维升药业(02561) - 2025 - 中期业绩

Company Announcements and Financial Summary This section details recent corporate announcements and provides a financial overview, highlighting increased losses and a significant rise in cash and cash equivalents Announcement Information Visen Pharmaceuticals released its unaudited condensed consolidated interim results for the six months ended June 30, 2025, and announced directorate and audit committee changes - The company released its unaudited condensed consolidated interim results announcement for the six months ended June 30, 2025[2] - The announcement also included the resignation of a non-executive director, appointment of an independent non-executive director, and changes to the audit committee composition[2] Financial Summary For the six months ended June 30, 2025, the company's R&D costs and administrative expenses increased, leading to an expanded loss of RMB 118 million, while cash and cash equivalents significantly grew to RMB 806 million due to global offering proceeds Financial Summary for the Six Months Ended June 30 | Metric | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Research and development costs | (46,621) | (38,917) | | Administrative expenses | (60,045) | (43,643) | | Loss for the period | (118,020) | (83,471) | Cash and Cash Equivalents at Period End: | Metric | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Cash and cash equivalents | 805,909 | 203,587 | - Loss for the period increased by 41.4% year-on-year to RMB 118 million[4] - Cash and cash equivalents significantly increased from RMB 204 million at the end of 2024 to RMB 806 million as of June 30, 2025, primarily due to net proceeds from the global offering[4][33] Business Overview and Product Pipeline This section outlines the company's profile, strategic focus, and detailed progress of its core and key product pipeline candidates Company Profile and Strategy Established in November 2018, Visen Pharmaceuticals is a late-stage biopharmaceutical company focused on endocrine disease treatments in China, with one core and two key products under exclusive license - Established in November 2018, the company is a late-stage biopharmaceutical company with products nearing commercialization, focused on providing specific endocrine disease treatments in China (including Hong Kong, Macau, and Taiwan)[9] - The company possesses one core product, lonapegsomatropin, and two key products, palopegteriparatide and navepegritide[9] - The company has secured exclusive licenses to develop, manufacture, and commercialize all candidate drugs in China (including Hong Kong, Macau, and Taiwan)[12] Core Product: Lonapegsomatropin Lonapegsomatropin, the company's core product for pediatric growth hormone deficiency, has completed China Phase 3 trials, submitted BLA, and is advancing towards commercialization, local production, and market access - Lonapegsomatropin is the only long-acting growth hormone to demonstrate superiority and comparable safety in a positive drug-controlled, parallel-group trial against daily human growth hormone for pediatric growth hormone deficiency[5][15] - The BLA was accepted by the NMPA on March 7, 2024, and entered its second technical review on May 21, 2025, with approval anticipated in Q4 2025[10][17] Product Overview and Clinical Progress Lonapegsomatropin is a once-weekly long-acting growth hormone replacement therapy, demonstrating superior annualized height velocity (AHV) and comparable safety to daily injections in China Phase 3 trials - Lonapegsomatropin has completed a Phase 3 pivotal trial in China for children aged 3 to 17 with growth hormone deficiency, demonstrating statistically significant superior 52-week AHV compared to short-acting (daily injection) human growth hormone[15] - This product is the only long-acting growth hormone that continuously releases unmodified human growth hormone in vivo between weekly doses, with a molecular composition identical to endogenous growth hormone[15] Registration and Commercialization Progress Lonapegsomatropin's BLA is in its second technical review, with expected approval in Q4 2025, supported by approved auto-injector devices and a commercial supply agreement with Ascendis Pharma - Lonapegsomatropin's BLA application was accepted by the NMPA on March 7, 2024, and initiated its second technical review on May 21, 2025, with approval expected in Q4 2025[17] - Import medical device registration applications for the auto-injector and needles were approved in April 2024 and April 2025, respectively[5][17] - On June 12, 2025, the company entered into a commercial supply framework agreement with Ascendis Pharma to ensure the supply of its core product post-launch[5][18] Local Production and Global Development The company is collaborating with Wuxi Biologics for local production of lonapegsomatropin, developing Dual Chamber Device (DCD) technology, and noting global trial results and US FDA approval for adult GHD - The company is collaborating with Wuxi Biologics for the commercial production of lonapegsomatropin, having completed technology transfer for key reagents and intermediates, aiming to complete drug substance technology transfer by end of 2025 and full technology transfer and localization by 2027[19] - The company successfully developed Dual Chamber Device (DCD) technology as a drug delivery platform for its self-developed formulations and has obtained multiple patents[5][20] - Results from the enliGHten trial, published in Hormone Research in Paediatrics, showed lonapegsomatropin treatment for pediatric growth hormone deficiency patients resulted in sustained height improvement for up to 6 years[22] - Ascendis Pharma announced that the US FDA approved SKYTROFA® (lonapegsomatropin-tcgd) for replacement of endogenous growth hormone in adult growth hormone deficiency[22] Commercialization Plan and Market Access To prepare for lonapegsomatropin's anticipated Q4 2025 approval, the company is expanding its commercial team and forming strategic partnerships to broaden market coverage and accelerate product adoption - The company is expanding its field medical representatives, medical training, channel management, medical affairs, and customer service personnel to strengthen its commercial team in anticipation of the core product's expected approval in Q4 2025[23] - Strategic cooperation agreements have been signed with Shanghai Pharmaceuticals Holding Co., Ltd. and United Family Healthcare to jointly develop diagnostic and service capabilities for pediatric growth and development medical needs[23] - A strategic cooperation framework agreement was signed with Anke Bio to jointly promote lonapegsomatropin in certain geographical regions in China to expand commercial coverage and accelerate product adoption[5][23](