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Hepagene’s FXR Agonist HPG1860 Shows Positive Phase IIa Data in NASH Study
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China-based liver disease specialist Hepagene Therapeutics (HK) Limited has revealed positive data from the Phase IIa clinical study of its in-house developed FXR agonist HPG1860 in non-alcoholic steatohepatitis (NASH). The results highlight the drug’s potential in addressing this metabolic liver disease. Phase IIa RISE Study ResultsThe multi-center, randomized, double-blind, placebo-controlled…
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BMS’s Opdivo Approved in China for Neoadjuvant Therapy in Urothelial Carcinoma
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US-based Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another new indication approval in China for its programmed death-1 (PD-1) inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use as a neoadjuvant therapy for patients with urothelial carcinoma (UC) at high risk of recurrence after radical resection. This marks the…
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Harbour BioMed Receives FDA Approval for HBM1007 Clinical Study
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China-based Harbour BioMed (HKG: 2142) has announced receiving approval from the US FDA to initiate a clinical study of its monoclonal antibody (mAb) HBM1007, a fully-human antibody targeting CD73. This marks a significant step forward in the development of innovative therapies targeting this key biomarker. HBM1007: Mechanism and DevelopmentHBM1007 is…
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Joincare’s Biosimilar Tocilizumab Approved for Marketing in China
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China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that its subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology Co. Ltd has received marketing approval in China for its biosimilar version of Roche Holding AG’s (OTCMKTS: RHHBY) Actemra/RoActemra (tocilizumab). This approval marks a significant milestone in expanding treatment options for…
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CANbridge Pharmaceuticals Initiates Phase II Dosing for CAN103 in Gaucher Disease
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China-based CANbridge Pharmaceuticals, Inc. (HKG: 1228) has announced the first patient dosing in the Phase II part of the ongoing CAN103 Phase I/II study. The trial is focused on treatment-naïve patients with Gaucher disease (GD) Types I and III in China. This milestone marks a significant step forward in the…
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CDE Grants Priority Review to Takeda’s Vonicog Alfa, Zhongmei’s Rilonacept, and Zai Lab’s SUL-DUR
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The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s rilonacept, and Zai Lab’s sulbactam/durlobactam (SUL-DUR) are set to obtain priority review statuses. These designations highlight the significance of these therapies in addressing critical medical needs. Vonicog Alfa: Vascular Hemophilia TreatmentVonicog alfa is a recombinant…
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Immunofoco’s CLDN18.2-Targeted CAR-T Therapy IMC002 Accepted for CDE Review
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China’s Center for Drug Evaluation (CDE) has accepted a clinical trial filing for IMC002, an in-house developed CLDN18.2-targeted chimeric antigen receptor (CAR)-T therapy by Suzhou Immunofoco. This marks a significant milestone for the Chinese firm, which aims to develop the drug for treating advanced digestive system tumors with CLDN18.2 expression,…
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Keymed Biosciences’ CMG901 Shows Promising Results in Phase Ia Study for Solid Tumors
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China-based Keymed Biosciences Inc. (HKG: 2162) has revealed the latest data update from a Phase Ia dosage escalation study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of its CMG901. The study focuses on CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) for advanced solid tumors. The data…
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Staidson’s STSP-0601 Begins Phase II Study for Hemophilia Treatment
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China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced the first subject dosing in a Phase II clinical study for its Category 1 biologic STSP-0601. The study aims to evaluate the drug as an on-demand treatment for bleeding in patients with hemophilia A or B without inhibitors. This marks…
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Everest Medicines’ EVER206 Shows Positive Phase I Results in China
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China-based Everest Medicines (HKG: 1952) has announced top-line results from a Phase I study in China, demonstrating that EVER206 (also known as SPR206), a novel intravenous polymyxin derivative, is well-tolerated with no evidence of acute kidney injury or new safety signals. The study supports Everest’s plans to initiate next-phase clinical…
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Junshi Biosciences’ Neotorch Study Achieves Superiority in Lung Cancer Trial
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Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its randomized, double-blind, placebo-controlled, multi-center Phase III Neotorch study has completed the pre-set interim analysis. The study assessed the efficacy and safety of its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with chemotherapy as a perioperative treatment for patients…
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Hengrui’s EZH2 Inhibitor SHR2554 Nears Breakthrough Therapy Designation
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China-based Jiangsu Hengrui Pharmamceuticals (SHA: 600276) has announced that its enhancer for the zeste homolog 2 (EZH2) inhibitor, SHR2554, is set to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. The designation is for use in relapsed/refractory (r/r) peripheral T-cell lymphoma, marking a…
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Hansoh’s HS-10517 Greenlit for COVID-19 Clinical Study by NMPA
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its HS-10517, a Category 1 anti-COVID-19 drug co-developed by the Global Health Drug Discovery Institute (GHDDI). The study will focus on mild to moderate COVID-19…
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Junshi Biosciences’ COVID-19 Drug JT001 (VV116) Accepted for NMPA Review
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its oral nucleoside analog drug JT001 (VV116) for treating COVID-19 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development and potential market approval of the drug in China.…
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Bristol-Myers Squibb’s Opdivo Gains New Indication for NSCLC Neoadjuvant Therapy in China
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US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another indication approval in China for its PD-1 inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use in combination with chemotherapy as neoadjuvant therapy for adult patients with resectable non-small cell lung cancer (NSCLC), regardless of PD-L1 expression levels.…
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Daiichi Sankyo’s Mirogabalin Nears China Market Entry with CDE Review
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced that China’s Center for Drug Evaluation (CDE) has accepted its market approval filing for mirogabalin besylate, a novel chronic pain treatment. The drug is specifically targeted at diabetic peripheral neuropathic pain (DPNP), a condition that affects a significant number of patients with…
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Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG’s (OTCMKTS: RHHBY) blockbuster Actemra/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche’s originator drug, which has been…
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Abbisko’s ABSK021 Gains NMPA Approval for Phase II Study in cGVHD
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib) in chronic graft versus host disease (cGVHD). This marks a significant step forward in the development of…
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CStone’s RET Inhibitor Gavreto Approved in Taiwan for Lung and Thyroid Cancers
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CStone Pharmaceuticals (HKG: 2616) has announced receiving marketing approval in Taiwan for its RET inhibitor Gavreto (pralsetinib), a drug in-licensed from US-based biotech Blueprint Medicines in June 2018. The approval covers the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC), advanced or metastatic…
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Simcere’s COVID-19 Drug SIM0417 Accepted for Special Review by NMPA
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for SIM0417 into its special review channel. The oral COVID-19 drug candidate is co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the…
