In response to the massive opportunities brought by the U.S. BioSecure Act, Taiwanese companies are actively striving to position themselves within the global supply chain reshuffle. Josephine Hai-I Shen, Vice Chairman of the Biotechnology and Pharmaceutical Industries Association, is organizing an alliance of companies, while Taiwan Bio Therapeutics (TBMC) has initiated a strategic collaboration with U.S. company Resilience. Taiwan Bio Therapeutics is also establishing a production base in Phoenix, Arizona, aiming to secure a spot in the international competition.

Experts believe that the BioSecure Act, recently passed by the U.S. House of Representatives, will accelerate the decoupling from China ("de-Sinicization") and create unprecedented opportunities for Taiwanese companies. Gene technology, innovative drugs, vaccines, and biologics are expected to be the most significant areas of growth.

Bora Pharmaceuticals, Tanvex BioPharma, Easywell Biomedicals, and Yung Shin Pharmaceutical Industrial, which already have production bases in the U.S., will benefit from localization advantages. Taiwan's CDMO (Contract Development and Manufacturing Organization) service providers, such as EirGenix and Mycenax Biotech, are also well-positioned. TaiMed Biologics, with its new factory in Hsinchu Biomedical Science Park, has already launched an HIV treatment drug in the U.S.

In the field of cell and gene therapy, StemCyte, a subsidiary of Microbio, has a GMP facility in the U.S. Additionally, Discovery Oasis in Phoenix, Arizona, has chosen Taiwan Bio Therapeutics as its anchor firm. Taiwan Bio Therapeutics will participate in the construction of the first building in the park, and once its Hsinchu Biomedical Science Park facility begins operations in July next year, it will be ready to accept CDMO orders.

Currently, Taiwanese companies' mass production capabilities are still limited. Josephine Hai-I Shen is actively organizing an alliance to enhance their visibility in the international market by joining forces and securing more orders.

Hsu-Sung Kuo, Chairman of Taiwan Bio Therapeutics, stated that the BioSecure Act is accelerating the decoupling from China. Global CDMO giants are already positioning themselves for U.S. expansion to seize the supply chain opportunities left by Chinese manufacturers. Taiwanese biotech firms need to form alliances quickly, with the hope of witnessing rapid growth in the cell industry over the next decade. Taiwan Bio Therapeutics will expand its presence in the U.S. market starting this year.

David Chang, CEO of Taiwan Bio Therapeutics, emphasized that biopharmaceuticals have high capital and technical barriers, making contract manufacturing the global trend. The passage of the BioSecure Act is inevitable, and companies worldwide have already begun positioning themselves. Ultimately, it will come down to the strength of the companies to secure business. The high cost of early-stage process development, coupled with the low cost-effectiveness, presents a gap in the current CDMO market. Taiwan Bio Therapeutics aims to address this by collaborating with Resilience to develop process technologies, which will later enable partnerships with domestic companies to take on overseas orders.

To expand order capacity, EirGenix has completed the construction of its microbial facility in Hsinchu Biomedical Science Park, featuring two production lines with a total capacity of 1,350 liters. The facility will officially begin operations next year, with plans to add two downstream production lines to establish a complete supply chain. Mycenax Biotech has invested NT$700 million in its biopharmaceutical filling production line, which will be operational by mid-October, with an annual production capacity of 10 million doses.

Resource (mandarin): 美生物安全法商機 台廠揪團卡位