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Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its Phase III PRESERVE 2 study of the CDK4/6 inhibitor Cosela (trilaciclib) in metastatic triple-negative breast cancer (mTNBC). The study enrolled 187 patients, with interim overall survival analysis expected during the second half of 2023. PRESERVE…
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Hengrui Medicine’s Pyrotinib Filing Accepted for Review by NMPA
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing for its tyrosine kinase inhibitor (TKI) pyrotinib has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is for use in combination with trastuzumab plus docetaxel in advanced, recurrent or…
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China Resources Partners with Fosun Pharma to Expand Global Healthcare Footprint
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China Resources (Holdings) Co. Ltd (HKG: 3320) has entered into a strategic partnership with compatriot firm Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) in the healthcare industry. The collaboration aims to accelerate the global layout and industrial development of both companies through strategic and business collaborations in…
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NMPA Approves JW Therapeutics’ Carteyva for Recurrent Follicular Lymphoma
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The National Medical Products Administration (NMPA) has granted another indication approval to China-based JW Therapeutics’ (HKG: 2126) Carteyva (relmacabtagene autoleucel injection). The anti-CD19 autologous chimeric antigen receptor (CAR) T-cell immunotherapy product can now be used to treat recurrent or refractory (r/r) follicular lymphoma (FL) in adults after second-line or above…
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Innovent’s Cyramza Gains NMPA Approval for Hepatocellular Carcinoma
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Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for its anti-tumor drug Cyramza (ramucirumab) in hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). The indication focuses on patients with alpha fetoprotein (AFP) ≥ 400 ng/mL who have previously been…
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Sciwind Biosciences Initiates US Phase I Study for GLP-1 Agonist XW014
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China-based Sciwind Biosciences Co., Ltd has announced the initiation and first patient dosing of a Phase I clinical study for its XW014 in the United States. The double-blind, randomized, placebo-controlled, single and multiple ascending dose study is designed to assess the safety, tolerability, food effects, pharmacokinetics, pharmacodynamics, and early treatment…
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Fujian Cosunter to Acquire UDCA Capsules Technology from Ruitailai
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced plans to enter into a technology transfer agreement with compatriot firm Fujian Ruitailai Pharmaceutical Technology Co., Ltd. Under the agreement, Cosunter will obtain all technologies, materials, and rights to Ruitailai’s ursodeoxycholic acid capsules (250mg) for RMB 13.5 million (USD 1.9…
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Fujian Cosunter Doses First Patient in Phase I Study of COVID-19 Drug GST-HG171
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has been dosed in a Phase I clinical study for its Category 1 drug candidate GST-HG171. The randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy Chinese…
