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Biosion Receives FDA Approval for Phase II Study of TSLP mAb BSI-045B
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Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) BSI-045B. The in-house developed BSI-045B is intended…
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OncoSec Medical’s TAVO-EP Combo Misses Primary Endpoint in Melanoma Trial
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US-based OncoSec Medical Inc., (OTCMKTS: ONCSQ), majority-owned by China-based Grand Pharmaceutical Group Ltd (HKG: 0512), has revealed disappointing data from a crucial pivotal Phase II trial assessing the firm’s lead DNA drug candidate TAVO-EP (tavokinogene telseplasmid) combined with the programmed death-1 (PD-1) monoclonal antibody Keytruda (pembrolizumab) as a treatment for…
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Jacobio Pharma Receives Approval for Phase I/IIa Study of LIF mAb in Advanced Solid Tumors
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to conduct a Phase I/IIa clinical study for its leukemia inhibitory factor (LIF) monoclonal antibody (mAb) in patients with advanced solid tumors. LIF as a Target for KRAS-driven TumorsLIF is a key target in KRAS-driven tumors, including pancreatic and…
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Nanjing Zenshine Pharmaceuticals’ ZX-7101A Meets Primary Endpoint in Phase II Influenza Study
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China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd announced that a Phase II clinical study for its anti-influenza drug ZX-7101A in adult simple influenza has successfully reached the primary endpoint. Design and Results of the Phase II/III StudyThe multi-center, randomized, double-blind, placebo-controlled Phase II/III study is designed to…
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Lynk Pharmaceuticals Concludes Phase I Study for JAK Inhibitor LNK01003 with Positive Results
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China-based Lynk Pharmaceuticals (Hangzhou) Co., Ltd has announced the successful conclusion of a Phase I clinical study for its Category 1 innovative drug candidate, LNK01003. The trial, which assessed the molecule in healthy volunteers, demonstrated a good safety profile, tolerability, and pharmacokinetics. Design and Outcomes of the Phase I StudyThe…
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Johnson & Johnson’s Talquetamab on Track for Breakthrough Therapy Designation in Multiple Myeloma
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China’s Center for Drug Evaluation (CDE) has indicated that US pharmaceutical giant Johnson & Johnson’s (J&J, NYSE: JNJ) GPRC5D/CD3 bispecific antibody (BsAb) talquetamab is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory (R/R) multiple myeloma (MM) in patients who have undergone at least…
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CSPC Pharmaceutical Receives FDA Approval for Phase I Study of CPO301 in Lung Cancer
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study assessing the safety, pharmacokinetics, and preliminary efficacy of its antibody-drug conjugate (ADC) CPO301 in patients with advanced lung cancer characterized by…
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Shanghai Fosun Pharmaceutical Gets NMPA Approval for FCN-338 Phase II Study
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline drug candidate, FCN-338. The study will assess the efficacy of FCN-338 in treating malignant hematological diseases of the…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Prolia
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving market approval from the National Medical Products Administration (NMPA) for its biosimilar version of US major Amgen’s Prolia (denosumab). This development marks Mabwell’s drug as the world’s second biosimilar of Prolia, which is used to treat osteoporosis in postmenopausal…
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Roche’s Cosentyx 300mg Dosage Approved by NMPA for Ankylosing Spondylitis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the National Medical Products Administration (NMPA) has approved the 300mg dosage regimen of Cosentyx (secukinumab) for use in treating ankylosing spondylitis (AS). This approval represents a significant advancement in the management of this chronic inflammatory disease. Approval Based on MEASURE 3…
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Changzhou Qianhong Bio-pharma Receives NMPA Approval for QHRD107 Phase II AML Study
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China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced obtaining approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug QHRD107 in acute myeloid leukemia (AML). The drug is being developed for use in combination with venetoclax and/or azacitidine,…
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Konruns Pharmaceutical Reports Positive Efficacy Results for KC1036 in Advanced ESCC
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the publication of efficacy study results for its Category 1 chemical drug, KC1036, in the treatment of advanced esophageal squamous cell carcinoma (ESCC). The drug was evaluated as a second-line therapy for patients who have already failed previous standard treatments. Study…
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Cellular Biomedicine Group Initiates Phase III Study for AlloJoin in Knee Osteoarthritis
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has announced the initiation of a Phase III clinical study for its allogeneic human adipose mesenchymal progenitor cell injection, AlloJoin. This follows a successful randomized, double-blind, controlled multi-center Phase II clinical study, which included a 96-week follow-up and preliminarily demonstrated a…
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Abbisko Therapeutics Secures Orphan Drug Designation for FGFR4 Inhibitor ABSK012
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its next-generation FGFR4 mutant inhibitor, ABSK012, intended for the treatment of soft-tissue sarcoma. Preclinical Efficacy of ABSK012 Against FGFR4 MutantsPreclinical studies have…
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HutchMed Completes NDA Submission to US FDA for Frquintinib in Metastatic CRC
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its oral inhibitor of VEGFR-1, -2, and -3, fruquintinib. The drug is proposed for the treatment of refractory metastatic…
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Huadong Medicine Wins NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide). This new biosimilar is intended for use in treating patients with type 2 diabetes. Liraglutide…
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Fosun Pharmaceutical Gets NMPA Approval for FCN-159 Phase II Study in LCH
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study of its novel small molecule chemical drug, FCN-159. The study will evaluate the drug’s efficacy as a treatment…
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Shanghai Fosun Pharma Commences Phase III Trial for HER2-Targeted FS-1502
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a prominent Chinese pharmaceutical company, has announced the start of a Phase III clinical study in the Chinese mainland for its HER2-targeted antibody drug conjugate (ADC), FS-1502. The study is focused on the treatment of HER2-positive unresectable, locally advanced, or…
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CStone Pharmaceuticals’ Sugemalimab Study Published in JCO for R/R ENKTL Treatment
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, announced that the Journal of Clinical Oncology (JCO) has published the results of the registrational clinical study GEMSTONE-201 for the PD-L1 antibody sugemalimab in the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). This study represents the largest registrational clinical…
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ImmVira’s MVR-C5252 Receives NMPA Approval for Glioma Treatment Development
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China-based biotechnology company ImmVira has received approval from the National Medical Products Administration (NMPA) for its potentially groundbreaking oncolytic virus product, MVR-C5252, which is under development to treat gliomas. This first-in-class product marks a significant step forward in the treatment of brain tumors. Global Context and PrecedenceIn June 2021, Japanese…
