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GenFleet Therapeutics Submits IPO Application to HKEX, Backed by CITIC Securities
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On December 27, 2024, GenFleet Therapeutics, a biopharmaceutical company based in Shanghai, submitted its application for listing on the Hong Kong Stock Exchange (HKEX), with CITIC Securities serving as the exclusive sponsor and overall coordinator. Company Background and FocusEstablished in 2017, GenFleet Therapeutics is a market-stage biopharmaceutical company specializing in…
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GenFleet’s SLS009 Receives Fast-Track and Orphan Drug Designations from U.S. FDA for Lymphoma and Leukemia
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Shanghai-based biotech GenFleet Therapeutics announced that its CDK9 inhibitor, SLS009 (GFH009), has received fast-track and orphan drug designation (ODD) statuses from the U.S. FDA. These designations highlight the drug’s potential as a treatment for recurrent or refractory peripheral T-cell lymphoma (PTCL) and recurrent or refractory acute myeloid leukemia (AML). In…
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GenFleet Therapeutics’ SLS009 Receives FDA Fast-Track Status for PTCL Treatment
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Shanghai-based biotech GenFleet Therapeutics has announced that its investigational drug SLS009 (GFH009) has received fast-track status from the US FDA for the treatment of recurrent/refractory adult peripheral T-cell lymphoma (PTCL) patients. This CDK9 inhibitor was previously awarded an orphan drug designation (ODD) by the FDA in mid-October, highlighting its potential…
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Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
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The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This…
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GenFleet Therapeutics’ CDK9 Inhibitor SLS009 Earns Orphan Drug Status for AML
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Shanghai-based biotechnology company GenFleet Therapeutics has announced that its CDK9 inhibitor, SLS009 (GFH009), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation is a significant milestone, recognizing the drug’s potential to address a rare and…
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GenFleet Therapeutics and Verastem Oncology Ink Licensing Deal for RAS Pathway Cancer Therapies
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China-based GenFleet Therapeutics has entered into an exclusive licensing and early development agreement with US firm Verastem Oncology (NASDAQ: VSTM). Under the agreement, Verastem will obtain development and commercialization rights to GenFleet’s three oncology discovery programs targeting RAS pathway-driven cancers, excluding Greater China. Financial Terms and Potential Deal SizeThe agreement…
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Innovent Biologics’ GFH925 Earns Breakthrough Therapy Designation for KRASG12C CRC Treatment
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The Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics’ (HKG: 1801) Category 1 chemical drug GFH925 has been awarded a breakthrough therapy designation (BTD) for the treatment of KRASG12C mutant advanced colorectal cancer (CRC). This designation highlights the potential of GFH925 in addressing a significant unmet medical…
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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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GenFleet and Merck KGaA Partner on European Clinical Study for KRAS G12C Inhibitor
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China-based GenFleet Therapeutics Inc. has announced a European multi-center clinical study and drug supply agreement with Germany’s Merck KGaA. The collaboration will conduct an open, multi-center, Phase Ib/II clinical study to assess the efficacy of combining GenFleet’s KRAS G12C inhibitor, GFH925, with Merck’s Erbitux (cetuximab) in treatment-naïve advanced non-small cell…
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GenFleet Therapeutics’ GFH018 Receives CTA Approval for Two Clinical Trials in China
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Shanghai-based biotech company GenFleet Therapeutics announced that two clinical trial applications (CTAs) for its drug candidate GFH018 have been approved in China. GFH018 is a small molecule designed to specifically target and inhibit TGF-ß R1. Clinical Trial Details SignificanceThe TGF-ß signaling pathway is a key target for multiple solid tumors.…
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GenFleet Collaborates with BioLineRx to Develop Motixafortide for Pancreatic Cancer in China
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China-based GenFleet Therapeutics has entered into a collaboration with Israel’s BioLineRx Ltd (NASDAQ: BLRX) to advance the development of motixafortide, a C-X-C chemokine receptor type 4 (CXCR4) inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC) in China. This partnership underscores GenFleet’s commitment to bringing innovative oncology therapies to Chinese…
