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InnoCare Pharma’s Orelabrutinib Placed on Partial Clinical Hold by FDA
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced that the US FDA has placed orelabrutinib for use in multiple sclerosis (MS) on partial clinical hold. As a result, new enrollment of the Phase II study in the United States will not be initiated. Participants in the US who have…
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Hainan Poly Pharm Receives FDA Approval for Generic Lincomycin
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the US FDA for its generic version of US-based Upjohn’s lincomycin. This approval marks a significant milestone for Poly Pharm in expanding its presence in the US market. Drug Profile and IndicationsLincomycin, first approved in the…
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Innovent Biologics’ GFH925 Receives Breakthrough Therapy Designation
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China’s Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics (HKG: 1801) has received a breakthrough therapy designation (BTD) for its Category 1 chemical drug GFH925. The drug is intended for the treatment of KRASG12C mutant advanced non-small cell lung cancer (NSCLC) in patients who have previously received…
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Junshi Biosciences’ PD-1 Inhibitor Tuoyi Faces FDA Review Delay
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Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that they have not received an action letter from the US FDA regarding the Biologics License Application (BLA) for the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The ongoing delay is attributed to the failure to inspect the manufacturing site. The…
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Huadong Medicine’s Lanluma V and X Approved for Use in Hainan
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval from the Hainan Medical Products Administration for its poly-l-lactic collagen stimulators Lanluma V and X as clinically urgent medical devices for designated use in the Arsmo (Hainan) Aesthetic Hospital in the Boao Lecheng Medical Tourism Pilot Zone. The product…
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Antengene and MSD Collaborate on Global Clinical Study for ATG-037
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China-based Antengene Corporation Limited (HKG: 6996) has announced a global clinical collaboration with Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) to conduct a multicenter, open-label, Phase I dose-finding study for ATG-037 as a monotherapy and in combination with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab). The targeted indication is locally advanced…
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IASO Biotherapeutics Receives FDA Approval for CT103A IND Application
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China-based IASO Biotherapeutics has announced approval from the US FDA for an Investigational New Drug (IND) application for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy CT103A (equecabtagene autoleucel). The therapy will be assessed in US-based clinical trials for relapsed/refractory multiple myeloma (r/r MM). Drug Profile and DevelopmentEquecabtagene autoleucel…
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Shenzhen Würzburg Dynamics Raises RMB 100 Million in Series A Financing Round
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China-based Shenzhen Würzburg Dynamics has reportedly raised RMB 100 million (USD 14.36 million) in a Series A financing round. The funding was led by 3E Bioventures Capital, with contributions from Tzitzit Asset and Fosun Health Capital. The proceeds will be used for research and development and market construction for multiple…
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AcornMed Raises RMB 200 Million in Series B Financing Led by Yikai Venture Capital
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AcornMed, a tumor precision medicine specialist based in Beijing, has reportedly raised RMB 200 million (USD 28.7 million) in a Series B financing round led by Yikai Venture Capital. Other investors included Lichen Investment, Qingdao Hongteng, and Wushi Capital. The proceeds will be used for research and development of tumor…
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CSPC’s NBL-020 Receives FDA IND Approval for Advanced Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving Investigational New Drug (IND) approval from the US FDA for its antibody-drug NBL-020. The targeted indication is advanced solid tumors, marking a significant step forward in the development of this innovative therapy. Drug Profile and Mechanism of ActionNBL-020 is an…
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Jiangsu Chia Tai Tianqing’s TQB2102m Gains NMPA Clinical Approval
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Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd’s (CTTQ) Category 1 biologic product TQB2102m, an HER2 targeted antibody drug conjugate (ADC), has obtained clinical approval from the National Medical Products Administration (NMPA). The targeted indication is advanced malignant tumors, with no similar product currently approved for marketing anywhere in the world.…
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WuXi XDC Partners with GeneQuantum for ADC Development
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China-based WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced a partnership with compatriot firm GeneQuantum Healthcare (Suzhou) Co., Ltd in relation to antibody-drug conjugate (ADC) development. The collaboration aims to advance the development and…
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Hengrui Pharmaceuticals Receives New Approval for Remimazolam Tosylate
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced one new supplementary approval for its gamma-aminobutyric acid type A (GABAA) receptor antagonist remimazolam tosylate. The approval, with the indication being sedation and anesthesia during non-tracheal intubation surgery / operation, marks the drug’s fourth market approval. Previous Approvals and Clinical StudiesRemimazolam tosylate…
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Neurophth Partners with Apellis for Gene Therapy Development in AMD
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced a strategic partnership with US firm Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) to develop a gene therapy based on the complement regulation mechanism for geographic atrophy (GA) / dry age-related macular degeneration (dAMD). Financial details of the partnership were not disclosed. Apellis’…
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Jing Medicine’s HJM-353 Gains Clinical Trial Approvals in US and China
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China-based Jing Medicine Technology (Shanghai) Co., Ltd’s HJM-353 has obtained clinical trial approvals in the US and China. The investigational embryonic ectoderm development (EED) inhibitor is expected to enter a Phase I clinical study for advanced blood cancer and solid tumors. Mechanism of Action and DevelopmentPolycomb repressive complex 2 (PRC2)…
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Jiangsu Vcare PharmaTech Raises RMB 200 Million in Series B Financing Round
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China-based Jiangsu Vcare PharmaTech Co. Ltd has reportedly raised over RMB 200 million (USD 28.67 million) in a Series B financing round. The round was led by Changjiang Venture Capital, with additional investments from Hongcheng Investment, Huadian Investment, Yangtze Investment, and SDIC. The proceeds will be used for clinical development…
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MindRank AI Receives FDA Approval for MDR-001 Clinical Study in Obesity
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Hangzhou-based artificial intelligence (AI)-driven biotech MindRank AI has announced obtaining approval from the US FDA to conduct a clinical study for its oral, small molecule GLP-1 receptor agonist (RA) drug MDR-001 in obesity. This marks a significant milestone in the development of MDR-001, positioning MindRank AI to advance its innovative…
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Hangzhou Biotest Receives FDA EUA for COVID-19 Antigen Self-Testing Reagent
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China-based Hangzhou Biotest Biotech Co., Ltd has announced receiving an Emergency Use Authorization (EUA) from the US FDA for its novel coronavirus antigen self-testing reagent. This authorization marks a significant step in expanding the availability of COVID-19 testing options in the US market. Product Details and UsageThe COVID-19 antigen self-testing…
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Junshi Biosciences Licenses PD-1 Inhibitor Tuoyi to Hikma MENA FZE
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a licensing agreement with UK-headquartered Hikma MENA FZE, granting the latter exclusive development and commercialization rights to its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in Jordan, Saudi Arabia, the United Arab Emirates, Qatar, Morocco, and Egypt, among a total of 20…
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Shanghai Pharmaceuticals Secures Exclusive Rights for Shionogi’s Ensitrelvir in China
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Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has announced an import and distribution agreement with Japan-based Shionogi & Co., Ltd, becoming the exclusive importer and agent of the latter’s oral COVID-19 therapy ensitrelvir in mainland China. The two-year deal also includes a collaboration on innovative and generic drugs. Financial details of…
