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Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD) status from the US FDA for its Category 1 drug ABSK021, also known as pimicotinib. The designation is for the treatment of inoperable tenosynovial giant cell tumor (TGCT) and is based on positive Phase Ib…
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CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment
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The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to obtain priority review status, with the drug in line for conditional approval. HL-085 is being developed to treat advanced melanoma with NRAS mutations in patients previously treated with immunotherapy. The investigational MEK inhibitor is undergoing…
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China’s Multi-Bureau Plan Aims to Eradicate Cervical Cancer by 2030
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The National Health Commission (NHC), Ministry of Education, Ministry of Civil Affairs, and six other bureaus have released the “Accelerating the Eradication of Cervical Cancer Action Plan.” The initiative seeks to establish a multi-bureau network focused on driving cervical cancer prevention and control mechanisms with the goal of eradicating the…
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JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911
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Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by its US subsidiary VITRAC Therapeutics, LLC for its small molecule aurora A kinase (AURKA) inhibitor VIC-1911. The molecule is being assessed both as a monotherapy and in combination with sotorasib for the treatment of KRAS…
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Akeso Receives First $300M Installment from Summit for Bispecific Antibody Ivonescimab
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Akeso Inc. (HKG: 9926) has announced receiving the first installment of USD 300 million as part of an upfront fee paid by US-based Summit Therapeutics Inc. (NASDAQ: SMMT) under the firms’ December 2022 licensing deal for the bispecific antibody (BsAb) ivonescimab. The initial payment includes USD 274.9 million in cash…
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InnoCare’s Gunagratinib Shows Promising Data in Cholangiocarcinoma at ASCO-GI 2023
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Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune diseases, has announced the latest data for its pan-fibroblast growth factor receptor (FGFR) inhibitor gunagratinib (ICP-192) in cholangiocarcinoma at the ASCO-GI 2023 meeting. The findings highlight the drug’s potential in treating this challenging form of…
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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…
