News&Media

2018-08-08 KY liver cancer new drug PTS100 clinically locked liver cancer patients accelerated phase II trial

201888日,台北

Gongwin Biopharm Co., Ltd. (hereinafter referred to as “KY”, stock code: 6617), a new drug for primary liver cancer (HCC), PTS100, has been approved by Taiwan TFDA for clinical phase II trials and is currently in clinical trials at National Taiwan University Hospital. The trial will evaluate the safety and efficacy of intratumoral injections in patients with primary liver cancer who are not eligible for surgical resection or existing localized treatment. KY said that patients have been evaluated and the goal is to complete the first year of tracking all patients in the next two years.

KY pointed out that its new liver cancer drug PTS100 has been clinically tested under the approval of China's CFDA. At that time, 75 patients with advanced liver cancer received PTS100 injection, and after four weeks of follow-up observation, a total of 60% of the subjects had tumor necrotic area. More than 50% of the subjects; and more than 72% of the subjects' tumors did not continue to deteriorate, and past experience in the human body allowed the PTS100 to successfully conduct clinical phase II trials in Taiwan.

According to the statistics of the Department of Health and Welfare, liver cancer has been one of the top ten causes of cancer death in Taiwan for more than 20 years. It is the leading cause of cancer death in men. The number of deaths due to liver cancer in China exceeds 8,000 each year. The treatment of liver cancer requires According to the size and number of liver tumors, the patient's age and physical condition, the doctors evaluate the common methods such as surgical resection, transcatheter arterial chemoembolization (TACE), radiofrequency ablation (RFA) or leishawa. Because the early symptoms of liver cancer are not obvious, many patients are not suitable for surgical resection and radiofrequency ablation at the time of diagnosis. Hepatic arterial chemoembolization is one of the standard treatment methods for patients with advanced liver cancer. Only after the failure of embolization treatment, only leisha is left. Tile and immunotherapeutic drugs are available.

KY said that the second phase of the clinical trial conducted in cooperation with the National Taiwan University Hospital was to inject the PTS100 into the liver tumor to directly destroy the cancer cells through ultrasound imaging, which is a "mini-invasive targeted chemotherapy". -Ablation Therapy), the target audience is locked in patients with primary liver cancer who are not suitable for surgical resection or local local area treatment. It can fill the gold treatment period before the disease worsens, and expects to bring a disease to patients with liver cancer. Innovative treatments. For further information on clinical information, please visit the Taiwan Drug Clinical Trial Information Network (http://www1.cde.org.tw/ct_taiwan/)


News contact:

Gongwin Biopharm Deputy General Manager Xiao Sixin  (02)2503-5282  pierre@gongwinbiopharm.com

IR Trust    Associate Deng Ning     (02)2585-5705/0911-705-207  tengning@ir-trust.tw

About Gongwin Biopharm:

Founded in 2014, Gongwin Biopharm (Gongwin Biopharm Holdings Co., Ltd., stock code: 6617) is a biotechnology pharmaceutical company based in Taiwan, focusing on the development of new drugs for small molecule anticancer chemical ablation. Gongwin Biopharm breaks away from traditional cancer treatment thinking and combines minimally invasive surgery to develop new anticancer drugs with PTS as the main active ingredient, providing cancer patients with the option of directly eliminating tumors. PTS as a new drug development began in the 1980s. After years of research, the inventors Wu Yizhuang and Dr. Shi Jiaxuan completed the Phase III clinical trial of PTS-302 new drug for non-small cell lung cancer in 2011. And accelerate the application for a drug license to the Chinese CFDA.

In view of the maturity and energy and layout of Taiwan's R&D environment, PTS International Inc. established Gongwin Biopharm and Gongwin Holdings in Taiwan in 2014 and completed the integration and restructuring in December 2015. With Gongwin Biopharm, a subsidiary of Gongwin Holdings, as its operational headquarters, it promotes the Group's global drug research and development, clinical research, manufacturing technology, international licensing and marketing planning and promotion, based in Taiwan and looking to the world.

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