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Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for recurrent-metastatic cervical cancer, according to the National Medical Products Administration (NMPA) website. This drug marks the first programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) for cervical cancer in China. Socazolimab, originally developed by US-based Sorrento…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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Gilead Acquires Pre-Clinical IL-18BP Targeting Antibody Candidate from Compugen in $848 Million Deal
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Gilead (NASDAQ: GILD) has licensed a potential first-in-class IL-18 binding protein (IL-18BP) targeting antibody candidate from cancer immunotherapy developer Compugen (NASDAQ: CGEN), which is currently in the pre-clinical stage. Gilead will assume development responsibilities from Phase II onwards and will pay USD 60 million upfront, with up to USD 788…
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MSD Partners with Owkin to Develop MSI-H Biomarker Screening for Cancers
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US pharmaceutical company Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a partnership with French firm Owkin to develop and commercialize a pre-screening procedure for identifying the microsatellite instability- (MSI) H biomarker in various cancers. The initiative aims to test for MSI-H in endometrial, gastric, small intestinal, and…
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Sanofi Expands Oncology Portfolio with NK Cell Engager In-License from Innate Pharma
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Sanofi (NASDAQ: SNY) has in-licensed a natural killer (NK) cell engager candidate for solid tumors from France-based Innate Pharma (NASDAQ: IPHA), as per an agreement reached in 2022. Sanofi will pay an initial fee of EUR 15 million (USD 16.4 million) and is committed to potential milestone payments of up…
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Konruns Pharmaceutical Gets NMPA Approval for KC1036 Clinical Study in Juventus sarcoma
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate KC1036 in advanced Juventus sarcoma for adolescents aged 12 and above. KC1036, a tyrosine kinase inhibitor (TKI) that targets AXL, VEGFR2, and FLT3, is…
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China Grand Pharmaceuticals Secures Distribution of Sirtex’s SIR-Spheres for Liver Cancer
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) announced that its subsidiaries, Beijing Purevalley Biotechnology Co., Ltd and Chengdu Purevalley Biotechnology Co., Ltd, have entered into a distribution agreement with Australian firm Sirtex Medical Ltd. This agreement centers on the distribution of Sirtex’s SIR-Spheres (Y-90 microsphere) injection, a…
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European Commission Expands Keytruda Indications for Advanced Cancer Treatments
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The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications for its leading anti-PD-1 therapy, Keytruda (pembrolizumab), approving its use as a first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic biliary tract carcinoma (BTC) and HER2-negative gastric or gastroesophageal junction (GEJ)…
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HighField Biopharmaceutical Doses First Patient in HFK1 Clinical Trial Targeting Solid Tumors
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Hangzhou-based HighField Biopharmaceutical, a leader in immuno-oncology focused on innovative lipid-based therapies, has announced the initiation of dosing for the first patient in a clinical trial of its candidate HFK1. This investigational drug is an immunoliposome encapsulating doxorubicin, aimed at targeting various solid tumors. The trial is being conducted concurrently…
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BGI Genomics Receives NMPA Approval for Innovative Colorectal Cancer Detection Kit
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BGI Genomics Co., Ltd. (SHE: 300676), a leading genomics firm based in China, has announced the approval of its medical device license from the National Medical Products Administration (NMPA) for a novel gene methylation detection kit. The kit employs fluorescence PCR technology to assess the combined methylation status of the…
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InventisBio’s KRAS G12C Inhibitor D-1553 Advances Toward Priority Review in China
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According to the China Center for Drug Evaluation (CDE), Shanghai-based InventisBio Co., Ltd. (SHA: 688382) is on track to secure priority review status for its KRAS G12C inhibitor, D-1553, aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed KRAS G12C mutation, particularly in patients…
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Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced unresectable or metastatic HER2-negative…
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FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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Bio-Thera Solutions Gets NMPA Green Light for PD-1 Inhibitor BAT1308 in Endometrial Cancer
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its programmed death-1 (PD-1) inhibitor, BAT1308, in the treatment of endometrial cancer. BAT1308 is an internally developed…
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MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
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The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine…
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Bayer Partners with ClearNote Health to Explore Prostate Cancer Treatment Response
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German multinational pharmaceutical company Bayer (ETR: BAYN) has partnered with U.S. diagnostics firm ClearNote Health to delve into the study of treatment response and resistance in metastatic hormone-sensitive prostate cancer. The collaborative project will leverage ClearNote’s epigenomic platform, which employs machine learning algorithms to analyze patient blood samples, monitor DNA-based…
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3D Medicines Initiates Phase III Trial for Envafolimab in NSCLC Patient
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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the enrollment of the first patient in a Phase III clinical study for its PD-L1 monoclonal antibody (mAb), envafolimab. The randomized, controlled, double-blinded, multi-center trial will evaluate envafolimab in combination with chemotherapy as a neoadjuvant/adjuvant therapy for patients with resectable…
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Lepu Biotechnology’s Pancreatic Cancer Drug Earns Orphan Drug Status from FDA
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Lepu Biotechnology Co., Ltd (HKG: 2157), a Chinese pharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), MRG004A, which is being developed to treat pancreatic cancer. MRG004A is an innovative ADC that targets…
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AbelZeta Pharma Expands Janssen Partnership to Include Commercial Rights in China
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AbelZeta Pharma Inc., a Sino-US biotechnology company with operations in Rockville, Maryland, and Shanghai, China, has announced an updated global collaboration and licensing agreement with Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ). According to the revised agreement, Janssen will now secure commercialization rights to CAR-T therapies C-CAR039…
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AbbVie and Genmab’s Epcoritamab Shows Promising Results in Follicular Lymphoma Study
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AbbVie (NYSE: ABBV) and Genmab (NASDAQ: GMAB) have presented Phase I/II clinical data for their T-cell engager, Tepkinly/Epkinly (epcoritamab), in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of therapy. Interim results, with a median follow-up of 17.4 months, showed that the…
