-
Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
•
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…
-
Livzon Pharmaceutical’s Leuprorelin Acetate Microspheres Passes China’s GQCE
•
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…
-
BrightGene Bio Receives FDA Clearance for Generic Eribulin APIs, Advancing in Breast Cancer Treatment
•
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…
-
Henlius Biotech Secures Exclusive Rights to Commercialize Convalife’s Generic Neratinib in China and Abroad
•
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…
-
Shanghai Henlius Biotech Secures Exclusive Rights to Convalife Pharmaceuticals’ Generic Neratinib in China
•
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…
-
Novartis Intensifies Legal Action Against FDA Over Entresto Generic Approval
•
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…
-
Shanghai Pharmaceuticals Secures NMPA Nod for Roche’s Valcyte Generic
•
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)…
-
U.S. Senate Passes Affordable Prescriptions for Patients Act to Limit Patent Thicketing
•
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…
-
Easton Pharmaceutical Receives NMPA Approval for Generic Oxcarbazepine
•
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…
-
China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
•
Jiangsu Hengrui Medicine 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…
-
China’s Sichuan Huiyu Pharmaceutical Halts Generic Cytosar Launch Following Strategy Review
•
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…
-
Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
•
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…
-
NMPA Releases 81st Batch of Reference Drugs for Generic Quality Consistency Evaluation
•
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
-
Sanofi Projects EUR 13 Billion in Dupixent Sales for 2024 Despite Q1 Challenges
•
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…
-
ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
•
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…
-
Hengrui Medicine Scores First-Mover Status with FDA Approval for Generic Astagraf XL
•
Jiangsu Hengrui Medicine 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…
-
NMPA Expands Generic Drug Catalog with 74th and 75th Batches for Quality Consistency Evaluation
•
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,…
-
Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
•
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,…
-
Yifan Pharmaceutical Wins Nod for Generic Diazoxide Oral Suspension in China
•
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…
-
Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
•
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…
-
Ambio Gains FDA Approval for Generic Forteo, Challenging Eli Lilly’s Osteoporosis Market
•
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…
-
Aurobindo Pharma’s China Plant Secures EU GMP Approval, Eyes Revenue Generation
•
India-based Aurobindo Pharma reportedly received EU GMP approval for its China-based manufacturing plant last week, as reported by The Hindu Times. The site is anticipated to start generating revenues from the end of Q4 of the company’s fiscal year (FY) 2024 or early in Q1 FY 2025. Manufacturing and Market…
-
CDE Releases 76th Batch of Chemical Generic Reference Preparations
•
The Center for Drug Evaluation (CDE) has released the 76th batch of chemical generic reference preparations, which includes 11 new specifications, 16 additional specifications, and updates to 22 previously published specifications. The updates encompass the addition of domestic generic names and Marketing Authorization Holder (MAH) information. Specifications Fail Review for…
-
Easton Pharmaceutical Receives FDA Approval for Generic Nalmefene
•
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced receiving Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Hikma Pharma’s (LON: HIK) Revex (nalmefene). Nalmefene is utilized to reverse the effects of opioid drugs, including respiratory suppression caused by…
-
Organon Reports Q3 2023 Financials with Mixed Results, Notable Decline in Women’s Health Sales
•
US-based Organon (NYSE: OGN) has released its financial results for the third quarter of 2023, showing a 1% year-on-year (YOY) decrease in sales to USD 1.519 billion in constant currency terms. The company’s performance was marked by a 7% decline in Women’s Health sales to USD 418 million, a 10%…
-
Sino Biopharmaceutical’s TQG3902 Injection Receives NMPA Approval for Septic Shock Clinical Trial
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biotech company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its TQG3902 injection, which is under development to increase blood pressure in adults with septic shock or other distributed shock. This…
-
Dr. Reddy’s Laboratories Reports 9% YOY Revenue Growth in Q2 2024 Fiscal Year
•
India-based generics giant Dr. Reddy’s Laboratories Ltd (NYSE: RDY) has released its financial report for the Q2 2024 fiscal year ended September 30, 2023. The company reported consolidated revenues of USD 828 million for the quarter, marking a 9% year-on-year (YOY) increase. This growth was primarily driven by robust generic…
-
Sanofi SA Reports Q3 2023 Financials with Focus on R&D and Dupixent Growth
•
French pharmaceutical giant Sanofi SA (NASDAQ: SNY) released its Q3 2023 financial results, reporting a net sales decrease of -4.1% year-on-year (YOY) but an increase of 3.2% in constant currency terms, reaching EUR 11.96 billion (USD 12.64 billion). Despite maintaining the forecast for 2023 earnings per share (EPS) growth, Sanofi…
-
Asieris Pharma Launches Generic Votrient for Renal Cell Carcinoma in China
•
China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd, trading as Asieris Pharma (SHA: 688176), has announced the issuance of the first prescription for its generic version of the UK pharmaceutical major GSK’s (NYSE: GSK) Votrient (pazopanib) in China. This milestone not only marks the entry of a new treatment…
-
CDE Introduces New Guidelines for Generic Drug Quality and Efficacy Consistency Evaluation
•
The Center for Drug Evaluation (CDE) has released a new set of Guidelines for “the Acceptance and Review of Quality and Efficacy Consistency Evaluation of Generic Drugs.” Although described as a draft proposal with a one-month feedback period from the date of issuance, the guidelines are set to take immediate…
-
CSPC Pharmaceutical Group Receives NMPA Approval for Irinotecan Liposome Injection
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its irinotecan liposome injection. The drug is indicated for the treatment of metastatic pancreatic cancer in patients after gemcitabine treatment and is also used in…
-
Amneal Pharmaceuticals Receives China Approval for Sevelamer Carbonate
•
US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the Chinese market for its sevelamer carbonate, marking the company’s inaugural product approval in China. The drug is indicated for the treatment of hyperphosphatemia in patients with chronic kidney disease who are undergoing dialysis. Sevelamer represents…
-
Hansoh Pharmaceutical Receives NMPA Approval for Generic Ofev (Nintedanib)
•
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Boehringer-Ingelheim’s Ofev (nintedanib). This development marks a significant step for the company in expanding its portfolio of generic drugs. Nintedanib’s Approval History…
-
Zhejiang Huahai Pharmaceutical Receives FDA Approval for Generic Vyvanse
•
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Japan firm Takeda’s (TYO: 4502) Vyvanse (lisdexamfetamine). Vyvanse is a medication used to treat attention-deficit hyperactivity disorder (ADHD). Lisdexamfetamine’s…
-
Novartis Defends Entresto Patents as Generic Approvals Trigger Legal Response
•
On August 24, 2023, generic versions of Novartis’ (NYSE: NVS) heart failure therapy Entresto (sacubitril, valsartan) received market approvals, with Chinese firms Nanjing F&S Pharmatech Co., Ltd and CSPC Pharmaceutical Group Ltd (HKG: 1093) receiving the honors. This development prompted a statement from Novartis on August 28, 2023, asserting that…
-
CSPC Pharmaceutical’s Generic Entresto Approved in China for Heart Failure Treatment
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its generic version of Swiss giant Novartis’s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan), has been approved for marketing in China. This approval comes on the same day as its compatriot firm Nanjing F&S Pharmatech Co., Ltd secured the…
