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BioMarin Pharmaceutical to Discontinue Vimizim Import License in China
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BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) has announced its decision not to renew the Import Drug License (IDL) for Vimizim (elosulfase alfa) in China when it expires in May 2024. The company is currently exploring feasible ways to ensure a continuous supply to patients currently undergoing treatment. Challenges in China’s Market…
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Vcanbio Receives NMPA Approval for VUM02 Stem Cell Therapy in Liver Failure and ARDS
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its VUM02, a human umbilical cord-derived mesenchymal stem cell therapy. The Category 1 therapeutic biologic product is set to be assessed in acute-on-chronic liver failure (ACLF)…
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Dizal Pharmaceutical Presents Updates on Sunvozertinib and Golidocitinib at ASCO 2023
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) and JAK1 inhibitor golidocitinib (DZD4205) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Sunvozertinib: A Promising EGFR Inhibitor for NSCLCSunvozertinib, under development for…
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Abbisko Therapeutics’ Pimicotinib Earns PRIME Status for TGCT from EMA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that its Category 1 drug ABSK021 (pimicotinib) has received Priority Medicine (PRIME) status from the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). This decision comes on the heels of positive results from an…
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NMPA Approves Shenzhen Core Medical’s Implantable Left Ventricular Assist System
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The National Medical Products Administration (NMPA) has issued market approval for the implantable left ventricular assist system developed by China-based Shenzhen Core Medical Technology Co., Ltd. This marks the fourth such device to reach the market in China, expanding options for patients with advanced heart failure. Product Composition and Clinical…
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uBriGene Partners with Everlife Biomed to Advance iPSC Therapy Preparation
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China-based uBriGene, a leading cell and gene therapy contract development and manufacturing organization (CDMO), has announced a strategic partnership with Everlife Biomed (Beijing) Co., Ltd., a biopharmaceutical company specializing in human immune privilege cell technology. The collaboration will focus on the development of induced pluripotent stem cells (iPSC) therapy preparations,…
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EpimAb Biotherapeutics Appoints Dr. Zhu Yonghong as Chief Medical Officer
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Shanghai-based biotech company EpimAb Biotherapeutics has announced the appointment of Dr. Zhu Yonghong to the role of Chief Medical Officer (CMO). Dr. Zhu will oversee all clinical development activities related to the firm’s pipeline candidates, succeeding Dr. Peng Bin who has recently retired. Dr. Zhu’s Impressive Background in Clinical DevelopmentDr.…
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CStone Pharmaceuticals and Servier Report Positive AGILE Study Results for Tibsovo at ASCO
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CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has published the latest results of the global Phase III AGILE study for Tibsovo (ivosidenib) combined with azacitidine in newly diagnosed acute myeloid leukemia (AML) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Phase III AGILE Study Design and FindingsThe…
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BioNTech’s DB-1303 ADC Shows Promising Results in Solid Tumor Phase I/IIa Trial
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Germany’s BioNTech (NASDAQ: BNTX) has released preliminary data from a Phase I/IIa trial for DB-1303, a DNA topoisomerase I-inhibiting antibody-drug conjugate (ADC) licensed from China-based Duality Biologics. The trial focused on patients with solid tumors, and the results indicated that 44.2% of patients exhibited an objective partial tumor response. Notably,…
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Gilead’s Kite Announces Breakthrough Phase III Results for Yescarta in r/r LBCL
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Gilead’s (NASDAQ: GILD) subsidiary Kite has published groundbreaking Phase III results for Yescarta (axicabtagene ciloleucel), a CAR-T therapy, in the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL). The study applauds Yescarta as the first treatment in 30 years to significantly improve survival in this indication. Compared to…
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ITabMed Ltd Receives NMPA IND Approval for A-337, a CD3-Activating BsAb Targeting EpCAM
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Shanghai-based biotech firm ITabMed Ltd has announced the receipt of Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate, A-337. A-337 is a CD3-activating bispecific antibody (BsAb) targeting EpCAM, a tumor-associated antigen (TAA) that is up-regulated and over-expressed in many solid tumor types,…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Accepted for Review by China’s NMPA
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China-based Luye Pharma Group (HKG: 2186) has announced that its market filing for lurbinectedin (LY01017) in metastatic small cell lung cancer (SCLC) has been accepted for review by China’s National Medical Products Administration (NMPA). The filing pertains to patients with tumor progression during or after platinum-based chemotherapy, and the RNA…
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Shanghai Runda Medical Science and Technology Partners with Huawei Cloud on AI in Healthcare
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China-based Shanghai Runda Medical Science and Technology Co., Ltd (SHA: 603108) is set to collaborate with telecoms giant Huawei Cloud on the construction of a large artificial intelligence (AI) model in the healthcare industry, with the aim of developing and offering smart medical services. Leveraging Expertise for Smart Medical ServicesUnder…
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Lee’s Pharmaceutical Subsidiary Zhaoke Ophthalmology Announces FDA Review of NVK002 for Pediatric Myopia
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that the US FDA has accepted for review the New Drug Application (NDA) for Vyluma Inc.’s NVK002, an atropine external use eye solution for pediatric myopia. The FDA has set a Prescription Drug User Fee…
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Legend Biotech Submits sBLA to Expand Carvykti Label for Relapsed Multiple Myeloma
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Legend Biotech Corporation (NASDAQ: LEGN) has announced the submission of a supplemental Biologics License Application (sBLA) to the US FDA. The sBLA aims to expand the label for Carvykti (ciltacabtagene autoleucel; cilta-cel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least…
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Zai Lab and Novocure’s TTFields Show Survival Benefit in NSCLC, Despite Stock Plunge
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China-based Zai Lab Ltd (ZLAB) (NASDAQ: ZLAB; HKG: 9688) and its partner Novocure Ltd (NASDAQ: NVCR) have presented positive results from the Phase III LUNAR clinical trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial evaluated the use of Tumor Treating Fields (TTFields) therapy in…
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Shanghai Junshi Biosciences to List GDRs on Swiss Exchange, Raising RMB 3.4 Billion
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is preparing to issue 68,292,200 Global Depositary Receipts (GDRs) on the SIX Swiss Exchange. This secondary listing is anticipated to raise a substantial RMB 3.4 billion (USD 480 million), which will be allocated to support research and development (R&D) projects,…
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CStone Pharmaceuticals Presents Ayvakit Data for Advanced GIST at ASCO 2023
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China-based CStone Pharmaceuticals (HKG: 2616) announced that new data from a post hoc analysis of the global Phase I NAVIGATOR and Phase I/II China bridging (CS3007-101) studies for Ayvakit (avapritinib) in advanced gastrointestinal stromal tumor (GIST) were presented in a poster discussion session at the 2023 American Society of Clinical…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-20117 Bispecific Antibody Clinical Study
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for HS-20117, a bispecific antibody (BsAb) targeting both EGFR and cMet in advanced solid tumors. Strategic Licensing Deal with BiotheusIn a significant move to expand its…
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Chinese Pharma Companies Update Pipelines at ASCO 2023 Annual Meeting
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A number of Chinese pharmaceutical companies have shared updates on their pipeline developments at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Among them are CSPC Pharmaceutical Group Ltd (HKG: 1093), Alphamab Oncology (HKG: 9966), and Innovent Biologics Inc. (HKG: 1801). CSPC’s CLDN18.2 ADC Demonstrates Promise in Phase…
