A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.

Start Date29 Oct 2026

Sponsor / Collaborator

Beizhen Biotechnology (Suzhou) Co., Ltd.

NCT06848296

/ Active, not recruitingPhase 1

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VSA012 Injection in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Are Complement Inhibitor Naïve or Have Not Received Complement Inhibitor Recently and Have Persistent Anemia Despite Previous Stable Use of C5 Complement Inhibitor

The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases including PNH. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system.The purpose of VSA012-1002 is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics and efficacy of VSA012 Injection in subjects with PNH.

Start Date15 Apr 2025

Sponsor / Collaborator

Bisirna Therapeutics Pte Ltd.

NCT06766929

/ Active, not recruitingPhase 1

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VSA012 After Single Ascending Doses in Healthy Volunteers

The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system (e.g. PNH) .The purpose of VSA012-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VSA012 Injection in adult healthy volunteers (HVs). HVs will receive a single dose of VSA012 or placebo.

Start Date20 Jan 2025

Sponsor / Collaborator

Beizhen Biotechnology (Suzhou) Co., Ltd.

100 Clinical Results associated with VSA-012

100 Translational Medicine associated with VSA-012

100 Patents (Medical) associated with VSA-012

100 Deals associated with VSA-012

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hemoglobinuria, Paroxysmal	Phase 3	China	Wei Ya Zhen Sheng Wu Ji Shu （ Su Zhou ） You Xian Gong Si	07 Sep 2026
C3 glomerulopathy	Phase 2	China	Wei Ya Zhen Sheng Wu Ji Shu （ Su Zhou ） You Xian Gong Si	07 Jan 2026
Glomerulonephritis, IGA	Phase 2	China	Wei Ya Zhen Sheng Wu Ji Shu （ Su Zhou ） You Xian Gong Si	07 Jan 2026
Glomerulonephritis, Membranoproliferative	Phase 2	China	Wei Ya Zhen Sheng Wu Ji Shu （ Su Zhou ） You Xian Gong Si	07 Jan 2026
Lupus Nephritis	Phase 2	China	Wei Ya Zhen Sheng Wu Ji Shu （ Su Zhou ） You Xian Gong Si	07 Jan 2026
Nephrosis	IND Approval	China	Wei Ya Zhen Sheng Wu Ji Shu （ Su Zhou ） You Xian Gong Si	27 Nov 2025

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06848296 (ASH2025)	Phase 1	Hemoglobinuria, Paroxysmal	18	VSA012 60 mg	xtmeyjjsnv(dpmzcyovku) = decreased to 30.2% and 83.9% from baseline at D14 and D42. mmnmqxkbva (ntinfrcmwn ) View more	Positive	06 Dec 2025

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