HanchorBio-KY, a newly listed emerging drug company, held an investor conference on the 15th. Chairman Scott S. Liu stated that the company’s anti-cancer fusion protein drug HCB101 completed its first external licensing in June this year, with a signing fee of USD 10 million (NT$312 million) already recognized in September revenue. Under the agreement, the company may receive up to USD 192 million in development and sales milestone payments, as well as post-launch sales royalties.
HanchorBio-KY was newly listed on the Emerging Stock Board in June and immediately secured its first HCB101 licensing deal, granting Shanghai Henlius Biotech exclusive commercialization rights for mainland China, Hong Kong, Macau, and select Southeast Asian countries. The company plans to submit an application for listing on the Innovation Board before the end of this year, aiming for a debut in the first half of next year.
Scott S. Liu noted that HCB101 is currently enrolling patients in a global multicenter combination therapy Phase 1b/2a clinical trial. Early data show that nearly all patients in the intermediate-dose, second-line gastric cancer group experienced tumor shrinkage. The company plans to prioritize development for second-line gastric cancer, with global licensing discussions expected to begin once key trial data are obtained next year.
The company aims to address the substantial clinical demand for second-line gastric cancer treatment. Following the collection of critical trial endpoints—ORR (objective response rate), PFS (progression-free survival), and OS (overall survival)—HanchorBio-KY will initiate global and regional partnership negotiations beyond the already licensed territories. Clinical trial data analysis is expected in the second to third quarter of 2026.
Liu highlighted that the total value of the first HCB101 licensing deal reached USD 202 million, significantly higher than the average total deal value of USD 74.6 million and average signing fee of USD 6.4 million for Phase 1 or 1/2 clinical-stage license-in deals in Greater China over the past four years. This sets a new regional record. Given HCB101’s unique mechanism of action and compelling clinical data, the company remains optimistic about its international licensing potential and has already signed NDAs with 30 of the world’s top pharmaceutical companies.
Beyond gastric cancer, HCB101 is also being developed for head and neck cancer. Current first-line treatments rely on immunotherapy or combination chemotherapy, which are highly toxic and often poorly tolerated, especially in elderly patients. Existing clinical data indicate that HCB101 demonstrates clinical efficacy both as monotherapy and in combination therapy. In Taiwan, a principal investigator-initiated Phase 1/2 clinical trial is underway, and the company plans to expand to a global multicenter Phase 1b/2a combination therapy trial, enrolling over 40 patients.
Liu added that using its FBDB technology platform, HanchorBio-KY has developed more than eight innovative protein biologics with broad-spectrum anti-cancer potential. HCB101 and HCB301 are the first to enter human clinical trials. The company plans to accelerate regional and multi-cancer clinical development for these two flagship products while sequentially submitting IND applications for other pipeline candidates. Once any of these anti-cancer drugs succeed, they could potentially target more than ten cancer types, offering enormous market potential, substantial revenue contribution, and enhanced corporate value. HanchorBio-KY remains positive and optimistic about its future prospects.
Resource: 漢康生技抗癌新藥HCB101臨床數據亮眼 拚明年國際授權並轉創新板
