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Viatris Launches First-of-Its-Kind Nasal Spray Dymista in China for Allergic Rhinitis
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Viatris Inc. (NASDAQ: VTRS), a leading global pharmaceutical company based in the U.S., has announced the official launch of its nasal spray combination therapy, Dymista (azelastine, fluticasone), in China. This medication is now available to treat moderate to severe seasonal and perennial allergic rhinitis in adults and children aged 12…
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Sansure Biotech Wins NMPA Nod for ALDH2 Gene Polymorphism Detection Kit
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Sansure Biotech Inc., (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its nucleic acid detection kit for the human ALDH2 gene polymorphism, utilizing the PCR fluorescent probe method. The kit is designed…
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Novo Nordisk Advances in China with Submission of Sogroya for Adult Growth Hormone Deficiency
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Denmark’s pharmaceutical heavyweight, Novo Nordisk (NYSE: NVO), has reached a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Sogroya (somapacitan), a long-acting somatotropin. This once-weekly treatment is designed to address adult growth hormone deficiency (AGHD) and has already received approval in the US in…
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AstraZeneca China Restructures Biopharma Unit to Boost Chronic Disease Management
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AstraZeneca (NASDAQ: AZN)’s Chinese subsidiary has announced a strategic restructuring of its China biopharmaceutical business unit (BBU), with Lin Xiao, currently the general manager of AstraZeneca China’s biopharmaceutical operations and head of the Hong Kong and Macau Region, being appointed to lead the division. The restructuring entails the integration of…
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Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
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Eli Lilly Partners with Haya Therapeutics to Tap the Dark Genome for Obesity Treatments
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Eli Lilly & Co. (NYSE: LLY), a leading figure in the pharmaceutical industry, has embarked on a drug discovery partnership with Switzerland’s Haya Therapeutics, a move that underscores its commitment to advancing its anti-obesity portfolio. The collaboration will tap into Haya’s cutting-edge expertise in the dark genome, the largely non-protein-coding…
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Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
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The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche (SWX: ROG) for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma…
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Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
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The Center for Drug Evaluation (CDE) has given the green light for the review of a new indication submission for Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) ivarmacitinib, as per the latest update on the CDE’s website. The potential new indication is speculated to be adult alopecia areata, aligning with…