TTY Biopharm and Taiho Pharmaceutical entered in an exclusive agreement of LONSURF® has received license approval from TFDA.

2018.1.15 最新消息

TTY Biopharm’s oncology drug LONSURF® has received license approval from Taiwan Food and Drug Administration, indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
TTY Biopharm (4105.TWO) continues its commitment to strengthen oncology business with continuous investments in developing new drugs and optimizing product portfolio for decades. TTY Biopharm signed an agreement with Taiho Pharmaceutical Co., Ltd. (Japan) last year and received an exclusive license to present registration dossier, develop new indications and launch LONSURF® in Taiwan.
For the past decade, colorectal cancer is the most common cancer in Taiwan. According to Taiwan Cancer Registry, 15,764 new cases of colorectal cancer were diagnosed in year 2014. Among of these new cases, around 17% of them were stage IV status and its 5-year survival rate is merely 12%.
LONSURF® is an oral combination anticancer drug consisted of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase inhibitor, tipiracil, at a molar ratio 1:0.5 (weight ratio, 1:0.471). Inclusion of tipiracil increases trifluridine exposure by inhibiting its metabolism by thymidine phosphorylase. Following uptake into cancer cells, trifluridine is incorporated into DNA, interferes with DNA synthesis and inhibits cell proliferation. Trifluridine/tipiracil demonstrates anti-tumor activity against KRAS wild-type and mutant human colorectal cancer.
1In the Phase III study (RECOURSE), the results of LONSURF® versus placebo group, on top of Best Supportive Care, in patients with previously treated metastatic colorectal cancer (mCRC), has showed a statistically significant 32% reduction in the risk of death and 52% reduction in the risk of progression. 2The most frequently observed clinically significant adverse events associated with LONSURF® were neutropenia, which occurred in 38% of those treated, and leukopenia, which occurred in 21%; 4% of the patients who received LONSURF® had febrile neutropenia, and one death related to LONSURF® was reported. The clinical efficacy and safety results were published on the New England Journal of Medicine and have already supported registration of LONSURF® for the treatment for advanced metastatic colorectal cancer 3in 41 countries and regions including Japan, U.S., EU, and Australia.
TTY Biopharm endeavors to specialize in the anti-cancer area and develop special drug formulations, especially well-known liposome products and other special delivery systems. Through building global partnerships and collaboration agreements, this new agreement of licensing in new oral oncology drug accelerates the completion of TTY Biopharm’s product portfolio, and also strengthens its technology platform to cure cancer related diseases, and brings more benefits to patients.
1 “Mayer R, Van Cutsem E, et al. Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer. N Engl J Med 2015; 372:1909-19.”
2 Extracted from the RECOURSE mayer article
3 “As of December 13, 2017”

<About Taiho Pharmaceutical Co., Ltd.>
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (, is an R&D-driven specialty pharma focusing on the three fields of oncology, allergy and immunology, and urology. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan, and is promoting business globally. In areas other than oncology as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also offers consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives.

For more information about Taiho Pharmaceutical, please visit

<About TTY Biopharm Co., Ltd.>
TTY Biopharm Co., Ltd. (4105.TWO), is a leading large-scale company which develops new medical entities, including innovative therapeutic modalities to fulfil unmet medical needs and devotes to R&D and manufacture on specialty products in drug delivery systems, i.e., liposome and microsphere technology. TTY is well-known for its continuous self-innovation and accumulated knowledge, technology and networked relationships from 1960. Globally, TTY has led in super-generic drugs and special formulations and had dealer distribution networks around the world and three main Asian subsidiaries in Vietnam, Philippines and Thailand; in Taiwan, TTY has ranked in top 1% of largest biopharmaceutical companies in oncology and critical infection fields. TTY has succeeded in penetrating its own R&D products into international regions and has become the best partner with global companies. TTY is not satisfied with triumphing in Taiwan and certain Asian markets only. In the future, based on its expertise in Asian markets, TTY will continue to strengthen its position in international markets through developing high-barriers and prove of concept new drugs and bio-drugs with innovative formulations. TTY’s collaboration and investments in developing drugs and innovative agents of novel ingredients will be expected. A long-term and sustainable growth will be thrived.