News&Media

2018-10-11 China Drug Certification Review Progress for Gongwin-KY Lung Cancer New Drug PTS302 is Worthy of Attention and Optimistic Market Prospects are anticipated

October 11, 2018, Taipei

Gongwin Biopharm Holdings Co., Ltd. (hereinafter referred to as “Gongwin-KY”, stock code: 6617) is a new drug development company which positions itself in minimally invasive intervention/topical therapy. The core technology of targeted tumor-ablation, established by Gongwin-KY, involves injecting drugs directly into tumors by means of minimally invasive intervention; it is characterized by concentrating the drug on the tumor site, therefore, the surrounding normal tissues are less affected, it has a high degree of safety, and, at the same time, it can effectively eliminate tumor cells. Through this core technology, Gongwin-KY currently has two PTS anti-cancer drugs, including lung cancer new drug PTS302 and liver cancer new drug PTS100, and they are in the inspection and registration, and clinical phase II stages, respectively.

The clinical trials of lung cancer new drug PTS302 in China from Phase I to Phase III were led by Zhong Nan-Shan, the father of respiratory tract in China. The clinical trial data on-site verification of this product was conducted by Center of Food and Drugs Inspection (CFDI) of CFDA last month. According to the latest announcement by CFDA, there are only 17 domestically-manufactured category one new drugs which have been included on the priority review and approval list, and Gongwin-KY’s PTS302 is also listed among them, and it is one of the few new drugs targeted for the treatment of malignant tumors. Therefore, well-known Chinese medical media is optimistic about the future market prospects of this drug, and the inspection, registration and review are also highly valued by the Chinese respiratory medical community. At present, Gongwin-KY also actively participates in cross-strait respiratory science seminars, with the expectation that after it successfully obtains Chinese new drug certificate for PTS302, it can quickly promote this drug through the sales channels of 300 AAA hospitals with minimally invasive intervention capability, and inject growth momentum for the company's good overall business operation in the future.

Looking forward to the future, Gongwin-KY stated that, so far, not only that the lung cancer new drug PTS302 has made good progress in the Chinese drug certification review, but also that PTS100 for liver cancer treatment is also recruiting patients for its phase II clinical trials in National Taiwan University Hospital. The recruitment is expected to be "inability or unsuitability for surgical resection of tumor, immediate liver transplantation, trans-catheter arterial chemoembolization (TACE) or local removal therapy“, and the targeted number of tumor is less than or equal to 4 per primary liver cancer patient. This trial is guided by ultrasound imaging, through percutaneous puncture, to inject PTS100 into liver tumor to directly eliminate cancer cells, and this is expected to become Taiwan's first representation of tumor minimally invasive treatment in the future. On the other hand, Gongwin-KY continues to actively research and develop new cancer drug, and plans to transfer its research and development laboratory to the its self-purchased Wu-Gu Industrial Park R&D Center. Currently, its procurement of related equipment and decoration are ongoing intensively, and the relocation is expected to be completed in the first half of 2019, refining Gongwin-KY’s overall research and development capacity.


Media Contact:
Pierre Hsiao, Assistant GM, Gongwin Biopharm (02)2503-5282  pierre@gongwinbiopharm.com
Assistant Manager, Ning Deng, IR Trust (02)2585-5705/0911-705-207  tengning@ir-trust.tw


About Gongwin:
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.


Disclaimer:
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.