By Fineline Cube 
Tibet Weixikang Pharmaceutical Co., Ltd. (SHA: 603676) announced that its lidocaine-tetracaine cream has received approval from the China National Medical Products Administration (NMPA) to conduct clinical trials for local anesthesia of intact skin prior to adult dermatological surgeries.
Regulatory Milestone & Drug Profile
| Attribute | Details |
|---|---|
| Company | Tibet Weixikang Pharmaceutical Co., Ltd. (603676.SH) |
| Product | Lidocaine-tetracaine cream (generic of Pliaglis) |
| Regulatory Status | NMPA clinical trial approval |
| Indication | Local anesthesia of intact skin before dermatological surgeries (adults) |
| Reference Listing | Included in 31st batch of NMPA’s reference list for chemical generics |
| Market Exclusivity | No domestic product currently available in China |
Origin & Formulation Details
Original Development:
- Originator: Zars Pharma
- US FDA Approval: June 29 2006
- Brand Name: Pliaglis
- Composition: 70 mg lidocaine + 70 mg tetracaine per gram of cream
Mechanism of Action:
- Dual local anesthetic combining amide (lidocaine) and ester (tetracaine) anesthetics
- Provides rapid onset and prolonged duration of action for dermatological procedures
- Applied as a topical cream on intact skin prior to surgery
Market Context & Competitive Landscape
| Market Segment | China Market Size | Current Status | Commercial Opportunity |
|---|---|---|---|
| Topical Anesthetics | ¥2.1 billion (≈ US$290 million) | Dominated by single-agent lidocaine products | High unmet need for dual-agent, long-acting formulation |
| Dermatological Surgery | >5 million procedures annually | Limited advanced topical anesthesia options | Premium pricing potential for Pliaglis generic |
| Generic Competition | None domestically | First generic applicant advantage | 3-5 year market exclusivity window if approved |
Strategic Advantages:
- First-to-Market: Potential first domestic generic of Pliaglis
- Clinical Need: Addresses demand for long-acting topical anesthesia in cosmetic and therapeutic dermatology
- Reimbursement Pathway: Dermatological surgery indication may qualify for outpatient procedure coverage
Development Timeline & Commercial Outlook
| Phase | Activities | Timeline |
|---|---|---|
| Clinical Trial | Bioequivalence vs. Pliaglis, safety in Chinese patients | Q1 2026 – Q4 2026 |
| NDA Submission | Package clinical data for NMPA review | H1 2027 |
| Potential Approval | Market authorization for dermatological anesthesia | 2028 |
| Commercial Launch | Multi-channel distribution to dermatology clinics | 2028‑2029 |
Revenue Projection: Analysts forecast ¥300‑500 million (≈ US$42‑70 million) peak annual sales if approved, given the premium pricing of long-acting topical anesthetics.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Weixikang’s clinical development timelines, regulatory review, and market potential for lidocaine-tetracaine cream. Actual results may differ due to clinical outcomes, competitive dynamics, and regulatory uncertainties.-Fineline Info & Tech