Lin Mao-Yuan, General Manager of Gongwin Biopharm, stated yesterday (15th) that since the launch of their new drug PTS for treating severe tracheal obstruction in central lung cancer in China in August last year, 52 hospitals have already completed the first prescription, with an expected increase to 90 by July. In addition to China, PTS is also applying for approval in Singapore, with plans to further penetrate the ASEAN and Australian markets.
Gongwin Biopharm will be listed on the Growth Enterprise Market in mid-June, with a tentative offering price of 136 NTD per share. The company will hold a pre-listing performance briefing today. Analysts estimate that Gongwin Biopharm's target sales volume for PTS in Chinese hospitals this year is expected to reach 3,800 to 5,000 units, challenging the breakeven point for operations this year.
Lin Mao-Yuan, General Manager of Gongwin Biopharm, stated that PTS is the world's first product that can directly inject tumors, causing cancer cells to die without harming normal cells. PTS302, used to treat severe tracheal obstruction in central lung cancer, was included in the Chinese Pharmacopoeia in 2020 and officially launched in China in 2023. Gongwin Biopharm spent 20 years to successfully transform industrial-grade materials into medical-grade materials through patented technology, becoming the only Taiwanese drug listed in the Chinese Pharmacopoeia.
Lin Mao-Yuan said that in addition to being listed in the Chinese market, PTS has recently obtained approval in Singapore through the "Named Patient Drug Program (NPA)" and is preparing to provide the new drug to patients in Singaporean hospitals. After collecting local case efficacy results, the company plans to formally submit an application for Singaporean drug approval in the second quarter and, after passing the inspection in Singapore, will also enter other ASEAN countries such as Malaysia and Thailand. Taiwan aims to obtain drug approval by 2026.
Lin Mao-Yuan stated that since obtaining market approval in August last year, PTS has covered 52 tertiary hospitals and the volume of patient medications per month is also increasing. The current monthly revenue growth trend is still an "addition" structure, mainly because China implemented a "two-invoice system" to sell and purchase real drugs. The hospital's drug review committee only meets every few months, and procurement only occurs after approval by the hospital. It takes time to bring in drugs. In addition to the 52 hospitals that have already been entered, there are still more than thirty hospitals where documents have been submitted. It is estimated that by July, 90 hospitals will be reached, and the target for the end of this year is to enter 180 hospitals and issue first prescriptions to 1,000 patients.
As penetration into hospitals increases, Lin Mao-Yuan said that the performance in the second half of the year will gradually enter a "multiplication" structure of rapid growth. This year's sales target is to reach 3,800 to 5,000 units. Analysts estimate that with a selling price of 8,000 RMB per injection, minus annual expenses of 120-150 million RMB, there is a chance for the operation to break even.
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