Pharmaceuticals
ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α -bias Bispecific Antibody Fusion Protein) from Phase 1 and 2 Clinical Studies on Immunotherapy-treated Advanced Malignant Melanoma
SAN FRANCISCO and SUZHOU, China, June 1, 2025 /PRNewswire/ -- Innovent Biologics, Inc (Suzhou) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, opht...
Breakthrough Clinical Data for LBL-024 in First-Line Treatment of Advanced EP-NEC Unveiled at 2025 ASCO Oral Session
NANJING, China, May 31, 2025 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs") today announced the presentation of groundbreaking clinical data from a multicenter phase Ib/II clinical trial evaluating LBL-024, an anti-PD-L1/4-1BB bispecific antibody, in combination with etoposide ...
CirCode Biomed Announces FDA Clearance for IND Application of HM2002, the world's first circular RNA drug being administrated in patients
SHANGHAI, May 30, 2025 /PRNewswire/ -- Shanghai CirCode Biomed Co. Ltd. (CirCode), an innovative biotech company pioneering circular RNA therapies, recently announced that its leading pipeline HM2002 received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FD...
Mabwell Receives NMPA Approval for Albipagrastim alfa for Injection (MAILISHENG)
SHANGHAI, May 30, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Albipagrastim alfa for Injection (trade name: MAILISHENG, R&D code: 8MW0511) developed by its wholly-owned subsidiary T-mab has officially obtaine...
Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT002, A Novel Platform-In-A-Molecule Bispecific Antibody for Broad I&I Conditions and U.S. FDA Clearance of IND Application for BBT001
* Preclinical data with BBT002 demonstrate its best-in-disease potential for improved efficacy and dosing convenience across respiratory, dermatology, and gastroenterology indications * Interim safety and pharmacokinetic data from BBT002-01 study anticipated in Q1 2026 * The clearance of BB...
GC Biopharma's Phase 3 Clinical Trial Results for Hunterase Published in SCIE-Indexed Journal
YONGIN, South Korea, May 30, 2025 /PRNewswire/ -- GC Biopharma, a South Korean pharmaceutical company, announced that the Phase 3 clinical trial results for Hunterase (idursulfase beta), its investigational drug for Hunter Syndrome (MPS II), have been published in Genetics in Medicine, an SCIE-in...
NEW THERAPY FOR CHILDREN WITH GROWTH HORMONE DEFICIENCY APPROVED IN AUSTRALIA
SKYTROFA® (lonapegsomatropin) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of paediatric growth hormone deficiency.[ 1] SINGAPORE, May 29, 2025 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the Austr...
First patient imaged in Phase III AMPLIFY trial with 64Cu-SAR-bisPSMA PET/CT
SYDNEY, May 29, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that it has imaged the...
Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence
BOSTON, May 29, 2025 /PRNewswire/ -- On May 20, Medicilon Preclinical Research ( Shanghai) LLC ("Medicilon") announces that it has successfully passed an on-site inspection by the FDA. The company receives an official Establishment Inspection Report (EIR) reaffirming its position as a trusted lead...
AccurEdit Therapeutics' ART001 Becomes China's First Gene Editing Therapy to Receive FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
RMAT designation expected to expedite development; 72 weeks interim clinical trial data showing sustainable reduction of TTR over 90% with no significant adverse events. SUZHOU, China, May 29, 2025 /PRNewswire/ -- AccurEdit Therapeutics today announced that its internally developed in vivo gene ...
Neuronata-R® Stem Cell Therapy Shows Promise in ALS Phase 3 Subgroup Analysis, Moves Toward FDA Accelerated Approval
Meaningful efficacy observed in slow-progressor subgroup; NfL biomarker improvements support potential for accelerated regulatory pathway SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Neuronata-R®, an autologous bone marrow-derived mesenchymal stem cell (MSC) therapy for amyotrophic lateral s...
Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA
SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previo...
Formosa Pharmaceuticals and Adalvo Limited Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain
TAIPEI, May 28, 2025 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Adalvo Limited ("Adalvo") in the European and Brazilian markets for exclusive rights to the commercialization of clobeta...
CARsgen's Satri-cel Granted Priority Review by the NMPA
SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical Products Administration (NMPA) has granted Priority R...
Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025
* DZD8586 demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2% * DZD6008, a BBB-penetrant 4th generation EGFR TKI, showed encouraging and durable anti-tumor activity with favorable safet...
Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths
* YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] * Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeabilit...
/DISREGARD RELEASE: Celltrion/
We are advised by Celltrion that journalists and other readers should disregard the news release, Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths, issued21-May-2025 over PR Newswire. ...
Mabwell Announces Clinical Data of Multiple ADCs to be presented at 2025 ASCO Annual Meeting
SHANGHAI, May 23, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced multiple clinical research results to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including phase Ib/II clini...
UniXell Biotechnology announces the first patient dosed with UX-DA001, an investigational autologous iPSC based cell therapy for the treatment of Parkinson's disease, in its Phase 1 study
SHANGHAI, May 23, 2025 /PRNewswire/ -- Shanghai UniXell Biotechnology Co., Ltd. (UniXell Biotech), a biotech company dedicated to innovative cell therapies, announced the successful first administration of its proprietary Parkinson's disease cell drug UX-DA001 inChina in March 2025. The Phase I c...
Nona Biosciences Collaboration Partner Pfizer Announces Presentation of Phase 1 Clinical Study Design on MesoC2, an MSLN-Targeting ADC, at the 2025 ASCO Annual Meeting
CAMBRIDGE, Mass., May 23, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company providing integrated solutions from "Idea to IND" (I to I TM), today announced that its collaborator, Pfizer, will present an abstract detailing the first-in-human Phase 1 clinical study design of MesoC...
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