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CStone Pharmaceuticals Publishes Ayvakit Study Results on Oncologist Website
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China-based CStone Pharmaceuticals (HKG: 2616) has published the results of the China-based bridging NAVIGATOR study for its Ayvakit (avapritinib), a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST), on the Oncologist website. The open-label, multi-center Phase I/II study was designed to assess the safety, pharmacokinetics, and anti-tumor efficacy…
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Biosion Completes Series B Financing Round Led by Guangfa Xinde Investment
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Biosion, a global, clinical-stage biotech committed to developing antibody-based therapies targeting immune and oncologic diseases, has announced the completion of a Series B financing round at upwards of RMB 100 million (USD 14.33 million). The funding was led by Guangfa Xinde Investment, with contributions from FangFund, Addor Capital, and Suxin…
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BGI Genomics Receives ANVISA Approval for Colorectal Cancer Detection Kit
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China-based genomics giant BGI Genomics Co., Ltd (SHE: 300676) has reported receiving product approval from Brazil’s National Health Surveillance Agency (ANVISA) for its colorectal cancer (CRC) early detection real-time PCR product. The diagnostic kit, used for the auxiliary diagnosis of CRC, is a non-invasive product that detects human genes SDC2,…
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InflaRx and Staidson Amend Deal to Advance Vilobelimab Regulatory Filing in China
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Germany-based biopharma InflaRx N.V. (Nasdaq: IFRX) has revealed an amendment to its underlying deal with China-based Staidson BioPharma Inc. (STS) to push forward a regulatory filing in China for the anti-C5a antibody vilobelimab (BDB-001). InflaRx will supply Staidson with an exclusive license to access the German firm’s clinical, manufacturing, and…
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Elpiscience Receives IND Approval for ES014 in China
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Shanghai-based Elpiscience Biopharmaceuticals Inc. has announced receiving Investigational New Drug (IND) approval in China to initiate a Phase I clinical trial for its bispecific antibody (BsAb) ES014 in patients with advanced solid tumors. ES014 is a potential first-in-class anti-CD39 x TGF-beta immunotherapeutic designed to activate T cells and overcome resistance…
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Ablaze Pharma and Yonghe Partner for Targeted Radiotherapy Development
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China-based Ablaze Pharma and Yonghe Pharmaceutical have struck a partnership agreement for the research and development (R&D) and commissioned manufacturing of targeted radiotherapy (TRT). Yonghe, Ablaze’s Contract Development and Manufacturing Organization (CDMO) partner, will provide R&D and cGMP-compliant manufacturing services from the pre-clinical to clinical stages. Company Background and Partnership…
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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’…
