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Bio-Thera Solutions Initiates First Patient Dosing in Phase I Study of BAT8007
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China-based Bio-Thera Solutions, Ltd. (SHA: 688177) has announced the first patient dosing in a multi-center, open, Phase I clinical study to assess the safety, tolerability, and preliminary efficacy of BAT8007, an antibody-drug conjugate (ADC) targeting Nectin-4. The study’s primary indication is general advanced solid tumors, with the goal of determining…
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Antengene to Begin Phase I Clinical Study of ATG-022 for Advanced Solid Tumors
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China-based Antengene Corporation Ltd (HKG: 6996) is poised to commence a Phase I clinical study to assess the safety and tolerability of ATG-022 in patients with advanced and metastatic solid tumors. The study will also determine the bioactive dose, maximum tolerable dose (MTD), and recommended Phase II dose (RP2D). ATG-022…
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Akeso Biopharma Enrolls First Subject in Phase III Study of Cadonilimab for Gastric Cancer
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first subject in a pivotal Phase III study for its innovative bispecific antibody (BsAb), cadonilimab (AK104). The study will assess cadonilimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJC).…
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CSPC Pharmaceutical’s PD-1 Monoclonal Antibody Enlangsubai Completes NMPA Market Approval Filing
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for its programmed-death 1 (PD-1) monoclonal antibody (mAb), Enlangsubai. The targeted indication is recurrent or metastatic cervical cancer with positive PD-L1 expression that has failed…
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Chipscreen’s Epidaza Receives TFDA Approval for Breast Cancer Treatment in Taiwan
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Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen. Indication and Target Patient…
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XtalPi and Chia Tai Tianqing Achieve Phase II Milestone in Cancer Drug Development
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has partnered with China’s Chia Tai Tianqing to reach the Phase II milestone in their small molecule cancer drug research and development (R&D) program. The collaboration leveraged Chia Tai Tianqing’s in-house innovative drug innovation platform and XtalPi’s AI drug discovery platform to achieve…
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Haihe Pharmaceutical Initiates Global Phase I Clinical Study for BET-BD2 Inhibitor HH3806
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the first patient dosing of a global multi-center Phase I clinical study for its in-house developed BET-BD2 inhibitor, HH3806, in Australia. This marks a significant milestone in the development of the drug, which targets the bromo and extra terminal (BET) binding domain 2…
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Zenshine Pharmaceuticals Raises RMB 100 Million in Series B Financing for Drug Development
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China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd reportedly raised over RMB 100 million in a Series B financing round. The round was led by Hankang Capital and included participation from Cybernaut, Yangzijiang Funds, Ennovation Ventures, and Matrix Partners China. The proceeds will be used to enhance the…
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CStone’s Ayvakit Shows Significant Improvements in ISM at AAAAI Meeting
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China-based CStone Pharmaceuticals (HKG: 2616) announced that its US partner, Blueprint Medicines, published detailed data from the PIONEER regulatory study for Ayvakit (avapritinib) at the American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting this year. Ayvakit is a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST)…
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Bio-Thera Solutions Initiates Phase I Study for Trop2-Targeting ADC BAT8008
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center, open Phase I study to assess the safety, tolerability, and preliminary efficacy of BAT8008, an antibody-drug conjugate (ADC) targeting Trop2 in advanced solid tumors. The study will also help determine the recommended Phase II dosage.…
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Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
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Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for the antibody drug conjugate (ADC) enfortumab vedotin, marketed under the brand name Padcev in the US. The filing…
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InnoCare Pharma Initiates Clinical Study for BCL2 Inhibitor ICP-248 in China
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced the first subject dosing in a clinical study for its B-cell lymphoma-2 (BCL2) inhibitor ICP-248. The study, approved in China in September last year, marks a significant step in the development of this novel therapy. Drug Profile and IndicationsICP-248 is a…
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Bio-Thera Solutions Initiates Phase I Study for Trop2-Targeting ADC BAT8008
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center, open Phase I study to assess the safety, tolerability, and preliminary efficacy of BAT8008, an antibody-drug conjugate (ADC) targeting Trop2 in advanced solid tumors. The study will also help determine the recommended Phase II dosage.…
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Astellas and Seagen File for NMPA Approval of Enfortumab Vedotin for Urothelial Carcinoma
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Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for the antibody drug conjugate (ADC) enfortumab vedotin, marketed as Padcev in the US. The filing seeks approval for…
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InnoCare Pharma Initiates Clinical Study for BCL2 Inhibitor ICP-248 in China
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced the first subject dosing in a clinical study for its B-cell lymphoma-2 (BCL2) inhibitor, ICP-248. The study was approved in China in September last year. This marks a significant milestone in the development of the drug, which is designed to treat…
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Haihe Pharma’s Glumetinib Gains Conditional NMPA Approval for NSCLC
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has received conditional market approval from the National Medical Products Administration (NMPA). This small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping, marking a significant advancement in…
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JW Therapeutics Launches Carteyva Clinical Study for High-Risk Lymphoma
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in the treatment of first-line high-risk large B-cell lymphoma. A significant milestone was reached with the completion of reinfusion therapy for the first patient. Previous Study Outcomes and Current Trial DesignThe…
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Haihe Pharma’s Glumetinib Receives Conditional Approval for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has obtained conditional market approval from the National Medical Products Administration (NMPA). The small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping. Development and Clinical FindingsGlumetinib, co-developed…
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JW Therapeutics Initiates Clinical Study for Carteyva in First-Line High-Risk Large B-Cell Lymphoma
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in first-line high-risk large B-cell lymphoma. The first patient has already completed reinfusion therapy, marking a significant step in the study’s progress. Previous Study ResultsThe pivotal RELIANCE study previously demonstrated that…
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Suzhou Porton Biologics Partners with Bennu Biotherapeutics for Gene and Cell Therapies
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China-based contract development and manufacturing organization (CDMO) Suzhou Porton Biologics Ltd has entered into a strategic partnership with compatriot firm Bennu Biotherapeutics, a T-cell therapy specialist based in Shanghai. The collaboration focuses on the area of gene and cell therapies (GCTs), with Porton providing comprehensive CDMO services to Bennu. The…
