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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…
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European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
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The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have shown disease progression after at least three prior…
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Jiangsu Hengrui Pharmaceuticals’ Fluzoparib Files for New Indication with China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for its poly (ADP-ribose) polymerase (PARP) inhibitor, fluzoparib. The filing seeks to expand the use of fluzoparib as a maintenance therapy for patients with advanced epithelial ovarian…
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Kintor Pharmaceutical Completes Enrollment in Phase II Study of GT20029 for Androgenetic Alopecia
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China-based Kintor Pharmaceutical Limited (HKG: 9939) has announced the completion of patient enrollment in a Phase II clinical study for its proprietary first-in-class proteolysis targeting chimera (PROTAC) compound, GT20029. The molecule is under development as a treatment for male androgenetic alopecia (AGA), and this marks the first time a topical…
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Novartis’s Leqvio (Inclisiran) Approved in China for Hypercholesterolemia Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received approval from the National Medical Products Administration (NMPA) for its cholesterol-lowering drug Leqvio (inclisiran). The drug is approved for use as an adjunct treatment with diet for adult patients with primary hypercholesterolemia, including heterozygous familial and non-familial cases, or mixed type dyslipidemia.…
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Novatim’s KQ-2003 and KY-0118 Advance with Clinical Trial Approvals in China
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China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd has recently obtained clinical trial clearances for two of its products in China. The products are KQ-2003, an autologous chimeric antigen receptor (CAR) T cell therapy for the fourth-line treatment of recurrent/refractory multiple myeloma, and KY-0118, a therapy aimed at…
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Sichuan Huiyu Pharmaceutical’s Plerixafor Gains Marketing Approval from Italian Medicines Agency
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received marketing approval for its plerixafor from the Italian Medicines Agency (AIFA). The drug is approved for use in combination with granulocyte colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) into the…
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Hainan Huluwa Pharmaceutical Gets NMPA Approval for Generic Briviact Clinical Study
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China-based Hainan Huluwa Pharmaceutical Group Co., Ltd (SHA: 605199) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of UCB Pharma’s Briviact (brivaracetam). The Category III injectable is in development for use as an adjuvant treatment…
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Luye Pharma Group Submits Market Approval Filing for Lurbinectedin in Metastatic SCLC in Macau
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China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing has been submitted to Macau’s medical products administration bureau for the company’s drug lurbinectedin (LY01017). The targeted indication is for the treatment of metastatic small-cell lung cancer (SCLC) in patients who experience tumor progression during or after…
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Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS
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Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to…
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Gilead’s Magrolimab Phase III Trial for AML Faces Partial Hold by FDA
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Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration (FDA) has imposed a partial hold on recruitment for a Phase III trial of its investigational anti-CD47 biologic, magrolimab, in acute myeloid leukemia (AML). The company has not disclosed the reason behind the FDA’s decision but has indicated…
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Pfizer’s RSV Vaccine Abrysvo Receives FDA Authorization for Maternal Immunization
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The US Food and Drug Administration (FDA) has authorized the use of Pfizer’s (NYSE: PFE) respiratory syncytial virus (RSV) vaccine, Abrysvo, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD in infants through active immunization of pregnant women between 32 and 36 weeks of gestation. This marks…
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J&J’s Teclistamab Granted Priority Review in China for Relapsed Multiple Myeloma
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson’s (J&J, NYSE: JNJ) teclistamab has been granted priority review for the treatment of recurrent or refractory multiple myeloma in China. The drug is being considered for conditional approval due to its breakthrough therapy designation (BTD) status, given…
