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Henlius Biotech’s HanBeiTai sBLA Accepted for HCC Treatment Review
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indication is hepatocellular carcinoma (HCC). Drug BackgroundHanBeiTai is also awaiting a regulatory decision…
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Alphamab Oncology Doses First Patient in KN046-209 Study for NSCLC
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China-based Alphamab Oncology (HKG: 9966) announced the first patient dosing in the multi-center, open-label Phase II KN046-209 study. The trial evaluates the efficacy, safety, and tolerability of KN046 (erfonrilimab) combined with axitinib in first-line locally advanced or metastatic PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) patients who have…
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Roche’s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment
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Swiss pharmaceutical giant Roche’s China unit announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approved indication is for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug BackgroundEntrectinib, the first ROS1 inhibitor with…
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Chongqing Pharscin’s Gabexate Mesylate Passes GQCE as First Generic in China
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China-based Chongqing Pharscin Pharmaceutical Co., Ltd (SHE: 002907) announced that its gabexate mesylate has passed the generic quality consistency evaluation (GQCE), making it the first generic version of the drug to achieve this status in China. The drug is used to treat acute mild (edematous) pancreatitis and as adjuvant therapy…
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Sunshine Guojian’s SSGJ-608 Hits Primary Endpoint in Psoriasis Study
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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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Zelgen Biopharmaceuticals’ Donafenib Receives NMPA Approval for Thyroid Cancer
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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’s Orelabrutinib sNDA Accepted for Marginal Zone Lymphoma
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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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Arbele’s ARB202 Enters Phase I Trial for Advanced Gastrointestinal Cancer
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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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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…
