新宝GG

Stock code: 002653.SZ
Youkepan? (Ciprocopan Succinate Tablets)
Drug Introduction

Haisco's independently developed Class 1 innovative drug, Ciprocopan Succinate Tablets—a next-generation complement Factor B inhibitor—was granted early marketing approval on July 21, 2026 through priority review and approval for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who are complement inhibitor-na?ve.

References

1. Red Blood Cell Disease (Anemia) Group, Hematology Branch, Chinese Medical Association. Chinese guidelines for the diagnosis and treatment of paroxysmal nocturnal hemoglobinuria (2024 edition) [J]. Chinese Journal of Hematology, 2024, 45(08): 727-737. 

2. Hematology Branch of Zhejiang Medical Association, Zhejiang PNH Working Group. Zhejiang expert consensus on complement inhibitor therapy for paroxysmal nocturnal hemoglobinuria (2025 edition) [J]. Zhejiang Medical Journal, 2025, 47(6): 561-565, 570.

3. https://www.onkopedia-guidelines.info/en/onkopedia/guidelines/paroxysmal-nocturnal-hemoglobinuria-pnh/@guideline/html/index.html

4. Internal Data


Download prescribing information

首页- 新宝GG集团创造事业平台
Youkepan? (Ciprocopan Succinate Tablets)
首页- 新宝GG集团创造事业平台
Comprehensive Efficacy Upgrade

Comprehensive Efficacy Upgrade

Effectively achieves comprehensive hemolysis control and anemia reversal; hemolysis controlled in 91.9% of patients, Hb levels significantly elevated, 94.6% of patients avoided transfusion[1]
Better safety profile

Better safety profile

Compared with C5 complement inhibitors, serious adverse events reduced by 67%, lower incidence of treatment-emergent adverse events[1]
Once-Daily Oral Administration

Once-Daily Oral Administration

World's first once-daily oral CFBi, optimized dosing regimen, improved medication adherence[1]
Reduced Risk of Breakthrough Hemolysis

Reduced Risk of Breakthrough Hemolysis

Reduces risk of missed-dose-induced breakthrough hemolysis (BTH), achieving long-term stable disease control[1]
Frequently Asked Questions
FAQs
Youkepan? (Ciprocopan Succinate Tablets)
Q

When was Ciprocopan approved?

A

It was approved on July 21, 2026.


Q

Is Ciprocopan an innovative drug?

A

It is a national Class 1 innovative drug.


Q

What is the indication of Ciprocopan?

A

It is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who are complement inhibitor-na?ve.


Q

What is the pharmacological action of Ciprocopan?

A

It is a selective small-molecule inhibitor of complement Factor B (FB).


Q

Which complement activation pathway does complement Factor B primarily participate in?

A

It is the alternative pathway.


Q

Which type of PNH is Ciprocopan indicated for?

A

It is indicated for classic PNH.


Q

What are the main mechanistic advantages of targeting complement Factor B?

A

It simultaneously controls intravascular hemolysis and extravascular hemolysis.


Q

What is the recommended dose of Ciprocopan?

A

It is 200 mg once daily.


Q

How should Ciprocopan be taken?

A

It may be taken with or without food.


Q

In the Phase III 301 study, what was the target achievement rate of Ciprocopan compared with the control group?

A

59.5%.


Q

What is the metabolic pathway of Ciprocopan?

A

Fecal excretion is the primary route of elimination (72.2±4.27%), and renal excretion via urine is the secondary route (21.7±2.61%).


Q

What modifications were made to the original drug iptacopan to obtain Ciprocopan?

A

They include three-membered ring modification and deuteration.


Q

What improvements does Ciprocopan have compared with iptacopan?

A

Permeability is enhanced with consequent improvement in oral bioavailability.


Q

In the Phase III 302 study, what was the target achievement rate of Ciprocopan compared with the control group?

A

52.8%.


Q

What are the advantages of Ciprocopan compared with currently marketed competing drugs?

A

Oral, once daily; no dose adjustment required for patients with mild, moderate, or severe hepatic insufficiency; no reproductive toxicity.

【网站地图】