Tanvex BioPharma, a subsidiary of the Bora Group, announced yesterday (June 30) that it has licensed its biosimilar NYPOZI to U.S.-based pharmaceutical company Invagen for commercial sales in the United States. Industry insiders note that this marks a new chapter for Tanvex, as it officially enters the global market with product launches expected to generate revenue, royalties, milestone payments, and profit-sharing income.

Tanvex stated that NYPOZI is not only its first biologic to be launched in the U.S., but also the first Taiwan-developed and Taiwan-manufactured biosimilar to receive U.S. approval. The product is set to launch in the second half of this year, marking two industry firsts.

Tanvex BioPharma USA, Inc., the company's U.S. subsidiary, has signed a licensing, sales, and manufacturing agreement with Invagen Pharmaceuticals, Inc., a wholly owned U.S. subsidiary of global pharmaceutical giant Cipla. Together, the companies will drive the commercial production and market launch of NYPOZI in the U.S. NYPOZI is a biosimilar to Neupogen, a white blood cell growth factor.

Under the agreement, Cipla will be responsible for marketing and selling NYPOZI in the U.S. market. Tanvex USA, as the manufacturer of record, will handle full-scale production and supply. Tanvex will generate commercial returns through product supply revenue, royalties, milestone payments, and post-launch profit sharing.

This is the first product from Tanvex’s San Diego facility—already approved by the U.S. FDA—to enter commercial production for the U.S. market. The strategic partnership not only brings to fruition Tanvex’s years of investment in biosimilar development, but also allows the company to concentrate its resources on expanding its CDMO business under the Bora Biologics brand. Moreover, it establishes Bora Biologics’ first commercial manufacturing track record in the U.S. market.

Stephen Lam, CEO of Tanvex, stated that the collaboration with Cipla to bring NYPOZI into the U.S. demonstrates global recognition of Tanvex’s R&D capabilities. He emphasized that this milestone represents a groundbreaking achievement for Taiwan's biotech sector, as it sees a domestically developed biosimilar successfully enter the U.S. market. Looking ahead, Tanvex will further concentrate its efforts on expanding its global CDMO services to meet the growing demand for high-quality biologics worldwide.

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