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Ascentage Pharma Gains CDE Approval for Phase I Study of APG-5918
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a multi-center, open-label, dose escalation and expansion Phase I study. The study will assess the safety, pharmacokinetics, and efficacy of its embryonic ectoderm development (EED) inhibitor APG-5918. The drug…
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Betta Pharmaceuticals’ BPI-D0316 Shows Promise in Phase II/III Lung Cancer Study
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced the summary report of a Phase II/III study for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) BPI-D0316. The study evaluated the drug as a first-line treatment for naïve locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR…
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Cowell Health Partners with AstraZeneca to Enhance Cancer Care at CIIE
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Cowell Health has announced a partnership with UK-based AstraZeneca (AZ, NASDAQ: AZN) at the 5th China International Import Expo (CIIE), aimed at enhancing precision whole disease course management services for cancer patients. The collaboration focuses on improving accessibility to novel cancer treatments and other health services, particularly for patients with…
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Adicon Partners with Illumina to Advance Oncology Detection Assay TSO 500
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China-based Adicon Holdings Limited has announced a strategic partnership with US-based Illumina (NASDAQ: ILMN) at the 5th China International Import Expo (CIIE). The collaboration targets the central laboratory program, aiming to enhance clinical studies and drug development plans centered around TruSight Oncology 500 (TSO 500), a research-only pan-cancer detection assay.…
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Pfizer Partners with China Cardiovascular Association to Tackle Heart Failure
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US-based Pfizer (NYSE: PFE) has initiated a strategic partnership with the China Cardiovascular Association (CCA), announced at the 5th China International Import Expo (CIIE). The collaboration will focus on exploring heart failure due to special causes, particularly thyroxine protein amyloid cardiomyopathy (ATTR-CM), aiming to revamp diagnosis and treatment protocols in…
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Cyramza Prescribed in China for Advanced Gastric Cancer
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Cyramza (ramucirumab) was first prescribed on November 6, 2022, at the Zhongshan Hospital in Shanghai and Beijing Cancer Hospital, marking a new treatment option for second-line advanced gastric cancer patients in China. This milestone follows the drug’s market approval in March 2022 for treating second-line advanced metastatic gastric cancer in…
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Merck’s Keytruda Receives 10th Indication Approval in China for TNBC
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US-based Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 10th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used to treat early high-risk triple negative breast cancer (TNBC) with tumors expressing PD-L1 (CPS ≥ 20) in…
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PingAn Good Doctor Partners with Roche and OrigiMed at CIIE
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The 5th China International Import Expo (CIIE) saw China-based Ping An Healthcare and Technology Co., Ltd (HKG: 1833), also known as PingAn Good Doctor, announce partnerships with Swiss giant Roche and its compatriot firm OrigiMed, a precision medicine company. The collaboration aims to expand the pan-solid tumor payment service mode,…
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Qilu Pharma’s QL1706 Shows Promise in Phase II Cervical Cancer Study
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China-based Qilu Pharmaceutical has published the latest results from a Phase II clinical study for QL1706, a dual-targeted antibody against programmed death 1 (PD-1) and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4). The findings were presented at the Chinese Society of Clinical Oncology (CSCO) annual meeting. Study Design and ResultsPrevious clinical studies…
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Eli Lilly Partners with AmoyDx and Burning Rock for Retevmo Companion Diagnostics
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The 5th China International Import Expo (CIIE) saw US-based Eli Lilly (NYSE: LLY) announce a partnership with China-based Amoy Diagnostics Co., Ltd (AmoyDx) and Burning Rock Biotech Ltd (NASDAQ: BNR). The collaboration aims to enhance the development of companion diagnostics (CDx) for Retevmo (selpercatinib), the world’s first highly-selective RET kinase…
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CIIE: MET HER2 Precision Diagnosis Alliance Formed to Advance Lung Cancer Treatment
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The 5th China International Import Expo (CIIE) witnessed the establishment of the MET HER2 precision diagnosis alliance, a collaborative initiative involving AstraZeneca, Daiichi Sankyo, HutchMed, Roche Diagnostics, AmoyDx, LBP Medicine, Deep Informatics, Histo Medical Pathological Diagnosis Center, Rightongene Bio, and Genetron. This alliance aims to enhance the implementation of HER2…
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Jiangsu Yahong Initiates Phase III Study for Hexvix in Bladder Cancer Detection
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced the enrollment of the first subject in a prospective, subject-controlled, multi-center Phase III clinical study. The study aims to assess the additional detection rate and safety of Hexvix, a bladder cancer diagnosis and postoperative detection product,…
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Betta Pharmaceuticals’ BPI-452080 Accepted for Review by NMPA
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that a clinical trial filing for its Category 1 drug candidate BPI-452080 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of the drug, which is designed to treat advanced solid…
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Qilu Regor’s RGT-264 Phosphate Tablets Approved for Phase I Study
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China-based biotech Qilu Regor Therapeutics Inc has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of its RGT-264 phosphate tablets in patients with advanced solid tumors. RGT-264 ProfileRGT-264 is a…
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Ascentage Pharma Announces Clinical Advances for Olverembatinib at ASH
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the latest clinical development of its olverembatinib (HQP1351), a third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), Bcl-2 inhibitor lisaftoclax (APG-2575), and MDM2-p53 inhibitor alrizomadlin (APG115) at the 64th American Society of Hematology (ASH) annual meeting this year. Olverembatinib in CML and Ph+ALLOlverembatinib can overcome drug…
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Abbisko Enrolls First Patient in Phase II Study for ABSK091 in Urothelial Carcinoma
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China-based Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the enrollment of the first patient in a Phase II clinical study for its investigational pan-FGFR inhibitor ABSK091, in combination with BeiGene Ltd’s anti-PD-1 antibody tislelizumab, for the treatment of urothelial carcinoma (UC). This marks the first clinical combination trial of…
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Akeso Biopharma Completes Enrollment for AK112 Phase III Study
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China-based Akeso Biopharma (HKG: 9926) has announced the completion of enrollment for its Phase III study of AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). The study aims to assess the drug in combination with chemotherapy for locally advanced or metastatic non-squamous non-small…
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BeiGene’s Brukinsa Receives EU Marketing Approval for Marginal Zone Lymphoma
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China-based biotech BeiGene Inc. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced receiving marketing approval from the European Committee (EC) for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved in the EU for the treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL) in patients who have…
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Dartsbio Licenses Potential First-in-Class BsAb DS005 to Duality Biologics
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China-based Dartsbio Pharmaceuticals, Ltd has announced a licensing deal with Duality Biologics, a novel modality drug developer operating out of the United States and China. The agreement grants Duality Biologics global rights to Dartsbio’s in-house developed, potential first-in-class bispecific antibody (BsAb) DS005 to develop a new antibody drug conjugate (ADC).…
