Welcome to the Investor Relations section of STURGEON USA.
Here, we invite you to explore our vision, strategic advancements, and commitment to pioneering regenerative solutions that redefine patient care.
Welcome to STURGEON USA Investor Relations
STURGEON USA is a dedicated
biotechnology and pharmaceutical entity
focused on leveraging the extraordinary
regenerative capabilities of sturgeon.
Our core mission is to develop and
commercialize novel therapies that
address significant unmet medical needs,
beginning with advanced wound
and skin regeneration based on sturgeon.
Founded: 2025. 07
CEO: Yongkwang Lee
U.S. Office: 1 Peters Canyon rd #160 Irvine, CA 92606
GMP: 781 Chestnut Ridge Road Morgantown,
WV 26505Our Vision: To be a global leader in regenerative biotech, delivering verifiable healing and renewed hope to patients worldwide.
Our Mission: To advance human health through the rigorous development of sturgeon-derived biopharmaceuticals, achieving regulatory approvals, and global commercialization of our innovative pipeline.
At the heart of our innovation lies RSO,
a groundbreaking API candidate derived from
the sturgeon's unparalleled vitality and regenerative
capabilities.
RSO – The Core Technology:
RSO serves as the foundational, next-generation
therapeutic agent for our pipeline.Novelty: A novel, pharmaceutical-grade
ingredient that directly leverages the sturgeon's
innate tissue regenerative capacity for
enhanced biological efficacy.Technological Advantage:
Developed utilizing our proprietary
water-solubilization technology. This innovation
significantly enhances bioavailability
and deep dermal absorption, effectively
overcoming the inherent limitations associated
with traditional delivery systems.
Lead Candidate: Total Care Cream
This product spearheads the commercialization
efforts for the RSO platform.Product Profile: A high-contented RSO
formulation designed to treat a broad spectrum
of challenging dermatological conditions.Indications: Demonstrates compelling clinical
efficacy across a range of indications, including
pressure ulcers, thermal burns, atopic dermatitis,
psoriasis, and acne vulgaris.
Regulatory Pathway (U.S. FDA):
We are pursuing a systematic regulatory strategy
to ensure global market entry via U.S. FDA approval.Strategic Goal: Currently progressing through
the NDA pathway, targeting final FDA approval
for both NDA and OTC drug classifications.
1. Future Pipeline Expansion
Following the successful market entry of Total Care
Cream, we are strategically expanding the application
scope of the RSO platform.
Pipeline Strategy: Our plan includes securing
FDA NDA approval for additional
RSO-based pharmaceutical products.Examples: Future pipeline candidates are projected
to include specialized gynecological care treatments
and hemorrhoid topical ointments etc…2. Target Market Focus
We are targeting two key, rapidly expanding markets
where our flagship product, Total Care Cream,
holds a distinct competitive advantage.Chronic Wound & Pressure Ulcer Management:
This market is rapidly expanding,
driven by aging global demographics,
making it a critical focus area.Total Care Cream, with its superior healing
properties, is strategically poised to establish
itself as a next-generation standard of care.
3. Business Development & Partnerships
We actively seek and foster partnerships that are
strategically aligned with our mission.
To accelerate market penetration and maximize
commercial value globally, we operate with flexible
engagement models.
SturgeonBio Targets Global Expansions with U.S. Subsidiary and New GMP Facility Lease
Securing Production Facilities in West Virginia: “Equipment Installation Underway for Year-End Production Start”
Flagship Products, Including Total Care Cream, Now Available in U.S. Pharmacies Following OTC Registration
CEO Lee Yong-Kwang: “GMP Facilities are a Prerequisite for FDA IND and NDA”
Presenting a New Model for ‘K-Bio’ Through Advanced Bio-Beauty Technology Based on Refined Sturgeon Oil
SturgeonBio Co., Ltd. (CEO Lee Yong-kwang), a pioneer in sturgeon-derived bio-technology, is accelerating its global expansion.
Following the successful U.S. registration of its products as OTC drugs and the establishment of its local subsidiary,
"Sturgeon USA," the company has now secured a production facility equipped with pharmaceutical GMP standards.
Leveraging its proprietary "Refined Sturgeon Oil" technology, SturgeonBio has maintained a robust growth trajectory in the functional food and cosmetic sectors.
The establishment of this U.S. manufacturing base is being hailed as a landmark case for the integration of K-Beauty and K-Bio on the international stage.
CEO Lee Yong-kwang met with officials from the WVU Innovation Corporation in West Virginia on the 6th to finalize strategic details.
The company expects to sign a lease agreement this month for a 17,800-square-foot GMP-compliant facility.
The installation of state-of-the-art production equipment is projected to take approximately one year, with locally manufactured products slated for nationwide distribution
across the U.S. by the end of this year.
In addition to its manufacturing milestones, SturgeonBio unveiled a comprehensive roadmap for drug development.
The company plans to produce API via contract manufacturing between March and May of this year.
This will be followed by a rigorous preparation phase for an IND application in the second half of the year (July–October).
Looking ahead, SturgeonBio aims to submit a NDA by the second quarter of next year, further solidifying its presence in the global bio-pharmaceutical market.
CEO Lee Yong-kwang emphasized the significance of this milestone, stating,
“Securing a GMP-compliant facility is a prerequisite for the IND process.
This marks a pivotal moment as SturgeonBio has finally reached the stage where we can officially proceed
with an FDA IND application.”
The IND application is a formal procedure to obtain approval from regulatory bodies, such as the U.S. FDA,
before initiating clinical trials on human subjects. This approval is mandatory to collect data on safety
and efficacy, serving as a critical safeguard to ensure the scientific and ethical integrity of
the drug development process. Once IND approval is granted, the company will conduct
sequential clinical trials—Phase 1 (safety), Phase 2 (efficacy), and Phase 3 (large-scale safety and efficacy)
—which ultimately lead to the NDA upon successful completion of all stages.
◇ FDA OTC Registration Complete: Full-Scale Entry into Pharmacy Networks
SturgeonBio successfully completed the U.S. FDA OTC registration for its flagship product line last year,
marking its official entry into the U.S. pharmaceutical distribution channel.
The company’s signature "Total Care Cream" is now available in approximately 250 pharmacies
across the United States. The product has gained significant traction for its proven efficacy
in strengthening skin barriers and alleviating symptoms of atopy and various skin irritations.
Following the establishment of its pharmaceutical subsidiary, "STURGEON USA," last year,
SturgeonBio has further solidified its local footprint by finalizing a lease agreement for
a GMP-compliant manufacturing facility in West Virginia.
◇ Expanding Global Exports to 20+ Countries Amid Successive Research Breakthroughs
Beyond the United States, SturgeonBio has established a robust export network spanning more than 20 countries,
including Japan, Singapore, Vietnam, Malaysia, and the Philippines.
Notably, the company has secured a supply contract with approximately 350 pharmacies across Japan, further broadening its international reach.
The company has also solidified the scientific foundation of its proprietary "Refined Sturgeon Oil" by publishing numerous research papers in international journals.
These studies demonstrate the oil’s efficacy in preventing atopic dermatitis, respiratory viruses, and colitis.
These achievements are the culmination of persistent R&D efforts since the "Sturgeon Extract" was first listed in the ICID in 2019.
SturgeonBio currently holds 22 domestic and international patents and has obtained all major certifications, including ISO 22716, ISO 9001, and ISO 14001.
Moving forward, SturgeonBio plans to operate its own production lines in the U.S. to expand its portfolio of FDA-approved OTC products
while accelerating its transition toward the NDA phase. Industry analysts have noted that SturgeonBio’s entry into the U.S. market is a rare
and remarkable case for a Korean mid-sized biotech firm, successfully completing a four-stage vertical integration:
"Ingredient Development – OTC Registration – Local Production – Distribution Network."
"The company’s strategic positioning significantly enhances its prospects for success in the global market," an industry official added.
Join Us in Shaping the Future.
If you are interested in investment opportunities with STURGEONUSA,
please send us an email at sgb@sturgeonbio.com