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Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
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The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Previously approved in China…
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Hengrui Pharmaceuticals Receives NMPA Approval for Phase II Cervical Cancer Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will investigate the combination of its PD-L1 monoclonal antibody adebrelimab (SHR-1316) with concurrent chemotherapy for the treatment of locally…
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Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
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Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
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RemeGen’s MSLN-Targeted ADC RC88 Clears to Begin Phase I/IIa Study in China
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RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a leading Chinese biotech firm, has announced that it has received approval from China’s Center for Drug Evaluation (CDE) to initiate a Phase I/IIa clinical study for RC88, a mesothelin (MSLN)-targeted antibody drug conjugate (ADC). The trial will assess the safety and efficacy…
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Chipscreen NewWay Biosciences Initiates Phase I Trial for PD-1/CD40 Bispecific Antibody Candidate NWY001
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China-based Chengdu Chipscreen NewWay Biosciences Co., Ltd has announced that the first patient has been dosed in a Phase I clinical trial for its investigational PD-1/CD40 bispecific antibody (BsAb) candidate, NWY001. The multi-center, non-random, open-label trial is conducted under the leadership of Sun Yat-Sen University Cancer Center, with objectives to…
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3D Medicines Secures Registration for Envafolimab in Macau for Advanced Solid Tumors
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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the registration of its PD-L1 monoclonal antibody (mAb) envafolimab in Macau. The approval designates envafolimab for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. Envafolimab is notable for being the world’s first…
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Neuboron Medtech Secures Clinical Trial Approval for First BNCT Drug in China
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Neuboron Medtech Ltd., based in China, has received clinical trial approval for its borofalan (10b) injection, as indicated on the website of China’s Center for Drug Evaluation (CDE). This marks the first boron neutron capture therapy (BNCT) to enter regulatory studies in China and the second globally, targeting recurrent malignant…
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SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
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SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted a pre-licensing application for the import of Orserdu (elacestrant) in Macau, seeking approval for its use in treating advanced or metastatic breast cancer. Elacestrant, a next-generation selective estrogen receptor degrader (SERD) developed by Eisai (TYO:…
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RemeGen Secures Fast-Track Designation for RC88 in Platinum-Resistant Ovarian Cancer
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China-based biotech RemeGen Co., Ltd (HKG: 9995; SHA: 688331) has received fast-track designation (FTD) from the US FDA for its pipeline candidate RC88, a mesothelin (MSLN)-targeted antibody-drug conjugate (ADC). This designation recognizes RC88’s potential as a treatment for platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. Developed in-house,…
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CSPC Pharmaceutical Secures FDA Approval for Clinical Study of JMT106 in GPC3-Positive Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received approval from the US FDA to commence a clinical study for its bispecific fusion protein, JMT106, targeting GPC3-positive solid tumors. JMT106 is designed to target both GPC3 and interferon receptors, aiming to elicit antibody-dependent cellular cytotoxicity (ADCC) while activating the immune…
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BioNTech Acquires Pre-Clinical Asset and ADC Technology from Portuguese Biotech CellmAbs
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Germany’s BioNTech (NASDAQ: BNTX) has licensed a pre-clinical antibody candidate and additional antibody-drug conjugate (ADC) technology from Portugal-based biotechnology company CellmAbs. The agreement marks Portugal’s first billion-dollar transaction in the life sciences sector. Under the terms, CellmAbs will receive undisclosed upfront and near-term payments, potential milestone payments reaching several hundred…
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MSD’s Keytruda Gains FDA Approval for Advanced Cervical Cancer Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food and Drug Administration (FDA) for the use of its anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA cervical cancer. This marks…
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CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its chimeric antigen receptor (CAR)-T therapy, CT011. The study will focus on patients with GPC3 positive stage IIIa hepatocellular carcinoma (HCC) who are…
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Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its cancer drug candidate SIM0501, intended for the treatment of advanced solid tumors. SIM0501 is a small-molecule inhibitor of ubiquitin specific peptidase 1 (USP1), a protein that is…
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Fosun Kite and Medi Cover Launch First Value-Based Payment Plan for Lymphoma Treatment
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Fosun Kite and Medi Cover, a health management and patient service platform under Sinopharm (HKG: 1099), have jointly introduced the first value-based payment (VBP) plan for lymphoma associated with Fosun Kite’s chimeric antigen receptor (CAR) T cell therapy, Yescarta (axicabtagene ciloleucel). Under this innovative plan, eligible patients who do not…
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Bio-Thera Solutions Receives NMPA Approval for Combined Phase Ib/II Study of BAT7104 and BAT4706
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Bio-Thera Solutions Ltd (SHA: 688177), a Chinese biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a combined Phase Ib/II clinical study for its pipeline drugs BAT7104 and BAT4706 in patients with advanced malignant tumors. BAT7104 is a bispecific antibody (BsAb)…
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C4 Therapeutics Outlines 2024 Focus Amid 30% Workforce Reduction, Prioritizes Key Oncology Trials
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C4 Therapeutics (NASDAQ: CCCC), a leader in protein degradation, announced this week its strategic focus for 2024, which includes a significant reduction of 30% in its workforce. The U.S.-based company will prioritize ongoing Phase I/II trials for CFT7455 and CFT1946, targeting relapsed/refractory multiple myeloma (r/rMM) and BRAF V600X-mutant solid tumors,…
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Henlius Biotech Secures Exclusive Rights to Sermonix’s Lasofoxifene for Breast Cancer Treatment in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) has entered into a partnership and licensing agreement with U.S.-based Sermonix Pharmaceuticals Inc. for exclusive development, manufacturing, and commercialization rights in China for the investigational drug lasofoxifene. This ESR1 antagonist is being developed as a treatment for breast cancer. Under the terms of the…
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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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Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
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The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical…
