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隆培生长激素(lonapegsomatropin)
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维昇药业-B(02561.HK)上半年研发支出同比增长19.8%,核心产品隆培生产激素预期四季度获BLA批准
Ge Long Hui· 2025-08-27 14:57
Core Viewpoint - The company reported a mid-year performance with a significant increase in R&D spending and a strategic focus on commercializing its core product, lonapegsomatropin, expected to receive BLA approval by Q4 2025 [1][2] Financial Performance - R&D expenditure for the first half of 2025 was approximately RMB 46.62 million, representing a year-on-year increase of 19.80% [1] - The company incurred a loss of RMB 118 million during the same period [1] - As of June 30, 2025, cash and cash equivalents amounted to RMB 806 million, an increase of RMB 602 million compared to the end of 2024 [1] - The company secured an unsecured bank credit facility of RMB 300 million to enhance financial flexibility [1] Product Development and Commercialization - The company anticipates that its core product, lonapegsomatropin, will receive BLA approval in Q4 2025, followed by commercialization efforts later in the year [1] - To support commercialization, the company is expanding its commercial team, including hiring more medical representatives and enhancing training and customer service [1] Strategic Partnerships - The company has entered into a strategic cooperation agreement with Shanghai Pharmaceuticals to establish a necessary management framework compliant with GSP [2] - A partnership with United Family Healthcare was formed to develop diagnostic and service capabilities for children with growth and development medical needs [2] - Discussions with Anke Bio regarding joint promotion of lonapegsomatropin in specific geographic areas are underway, with a strategic cooperation framework agreement signed on July 14, 2025 [2]
维昇药业-B发布中期业绩 研究及开发成本4662.1万元 同比增加19.8%
Zhi Tong Cai Jing· 2025-08-27 14:57
Core Viewpoint - The company reported a mid-term performance for the six months ending June 30, 2025, highlighting a total other income of 5.301 million RMB and an increase of 19.8% in research and development costs to 46.621 million RMB [1] Group 1: Financial Performance - The company achieved other income of 5.301 million RMB during the reporting period [1] - Research and development costs rose to 46.621 million RMB, reflecting a year-on-year increase of 19.8% [1] Group 2: Strategic Collaborations - The company is collaborating with WuXi Biologics, designated as the local CDMO in China, for the commercialization of lonapegsomatropin [1] - In July 2023, the company entered into a comprehensive technology transfer plan with Ascendis Pharma for its core product [1] - A cooperation agreement was signed with WuXi Biologics in December 2023, where WuXi will act as the local CDMO for process development and validation [1] Group 3: Technology Transfer and Development Timeline - As of June 2025, the company has completed the small-scale research and development for key reagents and intermediates [1] - The goal is to complete the small-scale research and development for the core product's active ingredient by the end of 2025 [1] - Full technology transfer and localization are expected to be completed by 2027, enabling the company to produce the core product's active ingredient in collaboration with WuXi Biologics [1]
维昇药业-B(02561)发布中期业绩 研究及开发成本4662.1万元 同比增加19.8%
智通财经网· 2025-08-27 14:50
Core Insights - The company reported other income of 5.301 million RMB for the six months ending June 30, 2025, while research and development costs increased by 19.8% to 46.621 million RMB [1] Group 1 - The company is collaborating with WuXi Biologics, its designated local CDMO in China, for the commercialization of lonapegsomatropin [1] - In July 2023, the company signed a master technology transfer agreement with Ascendis Pharma, marking the beginning of technology transfer for core product manufacturing [1] - A cooperation agreement was established with WuXi Biologics in December 2023, where WuXi will act as the local CDMO for process development and validation, facilitating local production technology [1] Group 2 - As of June 2025, the company has completed the small-scale research and development for key reagents and intermediates, aiming to finish the small-scale R&D for core product bulk solution technology transfer by the end of 2025 [1] - The entire technology transfer and localization process is expected to be completed by 2027, which will enable the company to produce core product drug bulk solutions in collaboration with WuXi Biologics [1]