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Henlius Completes First Dosing in Head-to-Head Study of PD-1 Inhibitor HanSiZhuang
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a head-to-head bridging study for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The study is evaluating serplulimab as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) against Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), the…
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Full-Life Technologies Acquires Focus-X Therapeutics to Expand Pipeline
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Shanghai-headquartered Full-Life Technologies Ltd has announced the acquisition of New Jersey-based Focus-X Therapeutics. The move is expected to significantly expand Full-Life’s pipeline, including two compounds nearing clinical trials, provide a second innovative peptide-focused discovery platform, and leverage its Radio Technology manufacturing and logistics platforms to advance compounds into clinical development.…
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I-Mab Partners with Wuxi Diagnostics to Advance Biomarker-Driven Clinical Studies
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China-based I-Mab (NASDAQ: IMAB) has announced a strategic partnership with compatriot firm Wuxi Diagnostics to accelerate biomarker-driven clinical studies and explore the cutting edge of companion diagnostics (CDx) development. Financial details of the partnership were not disclosed. Clinical and Development ContextWith the deepening of research on tumor pathogenesis, immunotherapy, particularly…
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Lyvgen Biopharma Initiates Phase II Study for LVGN7409 in Advanced NSCLC
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Shanghai-based immuno-oncology therapeutics specialist Lyvgen Biopharma has announced the initiation of an open-label, multi-center, randomized Phase II clinical study to assess the efficacy and safety of its LVGN7409 in combination with docetaxel or nivolumab for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC). The combination study is set to…
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Fosun Pharma’s Henlius Completes Clinical Trial Filing for HLX301 in Australia
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its subsidiary, Shanghai Henlius Biotech (HKG: 2696), has completed a clinical trial filing for HLX301 in Australia. Henlius will conduct a Phase I clinical study in the country for the bispecific antibody (BsAb) targeting programmed-death-ligand 1 (PD-L1)…
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XtalPi Partners with CK Life Sciences to Develop AI Cancer Vaccine Platform
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has struck a partnership with China-based CK Life Sciences to develop an AI cancer vaccine research and development (R&D) platform. The collaboration aims to leverage the respective strengths of both companies to advance the development of AI-driven cancer vaccines. Financial details of the…
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Junshi Biosciences Files for UK Approval of PD-1 Inhibitor Tuoyi
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has filed for market approval with the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The filing seeks approval for the checkpoint inhibitor in combination with chemotherapy as a…
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China Releases Third Batch of VAT Discounts for Anti-Tumor and Rare Disease Drugs
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The Ministry of Finance, General Administration of Customs, State Taxation Administration, and National Medical Products Administration have jointly released the third batch list of anti-tumor drugs and rare disease drugs eligible for a value-added tax (VAT) discount. Starting from December 1, 2022, a total of 46 anti-tumor drugs and 19…
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AnchorDx Initiates US Registrational Study for UriFind Urothelial Carcinoma Diagnostic
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China-based AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing, has announced the initiation of a registrational clinical study for its urothelial carcinoma (UC) early diagnostic product UriFind in the United States, alongside the enrollment of the first patient. The study aims to verify UriFind’s performance and support the…
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Biocytogen Announces Successful Development of Fully-Human Nano Antibody RenNano
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Biocytogen (Beijing) Co., Ltd has announced the successful research and development of a fully-human nano antibody RenNano, following its previous achievements with RenMab and RenLite. The China-based Contract Research Organization (CRO) is now capable of developing fully-human monoclonal antibodies (mAbs), fully-human bispecific antibodies (BsAbs), and fully-human nano antibodies. RenNano ProfileThe…
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Alphamab Oncology and CSPC Announce Positive Phase II Data for KN026 in HER2-Positive Gastric Cancer
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China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced the publication of Phase II clinical study data for KN026 as a second-line treatment for HER2-positive locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) in the European Journal of Cancer (IF=10.002). The…
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JS InnoPharm and Strategia Holdings Form JSI Ventures in Boston
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Shanghai-based JS InnoPharm Ltd has announced an agreement with US firm Strategia Holdings LLC to establish JSI Ventures Inc. (JSV) in Boston, Massachusetts. The new venture aims to comprehensively integrate management teams and new drug research and development (R&D) projects from both companies. Dr. Keizo Koya, founder of Strategia, will…
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Kunshi Biotechnology and Puheng Technology Partner on 3D NAC-Organ Platform for CAR-Macrophage Screening
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Kunshi Biotechnology (Shenzhen) Co., Ltd and Suzhou Puheng Technology Co., Ltd have entered into a strategic partnership to utilize a 3D NAC-Organ technology platform to establish a high-throughput in vitro screening system for CAR-Macrophage cells. The collaboration aims to enhance the research and development (R&D) of new immunotherapies targeting solid…
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InnoCare Pharma’s Hibruka Receives HSA Approval for Mantle Cell Lymphoma in Singapore
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Health Sciences Authority (HSA) of Singapore for its Bruton’s tyrosine kinase (BTK) inhibitor Hibruka (orelabrutinib) to treat adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL). This marks a significant expansion of the drug’s…
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IASO Biotherapeutics Partners with Umoja Biopharma to Evaluate iCIL Platform
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China-based biopharma IASO Biotherapeutics has announced a research agreement with US immuno-oncology company Umoja Biopharma, Inc., to evaluate Umoja’s iCIL platform with IASO’s best-in-class chimeric antigen receptors (CARs). The collaboration aims to develop off-the-shelf therapies for patients with hematological malignancies, initially focusing on acute myeloid leukemia (AML), with the goal…
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Legend Biotech Receives IND Approval for LB2102 CAR-T Therapy
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced receiving Investigational New Drug (IND) approval for its LB2102, an autologous chimeric antigen receptor-T (CAR-T) therapy designed to treat adult patients with small cell lung cancer (SCLC) by targeting DLL3, a cell surface protein highly expressed in SCLC. Clinical Study DesignThe open-label…
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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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BeiGene’s Brukinsa Receives EC Approval for CLL Treatment
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China-based biotech BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving marketing approval from the European Committee (EC) for a new indication of its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved across the region to treat adult patients with treatment-naïve (TN) or relapsed/refractory…
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Subtle Medical Secures Series B Funding for AI-Powered Medical Imaging
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Subtle Medical, an Artificial Intelligence (AI)-empowered medical imaging company based in Guangdong, has reportedly raised “tens of millions” of US dollars in a Series B financing round. The round was led by Eastern Bell Capital and Primavera Venture Partners, with contributions from Fusion Fund, 3E Bioventures, Banyan Pacific Capital, Delta…
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Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Three New Drugs
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical trial approvals for three in-house developed drug candidates: HRS-1780, HRS-1358, and SHR-7367. These approvals mark significant milestones in the company’s pipeline development, positioning Hengrui to advance innovative treatments for chronic kidney disease and advanced malignant tumors. HRS-1780 ProfileHRS-1780 is an…
