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Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
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US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children…
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Everest Medicines’ Xerava Receives Marketing Approval from TFDA for cIAI Treatment
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Everest Medicines (HKG: 1952) has announced that it has received marketing approval for its antibiotic Xerava (eravacycline) from the Taiwan Food and Drug Administration (TFDA). This approval grants the drug permission to be used in the treatment of complicated intra-abdominal infections (cIAI) in Taiwan, expanding the drug’s reach in the…
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Konruns Pharmaceutical’s KC1036 Pediatric Indication Accepted for NMPA Review
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 chemical drug, KC1036, for a pediatric indication. This development signifies a significant step forward in the exploration of new treatment options for pediatric cancer…
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Elpiscience Biopharmaceuticals Initiates Phase I Trial for Anti-LILRB2 Antibody ES009
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Elpiscience Biopharmaceuticals, a China-based biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical trial in Australia for its pipeline candidate, ES009. This investigational drug is an anti-LILRB2 (ILT4) monoclonal antibody developed to target cancers, marking a significant step in the company’s oncology research…
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Tasly Pharmaceuticals Gets NMPA Approval for B1344 Clinical Study in NASH
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Tasly Pharmaceuticals (SHA: 600535), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its human fibroblast growth factor 21 injection, B1344, in patients with non-alcoholic steatohepatitis (NASH). This development marks a significant step in the…
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ImmuneOnco Initiates Phase I Trial for CD24-Targeted Monoclonal Antibody IMM47
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the first patient dosing in a Phase I clinical study in Australia for its investigational drug, IMM47, a first-in-class CD24-targeted monoclonal antibody (mAb). This marks a significant step in the development of a novel immunotherapy approach for cancer treatment. IMM47’s Mechanism…
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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…
