Comparable to K Drug? Anke Biotechnology HuA21 Clinical Data Readout, HER2-Positive Gastric Cancer First-Line Treatment Welcomes Domestic Strong Competitor | New Drug Value Decoding

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Produced by: Sina Finance Listed Company Research Institute

Author: Tianli

The CSCO (Chinese Society of Clinical Oncology) guideline recommendation levels serve as a bridge connecting high-level medical evidence with complex clinical decision-making. It’s not just a simple ranking but a comprehensive assessment considering evidence strength, drug accessibility, and expert consensus, directly influencing the treatment options seen in clinical practice and their prioritization.

CSCO guidelines categorize recommendation levels into three tiers. Level I is the standard treatment most patients should prioritize under current conditions, representing proven efficacy and accessibility for most patients. Level II indicates high evidence but slightly limited access, or slightly lower evidence with high expert consensus. Level III reflects lower evidence but common or exploratory clinical use, deemed acceptable by experts.

In the era of evidence-based oncology, CSCO guidelines are not only pocket references for clinicians but also a benchmark for evaluating the value of innovative drugs. Recently, with the clinical data readout of Anke Bio’s recombinant anti-HER2 humanized HuA21 monoclonal antibody injection in HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma, we analyze the treatment pathway based on CSCO guidelines to explore the drug’s future clinical positioning, market access potential, and breakthrough strategies in market competition.

Gastric/gastroesophageal junction (G/GEJ) adenocarcinoma is one of the common and highly lethal tumors worldwide. Optimization of treatment regimens has always been a focus. For newly diagnosed HER2-positive advanced patients, the standard treatment has upgraded from traditional “trastuzumab combined with chemotherapy” to a triplet regimen of “trastuzumab + pembrolizumab + chemotherapy.” The “Chinese Clinical Oncology Society Clinical Practice Guidelines 2025” list this triplet as a Level I recommendation.

This approval is based on the pivotal KEYNOTE-811 study. Compared to trastuzumab plus chemotherapy alone, adding immunotherapy significantly improves objective response rate (ORR) and survival benefits. The study enrolled 698 patients, randomized 1:1 to receive pembrolizumab or placebo, combined with standard chemotherapy and trastuzumab.

After a median follow-up of 50.2 months, the median overall survival (OS) in the pembrolizumab group was significantly better than the placebo group (20.0 months vs. 16.8 months). Additionally, the pembrolizumab group showed superior median progression-free survival (PFS) (10.0 months vs. 8.1 months) and ORR (72.6% vs. 60.1%).

Anke Bio’s HuA21 also targets HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma in combination with trastuzumab and chemotherapy. As of February 20, 2025, 60 first-line HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma patients have been enrolled. According to independent radiological assessment, the ORR was 80.8% in the HuA21 (30 mg/kg) group and 76.7% in the HuA21 (20 mg/kg) group, showing strong anti-tumor activity. The disease control rates (DCR) were 96.2% and 100%, respectively, with median PFS and OS data not yet mature.

From current data, HuA21 combined with trastuzumab and chemotherapy shows promising signals in ORR and DCR (ORR 76.7%-80.8%, DCR over 96%). When compared head-to-head with the pembrolizumab group from KEYNOTE-811, these results are competitive. However, in oncology, overall survival (mOS) remains the gold standard for drug value. HuA21’s median PFS and OS data are not yet mature; if future results confirm non-inferiority or superiority in survival benefits, it will solidify its market entry.

From a competitive perspective, the trastuzumab + pembrolizumab + chemotherapy triplet is already widely used in clinical practice, with high evidence levels, good accessibility, and a Level I recommendation in CSCO guidelines, making it the first-choice regimen for clinicians.

As a newcomer, HuA21 must make two key leaps to change this landscape. First, achieve insurance coverage. Although pembrolizumab is included in the national insurance list, its price remains high. As a domestically developed innovative drug, HuA21 can leverage pricing strategies and negotiate with the government to enter the insurance catalog at a more cost-effective price, significantly improving accessibility. Drawing on the successful experience of Henlius’ biosimilar trastuzumab (Hanquyu), domestic alternatives have natural advantages in price-sensitive Chinese markets.

Second, secure CSCO guideline recommendation. This requires solid clinical data and strong expert consensus. Currently in Phase II, HuA21 needs to initiate large-scale Phase III confirmatory trials to generate enough evidence to influence guideline updates. Additionally, academic promotion and collaboration with authoritative institutions like CSCO will be crucial for long-term adoption and recognition among clinicians.

Regarding market size, the potential for first-line HER2-positive gastric cancer treatment is substantial. With 32,000 to 65,000 new HER2-positive gastric cancer cases annually in China, and a treatment cycle of 6-12 months, assuming 50% of patients receive standard treatment and an annual treatment cost of 100,000–150,000 RMB, the market size could reach 1.6 to 4.8 billion RMB per year. If HuA21 captures 10%-15% of this market, annual sales could be between 160 million and 720 million RMB, supporting its position as a core product for Anke Bio in oncology.

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