Gongwin BioPharma's anti-lung cancer drug PTS302 is in its final stage of approval, and the Chinese drug certificate is expected to be issued this quarter. In addition to GWA301, which was approved by the U.S. FDA for animal drug trials and will begin to contribute to sales, we have also signed distribution and licensing agreements with our Australian distributor for Australia and New Zealand.
In the third quarter, the company announced its subsidiary had obtained a manufacturing license from the National Pharmaceutical Administration of China (NMPA). In the first year, the product will be introduced into 130 professional hospitals, reaching 25,000-30,000 people, and 800 hospitals in four years.
With the launch of PTS302 in China, the international market has also been activated, initially targeting six countries in Southeast Asia that have recognised the Chinese drug certificate. According to Gongwin, in the final stage of waiting for China's new anti-lung cancer drug certificate, PTS302 has already gained the attention of pharmaceutical companies in neighboring Asian countries, and related commercial activities have quietly started. Such a strategy of bilateral recognition of pharmaceutical regulations can also be quickly applied to advanced countries such as the European Union and North America. We will be able to capture the opportunity of the 2.2 million or more new lung cancer cases each year worldwide.
In terms of the development of new animal cancer drugs, the company announced on the 25th that it has entered into a licensing agreement with its Australian distributor for the registration, development and commercialisation rights for animal drugs in Australia and New Zealand and related collaboration matters. According to Co-credit, with the US FDA approving GWA301 as a "conditional approval drugs", many countries are excited about the possibility of selling drugs while conducting clinical (field) trials for animal cancer. Potential partners in New Zealand and Australia are currently actively consulting with the Australian Pesticides and Veterinary Medicines Authority (APVMA) on the possibility of promoting a similar approach in Australia, with a view to extending it to the pet horse market. Once it is viable in Australia, it will quickly spread like wildfire to other countries around the world.
The corporation noted that it believes it will see revenue from the US/China next year. Annual sales of the cancer drug in China are expected to reach RMB2.56 billion in 3-5 years after launch, which translates to over NT$10 billion. If we can quickly sign cooperation agreements with Singapore and Australia, there will be a steady stream of opportunities for international drug licensing and the company's brand awareness will be on the international stage.
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