Merck KGaA (ETR: MRK) announced that China’s National Medical Products Administration (NMPA) granted priority review approval for Pimicotinib hydrochloride capsules, the first Class 1 innovative drug approved in China for Tenosynovial Giant Cell Tumor (TGCT) in adult patients where surgery could cause functional limitations or severe complications. The approval is based on the global Phase III MANEUVER study, which showed the highest Objective Response Rate (ORR) among systemic TGCT treatments per RECIST v1.1.
Regulatory Milestone
Item
Details
Approval Date
22 Dec 2025
Agency
NMPA (China)
Product
Pimicotinib hydrochloride capsules
Drug Class
Class 1 innovative drug
Indication
Symptomatic TGCT in adults (surgery‑risk)
Review Pathway
Priority review
Clinical Basis
Global Phase III MANEUVER study
Clinical Evidence – MANEUVER Study
Endpoint
Pimicotinib
Significance
Objective Response Rate (ORR)
Highest among systemic TGCT therapies (RECIST v1.1)
Demonstrates superior efficacy
Clinical Outcomes
Significant improvement in symptoms and function
Addresses high‑unmet‑need population
Safety Profile
Manageable adverse events
Supports favorable risk‑benefit ratio
Deal Structure & Development Chain
Timeline
Event
December 2023
Abbisko Therapeutics grants Merck exclusive China rights for Pimicotinib
April 2025
Merck exercises global commercialization option for Pimicotinib (ABSK021)
December 2025
NMPA approves Pimicotinib for TGCT in China (global first)
Global Status
Merck holds worldwide rights (ex‑China option exercised)
Market Opportunity
Metric
Value
Context
China TGCT Prevalence
~10,000‑15,000 adult patients (2025)
Rare disease with limited treatment options
Global TGCT Market
$300‑500 million (2025)
Dominated by surgical resection; no approved systemic therapy
Pimicotinib Peak Sales
¥800 million‑1.2 billion (≈ US$112‑170 M) by 2030
60‑70% share of China TGCT market
Pricing Strategy
Premium orphan drug pricing
Eligible for NRDL fast‑track inclusion
Strategic Implications
For Merck:TGCT approval expands rare disease portfolio in China; Class 1 status ensures market exclusivity; priority review demonstrates regulatory efficiency; global rights position for US/EU filings based on MANEUVER data.
For Abbisko:Successful out‑licensing validates discovery platform; milestone payments from Merck provide non‑dilutive capital; global option exercise showcases asset quality.
For Patients:First approved systemic therapy offers alternative to high‑risk surgery; oral administration improves convenience; highest ORR provides hope for symptom control and function preservation.
Forward‑Looking Statements This brief contains forward‑looking statements regarding Pimicotinib’s commercial launch, market penetration, and global expansion. Actual results may differ due to competitive responses, pricing negotiations, or regulatory challenges.-Fineline Info & Tech
By Fineline Cube 