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Biosyngen’s First-in-Class Drug Candidate BRG01 Accepted for IND Review
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Biosyngen has announced that its investigational new drug (IND) filing for the first-in-class (FIC) drug candidate BRG01 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BRG01, an innovative therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC).…
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Alphamab Oncology’s KN019 Achieves Primary Endpoint in Phase II RA Study
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Suzhou-based biotech Alphamab Oncology (HKG: 9966) has announced that its China-based Phase II KN019-201 study, assessing the safety and efficacy of its cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immunosuppressive fusion protein KN019 in active rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX), has reached its primary endpoint. Study Design…
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Staidson’s STSP-0601 Receives Clinical Trial Approval for Hemophilia Treatment
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, STSP-0601. The approval is for the on-demand treatment of bleeding in patients with hemophilia A or B…
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Henlius Biotech Gets FDA Nod for HLX07 Clinical Study in CSCC
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its epidermal growth factor receptor (EGFR)-targeted monoclonal antibody (mAb), HLX07, in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). This marks…
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Zelgen Files NDA for Jacktinib to Treat Myelofibrosis in China
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has filed a New Drug Application (NDA) with the National Medical Products Administration (NMPA) for its JAK inhibitor, jacktinib, to treat medium to high risk myelofibrosis (MF). This includes primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post PV MF), and…
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Lepu Biotechnology’s MRG003 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation for its core product MRG003 in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The epidermal growth factor receptor (EGFR) targeted antibody drug conjugate (ADC) had previously obtained Orphan Drug…
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Lepu Biotechnology’s PD-1 Inhibitor HX008 Gains New Indication Approval
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its HX008, a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug, which was first approved in China in July this year for…
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Neurophth Biotechnology Doses First Patient in Phase III Trial for NR082
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that the first patient has been dosed in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01). The study is being conducted in China to evaluate the efficacy and safety of NR082, a recombinant adeno-associated virus serotype 2 (rAAV2), in…
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Bio-Thera Solutions Completes Phase I Study for COVID-19 Antibody BAT2022
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced the completion of all dosage groups (from 100 mg to 1500 mg) in a Phase I clinical study for its BAT2022. The results of the study demonstrated good safety across all dosage groups. BAT2022: Drug OverviewBAT2022 is a bispecific neutralizing antibody against COVID-19…
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Abbisko Therapeutics Doses First Patient in Phase I Study of ABSK043
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that the first patient has been dosed in a Phase I clinical study (ABSK043-101) for its in-house developed oral programmed-death ligand 1 (PD-L1) inhibitor, ABSK043, in patients with advanced solid tumors in China. The drug has previously completed multiple dose…
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Arctic Vision Enrolls First Patient in Phase III Study for ARVN002
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China-based ophthalmology specialist Arctic Vision has announced the enrollment of the first patient in a Phase III clinical study assessing the efficacy and safety of ARVN002 (atropine sulfate) for arresting myopia progression. The study is being conducted in China and marks a significant step forward in the development of this…
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Legend Biotech’s Carvykti Approved in Japan for Relapsed Multiple Myeloma
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma. The approval is limited to…
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NMPA Releases 59th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 59th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 67 new specifications, among which 15 are injectables. The update aims to further standardize and improve the quality of generic drugs in the…
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Harbour BioMed Doses First Subject in Phase I Study for HBM9378 in China
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China-based Harbour BioMed (HKG: 2142) has announced the completion of the first subject dosing in a Phase I clinical study for HBM9378 (SKB378), a next-generation fully human antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe asthma. The study is being conducted in China and marks a significant step…
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Telix Pharmaceuticals Gains IND Approval for TLX250-CDx in China
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE). The company will now commence a pivotal Phase III registration study in China for its TLX250-CDx (89Zr-girentuximab), an imaging agent used to support positron emission tomography…
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Fosun Pharma Launches 20ml SPSB Liquid Product in US Market
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Shanghai Fosun Pharma (Group) Co., Ltd (SHA: 600196, HKG: 2196) has reported the market launch in the US of its sodium phenylacetate and sodium benzoate (SPSB) liquid product, the only 20ml version available on the market. The product is being launched by its partner MAIA Pharmaceuticals Inc. (MAIA), a specialty…
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Tris Pharma and Pediatrix Therapeutics’ ADHD Drug Gains Priority Review in China
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The Center for Drug Evaluation (CDE) has indicated that the methylphenidate hydrochloride oral sustained-release dry suspension, developed by US firms Tris Pharma and Pediatrix Therapeutics, has been awarded priority review status for use in attention deficit hyperactivity disorder (ADHD). The drug falls into the category of “new varieties, dosage forms,…
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Angel Pharmaceuticals Gains CDE Approval for Mupadolimab Phase I/Ib Study
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China-based Angel Pharmaceuticals Ltd has announced that it has received approval from the Center for Drug Evaluation (CDE) to initiate a Phase I/Ib clinical study in China for its mupadolimab (formerly CPI-006) in advanced solid tumors. Angel Pharma owns the rights to mupadolimab in Greater China. Drug Overview and MechanismMupadolimab…
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Gluetacs Therapeutics Files IND for Molecular Glue Degrading Agent in China
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Gluetacs Therapeutics has reported filing an Investigational New Drug (IND) application for its first molecular glue degrading agent with the Center for Drug Evaluation in China. The company, which specializes in the development of small molecule drugs via protein degradation technology, has also secured an undisclosed amount of investment from…
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Brii Biosciences Publishes Positive Phase I Results for PPD Therapy BRII-296
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China-based Brii Biosciences Limited (HKG: 2137) has published the top-line results from a Phase I study for its long-acting, single-injection therapy for postpartum depression (PPD), BRII-296. The open-label, single ascending dose Phase I study assessed the safety, tolerability, and pharmacokinetics (PK) of BRII-296 as a single-injection treatment option for PPD…
