REMEGEN

Vor Bio acquired exclusive global rights (excluding Greater China) to develop and commercialize telitacicept, a dual-target fusion protein approved in China for multiple autoimmune diseases including generalized myasthenia gravis.

RemeGen announced that Telitacicept has officially been approved for marketing in China by the National Medical Products Administration for treating generalized myasthenia gravis.

• Pfizer has completed a record-breaking $6 billion acquisition deal with Chinese biopharmaceutical company 3SBio, energizing China's innovative drug industry and potentially driving further valuations upward. • RemeGen successfully raised HK$796 million through a premium placement, demonstrating strong investor confidence following the successful out-licensing of its RC18 asset. • The transactions highlight the growing momentum in China's biotech sector, with 3SBio's valuation expected to continue rising while competitor Akeso may face downward pressure. • China's 11th batch of national Volume-Based Procurement (VBP) rules are expected to include optimizations balancing competitive bidding prices with drug quality standards.

China's National Medical Products Administration (NMPA) has approved Remegen's antibody-drug conjugate disitamab vedotin (RC-48) for patients with HER2-positive advanced breast cancer with liver metastasis.

DelveInsight's 2025 pipeline analysis reveals over 30 companies developing 30+ therapies for IgA nephropathy treatment, representing a robust therapeutic landscape.

Telitacicept demonstrated a 98.1% response rate in reducing MG-ADL scores by ≥3 points at Week 24, potentially positioning it as best-in-class among treatments for generalized myasthenia gravis.

Disitamab Vedotin combined with Toripalimab achieved a 63.6% pathological complete response rate in muscle-invasive bladder cancer patients, nearly doubling traditional chemotherapy outcomes.

• Seagen has entered a $2.6 billion licensing agreement with Chinese biotech RemeGen for disitamab vedotin, a HER2-targeting antibody-drug conjugate, with $200 million paid upfront. • The drug has already received conditional approval in China for HER2-positive gastric cancer and breakthrough designation from FDA for bladder cancer. • This strategic move positions Seagen to compete with established HER2-targeting ADCs like AstraZeneca/Daiichi Sankyo's Enhertu and Roche's Kadcyla in multiple cancer indications.

• Disitamab Vedotin (DV) significantly improved progression-free survival (PFS) compared to Lapatinib plus Capecitabine in HER2-positive advanced breast cancer with liver metastasis. • The Phase III study (RC48-C006) is the first global prospective, randomized trial demonstrating the efficacy of a HER2-targeting ADC in this patient population. • DV demonstrated a manageable safety profile, consistent with previous experience, offering a potential new treatment option for previously treated patients. • The Biologics License Application for Disitamab Vedotin has been accepted and granted priority review by China's National Medical Products Administration.

RemeGen's marketing application for Taicercept (telitacicept) for generalized myasthenia gravis (gMG) treatment has been accepted by China's Center for Drug Evaluation.