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Mabwell Bioscience’s 9MW2821 Earns FDA Fast Track Designation for Triple Negative Breast Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational antibody-drug conjugate (ADC), 9MW2821. This candidate is designed to target Nectin-4 and is currently in development…
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NMPA Accepts 3SBio’s Filing for Anemia Treatment SSS06, Potential Game Changer for Dialysis Patients
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3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that the National Medical Products Administration has accepted its filing for market approval of SSS06, a recombinant erythropoiesis stimulating protein injection (rESP, CHO cells). This development marks a significant milestone for the company as it aims to…
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Huadong Medicine Secures Exclusive Rights to Oral Edaravone Candidate TTYP01 in Major Licensing Deal
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Huadong Medicine Co., Ltd (SHE: 000963), a prominent pharmaceutical company in China, has entered into an exclusive licensing agreement with Suzhou Auzone Biological Technology Co., Ltd, focusing on Auzone’s product candidate TTYP01, an oral formulation of edaravone. This strategic partnership positions Huadong to exclusively develop, regulate, manufacture, and commercialize the…
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Oricell Therapeutics’ GPRC5D-Targeted CAR-T Therapy Earns FDA Fast Track for Multiple Myeloma
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Oricell Therapeutics Co., Ltd, a leading biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative therapy, OriCAR-017. This chimeric antigen receptor (CAR)-T cell therapy is targeted at GPRC5D, aiming to treat recurrent refractory multiple myeloma…
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Simcere Pharmaceutical’s COVID-19 Therapy Xiannuoxin Earns Full Approval in China
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that its small-molecule COVID-19 therapy, Xiannuoxin (simnotrelvir, ritonavir), has received regular approval from the Chinese regulatory authorities, converting from its previous conditional approval status. This makes Xiannuoxin the first COVID-19 therapy of its kind to achieve full…
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Jiangsu Hengrui’s Subsidiary Conducts First Surgical Dosing in Parkinson’s Gene Therapy Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shanghai Regenelead Therapies Co., Ltd., has conducted the first surgical dosing in a clinical study for its dual adeno-associated virus (AAV) gene therapy, RGL-193, aimed at treating Parkinson’s disease (PD). The procedure…
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Shanghai Escugen Initiates Phase III Clinical Trial for Breast Cancer Drug Candidate ESG401
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Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
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Eisai and Biogen’s Alzheimer’s Therapy Leqembi Receives Marketing Approval in Hong Kong
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Eisai Co., Ltd, a Japanese pharmaceutical company, along with its co-development partner Biogen Inc. (NASDAQ: BIIB), has announced that they have received marketing approval in Hong Kong for their Alzheimer’s disease (AD) therapy Leqembi (lecanemab). Known as 乐意保 in Chinese, the drug is administered intravenously every two weeks and is…
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Pfizer’s Once-Daily Danuglipron Selected for Full Clinical Development for Type 2 Diabetes and Obesity
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Pfizer Inc. (NSE: PFIZER), a leading pharmaceutical company in the U.S., has announced that a once-daily oral formulation of danuglipron, its investigational GLP-1 agonist for the treatment of type 2 diabetes and obesity, has been selected for full clinical development. This decision is based on positive findings from an ongoing…
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Novo Nordisk’s Awiqli Faces FDA Setback as BLA Draws Complete Response Letter
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Novo Nordisk A/S (NYSE: NVO) announced that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) in response to the Biologics License Application (BLA) for Awiqli, the company’s once-weekly basal insulin icodec for diabetes treatment. The CRL from the FDA highlighted specific requests concerning the manufacturing process…
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CSPC Pharmaceutical’s RSV mRNA Vaccine SYS6016 Receives Clinical Trial Approval from NMPA
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its candidate mRNA vaccine, SYS6016, targeting the respiratory syncytial virus (RSV). The vaccine, SYS6016, is designed using mRNA molecules that…
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Sichuan Biokin Pharmaceutical Gets NMPA Approval for BL-M14D1 Clinical Trial in Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
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Beijing Sun-Novo Gets NMPA Green Light for STC008 Clinical Trial in Tumor Cachexia
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug candidate STC008. This study will focus on the treatment of tumor cachexia…
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KeChow Pharma’s Keluping, First NRAS Mutant Melanoma Therapy, Hits the Market
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Shanghai-based KeChow Pharma has announced the official market launch of its groundbreaking drug, Keluping (tunlametinib), the world’s first targeted therapy designed specifically for NRAS mutant melanoma. Tunlametinib, a novel ATP noncompetitive MEK inhibitor that targets NRAS mutations, received marketing approval in China in March this year. The drug was granted…
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Amgen Halts Development of Claudin 6-Targeting BiTE Immune Therapy AMG 794
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to halt the development of AMG 794, a half-life extended BiTE (bispecific T-cell engager) immune therapy that targets the oncofetal antigen Claudin 6 (CLDN6). This decision was disclosed on the clinicaltrials.gov website under the identifier NCT05317078,…
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Kymera Therapeutics’ Stock Soars on Sanofi’s Plans to Expand KT-474 Clinical Trials
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Kymera Therapeutics Inc. (NASDAQ: KYMR), a biopharmaceutical company based in the U.S., has announced that Sanofi intends to expand the clinical development program for the auto-immune skin disease drug KT-474 following a preliminary review that showed robust early data. Sanofi’s plan to broaden Phase II trials for the drug, which…
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Shanghai Vitalgen BioPharma Launches Phase I/II Gene Therapy Trial for Parkinson’s Disease
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Shanghai Vitalgen BioPharma Co., Ltd, a biopharmaceutical company based in China, has initiated a Phase I/II clinical study for its gene therapy candidate VGN-R09b at Huashan Hospital, targeting primary Parkinson’s disease (PD). VGN-R09b received clearance to proceed with clinical trials in China for primary PD and aromatic L-amino acid decarboxylase…
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Kintor Pharmaceutical Launches Global Cosmetic Line with Hair Loss Treatment Pyrilutamide
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Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the global launch of cosmetic products featuring pyrilutamide (KX-826) as the key ingredient. Pyrilutamide, an androgen receptor (AR) antagonist, is utilized as a topical application for the treatment of androgenic alopecia (AGA), a common condition leading to…
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Suzhou Sanegene Bio Receives NMPA Approval for Clinical Trial of Antihypertensive siRNA Drug
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Suzhou Sanegene Bio Inc., a leading RNAi specialist with research and development centers in both the US and China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug SGB-3908. This antihypertensive siRNA drug has been co-developed with Innovent Biologics,…
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Shanghai Junshi Biosciences’ HDAC Inhibitor JS125 Clinical Trial Application Accepted by NMPA
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for JS125 (WJ47156), a histone deacetylases (HDAC) inhibitor co-developed with Wigen Biomedicine Technology (Shanghai) Co., Ltd. This epigenetic regulator is intended for the treatment…
