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GeneoDx Biotech’s Cervical Cancer Screening Kit Wins NMPA Approval
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Shanghai GeneoDx Biotech Co., Ltd, a medical diagnosis unit of Sinopharm, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its “human ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 gene methylation detection kit (fluorescent PCR method).” This marks the first approval in China…
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MicroPort CardioFlow Medtech’s VitaFlow Liberty and Angelguide Approved in Colombia
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China-based MicroPort Scientific Corp’s (HKG: 0853) spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) announced that it has received marketing approval in Colombia for its second-generation transcatheter aortic valve implantation (TAVI) products, the VitaFlow Liberty transcatheter aortic valve implantation system and the first-generation tip pre-shaped super-stiff guide wire Angelguide. Product…
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HeNan Genuine Biotech Sets Azvudine Price at RMB300 per Bottle for COVID-19 Therapy
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China-based HeNan Genuine Biotech Co., Ltd has set the price of its COVID-19 therapy azvudine at no more than RMB300 (USD44.41) per bottle, according to Henan Daily, a local media outlet. Each bottle contains 35 pieces, with each tablet weighing 1mg. Drug BackgroundAzvudine is a Category 1 anti-HIV/AIDS drug targeting…
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Sinotherapeutics Inc. to Raise RMB600m via STAR Board IPO for Generic Drug Expansion
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Sinotherapeutics Inc., a Shanghai-based generic drug developer, is set to make an initial public offering (IPO) of 45.34 million shares on Shanghai’s Sci-Tech Innovation Board (STAR). The proceeds, amounting to RMB600 million (USD88.8 million), will be used for the construction of a preparation production complex and related supporting facilities, high-end…
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CDE Issues Q&As on COVID-19 Antiviral Drug Evaluation Criteria
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The Center for Drug Evaluation (CDE) has published a list of Q&As regarding the non-clinical and clinical evaluation criteria for new antiviral drugs against emerging COVID-19 variants. The aim is to guide the scientific research, development, and evaluation of new COVID-19 drugs. Clinical Study EndpointFor the primary efficacy endpoint of…
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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…
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Transcenta Appoints Dr. Caroline Germa as Global Drug Development Chief
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) announced the appointment of Dr. Caroline Germa as its executive vice president of global drug development and chief medical officer (CMO). Dr. Germa will report directly to CEO Dr. Qian Xueming. Role and ResponsibilitiesDr. Germa will lead the global development and translational research…
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NHC Issues Notification on Medication Safety Management and Rational Drug Use
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The National Healthcare Commission (NHC) has released a notification focusing on medication safety management and rational drug use. The notice outlines measures to enhance medication safety and promote rational drug use in medical institutions. Key Measures Evaluation and AssessmentThe management of drug safety will be included as part of the…
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Ningbo Health Gene Raises Hundreds of Millions in Series C Financing
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Ningbo Health Gene Technologies Co., Ltd, a China-based medical testing solution provider, has reportedly raised “hundreds of millions” of renminbi in a Series C financing round led by SCGC. Other investors included BioTrack Capital, Hefeng Venture Capital, Yingong Venture Capital, and Binjiang Xincheng Development Investment. The proceeds will be directed…
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Intuitive Surgical-Fosun JV Breaks Ground on Shanghai Medical Robot Base
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Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd, a joint venture (JV) between China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and US firm Intuitive Surgical, Inc, has commenced construction on a 2.08-hectare headquarters and industrialization base. The medical robot manufacturing R & D center is situated in Zhangjiang Hi-Tech…
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Bayer AG’s Q2 2022 Results Show Global Sales Growth Amid China VBP Pressures
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Germany-based pharmaceutical giant Bayer AG (VIE: BAYN) released its Q2 2022 financial report, revealing a global sales growth of 9.6% year-on-year (YOY) in constant exchange rate terms to EUR12.8 billion (USD13 billion). The growth was driven by strong performances in the Pharmaceuticals and Consumer Health segments. Pharmaceuticals and Consumer HealthIn…
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Intellective Biologics Raises Over RMB500m in Series C Financing Round
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China-based macromolecule-focused Contract Development and Manufacturing Organization (CDMO) Intellective Biologics (Suzhou) Co., Ltd has reportedly raised over RMB500 million (USD74.1 million) in a Series C financing round. The round was co-led by Tsing Song Capital and Gaorong Capital, with participation from Fuho Capital, CNCB Investment, Founder Securities, and Win Harbor…
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MicuRx Pharmaceuticals Completes RMB1.06B IPO for Antibacterial Drug Development
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Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals has officially made an initial public offering (IPO) of 130 million shares priced at RMB8.16 (USD1.21) per share on Shanghai’s Sci-Tech Innovation Board (STAR). With 655 million shares issued, the IPO will bring in RMB1.06 billion (USD157 million) for MicuRx. Product PipelineMicuRx’s MRX-I (contezolid),…
