EN

Stock code: 002653.SZ

Home

News

Innovation

Pipeline R&D Platforms

Products

Product List Product Topics Pharmacovigilance

Investors

Stock Information Company Announcements Market Data Q&A Investor Hotline

Join Us

Talent Philosophy Careers

About Haisco

About Us Business Presence

Contact Us

GLOBAL

English China

SIMEINING® (Crisabalin Besilate Capsules)

Crisugabalin Besilate Capsules

SIMEINING® (Crisabalin Besilate Capsules)

Drug Introduction

The world's first third-generation calcium channel modulator requiring no dose titration, a Class 1 new drug with an innovative fused-tricyclic caged structure, 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 post herpetic 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.

References

[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] Benzosulfenic Chlorogabalin Capsule Instructions for Use.

[6] Guo X, et al. J Diabetes Res. 2026;2026(1):e296073.

Download prescribing information

SIMEINING® (Crisabalin Besilate Capsules)

No titration required

No Dose Titration: Initiate treatment directly at the target dose for easy administration

Rapid onset

Rapid Onset: Significant pain relief and sleep improvement observed as early as Day 2 ^[4]

Good tolerance

Good Tolerability: Low incidence of dizziness, vertigo, and somnolence, mostly mild to moderate, requiring no intervention^[5]

Long-term administration for effective pain control^[6]

Solid R&D, Robust Evidence

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).

Successfully included in the National Reimbursement Drug List in 2025; as of May 2026, it has been used in 2951medical institutions, cumulatively benefiting overspan 1million patients.

Solid R&D, Robust Evidence

Solid R&D, Robust Evidence

Frequently Asked Questions

Common Questions and Answers

Simecin® (Clopidogrel Sulfonic Acid Capsules) Common Questions and Answers

Q

Simegin® (Clopidogrel Besylate) belongs to which generation of drugs?

A

It is the world’s first third-generation calcium ion channel regulator that does not require precipitation.

Q

What advantages does the convenient dosage of Simegin® (Clopidogrel Besylate) have?

A

No titration is required; treatment can be started with an effective dose directly.

Q

What are the molecular structure features of Simegin® (Clopidogrel Besylate)?

A

A innovative three-ring cage structure is adopted, enhancing molecular rigidity.

Q

How does Simegin® (Clopidogrel Besylate) interact with its target?

A

High target selectivity and binding strength, with a larger safety window

Q

When was the launch date of Simegin® (Clopidogrel Besylate)?

A

Approved for market launch in May 2024.

Q

What are the main indications for Simegin® (Clopidogrel Besylate)?

A

Used for diabetic peripheral neuropathy pain in adult diabetes (DPNP) and post-herpes zoster neuralgia (PHN).

Q

What is the significance of Simegin® (Clopidogrel Besylate) as a first-in-class treatment for DPNP?

A

It is the first new class of drug with a DPNP indication approved in mainland China, filling a treatment gap.

Q

What breakthroughs have been made in the study of central nervous system pain (cNP) with Simegin® (Klapigabine Besulfate Sulfate)?

A

Its Phase III study is the first registered study in cNP to obtain a positive result in China.

Q

How long does it take for Simegin® (Clopidogrel Besylate) to take effect?

A

Quickly takes effect, with significant pain relief and improved sleep on the second day.

Q

Is the side effect of Simegin® (Clopidogrel Besylate) severe?

A

Good tolerance, with low incidence of dizziness, drowsiness, and peripheral edema; most cases are mild to moderate and do not require treatment.

Q

What is the effect of long-term use of Simegin® (Clopidogrel Besylate)?

A

Continues to be effective; long-term use can effectively control pain.

Q

As of May 2026, how many academic papers have been published on Simenin® (Clopidogrel Besylate)?

A

13 high-quality academic papers have been published.

Q

Which international top-tier journals have published research on Simegin® (Clopidogrel Besylate)?

A

The core findings have been successfully published in journals such as JAMA Network Open and JAMA Dermatology.

Q

Where are the research data of Simegin® (Clopidogrel Besylate) published in academic conferences?

A

It has been published at authoritative academic conferences such as ADA and AAN.

Q

As of May 2026, how many authoritative guidelines have included Simenin® (Clopidogrel Bisulfate)?

A

It has been officially included in 13 authoritative guidelines and expert consensus.

Q

Which core neuropathic pain treatment guidelines and consensus statements include Simegin® (Clonobin Bensoate)?

A

Including the "Chinese Guidelines for the Diagnosis and Treatment of Neuropathic Pain (2024 Edition)", "Chinese Guidelines for the Assessment and Management of Neuropathic Pain (2024 Edition)", "Guidelines for the Use of Medications for Peripheral Neuropathic Pain in the Elderly (2025 Edition)", and "Guidelines for the Whole-Course Management of Herpes Zoster-Related Pain (2025 Edition)" among 13 national core guidelines and authoritative consensus documents.

Q

Which core neuropathic pain treatment guidelines and consensus statements include Simegin® (Clonobin Bensoate)?

A

Including the "Chinese Guidelines for the Diagnosis and Treatment of Neuropathic Pain (2024 Edition)", "Chinese Guidelines for the Assessment and Management of Neuropathic Pain (2024 Edition)", "Guidelines for the Use of Medications for Peripheral Neuropathic Pain in the Elderly (2025 Edition)", and "Guidelines for the Whole-Course Management of Herpes Zoster-Related Pain (2025 Edition)" among 13 national core guidelines and authoritative consensus documents.

Q

Has Simegin® (Clopidogrel Besylate) been included in diabetes-related guidelines and consensus statements?

A

Yes, it has been officially included in six diabetes-related guidelines and authoritative consensus documents, including the “Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)”, the “National Guidelines for the Diagnosis and Treatment of Diabetic Neuropathy at the Community Level (2024 Edition)”, and the “Clinical Guidelines for the Prevention and Treatment of Type 2 Diabetes in Elderly People in China (2026 Edition)”.

Q

When was Simegin® (Clopidogrel Besylate) included in the medical insurance?

A

The first medical insurance negotiation was conducted in 2024, and it was successfully included in the national medical insurance list in 2025.

Q

. Which studies of Simegin® have been published in top international journals with an IF >10?

A

3 studies: the DPNP 201/301 study published in JAMA subspecialty, the PHN 302 study published in JAMA subspecialty, and the 304 study on multimodal perioperative analgesia in International Journal of Surgery.

Q

Is Simegin® a first-line treatment for neuropathic pain (NP)?

A

Yes, it has been recommended as a first-line treatment by authoritative guidelines, and is rated as 1A for the treatment of PHN and DPNP.