Stock code: 002653.SZ
Simeining® (Crisugabalin Besilate Capsules)
The world's first third-generation calcium Calcium channel modulator requiring no dose titration, a Class 1 new drug covered by the National Reimbursement Drug List, with an innovative fused-tricyclic caged structure that selectively targets the α2δ-1 subunit, offering both efficacy and safety.
Launched in May 2024, it has been approved for two major indications: diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN) in adults.
The first Class 1 new drug approved in mainland China for the DPNP indication, filling a gap in the field.
The first positive Phase III registration study in China for central neuropathic pain (cNP).
- NP (Neuropathic Pain) has been included in the CDE's priority review.
[1] Gou X, et al. J Pharmacol Exp Ther. 2021;376(3):330-337.
[2] Guo X, et al. JAMA Netw Open. 2024;7(8):e2425614.
[3] Zhang D, et al. JAMA Dermatol. 2024;160(11):1182–1191.
[4] Pan T, et al. Pain Ther. 2025;14(4):1311-1329.
[5] Package Insert of Crisugabalin Besilate Capsules.
[6] Guo X, et al. J Diabetes Res. 2026;2026(1):e296073.
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No Dose Titration
Rapid Onset of Action
Good Tolerability
13 high-quality academic papers, with core findings published in top international journals such as JAMA Network Open (IF = 10.5) and JAMA Dermatology (IF = 11.5);
11 major presentations at global top conferences, including ADA (American Diabetes Association) and AAN (American Academy of Neurology).
Recommended by 13 authoritative guidelines and expert consensuses, such as Chinese Guideline for the Diagnosis and Treatment of Neuropathic Pain (2024 Edition), Chinese Guideline for Diabetes Prevention and Treatment (2024 Edition), and Guideline for the Whole-course Management of Zoster-Associated Pain (2025 Edition).
Which generation of drug does Simeining® (Crisugabalin Besilate) belong to?
It is the world's first third-generation calcium channel modulator requiring no dose titration.
What is convenient about the dosing of Simeining® (Crisugabalin Besilate)?
No dose titration is required; treatment can be initiated directly at the effective dose.
What are the molecular structural features of Simeining® (Crisugabalin Besilate)?
It features an innovative fused-tricyclic caged structure that enhances molecular rigidity.
How does Simeining® (Crisugabalin Besilate) perform in target binding?
It demonstrates high target selectivity and binding affinity, with a wider safety window.
When was Simeining® (Crisugabalin Besilate) launched?
It was approved for marketing in May 2024.
What are the primary indications of Simeining® (Crisugabalin Besilate)?
It is primarily indicated for treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN) in adults.
What is the pioneering significance of Simeining® (Crisugabalin Besilate) in the DPNP field?
It is the first Class 1 new drug approved in mainland China for the DPNP indication, filling a treatment gap.
What breakthrough has Simeining® (Crisugabalin Besilate) achieved in central neuropathic pain (cNP) study?
Its Phase III study is the first registration study in China to achieve positive outcomes for cNP.
How long does Simeining® (Crisugabalin Besilate) take to show onset of action?
It has a rapid onset, with significant pain relief and sleep improvement observed as early as Day 2.
Are the adverse reactions of Simeining® (Crisugabalin Besilate) significant?
It is well tolerated, with low incidences of dizziness, somnolence, and peripheral edema, mostly mild to moderate and requiring no intervention.
How effective is Simeining® (Crisugabalin Besilate) with long-term use?
It provides sustained efficacy, with long-term administration effectively controlling pain.
As of May 2026, how many academic papers on Simeining® (Crisugabalin Besilate) have been published?
Thirteen high-quality academic papers have been published.
Which top international journals have published studies on Simeining® (Crisugabalin Besilate)?
Core findings have been published in journals such as JAMA Network Open and JAMA Dermatology, etc.
At which academic conferences have study data on Simeining® (Crisugabalin Besilate) been presented?
They have been presented at authoritative academic conferences such as American Diabetes Association (ADA) and American Academy of Neurology (AAN).
As of May 2026, how many authoritative guidelines have included Simeining® (Crisugabalin Besilate)?
It has been formally included in 13 authoritative guidelines and expert consensus statements.
Which core neuropathic pain diagnosis and treatment guidelines and consensus statements include Simeining® (Crisugabalin Besilate)?
They include 13 national core guidelines and authoritative consensus statements, such as Chinese Guideline for the Diagnosis and Treatment of Neuropathic Pain (2024 Edition), Chinese Guidelines for the Assessment and Management of Neuropathic Pain (2024 Edition), Guidelines for Medication in Older Adults with Peripheral Neuropathic Pain (2025 Edition), and Guideline for the Whole-course Management of Zoster-Associated Pain (2025 Edition), etc.
Which core neuropathic pain diagnosis and treatment guidelines and consensus statements include Simeining® (Crisugabalin Besilate)?
They include 13 national core guidelines and authoritative consensus statements, such as Chinese Guideline for the Diagnosis and Treatment of Neuropathic Pain (2024 Edition), Chinese Guidelines for the Assessment and Management of Neuropathic Pain (2024 Edition), Guidelines for Medication in Older Adults with Peripheral Neuropathic Pain (2025 Edition), and Guideline for the Whole-course Management of Zoster-Associated Pain (2025 Edition), etc.
Has Simeining® (Crisugabalin Besilate) been included in diabetes mellitus-related guidelines and consensus statements?
Yes, it has been formally included in 6 diabetes-related guidelines and authoritative consensus statements, including Chinese Guideline for Diabetes Prevention and Treatment (2024 Edition), National Guideline for the Diagnosis and Treatment of Diabetic Neuropathy in Primary Care (2024 Edition), and Chinese Clinical Guideline for the Prevention and Treatment of Type 2 Diabetes in the Elderly (2026 Edition), etc.
When was Simeining® (Crisugabalin Besilate) included in the National Reimbursement Drug List?
It underwent its first medical insurance negotiation in 2024 and was successfully included in the National Reimbursement Drug List in 2025.
Which Simeining® studies have been published in top international journals (IF > 10)?
They include: the DPNP 201/301 study published in a JAMA sub-journal, the PHN 302 study published in a JAMA sub-journal, and the orthopedic perioperative multimodal analgesia 304 study published in the International Journal of Surgery.
Is Simeining® a first-line therapy for neuropathic pain (NP)?
Yes, it has been recommended as a first-line therapy by authoritative guidelines, with Grade 1A recommendations for the treatment of PHN and DPNP. |
