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Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
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LEO Pharma Initiates Phase III Clinical Trial for Delgocitinib in China
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Denmark-based LEO Pharma A/S has announced the commencement of a China Phase III clinical study with the enrollment and dosing of the first patient for its delgocitinib cream, marking the first clinical study for the product in China. This milestone signifies the company’s efforts to address moderate to severe adult…
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Coherus Biosciences Awaits FDA Decision on Toripalimab with Year-End Approval Forecast
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Coherus Biosciences Inc., (NASDAQ: CHRS), a US-based biotechnology company, has provided an update on the progress of its programmed death-1 (PD-1) inhibitor, toripalimab, at the US Food and Drug Administration (FDA). Toripalimab is under license from China’s Junshi Biosciences (HKG: 1877; SHA: 688180). The FDA has completed its clinical study…
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Cutia Therapeutics Files for Market Approval of CU-10201 with NMPA for Acne Treatment
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Cutia Therapeutics (HKG: 2487), a developer focused on dermatology therapies, has announced the submission of a market approval filing for its CU-10201 (4% minocycline foam agent for external use) to the National Medical Products Administration (NMPA) in China. The drug, which targets the treatment of non-nodular moderate to severe acne…
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United Laboratories Receives FDA Approval for Clinical Study of UBT251 for Obesity Treatment
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United Laboratories International Holdings Ltd (HKG: 3933), a Hong Kong-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 drug candidate, UBT251, for the treatment of overweight and obesity. UBT251: A Triple Agonist…
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BioTroy Therapeutics Receives US FDA IND Approval for Anti-Tumor Drug BT02
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BioTroy Therapeutics, a Shanghai-based developer of cancer immunotherapies, has announced the receipt of Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its innovative anti-tumor drug, BT02. This monoclonal antibody (mAb) targets solid tumors with a novel mechanism, representing a significant step forward in cancer…
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Sichuan Kelun-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
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The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
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EC Approves AbbVie’s Tepkinly for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of…
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Sanofi’s Altuviiio Receives Marketing Approval from Japan’s MHLW for Hemophilia A Treatment
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its first-in-class drug Altuviiio (Fc-VWF-XTEN fusion protein). This new treatment is indicated for controlling the bleeding tendency in patients with hemophilia A, a genetic disorder that…
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Japan’s MHLW Approves Eisai and BioArctic’s Leqembi for Alzheimer’s Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) for their amyloid-beta (Aβ)-targeting drug, Leqembi (lecanemab), as a treatment for slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This marks…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for Two Cancer Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
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Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
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AffaMed Therapeutics’ Luminate Receives Clinical Trial Approval for Dry AMD in China
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AffaMed Therapeutics, a China-based biotech firm, has announced the receipt of its first clinical trial approval in China for its pipeline candidate, Luminate (risuteganib; AM011). This development marks a significant milestone for the company, which acquired the Greater China manufacturing, development, and commercial rights to risuteganib from Hanmi Pharmaceutical, a…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-20105 Clinical Study in Solid Tumors
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study of its Category 1 drug candidate, HS-20105, for the treatment of advanced solid tumors. This development marks a…
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Shanghai Junshi’s Tuoyi Meets Primary Efficacy Endpoint in Phase III Melanoma Study
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that the Phase III MELATORCH study (NCT03430297) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has successfully reached the progression-free survival (PFS) primary efficacy endpoint. This study evaluates Tuoyi as a first-line…
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Abbisko Therapeutics Gets NMPA Approval for Irpagratinib Combination Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
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Hepagene Therapeutics’ HPG7233 Receives US FDA IND Approval for NASH Treatment
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Hong Kong-based biopharmaceutical company Hepagene Therapeutics Inc. has announced that the US Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) approval for its drug candidate, HPG7233. This small-molecule thyroid hormone receptor beta (THR-β) agonist is poised for development as a treatment for non-alcoholic steatohepatitis (NASH) and…
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Abbisko Therapeutics’ Irpagratinib Receives FDA Clearance for Phase I Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth…
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Sino Biopharmaceutical Submits IND Application for AT2R Antagonist TRD205 to FDA
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biotech company, has announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its AT2R antagonist, TRD205. The drug is intended to address neuropathic pain, a common and debilitating chronic condition that significantly…
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Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
