REGEN Biotech
REGEN Biotech, Inc. is the South Korean developer and product company behind AestheFill and PowerFill. REGEN is also identified as the manufacturer of AestheFill in current regulator records, including Australia and the Philippines. It is not the sponsor, approval holder, authorized representative, or distributor in every market; those roles are assigned locally.
Since September 10, 2025, REGEN has been controlled through Imeik International Limited, which completed the acquisition of an 85% shareholding. Imeik Technology Development Co., Ltd. holds 70% of Imeik International and therefore reported a 59.5% effective interest in REGEN (Imeik completion announcement 🔗). This ownership change does not, by itself, replace the legal manufacturer or local regulatory roles recorded for an individual product.
Company reference
Section titled “Company reference”| Field | Verified context |
|---|---|
| Legal name | REGEN Biotech, Inc. |
| Registered address | 1F, 20, Daehwa-ro 139beon-gil, Daedeok-gu, Daejeon, South Korea |
| Core products | AestheFill and PowerFill |
| Material relationship | PDLLA microspheres with sodium carboxymethylcellulose (CMC), according to the 2025 acquisition disclosure |
| Current control | Imeik International Limited owns 85%; Imeik Technology Development reports a 59.5% effective interest |
| Market model | REGEN as product company and manufacturer, with market-specific sponsors, representatives, importers, and distributors |
The registered address and the company’s research, production, and sales scope are reported in Imeik’s formal acquisition disclosure (Imeik REGEN acquisition announcement 🔗). REGEN’s own overview describes the company as a research-oriented bio-venture commercializing work developed with Korean research institutes (REGEN company overview 🔗). The collaboration statement supports company history, but it does not assign product-specific developer rights to every named institution.
Product-role matrix
Section titled “Product-role matrix”| Product | REGEN role | Manufacturing evidence | Product and regulatory boundary |
|---|---|---|---|
| AestheFill | Developer and product company | Regulator-confirmed manufacturer in Australia and the Philippines | Facial product; local sponsor, registration holder, importer, or distributor varies by market |
| PowerFill | Developer and product company | REGEN reports a joint Korean manufacture-license milestone with AestheFill in April 2014 | Separate body-use product context; AestheFill’s facial indication and registration cannot be transferred to it |
REGEN’s company history records separate clinical testing for AestheFill and PowerFill in 2012 and a Korean manufacture-license milestone for both products in April 2014 (REGEN history 🔗). Imeik’s acquisition disclosure likewise identifies both as REGEN products, describes both as PDLLA-microsphere and CMC formulations, and distinguishes AestheFill’s facial context from PowerFill’s body context (Imeik acquisition disclosure 🔗).
That evidence establishes a shared company and material platform, not product equivalence. PowerFill should not inherit AestheFill’s presentation, preparation, intended use, clinical evidence, or market authorization unless a PowerFill-specific label or regulator record supports the claim.
What the regulator records establish
Section titled “What the regulator records establish”| Market | Product record | Manufacturer | Separate local role |
|---|---|---|---|
| Australia | AestheFill-V200, Class III device, ARTG 402703; included January 20, 2023 | REGEN Biotech Inc | Qualtech Consulting Corporation Pty Ltd is the sponsor (TGA ARTG entry 🔗) |
| Philippines | Aesthefill, MDR-08598; issued November 3, 2025 and listed to expire September 2, 2030 | REGEN Biotech Inc | EG Healthcare Inc. is the importer/distributor (Philippines FDA record 🔗) |
| Malaysia | AestheFill family, GD9458322-83770; registration listed through December 28, 2026 | Not stated in the displayed registry entry | Parvus Sdn. Bhd. is the authorized representative (Malaysia MDA record 🔗) |
| China | AestheFill, registration number 国械注进20243130043, reported as obtained in January 2024 | REGEN is the product company in the cited disclosure | Mainland distribution rights are disputed in an unresolved arbitration; no exclusive distributor should be stated as settled |
These records show why manufacturer, sponsor, authorized representative, and importer/distributor must remain separate. They also do not establish worldwide availability. REGEN’s own AestheFill page says availability and intended use vary by country and directs clinicians to locally approved product information (REGEN AestheFill information 🔗).
China distribution remains unsettled
Section titled “China distribution remains unsettled”REGEN stated that it terminated the former mainland China exclusive-distribution agreement on July 18, 2025. The former distributor challenged that termination, and both claims and counterclaims were accepted for arbitration. A January 29, 2026 decision withdrew earlier interim measures but expressly was not a final award; Imeik’s first-quarter 2026 report continued to describe the arbitration as pending (January 2026 arbitration update 🔗, Imeik Q1 2026 report 🔗).
Accordingly, a reseller, importer, or distributor claim for mainland China should not be treated as a settled company role without a later final award or an updated official appointment.
Development and manufacturing evidence boundaries
Section titled “Development and manufacturing evidence boundaries”REGEN describes biodegradable-polymer microparticle and scaffold technology as a core capability. Its history links AestheFill development to clinical testing and patents for biodegradable polymeric microparticles. Current regulator records provide stronger, product-specific support for REGEN’s manufacturer role than the company history alone.
Neither type of evidence proves that:
- every porous PDLLA product uses REGEN technology
- a manufacturing-method patent establishes clinical superiority
- patent ownership equals product approval
- every AestheFill variant is registered in every market
- another PDLLA product shares AestheFill’s CMC-based formulation
REGEN’s 2025 acquisition disclosure also reports two Korean factories, but factory ownership, Korean GMP status, and a market’s named legal manufacturer are different facts. The applicable regulator record or IFU remains controlling for a particular product and market.
Distribution and authenticity
Section titled “Distribution and authenticity”REGEN states that it does not authorize online sales outside local official distributors and directs order inquiries to local distributors or partners (REGEN AestheFill information 🔗). That policy is useful for authenticity screening, but it is not itself proof that a seller is authorized or that a product is approved locally.
Reseller availability cannot establish:
- current registration or approval
- the exact locally authorized variant
- the approved intended use
- legal-manufacturer or importer identity
- storage, preparation, or use-window instructions
Selective timeline
Section titled “Selective timeline”| Date | Event | Why it changes interpretation |
|---|---|---|
| April 21, 2000 | REGEN Biotech incorporated in South Korea | Establishes the legal-company origin recorded in the acquisition disclosure |
| 2012 | REGEN reports separate AestheFill and PowerFill clinical tests and microparticle patents | Connects both products to REGEN’s development history without treating the products as interchangeable |
| April 2014 | REGEN reports a Korean manufacture license for AestheFill and PowerFill | Company-reported Korean manufacturing milestone; not a substitute for a current market record |
| January 20, 2023 | AestheFill-V200 entered in Australia’s ARTG | Independently identifies REGEN as manufacturer and Qualtech as sponsor |
| January 2024 | Imeik disclosure reports Chinese registration 国械注进20243130043 for AestheFill | Establishes a product-specific mainland China registration context |
| September 10, 2025 | Imeik International completed acquisition of 85% of REGEN | Changes parent-company and control context while leaving product-level regulatory roles market-specific |
Related pages
Section titled “Related pages”- AestheFill contains the product-specific formulation and preparation evidence.
- PDLLA separates AestheFill’s CMC-based system from PDLLA + HA products.
- AestheFill vs Juvelook explains why the shared PDLLA headline does not make the products or their company relationships equivalent.
- VAIM provides the closest initial Korean company comparison.
- Regional regulation distinguishes company-reported milestones from regulator-hosted product records.