Taipei, May 2, 2018
Gongwin Biopharm Co., Ltd. (hereinafter referred to as “KY”, stock code: 6617) handled 5.5 million shares of cash increase at a price of 54 yuan per share. It was successfully completed today and raised a total of 297 million yuan, which will be used to enrich working capital. In response to the implementation of the PTS100 liver cancer new drug phase II clinical trial in Taiwan, and the PTS302 lung cancer new drug in the future to obtain the Chinese market sales plan. Since the counter buying center has a net value of no less than two-thirds of the equity in applying for listing, KY said that after the successful completion of the capital increase, the company’s net worth has increased from 584 million yuan at the end of last year to 800 million yuan. Left and right, in line with the high standard, the net value should not be lower than the two-thirds of the relevant provisions of the share capital, and the first shot for the IPO plan of the future company to apply for the listing cabinet.
The company's PTS anticancer drug line includes PTS302 for severe airway obstruction in central lung cancer, PTS100 for primary liver cancer, PTS-02 for adenoid cystic carcinoma, and PTS500 for malignant pleural effusion. China, Taiwan, the United States, New Zealand and Australia and other markets are on the layout. Among them, the new lung cancer drug PTS302 has been submitted to the China Food and Drug Administration (CFDA) for application for the New Drug Inspection and Registration Review (NDA) at the beginning of this year, and has been officially approved for priority approval. The fastest Chinese medicine certificate is expected this year. Approved; Kyin-KY pointed out that PTS302 has adopted the innovative "minimally invasive targeted chemical ablation treatment" technology, which has the advantages of minimal wounds and no side effects of common chemotherapy, which is superior to the current therapy. The Chinese market sales plan will set up a seed education training team to promote more than 2,379 tertiary hospitals in China's provinces. PTS302 is expected to become a serious airway obstruction in China with central lung cancer after obtaining Chinese medicine certificates. The first line of treatment for patients undergoing surgery.
On the other hand, PTS100 liver cancer new drug has officially launched the second phase of human clinical trial in cooperation with National Taiwan University Hospital in February this year. It is expected that 30 patients will be admitted to the liver cancer patients who have failed to reach the standard of therapeutic treatment of arterial embolization. It is expected that the clinical acceptance and the first year of follow-up of the subject will be completed by the end of 2019, and then the application for the clinical phase III trial will be submitted. Gongxin-KY stressed that in addition to PTS100, PTS-02 and PTS500, the company still has other anti-cancer new drug product lines under development, and will have the opportunity to conduct relevant clinical trials in the future. The company believes that KY will build the future global PTS clinical drug production. The base, which was approved by the Ministry of Science and Technology in April this year, has been stationed in the Hsinchu Biomedical Park and is expected to be officially opened in 2020.
Looking forward to the future, the company believes that PTS302 is officially included in the green channel for CFDA priority approval. Under the reform trend of the Chinese government to speed up the listing of new drugs and shorten the approval process, it is expected to take the lead in paying attention to the company's overall operation and show good growth momentum. . Gongxin-KY said that it will gradually complete the establishment of a new drug research and development center and a PTS clinical drug production base in Taiwan, and continue to actively build a complete global treatment and sales map of PTS anticancer drugs to create a future overall operational contribution.
Pierre Hsiao, Assistant GM, Gongwin Biopharm (02)2503-5282 email@example.com
Assistant Manager, Ning Deng, IR Trust (02)2585-5705/0911-705-207 firstname.lastname@example.org
Gongwin Biopharm Holdings Co., Ltd. (stock code: 6617), founded in 2014, is a Taiwan-based biotechnology pharmaceutical company which focuses on the development of small molecule anti-cancer chemical ablation new drugs. Gongwin-KY steps away from traditional cancer treatment thinking, combines with minimally invasive surgery, and develops new anticancer drugs with PTS as the main active ingredient, providing cancer patients an option to directly eliminate tumors. PTS’s new drug development began in the 1980s. After years of research, in 2011, the inventors John Wu and Dr. Shi Jia-Shun completed Phase III clinical trial of PTS-302 new drug applied on non-small cell lung cancer in China. They also accelerated the application for a drug certificate from China CFDA.
In view of the maturity and energy of Taiwan's R&D environment and its global layout consideration, PTS International Inc. established Gongwin Biopharm and Gongwin Biopharm Holdings, respectively, in Taiwan in 2014, and completed the integration and restructuring in December 2015. Based in Gongwin Biopharm, a subsidiary of Gongwin Holdings, as its operational headquarters, it promotes the Group's global new drug research and development, clinical research, manufacturing technology, international licensing and marketing planning and promotion, truly based in Taiwan and looking out to the whole world.
This document and related information published at the same time contain predictive statements. Except for the facts that have occurred, all descriptions of future business operations, possible events and prospects (including but not limited to predictions, objectives, estimates, and operating plans) of Gongwin (hereinafter referred to as “the Company”) are all forward-looking statements. Predictive narratives are subject to different factors and uncertainties, causing considerable differences from the actual situations, and the factors include, but are not limited to, price fluctuations, actual demand, exchange rate fluctuations, market shares, market competition, laws, finance, and changes in the regulatory structure, international economic and financial market conditions, political risks, cost estimates, and other risks and variables beyond the control of the Company. These predictive narratives are based on predictions and estimations of the current situations, and the Company shall not be responsible for future updates.