Business News

Hisicor Pharmaceutical GroupJuly 13DayReceivedNational Medical Products Administration Drug Evaluation CenterNotice，Confirm Haisco'sBensoic Chlorophenylbeta-Barbituric Acid CapsulesThe application for new indication launch has been accepted. The new indication isNeuropathic pain。

Source of image:National Medical Products Administration Drug Evaluation Center

Neuropathic pain is a type of pain caused by abnormal reorganization of the nervous system due to diseases or injuries. Clinically, peripheral neural pain is more common, such as post-herpes zoster neural pain. Even if the underlying disease is cured, the pain may still persist. Similarly, central diseases can also cause this type of pain, with stroke and spinal cord damage being the most common cases. In terms of symptoms, neuropathic pain is not just“Pain” often comes with unusual sensations such as stinging, numbness, and even itching. These are all different manifestations of pain.

Bensoic Chlorophenylcarbinol CapsulesDeveloped independently by China,YesThe world's first third-generation calcium ion channel regulator without precipitation, featuring an innovative tricyclic cage structure, acts with high selectivityThe α2δ-1 subunit enhances molecular rigidity, offers high target selectivity and binding strength, while providing a larger safety window.，Treatment can be started with an effective dose directly, providing better pain relief and good overall tolerance.

Approved for market launch in May 2024, it has been approved in China for the treatment of diabetic peripheral neuropathy in adults (DPNP) and post-herpes zoster neuralgia (PHN).

Bensoic Chlorophenylbeta-Barbituric Acid CapsulesThe first to be approved in mainland ChinaA new class of drug for DPNP indication fills the treatment gap in this field. Its phase III study on central nervous system pain (cNP) is the first registered study to obtain a positive result in cNP in China.。

Bensoic Chlorophenylcarbinol CapsulesPublished in top international journal13A high-quality academic paper.11Next timeADA (American Diabetes Association), AAN (American Academy of Neurology), and other world-class conferences have released important guidelines. They have been recommended by 13 authoritative guidelines and expert consensus documents, including the “Chinese Guidelines for the Diagnosis and Treatment of Neuropathic Pain (2024 Edition)”, “Chinese Guidelines for the Prevention and Management of Diabetes (2024 Edition)”, and “Guidelines for the Whole-Course Management of Herpes Zoster-Related Pain (2025 Edition)”.

May 2026,Neuropathic painIndications have been changed CDE will be reviewed with priority.

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] Benzalkonium Chloride Gabalin Capsule Instructions for Use.

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

About Haisco

Haisco is an international pharmaceutical company that integrates research and development, production, and sales.(Stock code 002653.SZ), focusing on areas such as anesthesia and analgesia, chronic disease metabolism, digestive liver diseases, respiratory immunity, nervous system, and tumors. Adhering to innovation and globalization strategies, it aims to “become the most trusted international pharmaceutical company” and meets unmet clinical needs, caring for patients worldwide. Currently, Haisco Pharmaceutical Group has established a range of diversified research and development programs with independent intellectual property rights, including small molecule innovative drugs, biopharmaceuticals, and high-end generic drugs. Multiple projects are in the clinical development stage, and several innovative drugs have been commercialized, providing diverse innovative product solutions to the world. In 2025, the group’s revenue reached 4.388 billion yuan, with sales of innovative drugs increasing by more than 50%, and R&D investment accounting for over 25%. As of June 2026, 1285 patents have been applied for, and 428 have been authorized.

Forward-looking statement

Some of the information in this release may contain forward-looking statements. These statements are based on the company’s current expectations for future developments and may be influenced by various uncertain factors such as research and development progress, regulatory approvals, and market conditions. The actual results may differ from the related statements. The company provides explanations based on the information available on the release date only; except as required by laws and regulations, it has no obligation to update such statements. For detailed information, please refer to the company’s official website:www.haisco.com。