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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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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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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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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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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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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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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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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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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 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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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 (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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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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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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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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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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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…
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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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Chengdu-based biotech company Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the National Medical Products Administration (NMPA) has accepted its clinical filing for HP518, a Category 1 chemical drug intended to treat metastatic castration-resistant prostate cancer (mCRPC). HP518: A Promising PROTAC Drug for Prostate CancerHP518 is an androgen receptor (AR)…
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China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its monoclonal antibody ebdarokimab (AK101), which targets IL-12 and IL-23, has been accepted for review by the Center for Drug Evaluation (CDE) in China. The drug is intended for the treatment of moderate to severe plaque…