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Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
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Genesis MedTech Receives Chinese Market Approval for Antibacterial Absorbable Sutures
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Singapore-based medical device company Genesis MedTech has announced that it has received market approval in China for its absorbable sutures with antibacterial protection. This milestone marks the company as the first domestic brand to successfully develop such a product, enhancing its position in the medical device market. Innovation in Surgical…
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Grand Pharmaceutical’s GSP301 NS Meets Primary Endpoint in Phase III SAR Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China. Study Design and Patient EnrollmentThe randomized, double-blind, double-simulation, three-arm, multi-center, parallel-controlled Phase III…
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Canton Biologics Secures Over RMB 300 Million in Series C Financing for Expansion
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Canton Biologics Co., Ltd, a Guangzhou-based Contract Development and Manufacturing Organization (CDMO) specializing in biologic drugs, has reportedly raised over RMB 300 million (USD 27.5 million) in a Series C financing round. The round was led by SDIC Venture Capital, with additional investments from Guangdong Technology Financial Group, Taipu Life…
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Menarini Group Secures Exclusive License for Astellas’ Smyraf in Taiwan
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A. Menarini Asia-Pacific Holdings Pte. Ltd, a subsidiary of the Italy-based Menarini Group, has entered into a long-term exclusive licensing agreement with Japan-headquartered Astellas Pharma Inc (TYO: 4503). The partnership grants Menarini the rights to develop, manufacture, and commercialize the orally administered Janus kinase (JAK) inhibitor Smyraf (peficitinib hydrobromide) in…
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Haisco Pharmaceutical’s HSK16149 for Post-Herpes Neuralgia Accepted for NMPA Review
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the National Medical Products Administration (NMPA) has accepted for review a market approval filing for its drug candidate HSK16149 as a treatment for post-herpes neuralgia (PHN). This in-house Category 1 drug, an oral gamma-aminobutyric acid (GABA) analogue, is under…
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Asieris Pharmaceuticals’ APL-1202 Shows Positive Interim Analysis in MIBC Trial with BeiGene’s Tislelizumab
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed positive results from a Phase II interim analysis of its drug candidate APL-1202, combined with BeiGene Ltd’s (NASDAQ: BGNE; HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab, as neoadjuvant chemotherapy (NAC) in muscular invasive bladder cancer (MIBC). The trial has demonstrated…
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AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
