Qyuns Therapeutics to Acquire Remaining 34% Stake in CMC Subsidiary Cellularforce for RMB 86M – Full Ownership Secures NDA Pathway for IL-17A and IL-4Rα Antibody Pipeline

Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that its wholly-owned subsidiary Qyuns Safe Biology Medicine Co., Ltd. has entered into an equity transfer agreement to acquire an approximately 34.0001% equity stake in Cellularforce from Taizhou Huacheng Medical Investment Group Co., Ltd. for RMB 86.02 million ($11.9 million), achieving 100% indirect ownership of the critical CMC (Chemistry, Manufacturing, and Controls) subsidiary.

Transaction Overview

ItemDetail
AcquirerQyuns Safe Biology Medicine Co., Ltd. (wholly-owned subsidiary of Qyuns Therapeutics)
TargetCellularforce (CMC-focused subsidiary)
Stake Acquired34.0001% equity interest
Transaction ValueRMB 86.02 million (approximately $11.9 million)
Post-Transaction Ownership100% indirect ownership through Safe Biology Medicine
Announcement DateJune 26, 2026
Strategic PurposeFacilitate NDA submissions for core pipeline products

Subsidiary Profile: Cellularforce

  • Primary Function: CMC (Chemistry, Manufacturing, and Controls) operations
  • Core Capabilities:
  • Cell line development
  • Process development
  • Formulation development
  • Analytical method development
  • Quality control (QC) and quality assurance (QA)
  • Pilot production and commercial manufacturing
  • Strategic Role: Central manufacturing and development platform for Qyuns’ antibody pipeline
  • Integration Status: Will become fully integrated CMC arm under 100% Qyuns ownership

Cellularforce serves as the backbone of Qyuns’ biologics development infrastructure, providing end-to-end CMC capabilities essential for regulatory compliance and commercial-scale manufacturing of monoclonal antibodies.

Pipeline Impact & Regulatory Strategy

Core ProductTargetDevelopment StageCMC Dependency
QX002NAnti-IL-17A monoclonal antibodyPre-NDAHigh – requires robust CMC package
Oturkibart (QX005N)Anti-IL-4Rα monoclonal antibodyPre-NDAHigh – requires robust CMC package

The acquisition directly supports Qyuns’ near-term regulatory objectives by ensuring complete control over the CMC components of New Drug Applications (NDAs) for both lead candidates. Full ownership eliminates potential coordination challenges with minority stakeholders during the critical NDA preparation and regulatory review phases.

Strategic Rationale & Market Context

Strategic DriverAnalysis
Regulatory ControlComplete oversight of CMC data generation and submission processes
Operational EfficiencyStreamlined decision-making for manufacturing scale-up and process optimization
Intellectual Property SecurityEnhanced protection of proprietary manufacturing processes and analytical methods
Commercial ReadinessAccelerated pathway to commercial manufacturing upon NDA approval
Investor ConfidenceDemonstrates commitment to de-risking regulatory pathway for core assets

China’s biologics market continues rapid growth, with monoclonal antibodies representing a significant segment. The IL-17A and IL-4Rα targets address substantial markets in autoimmune diseases, including psoriasis, atopic dermatitis, and asthma, with combined global market potential exceeding $20 billion annually.

Financial Structure & Integration Benefits

The RMB 86.02 million consideration represents a strategic investment that secures full control over critical manufacturing infrastructure. The transaction is expected to be immediately accretive by:

  • Eliminating minority interest expenses
  • Enabling optimal resource allocation across the CMC platform
  • Accelerating NDA timelines through unified operational control
  • Reducing regulatory risk through consistent quality systems

Forward-Looking Statements
This brief contains forward-looking statements regarding the acquisition, regulatory submissions, and commercial prospects of Qyuns’ pipeline. Actual results may differ due to risks including regulatory decisions, clinical outcomes, and competitive dynamics.-Fineline Info & Tech