TTY Biopharm Co Ltd. (4105: Taiwan) announces that TS-1® Capsule, an oral anti-cancer drug, has Taiwan FDA approval for the treatment of previously platinum chemotherapy treated locally advanced and metastatic non-small cell lung cancer. This is the fourth indication for TS-1® Capsule in Taiwan.

According to the Health Promotion Administration, lung cancer is ranked 3rd in cancer incidence and 1st in cancer mortality in Taiwan in 2015. In 2015, 13,806 patients were diagnosed as lung cancer and around 60% of the patients are diagnosed in advanced stage (stage IIIB/IV). If the patient has EGFR or ALK mutation, the patient can receive target therapy and then platinum chemotherapy following progression. If the patient does not have EGFR or ALK mutation, chemotherapy will be first line of treatment. Regardless of whether the patients received first line target therapy or chemotherapy, patients will receive intravenous chemotherapy as second or later line treatments. In Taiwan, around 70% of the patients will receive second line treatment, which is mostly intravenous chemotherapy.

Starting September 12, patients will have a new oral anti-cancer drug option. TS-1® Capsule is the first oral anti-cancer drug to received approval in platinum treated failure locally advance and metastatic non-small cell lung cancer. This approval was based on non-inferiority of TS-1® Capsule to current standard of care in a Phase III Asian EAST-LC study conducted in Japan, Taiwan, Hong Kong, Singapore, and China. This Asian study demonstrated TS-1® Capsule is as effective as intravenous docetaxel with additional benefit of providing patients better quality of life and less hematological toxicity.

About EAST-LC Study EAST-LC is a randomized phase III study aims to prove non-inferiority of S-1 monotherapy to docetaxel in patients with previously platinum chemotherapy treated NSCLC in Asia. A total of 1,154 patients from 88 centers in Taiwan, Japan, Hong Kong, Singapore, and China were enrolled. In Taiwan the enrollment hospitals included National Taiwan University Hospital, Tri-Service General Hospital, Linkuo Chang Gung Memorial Hospital, Taichung Veterans General Hospital, and China Medical University Hospital. Study demonstrated S-1 is non-inferior to docetaxel in terms of overall survival, with manageable toxicity and the results have published in the journal, Annals of Oncology.

About TS-1® Capsule TS-1® Capsule, a member of the fluoropyrimidine class, is an oral chemotherapy combining three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anti-cancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU in the liver; and oteracil (Oxo), which decreases 5-FU phosphorylation in the gastrointestinal tract.
It has been marketed in Japan since 1999 and is approved in over 44 countries. Since the approval in 1999, TS-1® Capsule has become the standard of care for gastric cancer in Japan and was subsequently approved for six other indications: for the treatment of colorectal, head and neck, non-small cell lung, and metastatic breast, pancreatic, and biliary tract cancers.
TS-1® Capsule was developed by Taiho Pharmaceutical Co., Ltd., a Japan-based pharmaceutical company, and licensed to TTY for development and marketing in Taiwan. In Taiwan, TS-1® Capsule has been approved for treatment of Stage II (exclude T1) and Stage IIIA-IIIB gastric cancer patient after radical surgery, unresectable metastatic gastric cancer, locally advanced and metastatic pancreatic cancer, and in combination with irinotecan in oxaliplatin treated failure metastatic colorectal cancer.
For more information about TS-1® Capsule, please visit http://www.ts1.com.tw/TS-1_com/index.asp

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.
For more information about TTY Biopharm, please visit http://www.tty.com.tw/

About Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), 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 for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. 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 aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives.
For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en/