Greater Asia News

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Novotech Presents Technical Session on Clinical Trial Success Factors at BIOPLUS-INTERPHEX KOREA 2023

Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities will present a technical session at BIOPLUS-INTERPHEX KOREA 2023 for biotechs planning regional or global trials.

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Eblasakimab Monthly Dosing Shows Potential for Best-In-Class Therapy in Positive Phase 2b Study in Atopic Dermatitis

ASLAN Pharmaceuticals (NASDAQ: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced positive topline data from its Phase 2b dose-ranging study of eblasakimab in adult patients with moderate-to-severe atopic dermatitis (AD), the TREK-AD (TRials with EblasaKimab in Atopic Dermatitis) study.

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Genesis MedTech Receives Approval for Launch in China for ArtiSential™

Genesis MedTech, a leading medical device company, today announced that its ArtiSential™, a revolutionary series of articulating laparoscopic instruments, has successfully obtained approval from the China's National Medical Products Administration (NMPA) for market release.

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Lunit’s AI-Powered Lung Cancer Screening Solution Significantly Affects Radiologists’ Diagnostic Determination – Published in Radiology

Lunit (KRX:328130.KQ), a global provider of AI-powered cancer diagnostics solutions, today announced the publication of a study exploring the impact of medical AI solutions' accuracy on radiologists' diagnostic determination.

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Korea University Medicine Study Highlights a New Biomarker for Major Depressive Disorder

Researchers led by Professor Byung-Joo Ham and Associate Professor Kyu-Man Han from Korea University Medicine have successfully identified a neuroimaging-based biomarker for MDD in a recent study published on 8 May 2023 in Psychological Medicine.

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Zymedi announced their collaboration with the National Heart, Lung, and Blood Institute through a CTA CRADA to develop ZMA001 mAb, a potential treatment for Pulmonary Arterial Hypertension (PAH), a rare, female predominant disease

Zymedi, a Korean biotech venture-backed company, announced the signing of a clinical Cooperative Research and Development Agreement (CRADA) with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to develop ZMA001 for the treatment of pulmonary arterial hypertension (PAH).

REPEAT/Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States. Consistent with Humira, HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care.

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TiumBio and Hansoh Pharma Announce Clinical Trial Approval of ‘HS-10518/TU2670’ from NMPA in China

TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focusing on discovering and development innovative therapeutics for patients with rare and incurable diseases, and Hansoh Pharmaceutical Group Co., Ltd. (SEHX: 3692), a leading biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) approved Hansoh's Investigational New Drug (IND) application for clinical study of HS-10518 (also known as TU2670), the management of moderate to severe pain associated with endometriosis.

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Sosei Heptares Doses First Subject in Phase I Trial with HTL0048149, a First-in-Class GPR52 Agonist for Schizophrenia

Sosei Group Corporation (“the Company”; TSE: 4565), the world leader in G protein-coupled receptor (GPCR) focused structure-based drug design (SBDD) and development, announces it has dosed the first subject in a Phase I trial evaluating HTL0048149 (HTL’149), a first-in-class GPR52 agonist, which represents a novel mechanism of action for the treatment of schizophrenia and related neurological diseases.

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Datopotamab Deruxtecan Met Dual Primary Endpoint of Progression-Free Survival in Patients with Advanced Non Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial

Topline results from the TROPION-Lung01 phase 3 trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy.