ONENESS BIOTECH CO., LTD.

Unified Business No.

29108260

Industry

Pharmaceuticals & Medicinal Chemicals (273)

Main products

Pharmaceuticals & medicinal chemicals (276)

Location

35 F., No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist., Taipei City 100507, Taiwan (R.O.C.)↗
Pingtung County (1,669) · Nanzhou Township (16)

Listing

Listed (TPEx) (890) 4743

Organisation type

Company Limited by Shares

Founded

2008-06-02

Paid-in capital

NT$ 4,805,334,860

Representative

Kuo Hsien-shou

Phone

02-27031098

Website

https://onenessbio.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M

Ownership

Family-run (inferred)

North American market

FDA 510(k) clearance FDA medical device registration Health Canada medical device licence

Representative tenure

In office since 2024-06 (2 yrs); last handover 2024-06

Growth & profitability

Revenue 2026-09 YoY -18.5%, year-to-date +12.6%
Gross margin 42%, operating margin -519.5%, net margin 128.9% (2026-Q2 YTD)

Compliance record

Environmental penalties: 2 case(s) in 5 years, latest 2025-11-07, fines NT$ 66,000 (industrial waste)

Certifications 6

• ISO 45001 (962)Official registry Valid until 2027-08-31 · SGS Taiwan Ltd.
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported
• ISO 17025 (76)Self-reported
• ISO 9001 (4,294)Self-reported
• PIC/S GMP (46)Self-reported

Processes & materials 1

• Biotechnology (664) · Company nameSelf-reported

Patents 1

• 2024 Nucleic acid aptamer targeting lymphocyte activation gene 3 (LAG-3) and use thereof

North American market evidence 4

• FDA 510(k) clearance K261638 2026-06-17
  Bonvadis®
• FDA 510(k) clearance K251093 2025-06-09
  Bonvadis®
• FDA medical device registration 3015077448 2023-01-31 – 2026-07-02
  Dressing, Wound, Drug
• Health Canada medical device licence 193558

Public registers of the US FDA, the FCC and Health Canada, matched on the registered English name. An FDA import refusal is a negative record, but also shows goods actually shipped to the US. The FCC dataset ends in 2021.

Government programs & awards 1

• SBIR (Small Business Innovation Research) program 2015 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 1

• 2025-11-07
  PenaltiesEnvironmental penalties: latest case 2025-11-07; 2 case(s) in 5 years, fines NT$ 66,000

RSS feed · Recent changes at Taiwanese manufacturers →

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• TAIWAN BIOTECH CO., LTD. · Taoyuan City Public company (unlisted) ≥ NT$5B
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• KAISER PHARMACEUTICAL CO., LTD. · Tainan City NT$1–5B estimated
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• SOURIREE BIOTECH & PHARM. CO., LTD. · New Taipei City < NT$20M estimated
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Ranked by overlap in processes and materials, registered business activities, certifications and main products; rarer shared traits weigh more. Dissolved companies are excluded.

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