Adimmune
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Native name | 國光生物科技股份有限公司 |
|---|---|
| Type | Public |
| TWSE: 4142 | |
| Industry | Biopharmaceuticals, vaccines |
| Founded | 1965 |
| Headquarters | , |
Key people | Chi-Shean Chan (Chairman & CEO)[1] |
| Products | Human vaccines (influenza, JE, tetanus, etc.); CDMO services |
| Website | www |
Adimmune Corporation (Chinese: 國光生物科技股份有限公司) is a Taiwanese biopharmaceutical company headquartered in Taichung. Originally founded in 1965 as Taiwan’s first vaccine laboratory, it later evolved into a modern vaccine manufacturer and contract development and manufacturing organization (CDMO). The company is notable for being the only influenza vaccine manufacturer in Asia certified by both the European Union Good Manufacturing Practice (EU GMP) and the U.S. Food and Drug Administration (FDA), and the*only human vaccine manufacturer in Taiwan operating under PIC/S GMP standards.[2]
History
[edit]Adimmune traces its origins to 1965, when it was established as Kuo Kwang Serum and Vaccine Manufacture Co., Ltd. in northern Taiwan and collaborated with Japan's Kitasato Institute to produce early vaccines such as Japanese encephalitis and tetanus toxoid.
In 2001, the company was renamed Adimmune Corporation (ADIMMUNE, meaning Advanced Immunology).
By 2015, Adimmune's Fill and Finish Plant had received EU GMP certification; subsequently, in 2016, it gained PIC/S GMP validation from the U.S. FDA, establishing it as the only influenza vaccine-maker in Asia with those certifications.[3][4]
Products and services
[edit]Adimmune manufactures seasonal influenza vaccines—including trivalent and quadrivalent formulations—and other human vaccines like Japanese encephalitis, tetanus toxoid, and purified tuberculin. The company also provides CDMO services using both egg-based and cell-culture platforms at its PIC/S GMP-certified facilities in Taiwan, with an annual capacity of tens of millions of doses.[5][6][7]
Global recognition and partnerships
[edit]Adimmune has sought to expand its role in the global pharmaceutical and vaccine industry through international collaborations.[8] Adimmune’s accreditation by EU and U.S. regulatory authorities enables it to supply high-standard vaccines both domestically and internationally. The company has entered strategic partnerships and CDMO agreements to manufacture for firms such as Sanofi Pasteur, Crucell, and others.[9]
In January 2021, the company announced a partnership with South Korea’s largest ophthalmic drug manufacturer, SCD, to co-develop a biosimilar version of Eylea, an injection used to treat macular degeneration.[10]
In August 2021, Adimmune signed a memorandum of understanding (MOU) with BD, a global leader in injection devices. The strategic alliance aimed to strengthen cross-border pharmaceutical cooperation and was described as an important step in Adimmune’s international expansion.[11]
In May 2024, Adimmune signed a Standard Material Transfer Agreement 2 (SMTA2) with the World Health Organization (WHO) under the Pandemic Influenza Preparedness Framework. The agreement allows contracted vaccine and pharmaceutical companies to obtain influenza virus strains from WHO in real time in order to accelerate the development of new influenza vaccines or antiviral drugs. At the time, 14 companies from Europe, the United States, and Asia had signed such agreements; Adimmune was the first Taiwanese manufacturer to do so.[12]
Facilities
[edit]Adimmune operates modern PIC/S GMP-certified manufacturing plants, including both egg and cell-based production systems. The company’s Taichung facility supports pharmaceutical-grade filling, packaging, analytical testing, and quality control under global regulatory standards.[13]
Controversies
[edit]In April 2025, Taiwanese media reported that a whistleblower alleged misconduct at Adimmune’s Tanzi facility in Taichung. According to the claims, in late July 2024, an employee did not place 120 laboratory mice into the designated animal room during a typhoon holiday, instead leaving them in a laboratory for three days.[14] This reportedly led to contamination of the lab environment with rodent feces and urine, causing a strong odor. A second whistleblower further alleged that the same employee had previously instructed a vendor to leave laboratory mice in the open lobby area of a building entrance. Internal meetings at Adimmune reportedly classified these incidents as “minor oversights,” with no disciplinary measures taken and no follow-up decontamination of the affected areas.[15]
See also
[edit]References
[edit]- ↑ "Board of Directors". Adimmune. Retrieved 10 September 2025.
- ↑ 謝柏宏 (21 August 2025). "國光生斥資3億 建新產線". United Daily News (in Chinese (Taiwan)). Retrieved 8 September 2025.
- ↑ "History". Adimmune. Retrieved 10 September 2025.
- ↑ "Adimmune exhibition profile". BioAsia Taiwan expo. Retrieved 10 September 2025.
- ↑ "COMPANY PROFILE". Adimmune. Retrieved 10 September 2025.
- ↑ "CDMO capabilities". Adimmune. Retrieved 10 September 2025.
- ↑ 李青縈 (8 September 2025). "國光生技國際合作加溫 疫苗與高價生物相似藥雙線推進". NOW News (in Chinese (Taiwan)). Retrieved 10 September 2025.
- ↑ 何秀玲 (8 September 2025). "國光生：國際合作暢旺 疫苗及生物相似藥雙軌並進". Central News Agency (Taiwan) (in Chinese (Taiwan)). Retrieved 8 September 2025.
- ↑ "Chairman interview – Pharmaboardroom". Pharmaboardroom. Retrieved 10 September 2025.
- ↑ 郭鴻慧 (20 January 2021). "國光生聯手韓藥廠SCD 進軍生物相似藥市場". China Times (in Chinese (Taiwan)). Retrieved 8 September 2025.
- ↑ 彭暄貽 (20 August 2021). "國光生攜BD 攻醫藥代工". Commercial Times (in Chinese (Taiwan)). Retrieved 8 September 2025.
- ↑ 何秀玲. "國光生技與WHO簽協議 可第一時間取得病毒株加速疫苗開發" (in Twi). Retrieved 6 May 2025.
- ↑ "Capability". Adimmune. Retrieved 10 September 2025.
- ↑ 潘姵如 (22 April 2025). "國光生技爆鼠亂／120隻老鼠屎尿汙染實驗室 國光生技恐釀疫苗危機". Mirror Media (in Chinese (Taiwan)). Retrieved 23 April 2025.
- ↑ 潘姵如 (22 April 2025). "國光生技爆鼠亂3／汙染實驗室又虐待動物 出包員工觸犯天條國光生技回應了". Mirror Media (in Chinese (Taiwan)). Retrieved 23 April 2025.