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Daiichi Sankyo’s Enhertu Accepted for Review in China for HER2-Low Breast Cancer
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced that its market approval filing for Enhertu (T-DXd, trastuzumab deruxtecan), a HER2 antibody drug conjugate (ADC), has been accepted for review by the Center for Drug Evaluation (CDE) in China. The filing seeks approval for the treatment of adult patients with unresectable or…
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Fosun Kite’s Yescarta CAR-T Therapy Secures New Clinical Trial Approval in China
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Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead’s Kite Pharma, has received another clinical trial approval for its anti-CD19 chimeric antigen receptor (CAR) T therapy Yescarta (axicabtagene ciloleucel). The new indication targets adult large B-cell lymphoma (r/r LBCL) that…
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Recbio Completes Phase II Trial Enrollment for ReCOV COVID-19 Vaccine
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the completion of enrollment and dosing of all subjects in a Phase II clinical study for its ReCOV, a recombinant protein COVID-19 vaccine, with Pfizer’s mRNA vaccine Comirnaty as a control. The study, approved in the Philippines on August…
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Sirnaomics Initiates Phase I/II Trial for STP705 in Facial Squamous Cell Carcinoma
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the first subject systemic dosing in a Phase I/II clinical study for its therapeutic candidate STP705 in facial squamous cell carcinoma in situ (isSCC). The study is expected to be completed during Q1 2023. Study Design and ObjectivesThe open-label, dosage escalation…
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CSPC Pharmaceutical’s Mitoxantrone Liposome Approved for NMOSD Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for neuromyelitis optica spectrum disorders (NMOSD). This follows the product’s initial approval in January this year for the treatment of relapsed…
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Spinraza’s NRDL Inclusion Boosts SMA Patient Treatment in China
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The Meier Advocacy & Support Center for Spinal Muscular Atrophy (SMA) and the Shenzhen Research Institute of the Chinese University of Hong Kong jointly released a report titled “Research on the Quality of Life of Chinese SMA Patients.” The report indicates that among patients treated with Biogen’s Spinraza (nusinersen), 76.4%…
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ICT’s GCC19CART Enters US Phase I Study for Colorectal Cancer
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Sino-US firm Innovative Cellular Therapeutics (ICT) announced the involvement of the first subject in a US-based Phase I clinical study for its GCC19CART, a CoupledCAR-based cell therapy, in relapsed / refractory metastatic colorectal cancer (R / R mCRC). The subject has completed apheresis, with cells successfully produced. Study DetailsThe open-label,…
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BRL Medicine’s BRL-101 Receives Clinical Trial Approval for Beta-Thalassemia
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Shanghai-based BRL Medicine Inc. has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its BRL-101. The therapy is an autologous hematopoietic stem progenitor cell treatment for transfusion-dependent beta-thalassemia. Drug DetailsBRL-101 is a gene therapy developed through BRL’s in-house developed hematopoietic stem cell…
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Innovent Biologics Initiates Phase I Study of IBI311 for Thyroid-Associated Ophthalmopathy
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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 IBI311, an insulin-like growth factor 1 (IGF-1R) monoclonal antibody (mAb). Study DetailsThe Phase I dosage escalation study (CTR20221581) is designed to assess the safety and tolerability of…
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Junshi Biosciences’ JunMaiKang Biosimilar Gets NMPA Approval Filing
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China-based Junshi Biosciiences (HKG: 1877, SHA: 688180) has announced that another market approval filing for JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been accepted by the National Medical Products Administration (NMPA). In addition, the NMPA also accepted a clinical trial filing for…
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SciClone Licenses Menarini’s Vaborem to Tackle Drug-Resistant Infections in China
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SciClone Pharmaceuticals Inc (Nasdaq: SCLN), a China-based company since going private in 2017, announced a licensing agreement with Italy-based Menarini Group regarding the latter’s novel drug Vaborem (meropenem). Under the agreement, SciClone will obtain development, regulatory, and commercialization rights to the antibacterial drug in China. SciClone will pay Menarini Group…
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Zelgen Biopharmaceuticals’ ZGGS18 Receives NMPA Approval for Solid Tumor Treatment
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate ZGGS18. The molecule will be assessed as a treatment for general advanced solid tumors. Drug DetailsZGGS18 is a bispecific antibody (BsAb) targeting vascular…
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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…
