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Belief-Delivery BioMed’s BBM-H901 Granted BTD for Hemophilia B Prevention
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The Center for Drug Evaluation (CDE) website indicates that Shanghai Belief-Delivery BioMed Co., Ltd’s injectable BBM-H901 has been granted breakthrough therapy designation (BTD) status. The drug is approved for use in preventing bleeding in adult male patients with hemophilia B (congenital factor IX deficiency). Drug DetailsBBM-H901 is a Category 1…
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Sanjin Pharma’s Subsidiary Gets NMPA Nod for BC007 Cancer Study
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China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Biopharmaceutical (Shanghai) Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of BC007. The study will assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy…
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I-Mab and AbbVie End CD47 Antibody Trial but Continue Collaboration
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China-based biotech I-Mab (NASDAQ: IMAB) filed with the US Securities and Exchange Commission (SEC) that its co-development partner AbbVie Inc. (NYSE: ABBV) has decided to end a Phase Ib clinical trial of the CD47 monoclonal antibody (mAb) lemzoparlimab. The trial, which assessed the drug in combination with azacitidine and venetoclax,…
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Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG: 0512) generic carglumic acid is set for priority review. The indications include hyperammonemia due to N-acetylglutamate synthase deficiency, hyperammonemia due to isovaleric acidemia, hyperammonemia due to methylmalonic acidemia, and hyperammonemia due to propionic acidemia. Reason…
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Ascletis Pharma’s Gannex Initiates DDI Study for ASC42 in PBC
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Ascletis Pharma Inc. (HKG: 1672) announced that its wholly – owned US unit, Gannex, has initiated the first subject dosing in a drug – drug interaction (DDI) study for its drug candidate ASC42 in primary biliary cholangitis (PBC) in the United States. The study is designed to provide additional evidence…
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Luye Pharma’s Goserelin Acetate Injectable Accepted for Breast Cancer Review
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China-based Luye Pharma Group (HKG: 2186) announced that another market filing for its goserelin acetate sustained-release injectable microspheres (LY01005) as a treatment for breast cancer has been accepted for review by China’s Center for Drug Evaluation (CDE). The drug is already under review for its use in treating prostate cancer.…
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CDE Prioritizes Review for Sanofi’s Nexviazyme and WinHealth’s Ravicti
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The Center for Drug Evaluation (CDE) website indicates that two drugs have been selected for priority review status. The selected products are French giant Sanofi’s Nexviazyme (avalglucosidase alfa) and China-based Hong Kong WinHealth Pharma Group Ltd’s Ravicti (glycerol phenylbutyrate). Nexviazyme DetailsNexviazyme is an investigational enzyme replacement therapy (ERT) developed by…
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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…
