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荣昌生物(09995.HK):泰它西普PSS三期临床告捷 RC148进入全球开发
Ge Long Hui·2025-08-17 03:50

Company Updates - The company announced on August 13 that its self-developed innovative drug, Taitasip, a global first BLyS/APRIL dual-target fusion protein, has achieved the primary endpoint in the Phase III clinical trial for treating primary Sjögren's syndrome (pSS) and will soon submit a marketing application to the National Medical Products Administration (NMPA) [1] - Taitasip has shown significant clinical efficacy, with Phase II clinical data indicating a reduction of 4.3 points in the ESSDAI score after 24 weeks of treatment with 160mg, outperforming the placebo [1] - The drug has received multiple authoritative guideline recommendations in China and has been granted Fast Track designation by the FDA for its pSS indication, allowing for a global multi-center Phase III clinical trial [1] Product Development - The company’s novel bispecific antibody, RC148, has received FDA approval for clinical trials in the U.S. for various advanced malignant solid tumors, marking its entry into global clinical development [2] - RC148 is expected to enhance tumor-killing responses through immune checkpoint blockade and tumor angiogenesis inhibition, indicating its international clinical value and potential for global expansion [2] - In China, RC148 is progressing smoothly in clinical research for single-agent and combination therapies for advanced solid tumors, with promising efficacy and safety observed in early trials [2] Financial Forecast and Valuation - The company maintains its net profit loss forecast for 2025 and 2026 at 915 million yuan and 333 million yuan, respectively [2] - Positive Phase III clinical results for Taitasip are expected to enhance its future value, while the FDA approval for RC148's Phase II trial is anticipated to boost its global value [2] - Based on a DCF model, the company has raised its target price by 24.8% to HKD 95.34, indicating a potential upside of 23.1% from the current stock price [2]