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Zelgen Biopharmaceuticals’ ZGGS15 Earns FDA Approval for Advanced Solid Tumor Clinical Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US FDA for its bispecific antibody (BsAb), ZGGS15, which targets LAG-3 and TIGIT in advanced solid tumors. This marks ZGGS15 as the world’s first BsAb of its kind to reach the clinical…
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CSPC Pharmaceutical’s CPO301 Receives Health Canada Approval for Phase I Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from Health Canada to initiate a Phase I clinical study. The study will assess the safety, pharmacokinetics, and preliminary efficacy of its in-house developed antibody-drug conjugate (ADC), CPO301, in patients with advanced solid tumors,…
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Shanghai Fosun High Technology Partners with NICE for Joint Innovation Centers
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China-based conglomerate Shanghai Fosun High Technology (Group) Co., Ltd has entered into a partnership with the National Innovation Center par Excellence (NICE), a comprehensive national technology innovation center approved by the Ministry of Science and Technology (MOST). This collaboration aims to strengthen production, education, and research ties between the entities.…
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Samyang Holdings Partners with Yxintent for Lafullen Dermal Filler in China
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South Korea-based Samyang Holdings Biopharm Group has secured a partnership with Hangzhou-based Yxintent, a specialist in medical devices and aesthetics, for its dermal filler product Lafullen. The partnership deal grants Yxintent the development and commercialization rights to Lafullen in China, marking a significant step for Samyang as it expands into…
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Jacobio Pharma Gets Green Light for Phase I/IIa Study of PARP7 Inhibitor JAB-26766
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to initiate a Phase I/IIa clinical study for its in-house developed PARP7 inhibitor, JAB-26766, targeting advanced solid tumors. JAB-26766: A Potential Treatment for Squamous CancersThe oral small molecule PARP7 inhibitor is under development for the treatment of squamous non-small…
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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…
