HSK39297 / Haisco - LARVOL DELTA

Hiasco: Innovative drug HSK39297 tablets included in breakthrough therapy program [Google translation] (Sina Corp)

Breakthrough therapy • IgA Nephropathy

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1 trial • Complement-mediated Rare Disorders • Hematological Disorders • Hepatology • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Announcement from Hiseco Pharmaceuticals Group Co., Ltd. on the Acceptance Notice of the IND Application for the New Indication of the Innovative Drug HSK39297 Tablets [Google translation] (Sina Corp)

New trial • Age-related Macular Degeneration

Efficacy and Safety of HSK392975 in Anti-C5 Treated PNH Patients With Anemia (clinicaltrials.gov) - P3 | N=32 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Anemia • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of HSK39297 in Chinese Healthy Subjects: A Phase 1 Clinical Trial. (PubMed, Clin Transl Sci) - "PD analysis indicated that oral administration of HSK39297 tablets resulted in dose-dependent inhibition of the AP activity and Bb concentration. These findings support advancing HSK39297 into later-phase trials for complement-mediated glomerular diseases."

Clinical • Journal • P1 data • PK/PD data • Renal Disease • CFB

HSK39297-201: A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH） (clinicaltrials.gov) - P2 | N=47 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Trial completion • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Haisco plans to raise no more than 1.365 billion yuan through a private placement to invest in new drug research and development projects and replenish cash flow [Google translation] (STCN) - "On the evening of February 27, Haisco (002653) announced its plan to issue A-shares to specific objects in 2025. The company plans to issue no more than 70 million shares to specific objects, and the total amount of funds raised will not exceed 1.365 billion yuan....According to the plan, the research and development of innovative drugs raised by Haisco this time include HSK31679 (non-alcoholic fatty hepatitis), HSK31858 (respiratory diseases), propofol (general anesthesia), HSK39297 (paroxysmal nocturnal hemoglobinuria, primary IgA nephropathy), HSK21542 (postoperative pain, postoperative nausea and vomiting) and HL231 (respiratory diseases) and other drugs for subsequent domestic and overseas clinical research and market registration."

Financing • Anesthesia • Metabolic Dysfunction-Associated Steatohepatitis • Paroxysmal Nocturnal Hemoglobinuria • Respiratory Diseases

Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

HSK39297-101: A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects (clinicaltrials.gov) - P1 | N=96 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Trial completion

Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) - P2 | N=47 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

A randomized, double-blind, placebo parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HSK39297 tablets in the treatment of primary IgA nephropathy (ChiCTR) - P2 | N=80 | Not yet recruiting | Sponsor: Peking University First Hospital; Peking University First Hospital

New P2 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH） (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases