Taihe Biotechnology is listed on the market, and the growth curve of European and American drug licenses is expected to explode

Taihe Biotech (6467) was officially listed for trading today (20th) at an underwriting price of 105.6 yuan per share. With the self-developed transepithelial drug delivery system (TDS) as its core, the company focuses on the development of new 505(b)(2) new dosage forms and new drugs, and adopts a "value verification, strategic licensing" business model to build long-term revenue through licensing fees, milestone fees and sales profits.

Taihe stated that its main product, BEQIA anti-thrombotic oral dissolving film, has completed the U.S. NDA submission and entered the 10-month PDUFA review of the USFDA. April 22, 2027 is expected to be the target date for review completion, and it is expected to obtain a U.S. drug certificate. , the EU marketing authorization is expected to be approved in the fourth quarter of 2026; in addition, as BEQIA moves towards commercialization, TAH3341 long-acting anti-thrombotic oral dissolving film and TAH0031 pulmonary fibrosis oral and buccal dissolving film have continued to advance, becoming the company's second growth curve.

Chairman Li Shiren further pointed out that BEQIA uses Apixaban as the main ingredient and is an anti-thrombotic orally dissolving film that can be taken twice a day for life and can be taken without drinking water. It has completed pivotal clinical trials and has been confirmed to be bioequivalent to the original tablet. It is currently advancing the review of drug licenses in Europe and the United States. The next-generation product TAH3341 has introduced sustained-release technology, reducing the dosage frequency from twice a day to once a day, locking in business opportunities for the world's first sustained-release anti-thrombotic orally dissolving film.

As for another key product, TAH0031 is the world's first buccal dissolving film for pulmonary fibrosis. It absorbs drugs through the buccal mucosa, reduces gastrointestinal exposure, and improves clinical pain points such as severe diarrhea, liver toxicity, and inconvenience in swallowing that may be caused by current capsule dosage forms. Studies in Japan and the United Kingdom have shown that improving medication compliance with anti-fibrotic drugs is expected to reduce the overall risk of death by about 15% to 26% and extend the median survival period by about 4 months to more than 1 year. This shows that improved dosage forms not only improve convenience, but may also bring substantial therapeutic benefits.