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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), announced that its randomized, double-blind, placebo-controlled, multi-dose escalation and dose exploration Phase II clinical study for the anti-IL-17A monoclonal antibody (mAb) SSGJ-608 in moderate to severe plaque psoriasis has reached its primary endpoint. Study DetailsThe study,…
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application (sNDA) for its Category 1 anti-cancer drug donafenib in locally advanced / metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) has been approved by the National Medical Products Administration (NMPA). This is the second indication approval for…
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InnoCare Pharma (HKG: 9969) announced that a supplemental New Drug Application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib has been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking a new indication for patients with relapsed or refractory marginal zone lymphoma. Drug…
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Hong Kong-based biopharma Arbele announced that its CDH17 × CD3 bispecific T-Cell engager antibody, ARB202, has entered a Phase I clinical trial in the United States for advanced gastrointestinal cancer patients. The potential first-in-class drug has been dosed in the first patient, with the Phase I multi-center, open-label dose-escalation 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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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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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 (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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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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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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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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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 (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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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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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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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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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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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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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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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…