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U.S.-New Executive Order Strengthens Pharmaceutical Localization Yiwei, Taifu-KY Welcomes New Orders | Anue Juheng-Taiwan Stock News

U.S.-New Executive Order Strengthens Pharmaceutical Localization Yiwei, Taifu-KY Welcomes New Orders | Anue Juheng-Taiwan Stock News
U.S.-New Executive Order Strengthens Pharmaceutical Localization Yiwei, Taifu-KY Welcomes New Orders | Anue Juheng-Taiwan Stock News

US President Biden signed a new executive order to launch the National Biotechnology and Biomanufacturing Program to ensure that related technologies are manufactured in the United States, Taiwan Biotechnology Factory Taifu-KY (6541-TW), Yiwei (1799-TW), Polaris – KY(6550-TW) all have factories in the United States, which will directly benefit from this wave of local production opportunities and welcome new orders.

Yiwei responded that the US factory has a number of CDMO cooperation projects. If this policy is actively promoted, the company has the advantage of local production; Taifu said that the company is positioned in Non-GMP and focuses on the front-end development of drugs, and some orders It is expected that after development from the Taiwan factory, it will be transferred to the US factory for production.

After the United States passed the Chip Act to support the chip manufacturing industry, it promoted the national biotechnology and biomanufacturing program, mainly developing the U.S. biotechnology and pharmaceutical industry. The White House mentioned that China is actively investing in the biotechnology industry, jeopardizing the competitiveness of the United States, and hopes that the new program will reduce dependence on China’s new drugs, chemicals and other products, while creating new jobs in biotechnology and biomanufacturing.

In recent years, the United States has actively strengthened local manufacturing. In 2013, the Taiwanese factory Yiwei merged into Magnifica, an American company specializing in generic drugs and new dosage forms and new drugs, and its subsidiary TULEX Pharmaceutical Factory in New Jersey, USA, benefiting from the local production and supply policy of the United States, and won the US military. Orders with government tenders.

Yiwei said that in addition to the US government’s bidding orders, the commissioned development and manufacturing services (CDMO) business has also made progress recently. There are a total of 6 development projects including one new drug, three 505B2, and two difficult famous drugs, and the proportion of revenue is also From 30% to nearly 40%.

One of the 505B2 products, a liquid oral dosage form of epilepsy drug, obtained a US drug certificate at the end of last year. Currently, it is working with customers to change the dose, adjust the large volume to a small volume, and register the information with the US FDA. The new dose is expected to be launched in October.

After the adjustment of Taifu’s management team, it also adopts a diversified layout strategy. In addition to continuing to develop biosimilar drugs, it also expands the CDMO business. In the near future, the US factory will conduct factory inspection and certification, and will use the existing technology to strive for cooperation opportunities for medium-sized macromolecular drugs.

Polaris US factory is positioned as a leading factory with cGMP production equipment and high-level technical capabilities. It has been engaged in CDMO business since 2019. It has signed contracts with three companies including Helix BioMedix, Nanonotein, and Primmune. Among them, it has cooperated with Helix to develop and produce UVDE- TAT’s E. coli expression system with revenue contribution.

In addition, Nanotein mainly researches and develops CAR-T culture medium, and the two sides cooperate to develop products. In addition to being responsible for the development of mass production processes, Polaris has also obtained a 41% stake in Nanotein. , Polaris can be recognized as a 15% sales royalty, and it is expected to contribute to revenue next year.

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