breast Cancer Treatment
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BrightGene Bio-Medical Technology Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 688166), has announced the receipt of a First Adequate Letter from the US FDA for the active pharmaceutical ingredients (APIs) of its generic version of Eisai’s Halaven (eribulin), signifying that the drug has successfully…
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Henlius Biotech Secures Exclusive Rights to Commercialize Convalife’s Generic Neratinib in China and Abroad
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. Henlius has secured the exclusive commercialization rights for Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional licensing…
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Shanghai Henlius Biotech Secures Exclusive Rights to Convalife Pharmaceuticals’ Generic Neratinib in China
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SHANGHAI—Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. The deal grants Henlius the exclusive commercialization rights to Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional…
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Novartis Intensifies Legal Action Against FDA Over Entresto Generic Approval
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Novartis Inc. (NYSE: NVS) is intensifying its efforts to thwart the entry of generic competitors for its heart failure and hypertension medication, Entresto (valsartan + sacubitril), following the U.S. FDA’s approval of a generic version from India-based MSN Laboratories on July 24. A federal court judge in Delaware recently denied…
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Shanghai Pharmaceuticals Secures NMPA Nod for Roche’s Valcyte Generic
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Roche’s Valcyte (valganciclovir). Valganciclovir is a crucial medication primarily used to treat cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS)…
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U.S. Senate Passes Affordable Prescriptions for Patients Act to Limit Patent Thicketing
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In a significant move to curb drug prices, the U.S. Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150) last week. This legislation is designed to foster greater competition from generic and biosimilar drugs against their brand-name counterparts. The act’s primary objective is to impose a limit…
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Easton Pharmaceutical Receives NMPA Approval for Generic Oxcarbazepine
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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s oxcarbazepine. This neurogenic drug is now approved for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or…
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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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China’s Sichuan Huiyu Pharmaceutical Halts Generic Cytosar Launch Following Strategy Review
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a pharmaceutical company based in China, has announced the withdrawal of its market filing for a generic version of Cytosar (cytarabine), a drug originally developed by US firm Viatris. The decision to withdraw the filing, which was initially submitted in September 2022, is…
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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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NMPA Releases 81st Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 81st batch of reference drugs for generic quality consistency evaluation (GQCE) work, comprising a total of 84 specifications. This batch includes 44 new specifications and 40 specifications that have undergone modifications.- Flcube.com
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Sanofi Projects EUR 13 Billion in Dupixent Sales for 2024 Despite Q1 Challenges
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has released its guidance for the first quarter of 2024. Despite expectations that its top-selling interleukin blocker Dupixent (dupilumab) will face challenges from a co-pay assistance program in the first quarter, the company projects that the drug’s sales will reach EUR 13…
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ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
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Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched dapagliflozin, its self-operated product with marketing rights. This drug serves as a generic version of AstraZeneca (NASDAQ: AZN)’s Forxiga, a leading treatment for type 2 diabetes. The approval for dapagliflozin was secured through Nanjing F&S…
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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…
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NMPA Expands Generic Drug Catalog with 74th and 75th Batches for Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 74th and 75th batches of reference drugs for generic quality consistency evaluation (GQCE) work, further expanding the catalog to enhance the standardization of generic drugs in the market. The 74th batch encompasses 32 newly added specifications along with 28 modified specifications,…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
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Yifan Pharmaceutical Wins Nod for Generic Diazoxide Oral Suspension in China
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Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products for its generic version of German pharmaceutical giant Bayer’s diazoxide oral suspension. This signifies that the drug has successfully passed the generic quality consistency evaluation (GQCE) process…
