An interventional study of XH-S003 Capsule in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (part of Fosun Pharma) · Not applicable, Interventional, and Treatment
Among 51 studies in Hemoglobinuria, Paroxysmal with a site in China — 21 open to participants now, 29 under way, 11 of them phase 3. Hemoglobinuria, Paroxysmal · China.
Among the 51 studies in Hemoglobinuria, Paroxysmal with a site in China, this one is the 32nd largest by planned enrollment of the 47 interventional ones, is one of 12 that started in 2025, is the only one with no phase, reaches primary completion later than 27 of the 28 other live ones, and was the 46th registered.
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
This study's planned enrollment of 26 is below the median of 33 across 150 interventional studies indexed under Hemoglobinuria, Paroxysmal.
Browse Hemoglobinuria, Paroxysmal studies →21 of the 51 studies in Hemoglobinuria, Paroxysmal with a site in China are open now, in 1 country. Each count lists the studies.
Of the 30 Hemoglobinuria, Paroxysmal studies recruiting now, 14 (47%) set no upper age limit and 12 (40%) stop at 75 or younger; 12 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →51 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 12 started in 2025.
Median enrollment 40 across the 47 interventional studies, 402 across the 4 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
47 of 51 have an industry lead sponsor. The 10 most frequent:
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. is the lead sponsor of 34 studies on the registry; 21 are open to participants now.
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. has 3 studies filed under Hemoglobinuria, Paroxysmal — fewer than ten, so there is no comparison to draw.
11 of the studies in Hemoglobinuria, Paroxysmal with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07177859Phase 3Nanjing Chia-tai Tianqing PharmaceuticalA Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients | 2026-11 |
| NCT06933914Phase 3Wuhan Createrna Science and Technology Co., LtdLong-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria | 2026-12-30 |
| NCT07816237Phase 3Bisirna Therapeutics (Suzhou) Co., Ltd.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 | 2027-09-30 |
| NCT04747613Phase 3Novartis PharmaceuticalsLong-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria | 2027-10-18 |
| NCT07462780Shenzhen Kangzhe Biotechnology Co., Ltd.A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants | 2026-11 |
Among the 51 studies in Hemoglobinuria, Paroxysmal with a site in China, from their registry updates:
This is a multicenter, open-label study to evaluate the long-term safety and efficacy of XH-S003 capsules in PNH patients. About 26 PNH patients who had received and completed XH-S003 study treatment will be enrolled to take XH-S003 capsules orally according to protocol. Eligible subjects can maintain XH-S003 treatment until the end of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
XH-S003 capsule orally taken according to protocol until the end of treatment
Drug: XH-S003 Capsule
Optimized dose
Incidence and severity of adverse events
Time frame: through study completion，an average of 1 year
Proportion of subjects with Hb ≥120g/L compared with baseline (without RBC transfusion)
Time frame: through study completion，an average of 1 year
Change From Baseline in Hemoglobin in the absence of red blood cell transfusions
Time frame: through study completion，an average of 1 year
Proportion of participants who remain free from transfusions
Time frame: through study completion，an average of 1 year
Proportion of participants with breakthrough hemolysis (BTH)
Time frame: through study completion，an average of 1 year
Proportion of participants with Major Adverse Vascular Events (MAVEs)
Time frame: through study completion，an average of 1 year
Started Aug 2025 (actual). Primary completion is estimated for Sep 2029, 49 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. →