China Medical System Holdings Limited (HKG: 0867) announced a licensing agreement with Teikoku Seiyaku Co., Ltd., securing exclusive distribution rights for Lidoderm (lidocaine gel patch) in Mainland China. The 5% lidocaine patch, FDA-approved since 1999 for postherpetic neuralgia (PHN) and marketed in the EU as Versatis (2007), received China marketing authorization in 2024, addressing a significant unmet need in neuropathic pain management.
Transaction Overview
Element
Detail
Licensee
China Medical System Holdings Limited (HKG: 0867)
Licensor
Teikoku Seiyaku Co., Ltd. (Japan)
Product
Lidoderm (5% lidocaine gel patch)
Territory
Mainland China (exclusive distribution)
Manufacturing
Teikoku Seiyaku (supply responsibility)
Indication
Postherpetic neuralgia (PHN)
Global Approvals
US FDA (1999); EU EMA as Versatis (2007); China NMPA (2024)
Product Profile & Mechanism
Feature
Lidoderm Specification
Clinical Advantage
Active Ingredient
5% lidocaine
Local anesthetic; well-established safety profile
Mechanism
Voltage-gated sodium channel blockade
Reduces ectopic impulses in primary afferent nerves following injury
Neuropathic pain following herpes zoster (shingles)
Clinical Validation
Supported by domestic and international guidelines/consensus
Standard of care for PHN; reimbursement pathway clarity
Market Context & Strategic Positioning
Factor
Market Analysis
PHN Burden in China
~1 million new PHN cases annually following >3 million shingles cases; aging population drives incidence increase
Neuropathic Pain Gap
Limited effective topical options; oral gabapentinoids (gabapentin, pregabalin) have systemic side effects (sedation, dizziness, weight gain)
Lidoderm Differentiation
First and only FDA-approved topical PHN therapy; localized efficacy without CNS effects; elderly-friendly (no drug interactions)
CMS Commercial Strength
Established hospital and retail pharmacy network; pain management and neurology specialist relationships; NRDL negotiation expertise
Teikoku Manufacturing
Japanese quality standards; consistent supply; regulatory compliance with China GMP requirements
Regulatory & Commercial Roadmap
Phase
Activity
Timeline
Current
Licensing agreement execution; importation and distribution setup
Q1 2026
Launch
Hospital formulary access; pain specialist education; retail pharmacy distribution
Q2-Q3 2026
Reimbursement
NRDL inclusion negotiation for PHN indication
2026-2027
Market Expansion
Potential label expansion to other neuropathic pain indications
Post-approval
Forward‑Looking Statements This brief contains forward‑looking statements regarding Lidoderm commercial launch timelines in China, NRDL reimbursement outcomes, and postherpetic neuralgia market penetration. Actual results may differ due to competitive dynamics with generic lidocaine patches, physician prescribing habits for oral neuropathic pain agents, and pricing pressure from national procurement programs.-Fineline Info & Tech
By Fineline Cube