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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Medicine with an investment of USD 100 million in 2018, has announced the receipt of orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, edralbrutinib. The designation is awarded for the…
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China-based gene therapy developer Lingyi Biotechnology Co., Ltd has reportedly raised close to RMB 100 million (USD 14.5 million) in a Series A finance round. This significant investment was co-led by Efung Capital and Huafang Asset Management, with additional participation from Transfar Science City, Sequoia China, and Huaiji Capital. The…
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will evaluate the combination of HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, with Henlius’s programmed-death 1…
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Shanghai Junshi Biosciences Co., Ltd (SHA: 688180), a China-based biotechnology firm, has announced an exclusive license and commercialization agreement with India-based Dr. Reddy’s Laboratories (BOM: 500124). The agreement focuses on the programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), marking a significant step in the global expansion of this therapeutic agent. Territorial…
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China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strategic partnership with Shenzhen municipality, with the aim of intensifying collaboration on high-end medical devices, innovative drugs, pharmaceutical business, and medical wellness, among other sectors. The financial details of this agreement have not been disclosed, but the partnership signals…
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has joined forces with China Pharmaceutical University (CPU) to establish a joint research center in China. This collaboration aims to leverage the strengths of both institutions in the field of AI and pharmaceutical research. Innovative Laboratory Automation and Intelligent SystemsThe project features an…
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US-based medical technology firm Omega Medical Imaging has received marketing approval from the US Food and Drug Administration (FDA) for its Soteria.AI, an image-guided X-ray system specifically designed for interventional cardiology labs. This marks a significant milestone as Soteria.AI is hailed as the first artificial intelligence (AI)-enabled X-ray system approved…
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China-based Hasten Biopharmaceutical Co., Ltd has announced the acquisition of the commercial rights in China to Rocephin, a long-acting, broad-spectrum cephalosporin antibiotic, from Swiss pharmaceutical giant Roche (SWX: ROG). This strategic move expands Hasten’s product offerings and strengthens its position in the Chinese market. Comprehensive Agreement Includes Marketing Authorization and…
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China-based medical device firm Mindray (SHE: 300760) has released its financial reports for the year 2022 and the first quarter of 2023, showcasing robust growth across its main business units. In 2022, the company recorded a revenue of RMB 30.366 billion (USD 4.4 billion), marking a 20.17% increase year-on-year (YOY),…
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The Center for Drug Evaluation (CDE) website indicates that China-based Huadong Medicine Co., Ltd (SHE: 000963) is on course to obtain breakthrough therapy designation (BTD) for its mefatinib. This second-generation irreversible EGFR/HER2 inhibitor is targeted for the treatment of first-line advanced non-small cell lung cancer (NSCLC) with rare mutations in…
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China’s VivaVision Biotech Inc. has announced the successful completion of its Series D2 financing round, securing an investment exceeding RMB 100 million. The funding round was led by V-Capital, Shengze Investment, Sunbow Capital, and VVB Fund. The capital raised will be strategically allocated to accelerate the company’s multiple clinical studies…
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its drug 177Lu-LNC1003. This marks a significant milestone for the company as it advances its innovative treatment…
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Shanghai-based ABM Therapeutics, Inc. has announced the commencement of the first patient enrollment and dosing in a Phase I clinical study for its investigational drug ABM-168 in the United States. This open, dosage escalation, dosage expansion study, which received approval in the country in October 2022, is designed to assess…
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Kangrui Health, a leading data and intelligence application company based in Beijing, has entered into a significant 10-year partnership with West China Second University Hospital. The collaboration focuses on the “Children’s Medical Counseling Game – Wonderful Hospital Series” technology translation project, which is set to revolutionize pediatric care approaches. West…
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The Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics’ (HKG: 1801) Category 1 chemical drug GFH925 has been awarded a breakthrough therapy designation (BTD) for the treatment of KRASG12C mutant advanced colorectal cancer (CRC). This designation highlights the potential of GFH925 in addressing a significant unmet medical…
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China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 combined with Roche’s programmed death-ligand 1 (PD-L1) therapy Tecentriq (atezolizumab) alongside standard chemotherapy. This treatment is…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the completion of 1,200 patient enrollment in a Phase II/III clinical study for its Category 1 product, GST-HG171/ritonavir. This multi-center, randomized, double-blind, controlled trial is designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients.…
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China-based BeiGene, Ltd. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has reported financial results for the first quarter of 2023, highlighting recent business achievements and upcoming milestones. The company’s revenue for the three months ended March 31, 2023, was USD 447.8 million, marking a robust 46.05% increase year-on-year (YOY). Product revenue…
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Harbin Medisan Pharmaceutical Co., Ltd (SHE: 002900) has announced a significant patent and technology transfer agreement with China Pharmaceutical University (CPU) for the development rights of a peroxisome proliferator-activated receptor (PPAR) agonist. This agreement involves an upfront payment of RMB 11 million (USD 1.6 million) and potential milestone payments totaling…
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Meihua International Medical Technologies Co., Ltd (NASDAQ: MHUA), has announced the acquisition of a land plot in the Boao Lecheng Medical Tourism Pilot Zone of Hainan Province for RMB 24.06 million (USD 3.5 million), with a 50-year land usage right. The company plans to develop a comprehensive healthcare industrial park…