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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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China’s MOST Issues Updated HGR Rules Impacting Foreign Collaborations in Genetic Research
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China’s Ministry of Science and Technology (MOST) has issued the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” [HGR Rules], effective from July 1, 2023. These new Rules update the earlier “Regulations on the Management of HGR” [HGR Regulations] released in 2019, impacting several key clauses and…
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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…
