Workflow
新药地产化
icon
Search documents
济川药业:公司主动撤回此前递交的依坦进口生物制品上市申请
Zheng Quan Ri Bao Wang· 2026-01-08 13:13
Core Viewpoint - Jichuan Pharmaceutical (600566) has decided to fully implement the localization strategy for the recombinant human growth hormone injection, Yitan, in response to the development trends of the Chinese growth hormone market and the national new drug localization policy [1] Group 1: Strategic Decisions - The company has completed the technology transfer and process optimization for Yitan growth hormone α, with localization production capacity fully ready [1] - The clinical trial for the bioequivalence of imported and localized products has been approved by the National Medical Products Administration (NMPA) and has been initiated [1] Group 2: Market Focus - The company has proactively withdrawn its previous application for the import of the Yitan biological product to focus on the rapid submission of the localization application [1]
天境生物:主动撤回依坦生长激素a进口生物制品上市申请,全面实施地新药地产化战略
Cai Jing Wang· 2025-12-30 09:38
Core Viewpoint - Tianjing Biological and Jichuan Pharmaceutical announced a strategic decision to implement the localization strategy for the recombinant human growth hormone injection, "Yitan" [1] Group 1: Market Strategy - The decision is based on the strategic judgment of the development trend of the growth hormone market in China [1] - The companies are responding to the national policy on new drug localization and leveraging the commercial advantages of Yitan [1] Group 2: Production and Regulatory Progress - The technical transfer and process optimization for Yitan have been successfully completed, and the production capacity for localization is fully ready [1] - The clinical trial for the bioequivalence of imported and localized products has been approved by the National Medical Products Administration [1] - The companies have withdrawn the previous application for the import of Yitan to focus on the rapid submission of the localization application [1]