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Hybio Pharmaceutical’s Semaglutide API Receives FDA Review Acceptance
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the US Food and Drug Administration (FDA) has accepted for review the market filing for its semaglutide active pharmaceutical ingredients (APIs). This development marks a significant step for the company as it seeks to enter the global market with its…
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Mabwell Bioscience’s IL-11 mAb 9MW3811 Receives US FDA Clinical Trial Approval
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, 9MW3811. This molecule is an in-house developed IL-11 monoclonal antibody (mAb) intended for the treatment of idiopathic pulmonary fibrosis (IPF). Therapeutic…
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Hansoh Pharmaceutical Gets NMPA Approval for HIF-2α Inhibitor HS-10516 Clinical Study
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 candidate drug, HS-10516. The trial will evaluate the small-molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor as a potential treatment…
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Genevector Initiates Clinical Study for JWK001 in Neovascular Age-Related Macular Degeneration
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Chengdu-based adeno-associated virus (AAV) gene therapy developer, Genevector Biotechnology Co., Ltd., has announced the first patient dosing in a clinical study for its product candidate, JWK001. The molecule is under assessment as a potential treatment for neovascular age-related macular degeneration (nAMD). JWK001’s Mechanism of Action and Preclinical PerformanceJWK001 employs AAV…
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Convalife Pharmaceuticals Gets NMPA Approval for Generic Neratinib Clinical Study
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Shanghai-based Convalife Pharmaceuticals has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of Puma Biotechnology Inc’s neratinib. This study aims to explore the drug’s efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with rare…
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Croma-Pharma Initiates Phase III Clinical Trial in China for Hyaluronic Acid Dermal Filler
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Austria-based Croma-Pharma has revealed that the first patient is set to be enrolled in a clinical trial in China to support the approval of its hyaluronic acid dermal filler, Princess Volume Lidocaine. This randomized, multi-center, blinded, parallel Phase III study will confirm the safety and efficacy of Croma’s product, focusing…
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Sinocelltech Group Receives NMPA Approval for Biosimilar Version of Humira
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid…
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Bio-Thera Solutions’ BAT6026 Receives NMPA Approval for Atopic Dermatitis Clinical Trials
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate Phase I/II clinical trials for BAT6026, an OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD). The Role of OX40 in Immune Response and BAT6026’s MechanismOX40, an immune checkpoint expressed…
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Dizal Pharmaceutical’s Sunvozertinib Gets EU Approval for Global Phase III Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving the green light from EU authorities to proceed with the global, multi-center, random-controlled Phase III WU-KONG28 study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008). The study aims to assess the drug as a first-line treatment for…
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CSPC Pharmaceutical Gets NMPA Approval for ATM Inhibitor SYH2051 Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its in-house developed Category 1 chemical drug, SYH2051. The molecule is set to be assessed in the treatment of general solid tumors. ATM…
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China Medical System’s Diazepam Nasal Spray Receives NMPA Approval for Cluster Seizures
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China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its diazepam nasal spray. This dosage form is the first of its kind to gain approval in China and is set for use as a…
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Dizal Pharmaceutical Presents Updates on DZD8586 and Golidocitinib at ICML
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its JAK1 inhibitor golidocitinib (DZD4205) and DZD8586 at the 17th International Conference on Malignant Lymphoma (ICML) annual meeting. Golidocitinib: A Promising Treatment for PTCLGolidocitinib, the world’s first and only JAK1 inhibitor in regulatory trial stages, received…
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AstraZeneca’s Soliris Secures Third Indication for Myasthenia Gravis in China
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that its Soliris (eculizumab), a first-in-class C5 complement inhibitor, has obtained its third indication approval from the National Medical Products Administration (NMPA) in China. This approval allows the use of Soliris to treat adult patients with refractory generalized Myasthenia gravis (gMG)…
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Abbisko Therapeutics Initiates Phase II Study for Pimicotinib in Chronic Graft-Versus-Host Disease
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib), which is aimed at treating chronic graft versus host disease (cGVHD). Understanding cGVHD and the Role of CSF-1R InhibitionThe pathological and physiological…
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Genor Biopharma’s Geptanolimab NDA for PTCL Rejected by China’s NMPA
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has declined its New Drug Application (NDA) for geptanolimab, a programmed-death 1 (PD-1) inhibitor, for the treatment of recurrent/refractory peripheral T-cell lymphoma (PTCL). The drug, which was under development to treat a range of…
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CSPC Pharmaceutical’s CPO301 Earns Fast-Track Status for EGFR Mutant NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC), CPO301, has received fast-track status for the treatment of recurrent/refractory (R/R) or EGFR targeted therapy ineffective metastatic EGFR mutant non-small cell lung cancer (NSCLC). Preclinical Efficacy and Safety of CPO301Preclinical studies have demonstrated that…
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Salubris Pharmaceuticals’ Enarodustat Gains NMPA Approval for Renal Anemia Treatment
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the National Medical Products Administration (NMPA) for enarodustat, a novel drug candidate specifically targeting renal anemia. Enarodustat is a hypoxia-inducible factor proline hydroxylase inhibitor (HIF-PHI) developed for anemia in non-dialysis adult chronic kidney disease (CKD) patients.…
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Keymed Biosciences’ CM313 Monoclonal Antibody Shows Promise in Phase I Study for Multiple Myeloma
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. The trial focuses on the molecule’s potential use…
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HutchMed Presents Updated Data on Hematological Malignancy Therapies at EHA and ICML
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that new and updated clinical data related to two novel investigational therapies for hematological malignancies, HMPL-306 and amdizalisib, will be presented at the European Hematology Association (EHA) Annual Meeting and the 17th International Conference on Malignant Lymphoma (ICML). HMPL-306: A Dual…
