Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products,  announce  that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO® (Equecabtagene Autoleucel, co-developed and co-commercialized by Innovent and IASO Bio, Innovent R&D code: IBI326, IASO Bio R&D code: CT103A), the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

FUCASO^® (Equecabtagene Autoleucel) is a BCMA-directed CAR T cell therapy, using lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous selection and screening of the molecular structures, and comprehensive in vivo and in vitro evaluation, FUCASO^® has demonstrated rapid and potent efficacy as well as prolonged persistency in RRMM patients, providing higher and deeper responses and long-term clinical benefit. 

The NDA approval was based on the results from the FUMANBA-1 clinical study (CTR20192510, NCT05066646), a multi-center Phase I/II registrational clinical trial conducted in China to evaluate the efficacy of Equecabtagene Autoleucel in patients with RRMM. In June 2023, updated data from this ongoing study was presented as a poster presentation (Abstract Number: 8025) at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), in which Equecabtagene Autoleucel demonstrated remarkable efficacy and favorable safety profiles.

A total of 103 subjects received a dose of 1.0×10⁶ CAR-T cells/kg, with a median follow-up time of 13.8 (0.4, 27.2) months.

• Among the 101 evaluable patients, the overall response rate (ORR) was 96%, and the stringent complete response/ complete response (sCR/CR) rate was 74.3%. Median time to response (mTTR) was only 16 days, and the 12-month PFS rate was 78.8%. 95% of the patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Of the 12 patients with prior CAR-T therapy, 9 achieved CR, and 5 achieved sCR (including 4 patients that sustained sCR for over 18 months post-infusion). In 89 patients without prior CAR-T therapy, 78.7% reached sCR/CR.
• Of the 103 patients, only one experienced grade ≥3 cytokine release syndrome (CRS), and 2 experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). All patients with CRS or ICANS recovered after the treatment.
• Equecabtagene Autoleucel was still detectable in 50% and 40% respectively of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% of the patients were anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion.

The Principal Investigators of FUMANBA-1 study, Prof. Lugui Qiu, MD, Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology: "There's a significant unmet clinical need for the treatment of multiple myeloma (MM) in China. As a fully-human BCMA CAR-T therapy, FUCASO® has demonstrated remarkable efficacy, with evidence of deep and durable response for high-quality survival for MM patients. We believe that FUCASO's® approval will offers clinicians a novel breakthrough option benefiting patients with later-line RRMM."

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, "Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need of a treatment with well-tolerated and long persistence for RRMM patients in China. FUCASO®, as an innovative fully-human BCMA-directed T cell therapy, has demonstrated robust and long-lasting efficacy and outstanding safety in long-term follow-up data from the registrational clinical study, which underscores its potential to be a pioneering treatment option for patients with RRMM. We are very pleased with the approval of FUCASO® and hope it could benefit RRMM patients as the first approved BCMA CAR-T therapy in China."

Ms. Jinhua Zhang, Chairman and Chief Executive Officer of IASO Bio, stated, "We are excited that FUCASO® was approved as a new drug, which is a significant milestone for our team. FUCASO® is not only IASO Bio's first commercialized product but is also the world's first commercially available fully-human CAR-T therapy. Furthermore, FUCASO® is the first self-developed and independently manufactured CAR-T cell therapy in China as well as China's first approved BCMA CAR-T product and first approved cell therapy for the treatment of MM in China. The NMPA's NDA approval of FUCASO® will help us in achieving our strategic goal of bringing groundbreaking treatment options, as well as new hope for a potential cure, to MM patients in need."