SSGJ-610 / 3SBio - LARVOL DELTA

A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma (clinicaltrials.gov) - P2 | N=225 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Trial completion date: Apr 2027 ➔ Sep 2027 | Trial primary completion date: Sep 2026 ➔ Feb 2027 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety Study of 610 in Patients With Severe Asthma (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2026 ➔ Sep 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2027

Enrollment open • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Clinical trial of new asthma drug: recombinant anti-IL-5 humanized monoclonal antibody SSGJ-610 injection [Google translation] (Sohu.com) - "This is also the first IL-5 target biological agent approved in China for the treatment of severe asthma with increased EOS...Study drug: SSGJ-610 (Phase IIb); Trial type: Controlled trial (vs placebo); Registration number: CTR20244205....Dosage form of 610: injection; Specification: 1mL/bottle; Usage and dosage: subcutaneous injection; Experimental drug group A/group B; Medication schedule: 36W (weeks)."

Trial status • Asthma • Immunology

A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma (clinicaltrials.gov) - P2 | N=225 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety Study of 610 in Patients With Severe Asthma (clinicaltrials.gov) - P3 | N=480 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase II Study of 610 in Participants With Severe Eosinophilic Asthma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

3SBio announces 2020 annual results, tapping integrated platform advantages for steady growth (PRNewswire) - "In 2020, the Company obtained three new IND approvals....610, an anti-IL5 antibody, obtained the IND approval from the NMPA for the treatment of severe eosinophilic asthma....For 610, the dose-escalating phase I clinical trial in healthy volunteers was completed."

Trial completion • Asthma • Respiratory Diseases