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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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…