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XtalPi Inc. and China Pharmaceutical University Launch Joint AI Research Center in China
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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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Omega Medical Imaging’s Soteria.AI Receives FDA Approval for Interventional Cardiology
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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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NMPA Extends Public Feedback Period for ‘Drug Standardization Management Measures’ in China
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The National Medical Products Administration (NMPA) in China has announced an extension to the public feedback period for its draft proposal titled “Drug Standardization Management Measures.” Initially open for feedback from December 14, 2022, to January 13, 2023, the window has been extended to June 5, 2023. This initiative reflects…
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Hasten Biopharm Acquires Commercial Rights to Rocephin in China from Roche
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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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Mindray Reports Strong YOY Growth in 2022 and Q1 2023 Financial Results
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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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Anhui and Qinghai Provinces Update BMI Chronic Disease Drug Lists for Outpatient Reimbursement
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The healthcare security bureaus of Anhui and Qinghai provinces in China have separately released notifications regarding the adjustment of the basic medical insurance (BMI) chronic disease drug lists for outpatients. These lists are significant as they often result in improved reimbursement conditions for patients and can lead to certain drugs…
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Huadong Medicine’s Mefatinib Poised for Breakthrough Therapy Designation by CDE
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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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VivaVision Biotech Secures Over RMB 100 Million in Series D2 Financing for Ophthalmology Pipeline Expansion
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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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Yantai Dongcheng Pharma’s 177Lu-LNC1003 Cleared for US FDA Phase I Study
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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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ABM Therapeutics’ ABM-168 Begins Phase I Dosing in the US for Advanced Solid Tumors
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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 Partners with West China Second University Hospital for Pediatric Care Innovation
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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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China’s CDE Releases 69th Batch of Generic Chemical Reference Preparations for Public Review
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The Center for Drug Evaluation (CDE) in China has released the 69th batch of chemical generic reference preparations, which includes 10 new specifications and updates to 31 previously published specifications. This release is a significant step in the ongoing effort to standardize and improve the quality of generic drugs available…
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Innovent Biologics’ GFH925 Earns Breakthrough Therapy Designation for KRASG12C CRC Treatment
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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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CARsgen Therapeutics’ AB011 and Tecentriq Combo Gets NMPA Approval for Gastric Cancer Treatment
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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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Fujian Cosunter Pharmaceutical Completes Enrollment in Phase II/III Trial for GST-HG171/Ritonavir
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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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BeiGene Reports Q1 2023 Financial Growth, Advances Pipeline with Global Expansion Plans
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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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China’s Regulatory Bodies Unveil Guidelines to Strengthen Supervision of Medical Aesthetic Industry
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The State Administration for Market Regulation, National Health Commission, National Administration of Traditional Chinese Medicine, National Medical Products Administration, and Supreme People’s Court, among a total of 11 bureaus, have released the “Guidelines on Further Strengthening the Supervision of the Medical Aesthetic Industry.” These guidelines are designed to bring clarity…
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Medisan Pharmaceutical Secures PPAR Agonist Technology from China Pharmaceutical University
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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 Expands with New Healthcare Industrial Park in Hainan
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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…
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Ascletis Pharma’s ASC40 Meets Acne Treatment Goals in Phase II Trial
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, ASC40 (senifanstat), has successfully met primary and key secondary endpoints in a Phase II clinical trial for acne vulgaris. ASC40’s Mechanism of Action and Trial DesignASC40 is an oral, selective small-molecule inhibitor…
