suciraslimab (SM03) / SinoMab - LARVOL DELTA

SinoMab (03681.HK) Globally First-in-Class SM03 (Suciraslimab) Achieves Breakthrough Preclinical Results in SLE, Demonstrating Positive Immune Modulation with Potential Multi-Organ Protection and Superior Long-Term Safety (SinoMab Press Release) - "SinoMab BioScience Limited...is pleased to announce that its globally first-in-class innovative drug SM03 (suciraslimab) targeting Systemic Lupus Erythematosus (SLE) has achieved breakthrough preclinical results from In-vivo study...The primary mechanism of SM03 involves upstream inhibition of autoreactive B cell activation and autoantibody production, addressing humoral immune dysregulation (humoral immune axis). The synergistic mechanism can also modulate B and other immune cell interactions, thereby ensuring an alleviation of systemic autoreactive inflammation through a regulation of the immune network." Ask ChatGPT "

Preclinical • Systemic Lupus Erythematosus

CD22 modulation alleviates amyloid β-induced neuroinflammation. (PubMed, J Neuroinflammation) - "The pivotal therapeutic potential of targeting CD22 was demonstrated in Amyloid β (Aβ) induced-neuroinflammation in hCD22 transgenic mice...Intriguingly, we discovered that CD22 interact with Aβ and suciraslimab enhanced internalization of CD22-Aβ complex in microglia. Our data highlights the importance of sCD22 in driving neuroinflammation and the dual mechanism of targeting CD22 to resolve Aβ-induced inflammation and promote Aβ phagocytosis."

Journal • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • Movement Disorders • Parkinson's Disease • CCL3 • CD22 • IL12A • IL1B • IL23A • IL6 • TNFA

SinoMab-B (03681) released interim results, with revenue of RMB 2.026 million, up 48.4% year-on-year (Sina Corp) - "In the first half of 2024, the BLA application for the company's flagship product Suciraslimab (SM03) is in the final review stage of the National Medical Products Administration, including the completion of two necessary clinical site inspections required by the National Medical Products Administration and the GMP inspection of the Haikou production base in January of this year. As the world's first anti-CD22 monoclonal antibody for the treatment of RA independently developed by the company."

China filing • Rheumatoid Arthritis

The BLA submission of a blockbuster new drug product was accepted, and China Antibody-B (03681) competes for the golden track of autoimmune diseases with its unique innovation capabilities [Google translation] (Investing.com) - "...China Antibody-B announced that the China National Medical Products Administration has accepted the Biological Products License Application (BLA) for the company’s flagship product SM03 (Suciraslimab) for the treatment of rheumatoid arthritis (RA), with the acceptance number CXSS2300072."

Non-US regulatory • Immunology • Rheumatoid Arthritis

China Accepts SinoMab's Biologics License Application for Arthritis Treatment (Market Screener) - "China's medical products administrator accepted SinoMab BioScience's...biologics license application for its SM03 treatment for rheumatoid arthritis, according to a Tuesday filing."

Non-US regulatory • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

SinoMab Announces that Phase III Clinical Trial of its Flagship Product SM03 (Suciraslimab) Achieved the Primary Endpoint for Rheumatoid Arthritis (AsiaOne) - P3 | N=510 | NCT04312815 | Sponsor: SinoMab BioScience Ltd | "The Phase III study results showed that Suciraslimab was effective in suppressing disease activity and alleviating symptoms of active RA patients receiving MTX therapy. Relevant study result shall be published in academic journals and academic conferences....The Group will accelerate the commercialization of Suciraslimab and strive to submit the Biologics License Application (BLA) to the National Medical Products Administration (NMPA) in the third quarter of 2023 at its earliest, so as to achieve commercialization subsequently and consolidate the first-mover advantage in the first-in-target and first-in-class of new medicine."

Non-US regulatory • P3 data • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

SM03, an Anti-CD22 Antibody, Converts Cis-to-Trans Ligand Binding of CD22 against α2,6-Linked Sialic Acid Glycans and Immunomodulates Systemic Autoimmune Diseases. (PubMed, J Immunol) - P3 | "This in turn increased the activity of the downstream immunomodulatory molecule Src homology region 2 domain-containing phosphatase 1 (SHP-1) and decreased BCR-induced NF-κB activation in human B cells and B cell proliferation. This mechanism of action gives rationale to support the significant amelioration of disease and good safety profile in clinical trials, as by enabling the "self" recognition mechanism of CD22 via trans binding to α2,6 sialic acid ligands on autologous cells, SM03 specifically restores immune tolerance of B cells to host tissues without affecting the normal B cell immune response to pathogens."

Journal • Immune Modulation • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II randomized, double-blind, placebo-controlled study. (PubMed, Rheumatology (Oxford)) - P2 | "In active RA Chinese patients receiving background methotrexate, SM03 at a cumulative dose of both 2400 mg and 3600 mg is efficacious and well-tolerated throughout the 24 weeks of treatment. Moreover, SM03 has demonstrated a good safety profile."

Clinical • Journal • P2 data • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • CD22

A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=8; Completed; Sponsor: SinoMab Pty Ltd

Clinical • New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX (clinicaltrials.gov) - P3; N=510; Recruiting; Sponsor: SinoMab Pty Ltd; Trial completion date: Dec 2020 ➔ Jul 2022; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] EFFICACY AND SAFETY OF SM03, A RECOMBINANT ANTI-HUMAN CD22 MONOCLONAL ANTIBODY IN CHINESE PATIENTS WITH RHEUMATOID ARTHRITIS: A PHASE II RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO-CONTROLLED STUDY (EULAR 2020) - "In Chinese patients with active RA, both 2400mg and 3600mg cumulative doseof SM03,in combination with MTX were efficacious and well tolerated. throughout the 24 weeks of treatment.Moreover, SM03 has demonstrated a good safety profile, especially in terms of treatment-related infection, malignancy and immunogenicity."

Clinical • P2 data • Immunology • Oncology • Rheumatoid Arthritis • Rheumatology

Newly added product (clinicaltrials.gov) - P3, Rheumatoid arthritis

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