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SinoMab BioScience Receives NMPA Approval for Phase I Study of Atopic Dermatitis Drug SM17
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Hong Kong-based biotechnology company SinoMab BioScience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in China, assessing the safety of SM17, a first-in-class drug for atopic dermatitis (AD). The study is set to commence in the fourth quarter…
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Haisco Pharmaceutical Gets NMPA Approval for HSK21542 Chronic Pruritus Clinical Study
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug HSK21542, aimed at treating chronic pruritus. Understanding the Impact of Chronic PruritusPruritus, or itching, is an unpleasant sensation…
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United Laboratories’ UBT251 Receives Tacit Approval for NAFLD Clinical Study in China
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Hong Kong firm United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate UBT251 has been tacitly approved in China for a clinical study focusing on non-alcoholic fatty liver disease (NAFLD). UBT251: A Triple Agonist for Metabolic ImprovementsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent…
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Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).…
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AriBio Files for Phase III Clinical Trial Approval in China for Alzheimer’s Drug AR1001
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South Korean clinical-stage biotech AriBio Co. has announced the filing for Phase III clinical trial approval in China for its anti-Alzheimer’s disease (AD) drug candidate, AR1001. The filing is currently under review by the National Medical Products Administration’s Center for Drug Evaluation. Global Phase III Trial Expansion PlansAriBio aims to…
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United Laboratories Receives Tacit Approval for JAK1 Inhibitor TUL01101 Clinical Trial
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Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced tacit clinical trial approval for its Category 1 drug TUL01101, a small molecule JAK1 inhibitor. The upcoming trial will evaluate the efficacy of TUL01101 as a treatment for patients suffering from moderate to severe atopic dermatitis (AD). Filling the…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
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Chengdu Kanghua Receives FDA Approval for Clinical Trial of Norovirus Vaccine
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China-based Chengdu Kanghua Biological Products Co., Ltd (SHE: 300841) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its recombinant hexavalent norovirus vaccine. This development marks a significant step forward in addressing the global health challenge posed by norovirus, which is…
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Neurophth Biotechnology’s NFS-05 Gene Therapy Gets Australian Clinical Trial Approval for ADOA
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that it has received clinical trial approval from the Therapeutic Goods Administration of Australia for its candidate drug NFS-05. The therapy is set to be assessed as a treatment for autosomal dominant optic atrophy (ADOA), an inherited optic neuropathy. Understanding Autosomal…
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Shanghai Junshi Biosciences’ JS207 Bispecific Antibody Receives NMPA Clinical Trial Approval
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) in China has approved a clinical trial filing for its bispecific antibody (BsAb) JS207. The drug is under development to target PD-1 and VEGF for the treatment of advanced malignant tumors. Pre-Clinical…
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United Laboratories’ UBT251 Receives Tacit Approval for Obesity Clinical Study in China
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate, UBT251, has been tacitly approved in China for a clinical study to assess its effectiveness against overweight and obesity conditions. UBT251: A Triple Agonist for Metabolic ConditionsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP…
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MicuRx Pharmaceuticals Initiates Phase III Trial for MRX-4 in Complex Skin Infections
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its drug candidate MRX-4, focusing on the treatment of complex skin and soft tissue infections in China. The multi-center, randomized, double-blind, double-simulation Phase III trial aims to assess the safety and efficacy of MRX-4…
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Bayer Funds Landmark Trials for Kerendia in Heart Failure Treatment Expansion
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Germany-based pharmaceutical company Bayer (ETR: BAYN) has announced funding for three investigator-sponsored collaborative studies aimed at expanding its late-stage clinical development program of the mineralocorticoid receptor antagonist (MRA) Kerendia (finerenone) for heart failure (HF). These new trials will broaden the patient pool to include those with reduced (HfrEF), mildly reduced…
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AIM Vaccine Co., Ltd Launches Phase III Trial for 23-Valent Pneumococcal Vaccine
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the commencement of a Phase III clinical study for its 23-valent pneumococcal polysaccharide vaccine. The study is designed as a randomized, blind, similar vaccine-controlled trial, expected to enroll 1920 healthy subjects aged two years and older. Targeting Invasive Pneumococcal DiseasesThe 23-valent…
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CSPC Pharmaceutical’s Biosimilar Ozempic Equivalent Gets NMPA Clinical Trial Approval
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 analog Ozempic (semaglutide) has obtained clinical trial approval from the National Medical Products Administration (NMPA). The upcoming trial will assess the use of CSPC’s biosimilar in maintaining blood sugar control in…
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Harbour BioMed’s HBM9033 ADC Receives US FDA IND Clearance for Clinical Trials
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China-based Harbour BioMed (HKG: 2142) has announced receiving Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HBM9033. This ADC specifically targets human mesothelin (MSLN), a tumor-associated antigen that is upregulated in various solid tumors, including mesothelioma, ovarian, lung, breast,…
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MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction
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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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Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
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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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Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
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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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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…
