RemeGen (09995.HK, 688331.SH)

Executive Summary

RemeGen is a leading Chinese biopharmaceutical company focused on developing first-in-class biologics in autoimmunity, oncology, and ophthalmology. Its two key products are Telitacicept, a BLyS/APRIL dual-targeting fusion protein approved for systemic lupus erythematosus (SLE) in China, and Disitamab Vedotin, an anti-HER2 antibody-drug conjugate (ADC) approved for HER2-positive cancers. The company is expanding these drugs into additional indications, including IgA nephropathy for Telitacicept and HER2-low breast cancer for Disitamab Vedotin, with promising clinical data. RemeGen’s strong pipeline of novel ADCs and bispecific antibodies, combined with its proprietary technology platforms, positions it for sustained growth in China and potential global expansion. The company went public on the Hong Kong Stock Exchange (09995.HK) and Shanghai STAR Market (688331.SH), providing access to capital for R&D and commercialization. With a seasoned management team and over a thousand employees, RemeGen is well-equipped to navigate China's evolving regulatory and market dynamics.

Upcoming Catalysts (preview)

• Q2 2026Telitacicept NDA approval for IgA nephropathy in China85% success
• Q4 2026Disitamab Vedotin Phase III data for HER2-low breast cancer70% success
• Q3 2026RC88 (mesothelin-targeting ADC) Phase II data update60% success