With the global biosimilar industry undergoing structural transformation and contract development and manufacturing organization (CDMO) demand surging, Tanvex BioPharma (Tanvex-KY) and EirGenix are both accelerating expansion through “dual-base strategies” and “fully integrated capacity,” positioning themselves to compete on the international stage.
Tanvex CEO Stephen Lam previously noted that global pharmaceutical production is shifting toward “localized manufacturing,” especially in the U.S. market, where post–supply chain restructuring has led to soaring CDMO demand for partners with international regulatory expertise and flexible production capacity. Tanvex has adopted a “dual-base, dual-strategy” model: its Zhubei facility focuses on early-stage development and technology platforms, while the San Diego facility specializes in commercial-scale manufacturing and market launch support.
The San Diego site currently operates four 1,000-liter bioreactors and is expanding with two additional 2,000-liter production lines, expected to begin operations in the first quarter of next year. The site also has room for further expansion up to 5,000 liters to meet customers’ future commercial production needs.
Tanvex Chairman Bobby Sheng stated that the company currently has 25 ongoing collaboration projects with a combined potential market value of approximately US$71.8 million. Around 40% of these involve post-approval commercial production, and about half originate from U.S. clients. A prime example is the company’s partnership with global pharmaceutical firm Cipla on the TX-01 biosimilar, which not only generated US$4.5 million in upfront and milestone payments but also officially initiated the commercial production cycle at the San Diego facility.
Tanvex noted that this collaboration will provide a steady stream of CDMO supply revenue, expected to utilize around 10% to 15% of the company’s existing capacity, serving as a key driver of sustainable growth.
Meanwhile, EirGenix is advancing on three fronts—reverse engineering, international certification, and strategic alliances—to strengthen its global presence. In addition to maintaining stable order flows from Japanese, European, and U.S. clients, its first biosimilar for breast cancer, EG12014, has already received two regulatory approvals. In collaboration with global generic drug leader Sandoz, the product is expected to obtain U.S. FDA approval and enter the market in the first half of next year following supply chain improvements and supplemental filings.
EirGenix’s CDMO business is also gaining momentum. Its Xizhi microbial production facility has obtained Japan’s Ministry of Health, Labour and Welfare (MHLW) GMP certification and is now supplying active pharmaceutical ingredients (APIs) for a Japanese client’s commercial launch. The company’s new Zhubei plant, currently under expansion and scheduled to begin operations next year, will increase production capacity ninefold to support commercial-scale manufacturing of recombinant proteins and pDNA plasmids, key starting materials for mRNA and viral vector platforms.
Resource: CDMO需求增 泰福、台康生擴產卡位
