Core Viewpoint - The company reported strong performance in 1H25, with revenue of 731 million yuan, a year-on-year increase of 74.26%, despite a net loss of 30.09 million yuan, driven by high growth of its core product, Orelabrutinib, and the confirmation of an upfront payment from Prolium for licensing [1][2]. Financial Performance - Revenue for 1H25 reached 731 million yuan, representing a 74.26% year-on-year growth [1]. - The net loss for the period was 30.09 million yuan, indicating a significant narrowing of losses [2]. - Gross margin improved to 89.5%, up 3.8 percentage points year-on-year, primarily due to the rapid growth of Orelabrutinib and the licensing agreement with Prolium [2]. - Sales expenses increased by 55.3% to 244 million yuan, while R&D expenses rose by 5.7% to 450 million yuan [2]. Product Development and Market Expansion - Orelabrutinib sales exceeded expectations, generating 637 million yuan in revenue for 1H25, a 52.8% increase, benefiting from the continued growth of its exclusive indication for MZL [2]. - The company received approval for Tafasitamab for treating DLBCL in May 2025, marking it as the first CD19 monoclonal antibody approved for R/R DLBCL in China [2]. - Orelabrutinib has expanded its indications, receiving a level I recommendation in the CSCO guidelines for 1L CLL/SLL and is set to participate in this year's medical insurance negotiations [2]. - Ongoing global Phase III clinical trials for Orelabrutinib in treating PPMS and SPMS are being initiated, with NDA submission expected in 1H26 for ITP indication [3]. Profit Forecast and Valuation - The company has revised its 2025 loss forecast from 415 million yuan to 319 million yuan and the 2026 forecast from 225 million yuan to 203 million yuan due to better-than-expected sales of Orelabrutinib [4]. - The target prices for A/H shares have been raised by 36.0% and 77.3% to 35.00 yuan and 22.00 HKD, respectively, indicating an upside potential of 10.0% and 10.8% from current prices [4].
诺诚健华-U(688428):1H25业绩好于预期 关注国际化进展