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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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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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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 (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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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-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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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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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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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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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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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…
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Suzhou-based biotech firm Gracell Biotechnologies Inc., (Nasdaq: GRCL) has announced positive data for its pipeline candidate GC012F at the American Society of Clinical Oncology (ASCO) Annual Meeting. GC012F is a FasTCAR-T therapy targeting both B-cell maturation antigen (BCMA) and CD19, under development for the treatment of relapsed/refractory multiple myeloma (r/r…
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Biosyngen, a leading cell therapy developer based in Guangzhou, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its first-in-class nasopharyngeal carcinoma (NPC) cell therapy, BRG01. BRG01: A Pioneering Cell Therapy for NPCBRG01 is a genetically modified T cell product…
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The National Medical Products Administration (NMPA) in China has issued market approval to Lanzhou Kejin Taiji Corporation, Ltd. for its carbon ion therapy system, marking it as the second home-grown carbon ion therapy system in the country designed for the treatment of malignant solid tumors. Enhanced Features of the New…
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China-based Innovent Biologics (HKG: 1801) has announced a clinical study and supply agreement with German pharmaceutical giant Merck KGaA (NYSE: MRK). The collaboration aims to explore the combination of Innovent’s KRAS G12C inhibitor, IBI351, and Merck’s Erbitux (cetuximab) in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS…
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Shenzhen Abrobo Medical Robot Co, Ltd has reportedly raised RMB 100 million via a Series A financing round, marking a significant step forward for the company. The round was led by Guozhong Capital, with additional investments from Lenovo Capital and Long Hill Capital. The funds will be directed towards accelerating…
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US-based Coherus Biosciences Inc., (NASDAQ: CHRS) has disclosed that the US FDA has recently completed the long-awaited pre-licensing inspection of its partner Junshi Biosciences Ltd’s (HKG: 1877, SHA: 688180) manufacturing site for toripalimab in China. The inspection resulted in “three observations” from the FDA, which Coherus described as “readily addressable.”…
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National Medical Products Administration (NMPA) for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), befotertinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation that has…
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China-based biotech Antengene Corp., Ltd (HKG: 6996) has revealed that Australia’s Pharmaceutical Benefits Scheme (PBS) will reimburse the firm’s Xpovio (selinexor) plus bortezomib and dexamethasone combination therapy for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM), specifically for those who have previously received one other therapy. This…
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Hangzhou-based biotech HighField Biopharmaceuticals has revealed the publication of an abstract at this year’s American Society of Clinical Oncology (ASCO) annual meeting, showcasing preliminary data from a Phase Ia trial for its lead pipeline candidate, HF1K16. The trial, which focused on refractory metastatic cancer patients, indicated that HF1K16 was well…