Gongwin Biopharm (Gongwin-KY) announced yesterday (16th) that its subsidiary, Gongwin Biopharm Taiwan, has secured two key licensing deals for its lung cancer drug PTS302.
Following the signing of a Memorandum of Understanding (MOU) in May with Company F in Malaysia, both parties have now finalized a formal agreement. Under the agreement, Company F obtains the rights to register, commercialize, and distribute PTS302 in Malaysia. Gongwin Biopharm Taiwan will receive an upfront signing fee and milestone payments. Upon regulatory approval and market launch, Gongwin Biopharm Taiwan will be responsible for manufacturing the product, while Company F will serve as the distributor in Malaysia.
In addition, Gongwin Biopharm Taiwan signed an MOU yesterday with Company G to collaborate on a bridging clinical trial and drug registration for PTS302 in Taiwan. Once the drug is approved for market entry, both parties will jointly apply for National Health Insurance pricing and co-market the product. According to the MOU, Gongwin Biopharm Taiwan will receive milestone payments for the license and both companies will share the clinical trial costs and future sales profits.
Morrice Lin, General Manager of Gongwin-KY, noted that lung cancer remains the leading cause of cancer incidence and mortality worldwide. In advanced stages, tumors may obstruct the central airways, causing severe breathing difficulties and significantly impairing quality of life, often with life-threatening consequences. This reflects a major unmet medical need.
PTS302 targets malignant airway obstruction (MAO), the most challenging and fatal form of lung cancer, and is an innovative, minimally invasive, targeted tumor ablation drug. It has already received Class 1 New Drug approval in China (under the name "Tobesulfonamide Injection") and has been adopted in more than 200 top-tier and large hospitals, treating over a thousand cancer patients. The product is currently a major revenue driver for the company. In Taiwan, PTS302 has been used in compassionate care treatments, with its safety and therapeutic benefits receiving strong endorsement from the medical community.
To accelerate global regulatory approvals and commercialization of PTS302, Gongwin-KY has reached licensing agreements with both Company F and Company G, securing a presence in the Malaysian and Taiwanese markets as strategic entry points into the broader Asia-Pacific region.
Gongwin-KY noted that Company F was formerly the Malaysian subsidiary of a prominent Japanese corporation and has operated in Malaysia for over 30 years, specializing in oncology, pulmonary medicine, and urology. Company G brings over 60 years of regulatory and industry experience, with operations spanning pharmaceuticals, medical devices, aesthetic medicine, and health supplements. Its client portfolio includes global names such as Italy’s Chiesi, the UK’s AstraZeneca, and India’s Zydus Cadila and Glenmark. With its well-established medical sales channels in Taiwan, Company G will be a vital partner in driving market access.
The partnership with these two strategic collaborators is expected to accelerate the development and launch of PTS302 in Taiwan and the Asia-Pacific region, creating a win-win outcome for all stakeholders.
According to a market research report by Japan-based Global Information Inc. (GII), the lung cancer treatment market in the Asia-Pacific region was valued at USD 3.778 billion in 2022 and is projected to reach USD 10.96 billion by 2030, with a compound annual growth rate (CAGR) of 14.2%.
Resource: 共信-KY肺癌新藥PTS302插旗馬國、台灣，加速亞太市場開發
