CICC released a research report stating that it essentially maintains its forecast for REMEGEN's (09995) net losses attributable to shareholders of RMB 915 million in 2025 and RMB 333 million in 2026. Due to the positive Phase III clinical results of telitacicept for Sjögren's syndrome, which is expected to enhance telitacicept's future value potential, and RC148's approval for Phase II clinical trials in the US, which is expected to boost its overseas expansion potential and global value scope, based on the DCF model, the firm maintains the company's outperform rating and raises the target price by 24.8% to HK$95.34, representing 23.1% upside potential compared to the current share price.
CICC's main viewpoints are as follows:
**Recent Company Developments**
On August 13th, the company announced that its independently developed globally first BLyS/APRIL dual-target fusion protein innovative drug telitacicept for the treatment of primary Sjögren's syndrome (pSS) has achieved the primary endpoint in its Phase III clinical study design. The company will submit a marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration as soon as possible, with detailed data to be published at major international academic conferences.
**Telitacicept Can Sustainably and Effectively Improve Clinical Symptoms in Sjögren's Syndrome Patients, with Global Market Development Potential**
Phase II clinical data shows that using telitacicept 160mg for 24 weeks treatment can reduce the ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index) score by 4.3 points from baseline, significantly superior to placebo. Telitacicept can rapidly and sustainably improve immunoglobulin IgG, IgA, and IgM levels starting from week 4, with good safety and tolerability. Domestically, telitacicept for Sjögren's syndrome has received recommendations from multiple authoritative guidelines. Internationally, telitacicept's Sjögren's syndrome indication has been granted Fast Track designation by the US FDA and has been approved to conduct global multicenter Phase III clinical trials. The firm believes telitacicept is expected to rewrite global pSS clinical treatment protocols.
**Company's Original Bispecific Antibody RC148 Receives US FDA IND Approval**
RC148 is a novel PD-1/VEGF bispecific antibody. The firm believes RC148 is expected to synergistically enhance tumor killing response through immune checkpoint blockade and inhibition of tumor angiogenesis. RC148's FDA approval to conduct Phase II clinical research targeting multiple advanced malignant solid tumors in the US marks RC148's entry into the global clinical development stage, laying the foundation for subsequent product development. The firm believes RC148 has international clinical value and overseas expansion potential.
**RC148 Receives CDE's Preliminary Inclusion in Breakthrough Therapy**
RC148's monotherapy and combination therapy clinical studies for advanced solid tumors in China are progressing smoothly, with early-stage monotherapy showing good efficacy and safety in clinical trials. The indication for CDE's preliminary inclusion in breakthrough therapy is combination with docetaxel for treating driver gene-negative locally advanced or metastatic non-small cell lung cancer that has failed PD-1/PD-L1 inhibitor and platinum-containing chemotherapy (combination or sequential) treatment. The firm believes RC148 is expected to combine with ADCs and other drugs subsequently, further expanding potential clinical application scope.
**Risk Warnings:** Risk of R&D failure, risk of intensified industry competition, risk of international cooperation progress falling short of expectations.
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