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Inmagene and HutchMed Dose First Subject in IMG-004 Phase I Study
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China-based Inmagene Biopharmaceuticals and Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced that the first subject has been dosed in the US in a global Phase I clinical study for their drug candidate IMG-004. The double-blind, randomized, placebo-controlled, single and multiple dosage escalation study is designed to assess the…
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Zai Lab’s Q2 2022 Financials Show Revenue Growth and R&D Cost Cut
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) released its Q2 2022 financial report, recording USD48.2 million in total revenues during the period, up 30.62% year-on-year (YOY). The company’s research and development (R&D) expenditure was USD66.1 million, down 53.52% YOY. Zai generated a USD137.9 million net loss, compared with…
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BeiGene’s Tislelizumab Meets Primary Endpoint in Global HCC Study
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the global Phase III RATIONALE 301 study evaluating tislelizumab in first – line unresectable hepatocellular carcinoma (HCC) has met its primary endpoint. The study demonstrated that the programmed death – 1 (PD – 1) inhibitor tislelizumab was non – inferior to…
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Innovent Biologics’ IBI-112 Achieves Primary Endpoints in Psoriasis Phase II Trial
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China-based Innovent Biologics Inc. (HKG: 1801) announced that its interleukin-23 subunit p19 (IL-23p19) monoclonal antibody (mAb) IBI-112 (picankibart) has achieved primary endpoints in a Phase II clinical trial in China for moderate-to-severe plaque psoriasis. The multi-center, randomized, double-blind, placebo-controlled Phase II study (CIBI112A201; clinicaltrials.gov: NCT 05003531) enrolled 250 subjects randomized…
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Sciwind’s XW003 Shows Positive Weight Loss Results in Phase Ic/IIa Study
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Hangzhou-based Sciwind announced positive interim topline results from a 26-week Phase Ic/IIa clinical study of its drug candidate XW003 (ecnoglutide) in overweight or obese Chinese adult patients. Study DetailsThe ongoing multicenter Phase 1c/2a study in China involved 60 non-diabetic overweight or obese adult subjects. Participants were randomized into three cohorts…
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Hansoh Pharma Licenses TiumBio’s TU2670 for Endometriosis Treatment in Greater China
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced a licensing agreement with South Korea’s TiumBio Co., Ltd (KOSDAQ: 321550), securing exclusive development, regulatory filing, and commercialization rights to TiumBio’s drug candidate TU2670 in Greater China, including Hong Kong, Macau, and Taiwan. Agreement DetailsUnder the agreement, Hansoh has the rights…
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Gan & Lee Pharmaceuticals’ GZR4 Wins FDA Approval for Diabetes Treatment
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 therapeutic biologic product GZR4 for the treatment of diabetes. Product DetailsThe half-life of long-acting basal insulin analogs currently on the market ranges from…
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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…
