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Simcere’s Cosela Receives First Prescription in China for CDK4/6 Inhibition
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the issuance of the first prescription for its Cosela (trilaciclib) at the Jilin Cancer Hospital. This milestone marks the official clinical application of the first-in-class CDK4/6 inhibitor in China. Drug Background and DevelopmentTrilaciclib, discovered by US biotech G1 Therapeutics Inc., was in-licensed…
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Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive,…
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HutchMed Signs Licensing Deal with Takeda for Global Fruquintinib Development
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced a licensing deal with Japanese firm Takeda Pharmaceutical Co., Ltd (TYO: 4502, NYSE: TAK) to further the global development, commercialization, and manufacturing of fruquintinib in markets outside mainland China, Hong Kong, and Macau. Under the agreement, HutchMed will receive up…
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Legend Biotech’s Carvykti Meets Primary Endpoint in CARTITUDE-4 Phase III Study
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Legend Biotech (NASDAQ: LEGN) has released positive data from the CARTITUDE-4 Phase III study, evaluating Carvykti (ciltacabtagene autoleucel; cilta-cel) as a treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma (MM). The trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard…
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BeiGene’s Brukinsa Approved by FDA for Chronic Lymphocytic Leukemia
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the US FDA has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In a separate announcement, BeiGene also noted that the Medicines…
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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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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…
