Yisaituo (amdokitug) / 3SBio - LARVOL DELTA

A Multicenter, Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of SSGJ-608 in patients with moderate-to-severe plaque psoriasis (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

A Pivotal Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 3 Clinical Trial of SSGJ-608 in moderate-to-severe psoriasis. (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Efficacy and Safety of SSGJ-608 in Moderate-to-Severe Plaque Psoriasis: A Pivotal Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial. (PubMed, Am J Clin Dermatol) - P3 | "SSGJ-608 showed rapid and robust clinical response at week 12 and through week 52, and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis."

Journal • P3 data • Dermatology • Immunology • Psoriasis • IL17A

SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study. (PubMed, Front Immunol) - P3 | "SSGJ-608 is an anti-interleukin-17A monoclonal antibody with high specificity and high affinity and has shown promising efficacy in treatment of moderate-to-severe psoriasis in preliminary trials...SSGJ-608 was highly effective for treating patients with moderate-to-severe plaque psoriasis at 80mg Q2W and 160mg Q4W in a larger population, especially in patients previously treated with anti-IL-17 therapy, and exhibited a favorable tolerability profile in Chinese patients with moderate-to-severe plaque psoriasis. https://clinicaltrials.gov/, identifier NCT06299982."

Clinical • Journal • P3 data • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Infectious Disease • Metabolic Disorders • Psoriasis • Respiratory Diseases • IL17A

A Multicenter, Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of SSGJ-608 in patients with moderate-to-severe plaque psoriasis (EADV-Sp 2026) - "Introduction SSGJ-608 is an anti-interleukin-17A monoclonal antibody with high specificity and high affinity...This study featured a large sample size and sufficient exposure, further validating both the efficacy and safety profile of SSGJ-608. These findings suggest that SSGJ- 608 has the potential to ensure long-term therapeutic success and improve patient quality of life, while also presenting a lower risk of certain significant complications."

Clinical • P3 data • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Infectious Disease • Metabolic Disorders • Plaque Psoriasis • Psoriasis • Respiratory Diseases • IL17A

Efficacy and Safety of SSGJ-608 in Moderate-to-Severe Plaque Psoriasis: a Pivotal Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 3 Clinical Trial (EADV-Sp 2026) - "The safety profile was consistent with other drugs sharing the same target, with no new safety signals identified. These findings support SSGJ-608 as a promising new treatment option for this patient population."

Clinical • P3 data • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Infectious Disease • Plaque Psoriasis • Psoriasis • Respiratory Diseases • IL17A

Its core product TPIAO secured approval for a new indication; three novel drugs were successively approved for marketing... (The Manila Times) - "Amdokitug Injection (Yisaituo): Approved in February 2026 for the treatment of moderate-to-severe plaque psoriasis...Loncipoetin Alfa Injection (NuPIAO): Approved in March 2026 as the first domestic long-acting recombinant erythropoietin (EPO) biweekly formulation (a Class 1 innovative drug), indicated for hemodialysis patients with anemia caused by chronic kidney disease who are receiving erythropoietin therapy....Eltrombopag Ethanolamine Tablets: Approved in March 2026 for the treatment of immune thrombocytopenia (ITP) and severe aplastic anemia (SAA)."

China approval • Anemia • Aplastic Anemia • Immune Thrombocytopenic Purpura • Plaque Psoriasis

A Study to Evaluate the Efficacy and Safty of 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA) (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

Phase III Study of 608 in the Treatment of Active Ankylosing Spondylitis in Adults (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study to Evaluate 608 in Patients with Non- Radiographic Axial Spondyloarthritis (nr-axSpA) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants with Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=458 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS) (clinicaltrials.gov) - P2 | N=250 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Dermatology • Immunology • Psoriasis

A Study to Evaluate 608 in Patients With Ankylosing Spondylitis (AS) (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P2 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA) (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P2 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2024 ➔ Jul 2023

Enrollment open • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=139 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=139 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis

A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Trial primary completion date: Sep 2023 ➔ Jun 2024

Trial primary completion date • Dermatology • Immunology • Psoriasis

A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Dermatology • Immunology • Psoriasis