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PackGene and Genemagic Partner on AAV Production and CDMO Services
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China-based PackGene LLC has entered into a partnership with compatriot firm Genemagic Biosciences Co., Ltd. Under the agreement, PackGene will provide Genemagic with Contract Development and Manufacturing Organization (CDMO) services for the large-scale production of adeno-associated virus (AAV). In return, Genemagic will assist PackGene in enhancing its π-beta SF9 AAV…
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PersonGen BioTherapeutics’ TAA06 Receives Clinical Trial Approval for B7-H3 CAR-T Therapy
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The Center for Drug Evaluation (CDE) website indicates that PersonGen BioTherapeutics (Suzhou) Co., Ltd’s TAA06, an in-house developed chimeric antigen receptor (CAR)-T cell targeting B7-H3, has obtained tacit clinical trial approval for relapsed/refractory neuroblastoma. This approval signifies that the world’s first B7-H3 CAR-T therapy will enter the regulatory study phase.…
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Akeso Biopharma’s Cadonilimab Achieves National Delivery in China
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China-based biotech Akeso Biopharma (HKG: 9926) announced the national delivery of its cadonilimab (AK104), marking a commercial launch just six days after approval. The drug, conditionally approved in China on June 29th, is a self-discovered bispecific antibody (BsAb) indicated for the treatment of recurrent or metastatic cervical cancer that has…
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Sobi’s Anakinra (Kineret) Prioritized for Review in China for FMF Treatment
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The Center for Drug Evaluation (CDE) website indicates that Swedish Orphan Biovitrum AB’s (Sobi; BMV: SOBIN) market filing for its anakinra (trade name: Kineret) has been prioritized for review. The drug is indicated for autoinflammatory periodic fever syndrome (familial Mediterranean fever – FMF) in adults, adolescents, children, and infants eight…
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Arctic Vision Enrolls First Patient in ARVN003 Phase III Trial for Presbyopia
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China-based ophthalmic therapies developer Arctic Vision announced the first patient enrollment in a Phase III clinical study for its ARVN003, a proprietary pilocarpine formulation leveraging its micro-dosing platform Optejet. The study aims to evaluate the efficacy and safety of ARVN003 in temporarily improving vision in adults with presbyopia (long-sightedness) in…
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WuXi Biologics’ MFG14 Facility Approved for Microbial Product Manufacturing
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) announced that its MFG14 facility in Hangzhou has been released for manufacturing microbial-derived products. The facility has been successfully performing Chemistry, Manufacturing, and Controls (CMC) projects for multiple clients since early 2022, demonstrating the company’s capability to provide…
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JW Therapeutics Initiates Phase I Study of JWATM204 for Hepatocellular Carcinoma
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China-based JW Therapeutics (HKG: 2126) announced the initiation of a Phase I clinical study for its JWATM204 in patients with advanced hepatocellular carcinoma (HCC). This first-in-human study aims to evaluate the safety, tolerability, dose-limiting toxicity, and pharmacokinetic profile of JWATM204 in adult subjects with advanced HCC. It will also explore…
