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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…
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Janssen to Halt RSV Adult Vaccine Development, Impacting Phase III Trial
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary, Janssen, has announced its decision to terminate its respiratory syncytial virus (RSV) adult vaccine development program, which includes discontinuing a Phase III trial. This strategic move is a response to the current RSV vaccine landscape and is part of an effort to optimize…
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Pfizer’s Ritlecitinib Heads for Priority Review in China for Vitiligo Treatment
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The China’s Center for Drug Evaluation (CDE) website has indicated that Pfizer’s (NYSE: PFE) ritlecitinib, a Janus kinase 3 (JAK3) inhibitor, is on track for priority review status for the treatment of vitiligo in China. This development highlights the potential fast-track approval process for this novel therapy in addressing the…
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Transcenta’s Osemitamab Receives FDA Orphan Drug Designation for Pancreatic Cancer
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China-based biotechnology company Transcenta Holdings Ltd (HKG: 6628) has announced that its drug TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin 18.2 monoclonal antibody (mAb), has received orphan drug designation (ODD) status from the US FDA for the treatment of pancreatic cancer. This follows a previous ODD granted in 2021 for the…
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ImmuneOnco Achieves Full Enrollment in Phase II Study of IMM01 for CMML
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the successful completion of patient enrollment in its Phase II clinical study (IMM01-02), which investigates the combination of IMM01 with azacitidine for the treatment of naïve chronic myelomonocytic leukemia (CMML). The study has fully enrolled 20 patients, marking a significant milestone in the…
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Kintor Pharmaceutical Realigns Funds from COVID-19 Studies to Other Pipeline Candidates
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced a strategic change in the allocation of proceeds from previous subscriptions. The company has decided to redirect HKD 509 million (USD 64.8 million), initially intended for the clinical development and commercialization of proxalutamide, pyrilutamide, and AR-PROTAC GT20029, away from clinical studies for…
