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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…
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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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Hinova Pharmaceuticals’ HP518 for mCRPC Accepted for Review by China’s NMPA
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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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Akeso Biopharma’s Ebdarokimab (AK101) NDA Accepted for Review by China’s CDE
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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…
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Eli Lilly’s Retevmo Meets Primary Endpoint in Phase III Trial for RET-mutant Medullary Thyroid Cancer
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Eli Lilly (NYSE: LLY) has announced that its Phase III trial for the RET kinase inhibitor Retevmo (selpercatinib) has successfully met its primary endpoint in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). The trial demonstrated a significant improvement in progression-free survival (PFS) compared to cabozantinib or vandetanib,…
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FDA Grants Priority Review to Pfizer and Astellas’ Xtandi for High-Risk Prostate Cancer
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The US Food and Drug Administration (FDA) has granted priority review status to the submission by pharmaceutical partners Pfizer (NYSE: PFE) and Astellas (TYO: 4503) for their drug combination of Xtandi (enzalutamide) and leuprolide. This treatment is intended for patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) who are at high…
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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…
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Lynk Pharmaceuticals’ LNK01001 Shows Positive Results in Ankylosing Spondylitis Phase II Study
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China-based Lynk Pharmaceuticals Co., Ltd has announced positive topline results from the Phase II clinical study of its pipeline candidate, LNK01001, in the treatment of ankylosing spondylitis (AS). The randomized, double-blind, placebo-controlled, multi-center study involved 177 AS patients who had previously experienced insufficient efficacy or intolerance to non-steroidal anti-inflammatory drugs…
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Allist Pharmaceuticals’ Furmonertinib Wins NMPA Nod for EGFR-Mutated NSCLC Treatment
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its drug furmonertinib. The drug is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutation or EGFR L861Q…
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Zai Lab’s Repotrectinib Targets Breakthrough Therapy Designation for TRK-Positive Tumors
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The Center for Drug Evaluation (CDE) website has indicated that repotrectinib, a next-generation ROS1/TRK/ALK tyrosine kinase inhibitor (TKI) licensed by China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB), is on track to receive breakthrough therapy designation (BTD) status in China for the treatment of NTRK fusion-positive advanced solid tumors that…
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RemeGen’s Telitacicept Shows Positive Phase III Results in Rheumatoid Arthritis Study
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced positive results from the China Phase III clinical study for its telitacicept in the treatment of rheumatoid arthritis (RA). Following these results, the company has submitted a supplementary New Drug Application (sNDA) to the Center for Drug Evaluation (CDE). Previously,…
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Roche Subsidiary Genentech Addresses Accidental Disclosure of Tiragolumab Trial Data
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Swiss pharmaceutical major Roche (SWX: ROG), through its subsidiary Genentech, has released a statement addressing an accidental disclosure of the second interim analysis from an ongoing Phase III study. The study involves the anti-TIGIT biologic tiragolumab, used with and without the PD-L1 inhibitor Tecentriq (atezolizumab), for patients with PD-L1-high locally…
