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Hybio Pharmaceutical Inks Licensing Deal with Mullan Pharmaceutical for Liraglutide Biosimilar
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BEIJING—Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese biopharmaceutical company, has entered into a licensing agreement with fellow Chinese firm Mullan Pharmaceutical Co., Ltd, concerning the biosimilar version of Novo Nordisk’s Victoza (liraglutide). The agreement encompasses licensing rights, supply, and distribution for Hybio’s biosimilar, which is a glucagon-like peptide 1…
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Hybio Pharmaceutical Gets FDA Nod for Tirzepatide Raw Materials in DMF Filing
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its tirzepatide raw materials. Tirzepatide, a first-to-market dual GIP/GLP-1 receptor agonist, has been approved in the U.S.…
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Hybio Pharmaceutical’s Biosimilar Liraglutide Gets Temporary FDA Nod Pending Patent Expiry
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received temporary approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide). This indicates that the drug has met…
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3SBio Secures License for Semaglutide Biosimilar from Hybio Pharmaceutical
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced a licensing agreement with fellow Chinese firm Hybio Pharmaceutical Co., Ltd (SHE: 300199) for the development of a semaglutide biosimilar. Under this agreement, 3SBio will gain access to Hybio’s preclinical technical results for the drug and will be…
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Hybio Pharmaceutical Gets FDA Nod for Liraglutide Raw Materials with DMF Adequacy Letter
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a China-based pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the US Food and Drug Administration (FDA) for its liraglutide raw materials. The letter indicates no comments and no deficiencies, which is a significant step…
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Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its Category 1.1 chemical drug, HY3000, a nasal spray designed to target COVID-19. Mechanism of Action and EfficacyHY3000 is a new type of polypeptide membrane…
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Hybio Pharmaceutical’s Semaglutide Clinical Trial Filing Accepted by China’s NMPA
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for semaglutide, a Category 2.2 product. Category 2.2 products in China are new formulations of known drugs that aim to offer a demonstrable clinical benefit over the originator…
