HanchorBio’s core innovative therapy HCB101 has reached a significant value inflection point following the release of promising clinical data from its Phase Ib/IIa trial in second-line gastric cancer. The mid-dose cohort demonstrated a 100% Objective Response Rate (ORR), in stark contrast to the 26.5% ORR seen with the current standard of care (SOC). Institutional analysts note that this strong result could translate into durable Progression-Free Survival (PFS) and Overall Survival (OS) benefits, potentially accelerating international licensing deals within the next year. Meanwhile, the company’s licensed Chinese partner is expected to submit a New Drug Application (NDA) by the end of 2027.
HCB101 is an advanced 3.5th-generation CD47-targeting fusion protein designed to block the “don’t eat me” signal expressed by cancer cells through CD47 inhibition. This mechanism reactivates macrophage-mediated phagocytosis (innate immunity) and subsequently stimulates T-cell activation (adaptive immunity), generating a comprehensive anti-tumor immune response. CD47 is highly expressed across more than 15 types of cancers, giving HCB101 broad therapeutic potential in both solid tumors and hematologic malignancies.
In the ongoing Phase Ib/IIa trial, the latest data from the combination therapy arm (HCB101 + Ramucirumab + Paclitaxel) for second-line gastric cancer revealed striking results: all six patients in the 5–8 mg/kg mid-dose group achieved Partial Response (PR), resulting in a 100% ORR, which is statistically significant compared to the 26.5% benchmark of SOC.
HanchorBio stated that based on preliminary projections, when the sample size expands, the probability of maintaining an ORR above 40% is 99.9%, while exceeding 60% remains highly likely at 97.2%. The company plans to continue advancing trials with higher doses to obtain comprehensive ORR, PFS, and OS data, aiming to initiate Phase IIb/III studies as soon as possible. Internal evaluations are also underway to apply for Breakthrough Therapy Designation, with the goal of securing conditional approval based on ORR and PFS outcomes, and targeting NDA submission in China by late 2027.
Currently, the standard second-line therapy for gastric cancer offers an ORR of only 26.5% and a median PFS of 4.1 months, underscoring a significant unmet medical need. The global market for first- and second-line gastric cancer treatments is projected to reach approximately USD 4 billion by 2037.
Industry observers noted that many partial response cases have shown continued tumor shrinkage, indicating potential long-term PFS and OS benefits. The impressive mid-dose data are expected to strengthen HanchorBio’s position in global licensing negotiations, and as more efficacy results emerge, they are likely to accelerate partnership discussions, with a deal anticipated within the next 12 months.
Resource: 漢康HCB101步價值跳增拐點，二線胃癌1b/2a中劑量數據助燃國際授權
