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Hansoh Pharmaceutical Receives NMPA Approval for Generic Ofev (Nintedanib)
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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…
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Chia Tai Tianqing’s Generic Entresto Approved by NMPA, Launch Expected in 2026
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The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version of Swiss pharmaceutical giant Novartis’s heart failure therapy Entresto (sacubitril, valsartan) has been approved for marketing. However, the generic version will not be launched until 2026 when the originator’s patent expires. This follows the approval…
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Bayer Subsidiary’s Parkinson’s Treatment Bemdaneprocel Shows Promise in Phase I
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Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study for cell therapy bemdaneprocel in Parkinson’s disease has successfully met the safety and tolerability primary endpoint. After one year, no bemdaneprocel-related serious adverse events (SAEs) were reported. Additionally, dose-dependent improvement in motor symptoms and evidence…
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AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
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Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph…
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Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
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The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB, HKG: 9688) Margenza (margetuximab), an Fc-engineered monoclonal antibody (mAb) targeting HER2 and developed by MacroGenics Inc., has been approved for the China market. The drug is indicated for the treatment of metastatic HER2-positive breast cancer…
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AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an indication extension approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its orphan drug Soliris (eculizumab). The drug is now approved as a treatment for generalized myasthenia gravis (gMG) in pediatric patients who…
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Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Omicron XBB.1.5-adapted monovalent version of the SARS-CoV-2 vaccine Comirnaty, developed in partnership by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). The vaccine is intended for use in children…
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Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
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Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC) for an indication extension of its SMN2 splicing modifier Evrysdi (risdiplam). The drug is now approved for infants up to 2 months of age with a clinical diagnosis of spinal muscular atrophy (SMA) type 1,…
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MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
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The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab). The drug is now approved in combination with trastuzumab, originator Roche’s (SWX: ROG) Herceptin, and chemotherapy as a first-line therapy against locally advanced unresectable or metastatic HER2-positive…
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BMS’ Reblozyl Expands Indication to Include First-Line MDS-Related Anemia Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received an indication extension approval from the US Food and Drug Administration (FDA) for its first-in-class drug Reblozyl (luspatercept). The drug is now approved as a first-line treatment for low- to intermediate-risk myelodysplastic syndromes (MDS)-related anemia in adults who may require regular red blood…
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Zhejiang Huahai Pharmaceutical Receives FDA Approval for Generic Vyvanse
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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…
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Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
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The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US Food and Drug Administration (FDA) for Tyruko (natalizumab), marking it as the first biosimilar version referencing Biogen’s (NASDAQ: BIIB) blockbuster biologic Tysabri. Both monoclonal antibodies (mAbs) are indicated for treating Crohn’s disease and relapsing forms…
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Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
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Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory syncytial virus (RSV) vaccine, Abrysvo. The vaccine is approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy,…
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FDA Approves Gilead’s Veklury for COVID-19 Treatment in Patients with Hepatic Impairment
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The US Food and Drug Administration (FDA) has approved a new indication for Gilead’s (NASDAQ: GILD) antiviral Veklury (remdesivir), allowing for the treatment of COVID-19 in individuals with mild, moderate, and severe hepatic impairment without the need for dose adjustments. This makes Veklury the only COVID-19 therapy cleared across all…
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AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
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Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for the use of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a treatment for BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant…
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Microport EP Medtech’s Cryoablation Catheter and Equipment Approved as Innovative Devices in China
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Shanghai Microport EP Medtech Co., Ltd has announced that its balloon type cryoablation catheter and cryoablation equipment have been approved for marketing as innovative devices in China. This marks a significant advancement in the treatment of drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation, with the devices being the first of…
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CSPC Pharmaceutical’s Generic Entresto Approved in China for Heart Failure Treatment
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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…
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Dizal Pharmaceutical’s Sunvozertinib Approved by China’s NMPA for NSCLC Treatment
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This novel targeted therapy is now approved for the treatment of locally advanced or metastatic non-small cell lung…
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Nanjing F&S Pharmatech Secures First Generic Approval for Novartis’s Entresto in China
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Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S’s version, an in-house developed…
