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Eisai CEO Outlines Ambitions for Alzheimer’s Drug Leqembi After FDA Approval
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Following US FDA approval for Japan-based Eisai Co., Ltd (TYO: 4523) and Biogen Inc’s (NASDAQ: BIIB) novel Alzheimer’s therapy Leqembi (lecanemab), Eisai CEO Haruo Naito gave an interview with Nikkei setting out his ambitions for the drug. According to Naito, the US market eligible to use Leqembi annually currently stands…
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Dizal’s Sunvozertinib and Golidocitinib Combo Gets NMPA Approval for Phase II Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the safety, tolerability, and efficacy of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) in combination with the JAK1 inhibitor golidocitinib (DZD4205).…
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Luye Pharma’s BA1301 Receives CDE Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its antibody-drug conjugate (ADC) BA1301. The drug is indicated for use in Claudin18.2 (CLDN18.2)-positive advanced solid tumors, including advanced gastric cancer, adenocarcinoma of the gastroesophageal junction, and pancreatic cancer. This…
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HutchMed’s Sovleplenib Administered to First Patient in Phase II COVID-19 Study
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On January 4, Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) administered its novel, investigational, selective small-molecule inhibitor sovleplenib to the first patient at Huashan Hospital. The Phase II study is focused on severe/critical COVID-19 patients, marking a significant step in the development of this innovative therapy. Mechanism and DevelopmentSovleplenib…
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Salubris Pharmaceuticals Gains NMPA Approval for Phase I Study of SAL0133
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its 3CL protease inhibitor SAL0133 in adult patients with mild to common COVID-19. This marks a significant step forward in the development of…
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Henlius Completes First Dosing in Global Phase III Study for HanSiZhuang in LS-SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a global Phase III clinical study comparing its programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab) combined with chemotherapy and concurrent radiotherapy to placebo combined with chemotherapy and concurrent radiotherapy in limited stage-small cell lung cancer (LS-SCLC).…
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Boehringer Ingelheim Enrolls First Patient in Phase II/III Study for BI 907828
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German pharmaceutical giant Boehringer Ingelheim has announced the enrollment of the first patient in the Phase II/III Brightline-1 study for its investigational MDM2-p53 antagonist BI 907828. The study is taking place at the West China Hospital and aims to assess the efficacy and safety of BI 907828 compared to doxorubicin…
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Vcanbio’s Stem Cell Therapy VUM02 Accepted for Clinical Trial Review
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells) has been accepted for review by the Center for Drug Evaluation. VUM02 is a Category 1 therapeutic biologic product developed to treat patients with…
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CanSino Biologics’ mRNA Vaccine CS-2034 Shows Positive Safety and Immunogenicity Data
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China-based CanSino Biologics (HKG: 6185) has announced positive periodical data from a clinical study assessing the safety and immunogenicity of its COVID-19 mRNA vaccine CS-2034 as a sequential booster in adults aged 18 and above who have already received three doses of inactivated COVID-19 vaccines. The study, which began in…
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Jiangsu Aidea’s ACC007 Approved by NMPA for HIV-1 Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that its Category 1 compound preparation ACC007 (ainuovirine, lamivudine, tenofovir disoproxil) has been approved by the National Medical Products Administration (NMPA) for the treatment of newly treated adult patients with HIV-1 infection. This approval marks a significant step forward in…
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Haisco’s EGFR-PROTAC HSK40118 Accepted for Review by China’s NMPA
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its clinical trial filing for the oral small molecule EGFR-PROTAC HSK40118 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is EGFR mutant advanced non-small cell lung cancer (NSCLC). This marks a significant…
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EOC Pharma’s Entinostat NDA Accepted by China’s NMPA for Breast Cancer
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EOC Pharma, a biotech company operating in the US and China, has announced that its New Drug Application (NDA) filing for entinostat has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced…
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Transcenta’s TST003 Receives Clinical Trial Approval in China and US
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China – based biopharma Transcenta Holding Ltd (HKG: 6628) has announced that it has received clinical trial approval in China for TST003, its potential first – in – class monoclonal antibody (mAb) targeting Gremlin1. The drug candidate has already received IND clearance from the US FDA in September this year,…
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Henlius’ Hanbeitai Gains NMPA Approval for Expanded Indications
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that the National Medical Products Administration (NMPA) has approved a supplementary Biologic License Application (sBLA) for its biosimilar Hanbeitai (bevacizumab). The approval expands the indications for which Hanbeitai can be used, now including cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and…
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HutchMed Completes Enrollment for Phase III ESLIM-01 Study of Sovleplenib in ITP
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in the ESLIM – 01 study, a pivotal Phase III trial assessing the efficacy and safety of sovleplenib in treating adult patients with primary immune thrombocytopenia (ITP) in China. This marks a significant milestone in…
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RemeGen’s RC48 Gains NMPA Approval for Phase II Study in Bladder Cancer
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China – based biopharmaceutical company RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II study of its antibody – drug conjugate (ADC) candidate RC48 (disitamab vedotin). The study will assess the efficacy and safety of RC48…
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Jiangxi Jemincare Gains FDA Approval for Clinical Trial of JYB1907 in Solid Tumors
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China – based Jiangxi Jemincare Group has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 drug JYB1907. The monoclonal antibody (mAb) targets glycoprotein A dominant repeat (GARP) and transforming growth factor – β1 (TGF –…
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Mabwell Receives NMPA Approval for Clinical Trial of 9MW3011 in Rare Diseases
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China – based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 for the treatment of β – thalassemia and polycythemia vera. The drug, which already…
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Staidson’s Anti-C5a Monoclonal Antibody STSA-1002 Accepted for NMPA Review
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China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced that the clinical trial filing for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb) for use in acute respiratory distress syndrome (ARDS), has been accepted for review by the National Medical Products Administration (NMPA). About ARDS…
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Junshi Biosciences’ CGRP Monoclonal Antibody JS010 Accepted for NMPA Review
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that the clinical trial filing for JS010, its in-house developed CGRP monoclonal antibody drug candidate for treating migraine, has been accepted for review by the National Medical Products Administration (NMPA) in China. About CGRP and JS010CGRP is a neuropeptide composed of…
