HanchorBio (Hanchor-KY), focused on innovative anti-cancer drug development, announced on the 25th that its first cash capital increase for fiscal year 2025 has been successfully completed. The company issued 10,000 new shares at a premium of NT$68 per share, raising a total of NT$680 million, all of which has been fully received. The raised funds will be used to strengthen operational capital and, in addition to advancing the clinical trials of protein-based innovative drugs HCB101 and HCB301, will support several preclinical, first-in-class multifunctional biologics to accelerate their development and entry into clinical trials.

Chairman Scott S. Liu expressed gratitude to all shareholders for their recognition and support of the company’s drug development and operational growth. He noted that, due to strong subscription demand, some directors voluntarily waived their subscription rights to allow key investors to participate. The capital raised will primarily support ongoing clinical trials of HCB101 and HCB301, both of which possess broad-spectrum anti-cancer potential.

HCB101 is a highly specific 3.5th-generation SIRPα/CD47 fusion protein. In March 2025, it initiated an open-design, global, multicenter combination therapy Phase 1b/2a trial, targeting six major cancer types—gastric, colorectal, triple-negative breast, head and neck, small-cell lung, and liver cancers—covering 12 indications, with over 100 patients expected to be enrolled.

HCB301, a first-in-class multifunctional tumor immunotherapy biologic, has received Phase 1 clinical trial approval from the U.S. FDA and China’s NMPA. In April 2025, patient recruitment began for low-dose cohorts targeting advanced solid tumors and refractory classical Hodgkin lymphoma. The study plans dose escalation every six weeks and expects to complete Phase 1 trials by the end of 2026.

Liu highlighted that HCB101 already achieved its first licensing milestone by the end of June 2025, granting exclusive market development and sales rights in China and selected other territories to Shanghai Henlius for a total upfront licensing amount of up to US$202 million. Among the treated patients, 21 triple-negative breast and gastric cancer patients in China’s top-tier hospitals and 3 colorectal cancer patients in Taiwan showed controlled disease (SD; 8 cases) or significant tumor reduction (PR; 8 cases). Notably, in the mid-dose cohort (5–8 mg/kg) for second-line gastric cancer, the objective response rate (ORR) reached 100%.

Leveraging HCB101’s unique mechanism of action and promising clinical results, HanchorBio plans to seek Orphan Drug Designation (ODD) from the U.S. FDA and EU EMA, as well as Breakthrough Therapy Designation in the U.S., EU, and China to accelerate the drug’s market approval.

Liu emphasized that gastric cancer remains a prevalent malignancy with high incidence and mortality in both China and Taiwan. Treatment options for first- and second-line therapies are limited, and standard second-line treatments show poor efficacy, with a five-year survival rate as low as 31.6% in Taiwan. HanchorBio will prioritize the second-line gastric cancer market for HCB101, aiming to accelerate patient enrollment in the Phase 1b/2a trial to obtain ORR, PFS, and OS data, which will support progression to the next clinical stage and ongoing negotiations for global and regional licensing.

Resource: 6.8億現增資金活水到位，漢康-KY多項新藥開發加速向前