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Zhaoke Ophthalmology Enrolls First Patient in ZKY001 Phase II TPRK Study
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) spin-off Zhaoke Ophthalmology Ltd (HKG: 6622) announced the enrollment of the first patient in a Phase II clinical study for its ZKY001 in transepithelial photorefractive keratectomy (TPRK), a surgical procedure to treat myopia. ZKY001 is based on a peptide composed of seven amino…
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LianBio Completes Enrollment for Mavacamten Phase III Trial in oHCM
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China-based biotech LianBio (OTCMKTS: LIANY) announced that enrollment has been completed in the Phase III EXPLORER-CN clinical trial, assessing mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Drug BackgroundMavacamten, discovered by MyoKardia Inc. (Nasdaq: MYOK), is a first-in-class small-molecule drug that reversibly binds to myosin. It targets the…
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Recbio Completes Enrollment for HPV Vaccine REC603 Immuno-Bridging Study
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the completion of subject enrollment and first vaccination in an immuno-bridging study for its recombinant HPV 9-valent vaccine, REC603. The study targets younger-age groups and aims to compare the immunogenicity between REC603 and Gardasil 9. Meanwhile, follow-up on subjects…
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Everest Medicines’ Xerava NDA Accepted by Taiwan’s TFDA
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Everest Medicines (HKG: 1952) announced that its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra – abdominal infections (cIAI) has been accepted for review by the Taiwan Food and Drug Administration (TFDA). Partnership DetailsThe China-based biopharma also entered into an exclusive partnership agreement with TTY…
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HutchMed and AstraZeneca’s Tagrisso-Orpathys Combo Shows Promise in NSCLC Study
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Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) and AstraZeneca (AZ, NASDAQ: AZN) announced the preliminary results of the Phase II SAVANNAH study evaluating the combination of Tagrisso (osimertinib) and Orpathys (savolitinib) in patients with epidermal growth factor receptor – mutated (EGFRm) non-small cell lung cancer (NSCLC) with high levels…
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NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review
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The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status. About PNHPNH is a rare and fatal blood system disease with an incidence of approximately 1 to…
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Kintor Pharma Completes GT20029 Phase I Study for Hair Loss and Acne
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced the completion of dosing all 92 subjects in a Phase I clinical study of its GT20029 for androgenetic alopecia and acne in China. The randomized, double-blind, placebo-controlled study assessed the safety and pharmacokinetics of GT20029 (gel / tincture) in healthy subjects via single…
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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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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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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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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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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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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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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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Merck Launches Prevymis, a Non-Nucleoside CMV Inhibitor, in China
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US pharmaceutical giant Merck Sharp & Dohme (MSD, NYSE: MRK) announced the commercial launch of its non-nucleoside cytomegalovirus (CMV) inhibitor Prevymis (letermovir) in China. The drug received market approval in December 2021 for the prevention of CMV infection and CMV disease in adult recipients with CMV seropositive [R+] undergoing allogeneic…
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Zhongsheng Pharmaceutical Completes Phase I Study of RAY1216 for COVID-19 Treatment
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced the completion of subject enrollment and clinical observation for the Phase I clinical study of RAY1216, an innovative oral therapy for the novel coronavirus developed by its subsidiary Guangdong Raynovent Biotech Co., Ltd. The study results demonstrated good safety and pharmacokinetic…
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CSPC Pharmaceutical’s rhTNK-tPA Meets Primary Endpoint in Stroke Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the Phase III clinical study for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) in acute ischemic stroke has reached the pre-set primary endpoint. Study DetailsThe multi-center, prospective, randomized, open, blinded, non-inferiority Phase III clinical study was designed to…
