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BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China’s National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-naïve…
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Shanghai Junshi Biosciences’ Tuoyi Shows Promise in Phase III Study for ES-SCLC
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced encouraging results from the Phase III EXTENTORCH study, which assessed the company’s programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in combination with chemotherapy for first-line extensive stage small cell lung cancer (ES-SCLC). The trial has successfully reached its pre-set primary…
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Tianjin, Shandong, and Hainan Provinces Announce VBP Backup Suppliers for Round 8
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Tianjin, Shandong, and Hainan provinces in China have released their lists of backup suppliers following the recently completed Round 8 of the volume-based procurement (VBP) program. For the first time, the backup supplier system has been applied to drugs that are designated as being in dangerously short supply in clinics.…
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Suzhou GenAssist’s GEN6050 Receives US FDA Pre-IND Acceptance for Duchenne Muscular Dystrophy Treatment
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China-based Suzhou GenAssist Therapeutic Co., Ltd has announced that the US Food and Drug Administration (FDA) has accepted a pre-Investigational New Drug (pre-IND) application for the company’s first pipeline candidate, GEN6050. This in vivo base editing drug targets exon 50 skipping in the Duchenne muscular dystrophy (DMD) gene, with the…
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Sinopharm Partners with Fudan University to Establish National Innovation Platform
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China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strategic partnership with Fudan University, aimed at leveraging their respective strengths in technology, talent, market, and industry to jointly establish a national innovation platform. This collaboration will focus on the development of new products and technologies, the strengthening of…
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Reistone Biopharma’s Edralbrutinib Earns Orphan Drug Designation for NMOSD from US FDA
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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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Lingyi Biotechnology Secures RMB 100 Million in Series A Funding for Gene Therapy Pipeline
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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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Henlius Biotech’s HLX26 and HaiSiZhuang Combo for NSCLC Gets NMPA Phase II Approval
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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 Inks Exclusive License Deal with Dr. Reddy’s Laboratories for Tuoyi
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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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Sinopharm Partners with Shenzhen to Boost High-End Medical Device and Pharmaceutical Innovation
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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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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…
