roconkibart (JS005) / Shanghai Junshi Biosci - LARVOL DELTA

Shanghai Junshi Biosciences…announced that the new drug application ('NDA') for the company’s product, roconkibart injection (a recombinant humanized anti-IL-17A monoclonal antibody injection, product code: JS005), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy has been accepted by the…NMPA (GlobeNewswire) - "The NDA is mainly based on the multi-center, randomized, double-blind, parallel and placebo-controlled pivotal registrational phase 3 clinical study (study number: JS005-005-III-PsO)."

China filing • Psoriasis

Junshi Biosciences Announces the Phase 3 Study of JS005 (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis Met Primary Endpoints (GlobeNewswire) - "Junshi Biosciences plans to submit the new drug application of this product to the regulatory authorities in the near future....The study results showed that, compared to the placebo, JS005 significantly improved the area and severity of psoriasis lesion in participants, and the proportion of participants achieving a sPGA score of 0 or 1 was also significantly higher, and JS005 demonstrated good safety in participants with moderate to severe plaque psoriasis. The relevant study results will be announced at future international academic conferences."

Filing • P3 data • Psoriasis

Safety, Pharmacokinetics, and Efficiency of JS005, a Novel Anti-interleukin-17A Monoclonal Antibody, in Healthy Chinese Adults and Patients with Moderate to Severe Psoriasis. (PubMed, Acta Derm Venereol) - "In phase II of Study 2, the proportion of patients with at least a 75% improvement in the Psoriasis Area and Severity Index at week 12 was significantly higher in each JS005 group than in the placebo group (p < 0.001 for all comparisons). JS005 was highly effective in PsO patients."

Clinical • Journal • PK/PD data • Dermatology • Immunology • Psoriasis • IL17A

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Bioequivalence Study of JS005 Pre-filled Syringe and JS005 Auto-injector (clinicaltrials.gov) - P1 | N=272 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P1 trial

A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=747 | Active, not recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2024 ➔ Aug 2025

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

A Clinical Study of JS005 in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - P2 | N=261 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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

A Phase Ib/II Randomized, Double-blind, Placebo-controlled Study of Novel anti-IL-17A Monoclonal Antibody JS005 in Patients with Moderate to Severe Psoriasis (ACR Convergence 2023) - P1/2 | "This phase Ib/II study demonstrated that JS005 was highly effective and well tolerated in moderate to severe plaque psoriasis. Figure 1 Proportion of patients achieving PASI 75 over 24 weeks in Phase Ib trial (full analysis set) Figure 2 Proportion of patients achieving PASI 75 over 20 weeks in Phase II trial (full analysis set)"

Clinical • P1/2 data • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Psoriasis • IL17A

A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=702 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous JS005 Injection in the Treatment of Adults With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=702 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P3 trial • Dermatology • Immunology • Psoriasis

Safety, Tolerance, Efficacy and Pharmacokinetics of JS005 Multiple Dosing (clinicaltrials.gov) - P1/2 | N=183 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Nov 2022 | Trial primary completion date: Apr 2023 ➔ Oct 2022

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis • IL17A

Deep learning for predicting major pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer: A multicentre study. (PubMed, EBioMedicine) - "The proposed deep learning model could effectively predict MPR in NSCLC patients treated with neoadjuvant chemoimmunotherapy."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety, Tolerance, Efficacy and Pharmacokinetics of JS005 Multiple Dosing (clinicaltrials.gov) - P1/2 | N=166 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P1/2 trial • Dermatology • Immunology • Psoriasis • IL17A

Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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

Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active AS (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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

Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Clinical • New P1 trial