At a conference on April 1st, Tanvex BioPharma-KY's newly appointed Chairman, Chen Lin-Cheng, emphasized that the core strategy of focusing on biosimilar drugs and expanding the layout of Contract Development and Manufacturing Organization (CDMO) remains unchanged. The most anticipated biosimilar drug, TX01, for treating neutropenia, has received positive responses from the U.S. Food and Drug Administration (FDA) after multiple communications. Chen expressed hopes of sharing news soon.
Chen stated that to concentrate resources, Tanvex BioPharma, besides vigorously pursuing CDMO client orders, currently focuses only on TX01 and TX05, biosimilar drugs for treating breast cancer. After maximizing the value creation of these two drugs upon market launch, Tanvex BioPharma will then invest in the development of other biosimilar drugs such as TX04 for long-acting treatment of neutropenia.
Awaiting drug approval, Tanvex BioPharma reported a net loss per share of NT$16.58 last year. Analysts believe that with the expansion of the CDMO business and the potential approval of TX01 and TX05, the company's operations will gradually improve.
In line with the global trend of outsourcing biotech pharmaceutical development and manufacturing services, the government is heavily investing in the CDMO field this year. Chen highlighted Tanvex BioPharma's strategic advantage in accurately and correctly positioning itself in this market two years ago, providing a one-stop service business model.
Chen mentioned that due to Tanvex BioPharma's competitive advantage, ranging from Non-GMP pre-clinical trial production CDMO services to GMP contract manufacturing approved by the FDA, coupled with the ongoing struggle between China and the U.S., U.S. pharmaceutical companies are gradually shifting their CDMO orders away from Chinese-certified factories. Tanvex BioPharma's U.S. factory also enjoys a niche market. It has recently begun to accept orders, albeit with limited short-term revenue contribution, but with promising potential for medium to long-term development.
As for the biosimilar drug field, Tanvex BioPharma continues to strive towards becoming Taiwan's first company to independently research, develop, and successfully enter the commercial market in the United States. Currently, the application for inspection registration of the TX01 drug for market entry is pending final review notification from the U.S. FDA. Based on communications with the FDA, all responses have been positive. Chen expressed hopes of sharing news with everyone soon.
Chen stated that with the shift in product strategy, T anvex BioPharma will actively undergo organizational restructuring, cost control, and manpower optimization to streamline costs and enhance operational performance.
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