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Fosun Kite’s Yescarta Gains Priority Review Status for r/r LBCL
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China-based Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead subsidiary Kite Pharma, has revealed that Yescarta (axicabtagene ciloleucel) has obtained priority review status for adult large B-cell lymphoma (r/r LBCL) that is refractory to first-line immunochemotherapy or has…
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Genor Biopharma Initiates First Patient Dosing for GB263T in China
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced the first patient dosing in a Phase I/II clinical study for its pipeline candidate GB263T in advanced non-small cell lung cancer (NSCLC) and other solid tumors in China. The drug was first administered in a first-in-human trial in Australia in May…
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Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study
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China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in combination with its anti-CD73 monoclonal antibody (mAb) AK119 for…
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Innovent Biologics Publishes Mazdutide Phase Ib Study Results for Obesity
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the results of the higher-dose cohorts in a Phase Ib study for mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, in overweight or obese Chinese participants have been published online at eClinicalMedicine. Licensing Deal and Drug ProfileInnovent struck…
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Sihuan Pharma to Acquire Additional Stake in Heilongjiang Duoduo Pharma
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China-based Sihuan Pharmaceutical Holdings Group Ltd’s subsidiary, Beijing Centergate Technologies (Holding) Co., Ltd (SHE: 000931), has announced that Sihuan Pharma is set to acquire an additional 9.56% stake in Heilongjiang Duoduo Pharmaceutical Co., Ltd. Upon the deal’s closure, Sihuan will own a 78.82% stake in Duoduo Pharma, maintaining its position…
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NHSA Completes Expert Review for NRDL Price Negotiation Process
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The National Healthcare Security Administration (NHSA) has released a notification indicating that the expert review process for the selection of drugs eligible to enter the price negotiation process as part of this year’s update to the National Reimbursement Drug List (NRDL) has been completed. This marks a significant step in…
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BeiGene’s Brukinsa Receives Positive CHMP Opinion for CLL Approval
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). This recommendation is…
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Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
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Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104, a first-in-class bifunctional biologic. The drug will be evaluated as a treatment for paroxysmal nocturnal hemoglobinuria…
