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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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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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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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Cowell Health Partners with Gilead Sciences to Enhance Drug Accessibility
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Cowell Health has announced a partnership with US-based Gilead Sciences, Inc., (NASDAQ: GILD) aimed at leveraging Cowell’s smart pharmacy, integrated health management services, patient education, intelligent supply chain, and Internet “medicine + drug” platform, alongside Gilead’s expertise in disease prevention and treatment. The collaboration will focus on channel construction, operations,…
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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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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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Bristol-Myers Squibb’s Opdivo Secures Two New Approvals for Esophageal Cancer in China
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US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has received two new indication approvals in China for its PD-1 inhibitor Opdivo (nivolumab). The immunotherapy is now approved as adjuvant therapy for patients with pathological residual esophageal cancer or gastroesophageal junction cancer following neoadjuvant chemoradiotherapy (CRT) and complete surgical resection. Additionally,…
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Henlius’ PD-1 Inhibitor HanSiZhuang Approved for First-Line SCLC Indication
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving another indication approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor, HanSiZhuang (serplulimab). The drug is now approved for use in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), marking the…
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Agilis Robotics Completes Successful Animal Testing for Surgical Robot
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Hong Kong-based Agilis Robotics Ltd has successfully completed a second round of live animal testing using its proprietary surgical robotic system. The test, conducted by Dr. Jason Y.K. Chan, co-founder of Agilis Robotics, utilized the company’s second-generation device to remove artificial tumors from a live pig specimen using the en-bloc…
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3D Medicines’ 3D185 Receives Orphan Drug Designation for Gastric Cancer
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China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its pipeline drug candidate 3D185. The designation was granted for the drug’s potential use in treating gastric cancer and gastroesophageal junction carcinoma (GC/GEJ). This marks the…
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Hengrui’s Generic Cyclophosphamide Capsules Approved by China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its generic version of cyclophosphamide, marketed as Endoxan by UK firm Hikma Pharmaceuticals USA Inc. The approval allows Hengrui to market its capsules for the treatment of a wide range of…
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Akeso’s Penpulimab Secures New Approval for Lung Cancer Indication
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China-based Akeso Biopharma (HKG: 9926) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for the treatment of first-line or locally advanced/metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy. This marks a…
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Sino Biopharma’s PD-L1 Combo with Anlotinib Accepted for Review by China’s CDE
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its New Drug Application (NDA) filing for the combination of its anti-PD-L1 monoclonal antibody (mAb) TQB2450 and anlotinib has been accepted for review by the Center for Drug Evaluation (CDE). The Phase III study for this combination in first-line small cell…
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Konruns’ KC1036 Advances to Phase II Study for Lung Adenocarcinoma
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study of its Category 1 chemical drug KC1036. The study will assess the efficacy and safety of KC1036 in combination with docetaxel for the treatment of…
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Harbour BioMed’s HBM1020 Receives FDA Approval for US Phase I Study
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Harbour BioMed (HKG: 2142), a global biotech company operating in the Netherlands, the United States, and China, has announced receiving approval from the US Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I study of its monoclonal antibody (mAb) HBM1020. The study will assess the safety, tolerability,…
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Syneos Health Partners with Fosun Pharma to Commercialize Serplulimab in US
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US-based Syneos Health (Nasdaq: SYNH) has revealed a strategic partnership with Fosun Pharma USA Inc., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196), focused on the anti-programmed death-1 (PD-1) inhibitor serplulimab. Syneos will provide full commercial support in the United States for serplulimab’s development as…
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Roche’s Polivy Approved by China’s NMPA for Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the National Medical Products Administration (NMPA) has approved its antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin for injection). Polivy is the world’s first ADC targeting CD79b and is designed for use as a first-line treatment for diffuse large B-cell lymphoma…
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Takeda’s Mobocertinib Approved in China for EGFR Exon20ins NSCLC
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Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) China unit has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its lung cancer therapy mobocertinib. The drug is indicated for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during…
