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NMPA’s CDE Releases Draft Proposal for Benefit-Risk Assessment in Global Drug Development
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has issued the “Guiding Principles for Benefit and Risk Assessment Based on Multi-regional Clinical Trial Data in Global Synchronous Development of New Drugs (draft proposal)” and is soliciting public feedback for a period of two months. Consistency in…
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Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
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HuidaGene Receives CDE IND Approval for Ophthalmology Gene Therapy HG004
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) in China for its ophthalmology gene therapy, HG004. This gene replacement therapy drug utilizes a recombinant non-adeno-associated virus serotype 2 (non-AAV2) vector to deliver a functional human RPE65 gene…
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Inovio and ApolloBio Announce Positive Phase III Data for VGX-3100 Vaccine
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US-based Inovio Pharmaceuticals (NASDAQ: INO) and China-based ApolloBio Corp. (NEEQ:430187) have announced positive data from the Phase III Reveal 2 study for the DNA therapeutic vaccine VGX-3100 (known as ABC-3100 in China). The two firms are co-developing VGX-3100 under a 2018 licensing deal, with ApolloBio holding development and commercialization rights…
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Henlius Completes First Dosing in Global Phase III Study for HanSiZhuang in LS-SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a global Phase III clinical study comparing its programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab) combined with chemotherapy and concurrent radiotherapy to placebo combined with chemotherapy and concurrent radiotherapy in limited stage-small cell lung cancer (LS-SCLC).…
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Henlius’ Serplulimab Phase III Study Approved in Spain for LS-SCLC
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that its global, multi-center Phase III clinical study (NCT05353257) for HaiSiZhuang (serplulimab) in limited stage small-cell lung cancer (LS-SCLC) has been approved in Spain, a member country of the European Union (EU). The study will assess the PD-1 inhibitor combined with chemotherapy…
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Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its Phase III PRESERVE 2 study of the CDK4/6 inhibitor Cosela (trilaciclib) in metastatic triple-negative breast cancer (mTNBC). The study enrolled 187 patients, with interim overall survival analysis expected during the second half of 2023. PRESERVE…
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HutchMed’s H1 2022 Oncology Sales Surge 82% on Strong Product Performance
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China-based biopharma HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) reported strong financial results for the first half of 2022, with oncology product sales soaring 82% year-on-year (YOY) to USD 87.4 million. The company expanded its commercial team to 800 staff, driving growth across its key products. Product Sales Breakdown Revenue…
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Henlius Biotech’s HLX14 Biosimilar Wins TGA Approval for Global Phase III Osteoporosis Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) received approval from Australia’s Therapeutic Goods Administration (TGA) to conduct a global multi-center Phase III study of HLX14, its biosimilar of Amgen’s Prolia/Xgeva (denosumab), targeting postmenopausal osteoporosis in high-fracture-risk women. Study DetailsThe trial will evaluate the efficacy, safety, tolerability, and immunogenicity of HLX14…
