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Hybio Pharmaceutical Receives US FDA Approval for Biosimilar Victoza (Liraglutide)
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving official approval from the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of its biosimilar version of Denmark firm Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). Liraglutide: A Crucial Treatment for DiabetesLiraglutide, an analog of human…
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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…
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Hybio Pharmaceutical’s Liraglutide Biosimilar Withdrawn from NMPA Filing
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has approved its application to withdraw the market filing for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This decision comes as part of a strategic adjustment in response to policy and…
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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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Hybio’s COVID-19 Nasal Spray HY3000 Gets FDA Clinical Trial Approval
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving tacit clinical trial approval from the US FDA for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. This approval marks a significant step forward in the development of novel treatments for the virus, offering a new approach to…
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Hybio Pharma and CR Medicine Collaborate on Market Expansion
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has entered into a collaboration agreement with compatriot firm China Resource Medicine Commercial Holdings Ltd. The partnership aims to expand market reach, enhance promotion efforts, and boost sales. Financial details of the agreement were not disclosed. Hybio Pharma’s Strategic LeverageHybio Pharma, a key…
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Hybio Receives Ethical Approval for HY3000 COVID-19 Nasal Spray Phase II Study
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced receiving ethical approval for a Phase II clinical study protocol for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. The clinical filing for the product was accepted for review by the National Medical Products Administration (NMPA) in August 2022. Study…
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Hybio Pharmaceutical’s HY3000 Nasal Spray for COVID-19 Enters NMPA Review
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that its clinical trial filing for HY3000 nasal spray, a Category 1 chemical drug targeting COVID-19, has been accepted for review by the National Medical Products Administration (NMPA). Drug DetailsHY3000 is a novel polypeptide membrane fusion inhibitor that binds to the HR1…
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Hybio Pharmaceutical’s Liraglutide Filing Accepted by NMPA, Becomes Domestic Leader in GLP-1 Analog
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that its market filing for liraglutide, a Category 2.2 chemical drug, has been accepted for review by the National Medical Products Administration (NMPA). Hybio is now the only domestic firm to complete clinical trials via chemical synthesis and file for marketing of…
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Hybio Pharmaceutical Signs Tech Transfer Deal with China’s CDC for COVID-19 Vaccine Peptide Sequences
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that it has signed a technology transfer agreement with the National Institute for Viral Disease Control and Prevention, China’s CDC. The deal grants Hybio licensed use of technical secrets related to peptide sequences for vaccine development. Agreement DetailsHybio will pay an upfront…
