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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…
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Amgen’s Lumakras Faces Full Registration Review by FDA for KRAS-Mutated NSCLC
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The US Food and Drug Administration (FDA) is scheduled to review an application submitted by Amgen (NASDAQ: AMGN) for the full registration of its pioneering KRASG12C inhibitor, Lumakras (sotorasib), in October this year. The treatment targets locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). Amgen announced this…
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AstraZeneca’s Forxiga Demonstrates Clinical Benefits in Heart Failure and COPD Patients
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced evidence that its SGLT2 inhibitor, Forxiga (dapagliflozin), provides significant clinical benefits in patients with heart failure (HF) with preserved ejection fraction (pEF) and chronic obstructive pulmonary disease (COPD). This announcement highlights the potential of Forxiga in treating these conditions and underscores…
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AstraZeneca’s Forxiga Gains New Indication Approval in China for Chronic Heart Failure
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UK-based pharmaceutical major AstraZeneca plc (AZ, NASDAQ: AZN) has announced that China’s National Medical Products Administration (NMPA) has granted a new indication approval for its SGLT-2 inhibitor, Forxiga (dapagliflozin). The drug is now approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits…
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MSD’s Welireg Meets Primary Endpoint in Phase III RCC Study but Misses OS Milestone
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed that the ongoing Phase III study evaluating the first-in-class HIF-2α inhibitor Welireg (belzutifan) in previously treated advanced renal cell carcinoma (RCC) has shown statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, meeting its primary endpoint. However,…
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HutchMed’s Sovleplenib Achieves Primary and Secondary Endpoints in ESLIM-01 Phase III Trial
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China-based biopharmaceutical company HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib has successfully met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia (ITP). The trial was…
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Grand Pharmaceutical Group Initiates Phase I Study for Sepsis Treatment APAD
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the enrollment and dosing of the first subject in a Phase I study for APAD, a small-molecule compound targeting sepsis with a novel mechanism of action. The study is a randomized, double-blind, dosage escalation, placebo-controlled trial designed to assess the safety,…
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HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Gastric Cancer
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN) and approved in China on July 12, is to be awarded breakthrough therapy designation (BTD) in China. The BTD status is specifically for savolitinib’s use as a third-line treatment…
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Humanwell Healthcare Initiates Phase IIa Clinical Study for IPF Drug HW021199
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced the commencement of a Phase IIa clinical study for its Category 1 chemical drug, HW021199, in the treatment of idiopathic pulmonary fibrosis (IPF). The drug’s target has not been disclosed, other than to note that there is no market-approved product…
