Zhong Nanshan led the troops fighting against COVID-19 and cancer across the strait. Gongwin-KY (6617) stated today (8th) that the new drug review process for its anti-lung cancer drug technology PTS302 is expected to complete in Mainland China in the near future. The industry estimates that the drug certificate may be obtained in the fourth quarter the earliest, and the sales may kick off in the first quarter of next year. Gongwin products are exclusive technologies and shall have a strong oligopoly position in the mainland China market. Revenues are expected to reach NT$ 45 billion within three to five years.
Gongwin-KY’s share price has performed extremely strong recently, and the market is also very curious about the progress of its operations. Regarding the operational aspect, Gongwin-KY stated that its anti-cancer drug PTS302, based in Taiwan and focusing on the mainland China market, and is indicated for "central lung cancer tracheal obstruction". The chief (PI) of its clinical program is Zhong Nanshan, an anti-epidemic expert in mainland China as well as the leader of the high-level expert group on the National Health Commission. Zhong Nanshan has been in charge of Gongwin’s clinical trials in mainland China since phase II. He has led the trials for many years. Under his rigorous supervision and years’ of hard work, the drug certificate is expected to be obtained in the near future.
Zhong Nanshan rarely serves as the chief PI for any cross-strait new drug company. Hence, the industry believes that this project is of indicative significance. Once the drug certificate is obtained, it will be the first case of joint cooperation between the two sides of the strait to develop a key drug for a disease which is common for Chinese people. It is indeed a milestone. Furthermore, as lung cancer has an extensive presence in mainland China market, the potential for future sales is far beyond imagination.
In terms of sales planning, the institutional investors pointed out that Gongwin-KY has already found four sales agents for its anti-cancer drug PTS302 in mainland China. Initially, it plans to launch the drugs in Central China, South China, and North China markets. In the first year, it is estimated that the number of patients treated will be about 10,000. If each person takes five injections, and the unit price per injection is RMB 6,500, the revenues may amount to about NT$1.6 billion. After the drug is brought to the market, 70,000 people may be treated within two to three years. From the fourth year onward, the Company hopes to see 150,000 people receiving treatment, creating NT$24 billion. Based on a conservative estimation, starting from the fifth year, the revenue is expected to reach NT$45 billion.
In particular, in terms of COVID-19, Gongwin-KY also stated that the principal indications for its PTS500 are for the treatment of "malignant pleural effusion", anti-pulmonary fibrosis, and anti-pulmonary inflammation. In severe cases of COVID-19, Pulmonary edema and pulmonary fibrosis and inflammation are the key symptoms causing death.
Gongwin-KY further stated that the PTS500 technology is anti-lung inflammation and fibrosis, and is also expected to substitute for traditional therapies, opening up new opportunities for severe cases of COVID-19. The industry is convinced that under the professional blessing of Zhong Nanshan, it is also expected to become one of the key technologies to fight against COVID-19 for both side of the strait.
In addition, there are six other drug technologies currently under development by Gongwin-KY, including PTS302, applications in lung diseases and animal (canine and cat) cancers, as well as the field of aesthetic medical fat ablation. In the field of animals, there are currently collaborations with a number of animal hospitals, including National Taiwan University Veterinary Hospital; in the field of aesthetic medicine, new cooperation programs will be launched soon.
The founder of Gongwin-KY is John Y. J. Wu, a Taiwanese biomedical expert travling and living in the US. His family is the largest shareholder. Currently, his son Lester Wu serves as the chairman of the board. The Company was established in the US in 2000, formerly known as PTS International. In recent years, the Company has completed re-organization. Currently, PTS International is Gongwin’s subsidiary in the US. Gongwin’s current capital is about NT$1.031 billion, and its major shareholders include many well-known companies, including YC INOX CO., LTD, Nien Hsing Textile Co., Ltd, and SINBON Electronics.
It is reported that in the future, Gongwin’s market in mainland China will be managed by its over 70% owned subsidiary in mainland China, " Tianjin Chase Sun Jiandakang Pharmaceutical Technology Co., Ltd." To commemorate Zhong Nanshan’s contributions to the development of new drugs across the strait and saving countless patients suffering from lung diseases, John Y. J. Wu, the founder of Gongwin, decided many years ago to donate partial equity of Gongwin’s subsidiary "Chase Sun Jiandakang Pharmaceutical " to "Zhongnanshan Medical Foundation of Guangdong Province" founded by Zhong Nanshan; in other words, Zhongnanshan Medical Foundation is currently also a shareholder of Gongwin Group.
It is understood that PTS302, of which the drug certificate is about to be obtained, the drug certification application was filed with the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China in 2018. The clinical verification (unblinding) was approved in October of that year. Data supplementation was completed at the end of 2019. It is now the last mile before the drug certificate is obtained.
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