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Inventiva and Chia Tai Tianqing’s Lanifibranor Advances with CDE Filing
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France-based Inventiva S.A. and China’s Chia Tai Tianqing have successfully filed a clinical trial application with the Center for Drug Evaluation (CDE) for the Category 1 drug lanifibranor. The submission has been accepted for review, marking a significant step forward in the development of this promising treatment. Licensing and Regulatory…
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Simcere’s SIM0237 Begins Clinical Study for PD-L1 and IL-15 Targeting Bispecific Antibody
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the first patient in (FPI) a clinical study for its SIM0237, a bispecific antibody (BsAb) targeting PD-L1 and IL-15 in advanced solid tumors. The global multi-center, open-label Phase I study is designed to assess the safety, efficacy, and pharmacokinetics/pharmacodynamics of the drug.…
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AusperBio and Asymchem Form Strategic Partnership for Drug Development
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China-based firms AusperBio and Asymchem (SHE: 002821, HKG: 6821) have entered into a strategic partnership focusing on new drug R&D technical services, drug administration and regulation consultation, brand linkage communication, and more. This collaboration aims to enhance their capabilities in the pharmaceutical sector by leveraging each other’s strengths. Background of…
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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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Inventiva and Chia Tai Tianqing File Clinical Trial for Lanifibranor with CDE
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France-based Inventiva S.A. and China’s Chia Tai Tianqing have filed a clinical trial application with the Center for Drug Evaluation (CDE) for their Category 1 drug, lanifibranor. The application has been accepted for review. Lanifibranor is an oral peroxisome proliferator-activated receptor (PPAR) agonist designed to treat non-alcoholic fatty liver disease…
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Simcere Pharmaceutical Initiates Clinical Study for Bispecific Antibody SIM0237 in Advanced Tumors
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the first patient in (FPI) a clinical study for its bispecific antibody (BsAb) SIM0237, targeting PD-L1 and IL-15 in advanced solid tumors. The global multi-center, open-label Phase I study is designed to assess the safety, efficacy, and pharmacokinetics/pharmacodynamics of the drug. The…
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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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Biocytogen’s YH008 Gets NMPA Approval for Phase I Study
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced receiving approval from the China National Medical Products Administration (NMPA) to conduct an open-label Phase I dosage escalation study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (BsAb)…
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Inmagene’s Tavalisse First Prescribed in China for ITP Treatment
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China-based Inmagene Biopharmaceuticals has announced that its in-licensed drug Tavalisse (fostamatinib) has been first prescribed at the Hainan branch of Shanghai’s Ruijin Hospital. This marks a significant milestone in the availability of the oral spleen tyrosine kinase (SYK) inhibitor for the treatment of immunization thrombocytopenia (ITP) in China. Background and…
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BrightGene’s Generic Halaven Approved for Marketing in China
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Eisai’s (TYO: 4523) cancer therapy Halaven (eribulin). The approval signifies that BrightGene’s product, trade-named BoLiNing, has passed the generic quality consistency evaluation (GQCE). BoLiNing is…
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Inovio and ApolloBio Announce Positive Phase III Data for VGX-3100 Vaccine
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US-based Inovio Pharmaceuticals (NASDAQ: INO) and China-based ApolloBio Corp. (NEEQ:430187) have announced positive data from the Phase III Reveal 2 study for the DNA therapeutic vaccine VGX-3100 (known as ABC-3100 in China). The two firms are co-developing VGX-3100 under a 2018 licensing deal, with ApolloBio holding development and commercialization rights…
