Peijia Medical Limited (HKG: 9996) announced that China’s National Medical Products Administration (NMPA) approved the registration application for its TaurusTrio Transcatheter Aortic Valve (TAV) system, the first domestic device designed to treat native symptomatic severe aortic regurgitation (AR) via transfemoral access.
Regulatory Milestone
Item
Details
Approval Date
12 Dec 2025
Agency
NMPA (China)
Product
TaurusTrio TAV system
Indication
Native symptomatic severe aortic regurgitation (AR)
Innovation
First TAV system for AR via transfemoral approach
Launch Timeline
Q2 2026 (hospital channel rollout)
Technology Profile
Feature
TaurusTrio TAV System
Competitive Context
Origin
Developed under exclusive license from JenaValve Technology, Inc.
Leverages proven Trilogy THV platform
Access
Transfemoral (minimally invasive)
Avoids open‑heart surgery
Anchoring
Proprietary locator technology attaches to native leaflets
No calcification required, solving key AR treatment barrier
Alignment
Ensures commissural alignment
Reduces paravalvular leak risk
Differentiation
Addresses unmet need in AR patients lacking calcified anchor points
Existing TAVs approved only for aortic stenosis
Market Opportunity
Metric
Value
Implication
China AR Prevalence
~400,000‑500,000 severe AR patients (2024)
<15% receive surgical intervention
China TAV Market
¥2.5 billion (≈ US$350 M)
Currently 100% aortic stenosis‑focused
AR‑Specific Market
¥800 million‑1.2 billion potential by 2030
Untapped segment with no approved TAVs
Peak Sales Forecast
¥600‑900 million (≈ US$85‑125 M) by 2029
25‑30% share of eligible AR patients
Competitive Moat
First‑mover in China AR market; 3‑year regulatory exclusivity
Protected by Class III medical device innovation pathway
Strategic Implications
For Peijia:First‑mover advantage in AR segment; validates licensing strategy with JenaValve; strengthens structural heart portfolio ahead of potential NRDL negotiation in 2027.
For Physicians: Offers minimally invasive option for AR patients previously ineligible for TAV; locator technology reduces procedural complexity and learning curve.
For Patients:Avoids open‑heart surgery; provides treatment option for elderly or high‑surgical‑risk AR patients; expected 30‑day mortality reduction vs. medical management.
Forward‑Looking Statements This brief contains forward‑looking statements regarding TaurusTrio’s commercial launch timeline, market penetration, and clinical adoption rates. Actual results may differ due to pricing negotiations, competitive responses, and reimbursement hurdles.-Fineline Info & Tech
By Fineline Cube 