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Harbour BioMed’s HBM9033 ADC Receives US FDA IND Clearance for Clinical Trials
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China-based Harbour BioMed (HKG: 2142) has announced receiving Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HBM9033. This ADC specifically targets human mesothelin (MSLN), a tumor-associated antigen that is upregulated in various solid tumors, including mesothelioma, ovarian, lung, breast,…
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Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension application to the US Food and Drug Administration (FDA) for its FGFR kinase inhibitor Balversa (erdafitinib). The application seeks to expand the use of Balversa as a treatment for locally advanced or metastatic urothelial carcinoma…
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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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Boehringer Ingelheim Submits Three INDs for Survodutide Phase III Trials in China
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Germany-based Boehringer Ingelheim (BI) has announced the submission of three Investigational New Drug (IND) filings for regulatory Phase III global multi-center studies in China for its novel glucagon receptor/GLP-1 receptor dual agonist, survodutide. The drug is co-developed with Zealand Pharma, marking a significant step in advancing the drug’s clinical development.…
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Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review with the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Rybrevant (amivantamab). The submission seeks approval for Rybrevant in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or…
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MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has commenced Phase III development for its experimental proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, MK-0616, focusing on low-density lipoprotein (LDL) cholesterol reduction in adults with and without heterozygous familial hypercholesterolemia (HeFH). This marks a significant milestone as MK-0616 becomes the first oral…
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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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Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its third-generation antibody drug conjugate (ADC), STRO-002, in advanced malignant solid tumors. STRO-002: A Third-Generation ADC Targeting FRαSTRO-002, originated by US firm Sutro Biopharma Inc.,…
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Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
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China-based Youcare Pharmaceutical Group (SHA: 688658) has received ethical approval from the China-Japan Friendship Hospital to conduct a Phase II/III study assessing the efficacy and safety of its YKYYO17 aerosol inhalation agent as a potential treatment for mild-to-moderate COVID-19. The drug candidate is a broad-spectrum coronavirus membrane fusion inhibitor polypeptide…
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Novartis Defends Entresto Patents as Generic Approvals Trigger Legal Response
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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…
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Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing has been made in China for its drug candidate SHR0302, intended to treat active ankylosing spondylitis in patients who have responded poorly to non-steroidal anti-inflammatory drugs (NSAIDs). Phase II/III Study Results Support FilingThe filing is…
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Junshi Biosciences’ Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment
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China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA) for senaparib (JS109/IMP4297), a PARP inhibitor co-developed with compatriot firm Impact Therapeutics Inc., has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for use as a maintenance treatment…
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Jiangsu Kanion Pharmaceutical Gets NMPA Approval for SLE Clinical Trial with KYS202002A
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study of its pipeline candidate, KYS202002A, for the treatment of systemic lupus erythematosus (SLE). KYS202002A: A Monoclonal Antibody with Broad…
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Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in Macao
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China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, intended for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been accepted for review by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. The…
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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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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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Akeso Biopharma’s Ivonescimab Heads for Priority Review for NSCLC Treatment
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China-based Akeso Biopharma (HKG: 9926) has announced that its bispecific antibody (BsAb) ivonescimab (AK112), targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), is on course for priority review for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations that progress after treatment…
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GSK’s Shingrix Proves 100% Efficacy in Phase IV Trial for Chinese Patients
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UK-based pharmaceutical giant GSK plc (NYSE: GSK) has released efficacy data for its shingles vaccine, Shingrix (recombinant zoster vaccine; RZV), in a Chinese patient population. The Phase IV post-marketing ZOSTER-076 trial, conducted in China, involved nearly 6,000 participants aged 50 and over. The trial reported no cases of shingles in…
