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Bristol-Myers Squibb Terminates Partnership with Agenus on TIGIT/CD96 Bispecific Antibody
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its decision to end its collaboration with Agenus Inc. (NASDAQ: AGEN) regarding the development of the TIGIT/CD96-targeted bispecific antibody BMS-986442 (AGEN1777). This move follows an initial decision to advance the antibody to Phase II trials earlier this year, which resulted…
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Yantai Dongcheng Pharmaceutical Secures NMPA Nod for PSMA-Targeted Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug, 177LuLNC1011. This novel therapeutic is a prostate specific membrane antigen (PSMA)-targeted radioactive in vivo treatment…
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Lee’s Pharmaceutical Commences Phase I Clinical Trial for AI-Discovered HCC Drug AU409
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a leading biopharmaceutical company based in China, has announced the first dosing in a Phase I clinical study for AU409, an oral small molecule drug. The drug was discovered by Auransa Inc. using the AI platform SMarTR Engine and will be manufactured by Lee’s…
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ImmuneOnco Biopharmaceuticals Strikes Licensing Deal with Instil Bio for Global Rights to Dual-Targeted Antibodies
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has entered into a definitive licensing agreement with US-based Instil Bio Inc. (Nasdaq: TIL), granting InstilBio development and commercial rights outside China for ImmuneOnco’s proprietary PD-L1- and VEGF-targeted bispecific antibody, IMM2510, and its next-generation anti-CTLA-4 antibody, IMM27M. As per the agreement, a subsidiary…
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Sino Biopharmaceutical’s Benmelstobart Files for New Indication in China for Advanced RCC Treatment
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use…
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GSK’s Jemperli Receives EC Approval for Endometrial Cancer Treatment in Combination Therapy
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult…
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NICE and AstraZeneca Fail to Reach Agreement on Enhertu Reimbursement for NHS
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The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
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BioNTech’s mRNA Cancer Immunotherapy BNT111 Achieves Primary Endpoint in Phase II Trial
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Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
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FibroGen Inc. Enters Restructuring Mode After Late-Stage Trial Failures for Pamrevlumab
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US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all…
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National Comprehensive Cancer Network Renews Partnership with Medlive for Oncology Guidelines Access in China
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The National Comprehensive Cancer Network (NCCN), a leading non-profit academic organization in the US, has renewed its strategic partnership with Medlive, a Beijing-based medical information service provider focused on clinicians. This collaboration aims to further promote the NCCN Clinical Practice Guidelines in Oncology within China, ensuring they are accessible through…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its innovative antibody drug conjugate (ADC), SHR-A1921. The study will evaluate the efficacy and safety of SHR-A1921…
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3SBio’s Thrombopoietin Meets Primary Endpoint in Phase III Trial for Chronic Liver Disease Patients
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced the successful conclusion of the Phase III TPO106 clinical trial for its thrombopoietin drug in patients with chronic liver disease associated thrombocytopenia who are scheduled for invasive surgery. The trial has met its pre-set primary endpoint, paving the…
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CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
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Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of…
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Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This…
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Hengrui Pharmaceuticals Advances in Breast Cancer Treatment with NMPA Clinical Trial Greenlight
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a pharmaceutical heavyweight based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical studies on its innovative drug candidates. The study will explore the synergistic effects of HRS-6209 in combination with HRS-1358, HRS-8080, or aromatase inhibitors, and…
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Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
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Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
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Shanghai Escugen Partners with Innolake Biopharma to Develop Novel ADCs Using EZWi-Fit Platfo
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Shanghai Escugen, a Chinese biopharmaceutical company, has entered into a strategic partnership with fellow Chinese firm Innolake Biopharma to utilize Escugen’s innovative antibody-drug conjugate (ADC) platform, EZWi-Fit, in the development of ADC products targeting specific antigens selected by Innolake. Under the terms of the agreement, Innolake will employ EZWi-Fit to…
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Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
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Roche’s H1’24 Financials Show 5% Growth, Eye Care and Cancer Therapies Drive Sales
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Roche (SWX: ROG, OTCMKTS: RHHBY, SWX: RO), the Swiss pharmaceutical and diagnostics giant, has reported its financial results for the first half of 2024, with group sales remaining stable in Swiss franc terms. However, on a constant exchange rate basis, sales increased by 5% year-on-year to CHF 29.85 billion (USD…
