Drug Production

Opening a Door for the Taiwanese Pharmaceutical Industry With Chemical Engineering and Drug Production

In the 1990s, the Taiwanese government strongly supported biotechnology and pharmaceutical industries. As early as the 1970s, ITRI focused on the development of pharmaceutical and chemical manufacturing technologies and the R&D of active pharmaceutical ingredients with a wide range of applications. It cultivated long-term chemical technologies to develop the pharmaceutical industry. In the field of pharmaceutical manufacturing and production, the Institute developed cardiovascular drug manufacturing technology in 1990 and antibiotic intermediate (i.e., 7-ADCA) complete manufacturing process technology in 1993, helping Taiwan’s pharmaceutical industry develop key manufacturing processes. Moreover, in 1992 and 2002, ITRI established the Controlled Release Testing Plant and Traditional Chinese Medicine GMP Pilot Plant, which reduced the commercialization timeframe for new drugs.

This development of new drug technologies and their transfer to companies continued. For instance, ITRI transferred topical liposome application technology, anti-B Chinese herbal drug (i.e., BMEC-101) technology, and anti-asthmatic drug (i.e., BMEC-1217B) technology to Purzer Pharmaceutical (now Synmosa Biopharma Corporation), Sunko, and Hongya Biotechnology in 2000, 2004, and 2005, respectively. BMEC-1217B was the first Taiwanese Investigational New Drug (IND) to be approved by the US FDA. These examples show how the Institute has collaborated with companies to reduce the time it takes for products to hit the shelves.

ITRI has played a critical role in the development of the pharmaceutical industry by providing innovative technology to combat a range of illnesses, including cardiovascular disease, hepatitis, cancer, influenza, and immune disorders. Its efforts have spawned several successful startups such as Genhealth Pharma, BELX, and MegaPro Biomedical, which have helped revitalize Taiwan’s traditional Chinese and Western medicine industries.

In recent years, ITRI has established platforms to assist in the development of the pharmaceutical industry. In 2018, the Institute collaborated with German pharmaceutical company Merck for drug R&D and personnel training, thereby enhancing Taiwan’s ability to develop precision medicine drugs. In the following year, ITRI formed an alliance with Janssen, a subsidiary of Johnson & Johnson, to develop double-effect immunotherapy drug technology which was successfully introduced to the international market.

In 2021, the Institute made significant progress by developing eye drops to treat wet macular degeneration using a patented eye drop dosage platform technology. The technology was then transferred to Metagone Biotech. It also introduced new functional contact lens development technology that later was transferred to PEGAVISION. In 2022, it developed an anti-TIGIT antibody drug that uses antibody engineering technology to poison and kill cancer cells. Through these efforts, ITRI has demonstrated how its R&D, manufacturing, and production of new drugs are leading Taiwanese companies into the international pharmaceutical industry.

1973

ITRI engaged in the R&D of pharmaceutical and chemical manufacturing process technologies with focuses on the extraction of traditional Chinese medicine ingredients, and the synthesis of animal drugs and key intermediates.

1992

ITRI officially opened Taiwan’s first Controlled Release Testing Plant, combining fields such as polymer chemistry, pharmaceutical and dosage designs, analysis and inspection technologies, chemical manufacturing process amplification, and animal testing in order to develop drug release control dosages.

1993

ITRI developed antibiotic intermediate (i.e., 7-ADCA) complete manufacturing process technology, and encouraged companies to invest in the founding of Junxiang Chemical Company, the fourth manufacturer in the world to produce this new drug.

1995

ITRI established Taiwan’s first GMP-certified controlled release formulation factory with a cleanliness level of 10,000, helping domestic companies shorten the time it takes to commercialize their new drugs.

1996

ITRI developed Taxol manufacturing process technology. Taxol is a raw material used to create anticancer drugs.

1997

ITRI commenced the groundbreaking ceremony for the active pharmaceutical ingredient GMP Pilot Plant.

