GongWin (KY), a Biopharmceutical company, will be listed on the over-the-counter market in June this year. General Manager Mao-Yuan Lin stated on the 16th that GongWin's central-type lung cancer severe tracheal obstruction new drug, PTS302, has been officially procured by 12 Grade III hospitals since its sale in China in 2023. The company aims to have 45 Grade III hospitals complete procurement this year. GongWin will also create a global first in Taiwan by utilizing compassionate use therapy to improve malignant pleural effusion (MPE) in end-stage cancer patients with the PTS new drug, with the goal of initiating formal phase II/III clinical trials this year.
Analysts predict that as the PTS302 drug market gradually opens up, GongWin's revenue target for this year is expected to reach NT$150 million, challenging the breakeven point.
GongWin's consolidated revenue was NT$189.15 million last year, with a net loss per share of NT$0.81. Consolidated revenue for the first three months of this year was NT$54.87 million. Mao-Yuan Lin explained that the main reason for the operation not yet being on track is that oncologists in China are still familiarizing themselves with this new drug therapy. The treatment with PTS302 requires the drug to be injected into cancer cells through image-guided positioning technology. Although patients from 50 hospitals have started using this novel treatment, only 12 Grade III hospitals have officially begun procurement.
GongWin's target for the Chinese market this year is to have 180 hospitals use PTS302, with 45 Grade III hospitals making formal procurements. The medium to long-term plan is to have over 400 Grade III hospitals in China officially procure PTS302. In addition to the Chinese market, GongWin is also applying for PTS302 drug certification in Singapore. Before obtaining formal certification, it has obtained special approval for importation into Singapore and Malaysia. The next step includes applying for special importation approval in Thailand and Japan.
In addition to overseas markets, Mao-Yuan Lin explained that GongWin is the domestic company with the most approved compassionate use therapies. In addition to obtaining drug certification for central-type lung cancer severe tracheal obstruction in China, based on the spirit of humanitarian aid, GongWin cooperates with hospitals in Taiwan to provide compassionate treatment drugs for end-stage cancer patients with PTS. He explained that after more than 100 cases of compassionate treatment, it was found that 50% of medical interventions targeted improvement in malignant pleural effusion in end-stage cancer patients. Results showed that 40% of patients experienced significant improvement after receiving PTS injections.
Mao-Yuan Lin stated that with the support of the Center for Drug Evaluation (CDE) under the Foundation for Medical Inspection and Drug Regulation, GongWin is conducting a retrospective study of PTS compassionate treatment through Taipei Veterans General Hospital, which is expected to be completed in the third quarter of this year. The research report will serve as one of the supportive data for the multicenter clinical trial of malignant pleural effusion (MPE) in the fourth quarter of this year. There is a chance to initiate phase II/III clinical trials this year, striving to develop the world's first new drug to improve malignant pleural effusion.
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