CSPC Pharmaceutical (01093.HK): SYH2062 Hypertension Phase II Trial Initiated at First China Site; CRB-701 FDA Cleared for Pivotal OPSCC Trial

NewTimeSpace News: CSPC Pharmaceutical Group Limited (stock code: 1093) announced two pipeline milestones: the Phase II clinical trial (SYH2062-003) of its SYH2062 injection for the treatment of adult primary hypertension has been officially initiated at the first center in China; and CRB-701 (SYS6002), licensed to Corbus Pharmaceuticals, Inc., has received U.S. FDA approval to initiate the registrational clinical trial TEMPO-1 for second-line treatment of oropharyngeal squamous cell carcinoma (OPSCC).

According to the announcement, SYH2062 is a chemically modified double-stranded small interfering RNA (siRNA) of 21–23 nucleotides in length, utilizing N-acetylgalactosamine (GalNAc) conjugation technology for liver-targeted delivery. It specifically silences the angiotensinogen (AGT) gene, inhibits corresponding protein expression, alleviates overactivation of the renin-angiotensin system (RAAS), and thereby achieves effective pathway inhibition and long-term blood pressure control. The product received the Clinical Trial Approval Notification from China's NMPA in December 2024. Phase I clinical data in hypertensive patients have preliminarily validated its safety, pharmacokinetic, and pharmacodynamic characteristics. The Phase II trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating efficacy and safety in subjects with mild-to-moderate primary hypertension, with patient enrollment and screening currently being actively advanced.

Regarding CRB-701, the announcement stated that it is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4, a clinically validated tumor-associated antigen highly expressed in urothelial carcinoma, cervical cancer, and head and neck squamous cell carcinoma (HNSCC). The FDA had previously granted two Fast Track designations for HNSCC and cervical cancer indications. TEMPO-1 is a randomized controlled trial designed to evaluate efficacy and safety compared with investigator's choice of monotherapy (capecitabine, cetuximab, or docetaxel), with co-primary endpoints of objective response rate (ORR) to support potential accelerated approval and overall survival (OS) to support potential full approval. Corbus expects to initiate patient enrollment in the third quarter of 2026. The FDA's approval was based on data from the ongoing Phase I/II trial, which was recently presented at the 2026 ASCO annual meeting.

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