2000

ITRI developed topical liposome application technology and transferred it to Purzer Pharmaceutical. In 2009, approval certification was obtained, and the drug was officially launched on the market.

2002

ITRI synthesized and screened Echinops grilissii with anti-cancer effects. The Institute transferred related technology to the Synpac-Kingdom Pharmaceutical Company of the Koos Group.

2002

ITRI established Taiwan’s first Traditional Chinese Medicine GMP Pilot Plant, a multi-functional facility which met international standards.

2004

ITRI transferred its Chinese herbal medicine DNA sequence database to Lumosa Therapeutics and Scientific Pharmaceutical Elite Company, and helped KPC identify the origins of important medicinal materials.

2004

ITRI transferred the BMEC101 (a new Chinese herbal medicine to treat hepatitis B) technology to Sunko Ink Co., Ltd.

2005

ITRI marked major R&D achievements in anti-avian flu drugs, acquiring the technological capabilities to produce key raw materials such as shikimic acid and sialic acid. ITRI also successfully developed anti-influenza drugs and collaborated with Relenza.

2005

ITRI transferred the anti-asthmatic drug BMEC-1217B to Hongya Biotechnology. This was the first new drug developed to prevent and treat asthma in Taiwan as well as the first Taiwanese anti-asthmatic drug to be the subject of a US FDA IND permit application.

2007

ITRI transferred its shikimic acid rapid extraction and manufacturing technology to Syn-Tech Chem. & Pharm., enabling both the trial production and mass production of raw materials used to produce anti-influenza drugs.

2008

ITRI introduced Taiwan’s first Blood Brain Barrier (BBB) drug transmission technology. The technology was transferred to the Taiwan branch of the company to-BBB for the development of drugs for treating central nervous system diseases.

2011

ITRI transferred the R&D results of its anti-enteritis drug and technology platform (DLS-01) and anti-rheumatoid arthritis drug and technology platform (DLS-03) to BioLite.

2011

ITRI brought together the R&D capabilities of National Taiwan University and Taipei Medical University to develop ITRI-260, the first anti-cancer target drug candidate developed in Taiwan. ITRI later transferred related technology to Twi Biotechnology.

2013

ITRI developed collagen stent technology and transferred it to Meribank to produce new drugs for treating autoimmune diseases such as lupus erythematosus, multiple sclerosis, and type 1 diabetes.

2014

ITRI, H&D Venture Capital Investment, Synpac-Kingdom Pharmaceutical Company, and Innovative Technology Transfer cofounded MegaPro Biomedical Co., Ltd.

2014

ITRI facilitated the establishment of Genhealth Pharma using technology for anti-hepatitis and anti-inflammatory Chinese herbal medicine. Genhealth became the first natural medicine-based startup company in Taiwan.

2016

ITRI established BELX which focuses on the development of new plant-based drugs for treating tumors and chronic liver diseases.

2018

ITRI collaborated with German pharmaceutical company Merck to incorporate advanced manufacturing processes, develop prospective pharmaceutical technologies, and cultivate domestic high-level biotechnology pharmaceutical personnel.

2018

Former Vice President of Taiwan Chien-Jen Chen, accompanied by then General Director of ITRI’s Biomedical Technology and Device Research Laboratories Chii-Wann Lin, visited ITRI and Merck’s new drug manufacturing process training lab.

2019

ITRI formed an alliance with Janssen, a subsidiary of Johnson & Johnson to develop double-effect immunotherapy drug technology which was successfully introduced to the international market.

2021

ITRI developed Taiwan’s first wet macular degeneration eye drops for fundus lesions by using patented eye drop dosage platform technology, offering a replacement for existing ocular injection treatment.

2021

ITRI developed PTB323X, a new plant-based nonsteroidal drug that can effectively treat psoriasis.

2022

ITRI developed an anti-TIGIT antibody drug, effectively activating T and NK cells and thereby increasing the rate of poisoning and mortality of cancer cells multiple times.

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