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NMPA Approves BioFire Diagnostics’ Encephalitis/Meningitis Detection Kit
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The National Medical Products Administration (NMPA) website indicates that BioFire Diagnostics LLC’s encephalitis/meningitis multiple pathogen nucleic acid combined detection kit has been approved for marketing as an innovative product. The kit uses a closed nested multiplex PCR melting curve method for the qualitative detection of meningitis and/or nucleic acids of…
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BioDuro-Sundia and X-Chem Form Long-Term Partnership for Drug Discovery
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Two China-based companies, the Contract Research, Development, and Manufacturing Organization (CRDMO) BioDuro-Sundia and X-Chem, have announced a long-term partnership. X-Chem’s DNA-encoded chemical library (DEL) platform will be integrated into BioDuro-Sundia’s one-stop drug discovery platform to provide higher value to its global clients. Partnership DetailsX-Chem’s DEL platform includes a collection of…
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Dizal Pharma’s Sunvozertinib Shows Promise in NSCLC with EGFR Exon 20 Insertion
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has unveiled the latest positive data for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008). The drug is in late-stage global studies for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (Exon20ins) mutation, both in the second-line stage following…
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Hywin Holdings to Acquire Life Infinity for Health Management Expansion
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China-based wealth management firm Hywin Holdings is set to move into the health management business through the acquisition of Beijing iLife3 Technology Co., Ltd (Life Infinity). The share transfer and capital increase agreement will require over RMB140 million (USD20.7 million) for Hywin to gain a controlling equity interest. The transaction…
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HutchMed’s FRESCO-2 Study for Elunate in Colorectal Cancer Meets Primary Endpoint
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced that the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) has met the primary overall survival (OS) endpoint. The multi-center study, initiated in July 2020, recruited 691 patients…
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Frontier Biotech Partners with Kindstar to Boost Anti-Infection Testing, Especially for HIV
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China-based Frontier Biotechnologies Inc. (SHA: 688221) has entered into a partnership with compatriot firm Kindstar Global (HKG: 9960) to promote anti-infection diagnosis testing, with a particular focus on the HIV field. Financial details of the partnership were not disclosed. Partnership DetailsThe collaboration aims to increase access to Frontier’s long-acting HIV…
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Innovent Biologics Doses First Subject in IBI324 Phase I Study for DME
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China-based biotech Innovent Biologics Inc. (HKG: 1801) announced that the first subject has been dosed in a Phase I clinical study for its IBI324, a bispecific antibody (BsAb) targeting vascular endothelial growth factor A (VEGF-A) and angiopoietin2 (Ang-2) in diabetic macular edema (DME). Study DetailsThe Phase I dosage escalation study…
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Immvira’s Oncolytic Virus MVR-C5252 Receives FDA Orphan Drug Designation for Glioma
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Shenzhen-based Immvira Co., Ltd, a biotech company focused on oncolytic viruses, announced that it has received orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its herpetic oncolytic virus MVR-C5252. The designation is for the drug’s use in treating malignant glioma. Drug DetailsMVR-C5252, developed in-house…
