Source in Chinese: Investors.com
Benefiting from the fact that the Hsichih plant and the Zhubei QC Lab plant have been approved by Japan's PMDA, EirGenix announced on 20 September that it has signed a long-term supply contract with a partner for at least six years for support products for cancer patients, which will be conducive to the growth of its CDMO business.
According to EirGenix, the company is the first biopharmaceutical manufacturer in Taiwan that has been approved by Japan's official regulatory unit for two consecutive GMP inspections, and it is one of the limited biopharmaceutical manufacturers in Asia with various approvals from Japan's PMDA, the U.S. FDA, the European Union's EMA (in the process of reviewing), Australia's TGA, and Taiwan's TFDA, which underscores that the quality of its CDMO services has reached world-class standards.
In addition to the continuous production of the first product, EirGenix has just signed the second long-term supply agreement with a Japanese pharmaceutical company that has already begun to purchase APIs from EirGenix, and will produce products for sale in Japan.
According to EirGenix, the agreement it reached with its Japanese partner is an adjuvant therapy for cancer patients, with a global market of US$1.26 billion last year, with an annual compound growth rate of 10.6%, and estimated sales of US$1.92 billion in 2026; the partner is the first with a product of its kind launched in Japan, and it will have an advantage of market share, which is expected to continue to generate revenue for EirGenix's CDMO in the Japanese market.
EirGenix's CDMO business has been in operation since 2013, and has successively passed the inspections of major international regulatory agencies. The facility in Zhubei will also be launched in the fourth quarter of this year, and it is estimated that the microbiology plant in Sijhih will be fully loaded by 2025. EirGenix is also launching the construction of a large-scale microbiology plant in Zhubei this year, which is expected to be in line with the long term contracts already signed for the production of microorganisms in 2025, and to respond to the future of the international long-term customer base.