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CDE Considers Breakthrough Therapy Designation for Beijing Mabworks’ MIL162 and Amgen’s AMG 890
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The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s MIL162 and US firm Amgen’s AMG 890 are on track to receive breakthrough therapy designation (BTD) awards in China. MIL162 is under development as a treatment for primary membranous nephropathy (pMN), while AMG 890 targets…
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Fujian Cosunter Pharmaceutical’s COVID-19 Drug GST-HG171 Meets Primary Endpoint in Phase II/III Study
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the pivotal Phase II/III regulatory clinical study for its Category 1 product, GST-HG171/ritonavir, in mild/moderate COVID-19 patients has been unblinded and has successfully reached its primary endpoint. Design and Results of the StudyThe multi-center, randomized, double-blind, placebo-controlled study aimed…
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Boehringer Ingelheim’s Spevigo on Track for Priority Review for GPP Flare Prevention in China
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Germany-based Boehringer Ingelheim’s (BI) interleukin-36 receptor (IL-36R)-targeted orphan drug, Spevigo (spesolimab), in subcutaneous injection form, is poised for priority review status in China. This recognition from the Center for Drug Evaluation (CDE) is attributed to its potential use in preventing flares in generalized pustular psoriasis (GPP), following the molecule’s earlier…
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Bio-Thera Solutions’ PD-1 Inhibitor BAT1308 Approved for Cervical Cancer Clinical Trials in China
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Bio-Thera Solutions Ltd (SHA: 688177) has announced that its programmed death-1 (PD-1) inhibitor, BAT1308, has been approved to enter clinical trials for the treatment of cervical cancer in China. The molecule will be assessed in combination with platinum chemotherapy and with or without bevacizumab, as per the Chinese firm’s announcement.…
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Sinocelltech Group Launches Biosimilar Version of AbbVie’s Humira in China
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China-based Sinocelltech Group Ltd (SHA: 688520) has officially commercialized its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab), marking a significant milestone in the Chinese biosimilar market. The company has delivered the first batch of the biosimilar product, achieving commercialization in less than two weeks following regulatory approval. Humira’s Global…
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Grand Pharmaceutical Initiates Phase II STARBURST Study for TLX250-CDx in Indication Expansion
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the indication expansion Phase II STARBURST study for its TLX250-CDx (89Zr-DFO-girentuximab). The imaging agent is licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a 2020 deal valued at up to USD 225 million. The 2020…
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Shanghai Pharmaceuticals’ SPH3127 for Hypertension Gets MNPA Review Acceptance
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China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced that the National Medical Products Administration (MNPA) has accepted a market approval filing for its SPH3127, a Category 1 drug co-developed with Japan-based Mitsubishi Tanabe Pharma Corporation. The intended indication for this novel drug is hypertension. SPH3127: A Novel Oral…
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WinHealth Pharma Receives NMPA Approval for Glycerol Phenylbutyrate for Urea Cycle Disorders
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China-based Hong Kong WinHealth Pharma Group Ltd has announced receiving market approval from the National Medical Products Administration (NMPA) for its glycerol phenylbutyrate, a drug used as a long-term treatment for patients with urea cycle disorders (UCDs). This approval specifically targets patients who cannot achieve disease control through protein intake…
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Nanjing Leads Biolabs Receives FDA IND Approval for LBL-033 Phase I/II Clinical Trial
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China-based Nanjing Leads Biolabs Co., Ltd has revealed that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial for its pipeline candidate, LBL-033. This anti-MUC16/CD3 bispecific antibody (BsAb) is set to be investigated as a potential…
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TG ImmunoPharma Receives FDA Approval for Phase I Clinical Study of TGI-6 Bispecific Antibody
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its bispecific antibody (BsAb), TGI-6. This development marks a significant step forward in the company’s efforts to bring innovative immunotherapies to patients…
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IASO Bio Receives FDA IND Approval for IASO-782 for Autoimmune Disorders
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China-based IASO Bio has announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) filing for its pipeline candidate, IASO-782. This injectable drug candidate will be assessed in US clinical trials for the treatment of various autoimmune hematological disorders, including primary immune thrombocytopenia (ITP)…
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Aosaikang Pharmaceutical’s ASKB589 Shows Promising Results in Solid Tumor Treatment Study
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed the latest results from a Phase I/II study for its Category 1 biologic product candidate ASKB589, which is being assessed as a treatment for solid tumors. The findings were presented at the 15th International Gastric Cancer Association (IGCA) meeting, highlighting the…
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Roche’s Evrysdi Receives NMPA Approval for Wider SMA Patient Age Range
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that its blockbuster nervous system drug Evrysdi (risdiplam) has received market approval from the National Medical Products Administration (NMPA) to treat spinal muscular atrophy (SMA) in patients aged 16 days and above. This marks an expansion of the drug’s indication in China,…
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MicuRx Pharmaceuticals’ MRX-4/Contezolid Combo Receives Clinical Trial Approvals for Diabetic Foot Infection
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced receiving clinical trial approvals for its novel anti-microbial agent MRX-4, combined with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in Israel, Bulgaria, Slovakia, Croatia, Poland, and Brazil. In-House Developed Oxazolidinone AntibioticsBoth MRX-4 and contezolid are in-house developed new-generation…
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BeiGene to Showcase Brukinsa Data at ICML, Highlighting Efficacy in Relapsed Follicular Lymphoma
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China-based biopharmaceutical company BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML). The data highlights the potential of Brukinsa in combination with obinutuzumab for the treatment of…
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Fosun Pharma Initiates Phase II Study of HLX26 and Serplulimab Combo for Metastatic CRC
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II clinical study in China for HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, in combination with its programmed-death 1 (PD-1) inhibitor HaiSiZhuang (serplulimab) for the treatment of metastatic…
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Takeda and HutchMed’s Elunate Study Results Published in The Lancet
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Takeda (TYO: 4502) and HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) have announced that the results of the Phase III FRESCO-2 study for Elunate (fruquintinib) in previously treated metastatic colorectal cancer (mCRC) have been published in The Lancet journal. The global Phase III study, conducted across the US, Europe, Japan,…
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CStone’s Sugemalimab Shows Promising Survival Rates in Stage IV NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the prestigious journal Nature Cancer has published the overall survival (OS) interim analysis from the registrational clinical study GEMSTONE-302. The study evaluates the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab as a first-line treatment for stage IV non-small cell lung cancer (NSCLC). GEMSTONE-302…
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Jiangxi Jemincare’s JYB1907 Receives NMPA Approval for Clinical Study in Solid Tumors
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China-based Jiangxi Jemincare Group has announced that it has received approval from the China National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug, JYB1907, a monoclonal antibody (mAb) targeting GARP and TGF-β1, in patients with locally advanced malignant solid tumors. The drug had previously…
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Cytocraft Biotech’s SDT-T002 Cell Therapy Approved for Advanced Liver Cancer by NMPA
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China-based Cytocraft Biotech Development has announced that its cell therapy, SDT-T002, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of advanced liver cancer that has failed standard treatment. Cascade Primed Immune Cells (CAPRI) Cell Therapy OverviewCytocraft boasts its Cascade Primed Immune Cells (CAPRI)…
