XinJiuNing®: The First Gene Therapy for Hemophilia B in China
A single-dose breakthrough redefining life for adult patients
What is XinJiuNing®?
Approved by NMPA on April 10, 2025
Treats moderate to severe Hemophilia B in adults aged 18–35
Based on AAV843 – a proprietary, AI-engineered viral vector
About Hemophilia B
Hemophilia B is an inherited bleeding disorder caused by a deficiency of coagulation factor IX (FIX) . For a long time, patients have relied mainly on frequent lifelong intravenous injections of prothrombin complex (PCC) or coagulation factor IX for replacement therapy. Continuous and frequent bleeding in patients can easily lead to severe damage to joint structure and function, and the disability rate remains high. This not only brings great physical pain and inconvenience to patients, but also carries the risk of infection, thrombosis, etc. The high cost of treatment also places a heavy financial burden on patients’ families for a long time.
First Case in the World1--No Bleeding!
A patient who went through Unilateral total knee arthroplasty (TKA) 2 after using XinJiuNing®, ended up with a clean surgical wound with no obvious bleeding and swelling, without using any exogenous factor IX infusions during the perioperative period — It’s the first case in the world！
Note：
1. The case is published by Xue F on et al., N Engl J Med. , in Oct 27, 2022.
2. A surgical procedure in which only one knee joint—either the left or the right—is completely replaced with a prosthetic implant
What Makes XinJiuNing® Revolutionary?
One-Time Treatment
- Delivers gene therapy directly to hepatocytes via intravenous injection
- FIX activity reached 49.7 IU/dL within 3 days, maintained at 55.08 IU/dL by Week 52
- Turns liver into a “mini pharmaceutical factory” producing FIX sustainably
Global-Grade Therapy at 1/10 the Cost
- Costs less than 10% of similar FDA-approved gene therapies (e.g., US$3.5M list price).
- Manufactured entirely in China with full commercial capacity (100,000 doses/year).
Proven Safety & Efficacy
- 80.8% of trial patients had zero bleeding episodes post-treatment.
- No serious adverse events, no FIX inhibitors, no thrombosis reported.
Conventional AVV Vector's Limitations
- Transduction of non-target cells
- Low in gene delivery efficiency
- Neutralizing antibodies against conventional AAV
- Serotypes restricts the treatable population and prevents re-administration of the vector
Who Is Eligible?
XinJiuNing® is currently indicated for:
- Adults aged 18 to 35
- Diagnosed with moderate or severe Hemophilia B
- Without inhibitors to FIX
FAQs– Frequently Asked Questions
Q: Is XinJiuNing® a permanent cure for Hemophilia B?
A: It is not a one-time cure, but a long-acting gene therapy that may drastically reduce or eliminate the need for regular FIX infusions.
Q: Is it FDA approved internationally?
A: XinJiuNing® is approved by China's National Medical Products Administration (NMPA) and aligns with international clinical standards. Global expansion plans are underway.
Q: What’s the vector technology behind it?
A: The product uses a proprietary AAV843 capsid, developed through AI-based CapsidX™ platform for high tropism, low immunogenicity delivery.
Clinical Trial Highlights
- Participants: 26 adult patients with moderate to severe Hemophilia B
- Dose: Single IV dose of 5×10¹² vg/kg
- Follow-up duration: 52 weeks
Contact Us
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One Shot.
Life-time Relief.
Revolutionary Hemophilia B
Gene Therapy Now Approved in China
XinJiuNing®:
The First Gene Therapy for Hemophilia B in China
What is XinJiuNing®?
Based on AAV843 – a proprietary,
AI-engineered viral vector
About Hemophilia B
What Makes XinJiuNing® Revolutionary?
One-Time Treatment
- Delivers gene therapy directly to hepatocytes via intravenous injection
FIX activity reached 49.7 IU/dL within 3 days,
maintained at 55.08 IU/dL by Week 52
Turns liver into a “mini pharmaceutical factory”
producing FIX sustainably
Global-Grade Therapy at 1/10 the Cost
- Costs less than 10% of similar FDA-approved gene therapies (e.g., US$3.5M list price)
Manufactured entirely in China with full commercial
capacity (100,000 doses/year)
Proven Safety & Efficacy
- 80.8% of trial patients had zero bleeding episodes post-treatment
No serious adverse events, no FIX inhibitors,
no thrombosis reported
Who Is Eligible?
- Adults aged 18 to 35
- Diagnosed with moderate or severe Hemophilia B
- Without inhibitors to FIX
Frequently Asked Questions
Q: Is it FDA approved internationally?
A:XinJiuNing® is approved by China’s National Medical Products Administration (NMPA) and aligns with international clinical standards. Global expansion plans are underway
Q: Is XinJiuNing® a permanent cure for Hemophilia B?
A: It is a long-acting gene therapy. After one injection, the expected effect (drastically reduce or eliminate the need for regular FIX infusions)will be achieved in about 52 weeks. It effectively avoids the inconve-nience and pain of regular and repeated injections.
Q: What’s the vector technology behind it?
A: The product uses a proprietary AAV843 capsid, developed through AI-based CapsidX™ platform for high tropism, low immunogenicity delivery.
Clinical Trial Highlights
Phase III Study (BBM-H901, 2024)
Participants: 26 adult patients with moderate to severe Hemophilia B
Dose: Single IV dose of 5×10¹² vg/kg
Follow-up duration: 52 weeks
[ Source: NMPA Clinical Report, 2025 | Published in The Lancet Haematology ]
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