Kangfang Biotech: ASCO HARMONi‑6 Preliminary Data—Focus on Whether the OS HR Meets the Threshold

Overview

Bernstein has released a research report previewing the results of Kangfang Bio’s HARMONi‑6 trial at the ASCO 2026 conference. The report notes that market pricing will likely hinge on the interim overall survival (OS) hazard ratio (HR) and whether it meets the high expectations set by the plenary session. The firm maintains a “Market Perform” rating on Kangfang Bio, with a target price of HK$130, arguing that while the data are encouraging, the risk-reward profile remains skewed to the downside and is already partially priced into the recent share-price pullback.

Core views

The core focus is on interpreting the interim overall survival (OS) data from the HARMONi‑6 trial. Bernstein’s base-case scenario projects that the interim OS hazard ratio (HR) will hover near the O’Brien–Fleming boundary: either a “technical victory” in the 0.70–0.72 range—statistically significant, with moderate yet consistent separation of the curves—fully supporting the company’s presentation at ASCO; or a “directionally positive” outcome in the 0.72–0.74 range, which, while potentially crossing the statistical threshold, would still signal a favorable trend and leave room for eventual OS superiority. The firm anticipates that, should a “technical victory” materialize, market reaction would be positive but muted—potentially offering 10–20% upside before profit-taking could temper gains. By contrast, a merely “directionally positive” result would likely elicit a subdued or even slightly negative response. Notably, CanFang Bio has thus far refrained from issuing headline‑grabbing announcements regarding statistically significant OS HRs, a move that may align with ASCO’s strict confidentiality protocols but also heightens uncertainty. The firm judges the likelihood of an HR above 0.75 to be very low, as such a figure would struggle to sustain the company’s standing at the conference; conversely, an HR below 0.70 would constitute a robust clinical win, promptly validating the OS benefit of PD‑1/VEGF bispecific antibodies. Beyond lung cancer, the report also highlights Phase II data for AK112 in first‑line metastatic colorectal cancer (mCRC) with non‑MSI‑H/dMMR status. These results show an objective response rate (ORR) of approximately 71% and a 6‑month progression‑free survival (PFS) rate of 85–95%, outperforming standard therapies based on bevacizumab and cetuximab when compared across trials. While this bolsteres market confidence in the potential of PD‑L1/VEGF bispecific mechanisms in immunologically “cold” tumors, the small sample size, lack of randomization, and reliance on early‑stage endpoints currently fall short of substantiating a broad oncology‑wide bull case. Looking ahead to post‑ASCO, the overarching narrative for CanFang Bio centers on a tightly scheduled pipeline of key NSCLC data readouts spanning late 2026 through 2027. The final PFS results from the HARMONi‑3 trial in squamous cell carcinoma, expected in late 2026, represent the next major global efficacy milestone following ASCO. Meanwhile, the FDA’s PDUFA decision on November 14, 2026, concerning second‑line treatment for EGFR‑mutant NSCLC, will mark the first true regulatory approval inflection point, shaping the pace of evoribetamab’s expansion beyond China.

Analysis framework

The institution employed a scenario‑analysis approach grounded in clinical trial statistics. First, using the Lan–DeMets alpha‑spending framework and O’Brien–Fleming boundaries, it estimated the hazard ratio (HR) threshold required to achieve statistical significance at various information‑proportional levels—projected to range from a low end of 0.7x to a mid‑range value. Second, drawing on historical data—such as the long‑tail survival benefits observed in the HARMONi‑A study and the global HARMONi trials—the firm assessed the robustness of AK112’s biological activity. Finally, by comparing the overall survival (OS) curve profiles of competing products—including Keytruda and CStone’s sac‑TMT—the analysis evaluated AK112’s competitive edge. For valuation, a hybrid methodology was applied: discounted cash flow (DCF), price‑to‑sales multiples, and peak‑sales multiples, each assigned a 33% weight, to arrive at the target price.

Methodology notes

• Industry/ Sector Analysis FrameworkOthers

  Statistical Boundary for Interim Analysis in Clinical Trials (O’Brien-Fleming Boundary)

  In drug development, to control the false-positive error rate, interim analyses employ more stringent statistical significance thresholds (higher Z-scores and lower required hazard ratios). Drawing on this statistical principle, the research report calculates that, for the HARMONi‑6 trial to be deemed successful, its interim OS hazard ratio must fall below a specific threshold—such as 0.72–0.74—using this figure as a benchmark for gauging the stock’s price reaction.

• Valuation MethodologySOTP Segment Valuation

  Blended Valuation

  For biotechnology companies, relying on a single valuation approach may introduce bias. The research report integrates three methods—discounted cash flow (DCF), price-to-sales (P/S), and peak‑sales‑multiple valuations—assigning equal weights to each, thereby deriving a more robust target price. This approach strikes a balance among long‑term cash flow projections, the company’s current revenue scale, and the market’s pricing of its potential peak sales.

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• Canfang Technology (9926.HK)

  The core beneficiary stock sees its share price directly driven by the clinical data for its lead product, AK112 (evoribetamab).

  Strengths

  The PD-1/VEGF bispecific antibody demonstrates superior long-term survival benefits compared to Keytruda in patients with refractory EGFR mutations; its clinical development is among the most advanced globally, with several pivotal endpoints expected in 2026–2027.

  Weaknesses

  HARMONi-3’s interim PFS did not achieve statistical significance, raising the bar for expectations regarding OS data; meanwhile, domestic sales ramp-up and overseas licensing revenues remain subject to uncertainty.

  Comparison

  Compared with BMS’s BNT327, which is expected to complete its pivotal trial in 2031, and Pfizer’s SSGJ-707, slated for readout in 2028–2029, Conba Pharmaceutical’s development timeline is several years ahead.

  Risks

  The trial results fell short of expectations; domestic sales growth was lower than anticipated; and global royalty revenues failed to materialize.

Key data

• HARMONi-6 projected mid‑term OS HR range0.70 - 0.74Under the baseline scenario, statistical significance must be achieved to demonstrate efficacy.
• HARMONi-6 CRC Phase II ORR~71%Superior to standard therapy (~47–49%), but with a small sample size.
• HARMONi-6 CRC Phase II 6‑month PFS rate85-95%Demonstrates early, persistent trends.
• Target Price130.00 HKDImplies 14% upside potential
• 2026E Revenue ForecastCNY 5.441 billionCompound annual growth rate of 60.1%

Impact & implications

The research report views ASCO 2026 as a milestone rather than an endpoint. Even with robust HARMONi‑6 data and supportive CRC results, investors are likely to remain cautious until the final PFS and OS outcomes from HARMONi‑3 become available. In terms of calendar‑driven catalysts in the PD‑1/VEGF bispecific antibody space, CanFang Bio is clearly ahead of its peers—such as BMS’s BNT327 and Pfizer’s SSGJ‑707—whose pivotal Phase III trials are not expected to report until 2028–2031. This positions CanFang Bio with a clearer commercialization roadmap and a more defined window for data validation over the coming years.

Risks

• The test results may be worse than expected.
• Domestic sales ramp-up may fall short of expectations.
• Global licensing revenue may fall short of expectations.

What to watch

• May 31, 2026: Interim OS Data Readout from ASCO HARMONi-6
• Second-half 2026: Final PFS readout for HARMONi-3 in squamous cell carcinoma
• November 14, 2026: HARMONi FDA PDUFA Decision
• First PFS readout for HARMONi-3 in non-squamous cell carcinoma in the first half of 2027.