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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
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China-based Jiangxi Jemincare Group (SHA: 603222) has announced receiving clinical trial approvals for six of its Category 1 chemical drugs in China and the United States, with indications spanning cancer, kidney diseases, and infectious diseases. JMKX003801, approved for study in China for severe infections caused by Gram-negative bacteria, has demonstrated…
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CStone Pharmaceuticals Regains Exclusive Rights to Tibsovo in Greater China and Singapore
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced an agreement with French pharmaceutical company Servier that returns exclusive development, manufacturing, and commercialization rights to Tibsovo (ivosidenib) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan, as well as Singapore. Originally developed by US-based Agios Pharmaceuticals,…
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Sanofi Halts Development of Tusamitamab Ravtansine After Missed Trial Endpoints
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Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following disappointing results from a Phase III trial in metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients with high CEACAM5 expression. The trial did not meet its dual primary endpoints, as indicated by an interim…
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CStone Pharmaceuticals Disbands Sales Team for Gavreto After NRDL Setback
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CStone Pharmaceuticals (HKG: 2616) has confirmed media reports regarding the dismissal of its sales team for Gavreto (pralsetinib), marking a significant shift in the Chinese company’s commercial strategy for its first product to reach the market. Gavreto, which was licensed to Allist Pharmaceuticals Co., Ltd in November 2023, did not…
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Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient enrollment for a Phase III clinical trial of anlotinib, marketed under the trade name FOCUS V, in conjunction with chemotherapy for first-line treatment of advanced soft tissue sarcoma. The trial, conducted by Jiangsu Chia Tai…
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Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
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GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), will update the warning label for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), to account for the potential risk of myeloid neoplasms in patients…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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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…
