Summary of Key Findings
Kangfang Biotech’s PD-1/VEGF bispecific antibody, Yivoxi, demonstrated a significant increase in overall survival (OS) in a Phase III clinical trial for advanced squamous non-small cell lung cancer compared to BeiGene’s PD-1 monoclonal antibody, Tislelizumab, combined with chemotherapy. The risk of death was reduced by 34%, the median survival period increased from 23.7 months to 27.9 months, and the 24-month survival rate was 16 percentage points higher. This is the first bispecific antibody in the world to outperform PD-1 combined with chemotherapy in the lung cancer field, reviving the once lukewarm PD-1/VEGF bispecific antibody sector. However, the data are based solely on a Chinese population, and its global applicability still needs to be verified.
How Long Can This Drug Really Extend Patients’ Lives? – The “Survival Advantage” of OS Data
Overall survival (OS) is the gold standard for evaluating the effectiveness of cancer drugs; it simply refers to the time from when the drug is administered until the patient passes away. The trial data are quite substantial:
- Median Survival Period: Patients treated with Yivoxi and chemotherapy had a median survival of 27.9 months, compared to 23.7 months for those treated with Tislelizumab and chemotherapy, an increase of 4.2 months (equivalent to an additional 126 days).
- Long-Term Survival Rates: At 12 months, 78.9% of the Yivoxi group were still alive, compared to 72.2% in the control group; at 24 months, 64.7% of the Yivoxi group survived, compared to only 48.6% in the control group—meaning that Yivoxi could extend the lives of 16 out of every 100 patients by more than two years.
- Risk of Death: The risk of death in the Yivoxi group was 34% lower, indicating a one-third reduction in the likelihood of patient mortality.
These data show that Yivoxi not only extends patients’ lives but also provides a clear survival advantage over time, making it a drug that truly offers “long-term benefits.”
Why Is the Industry So Excited? – Breaking the “Dominance” of PD-1
PD-1 monoclonal antibodies are currently the leaders in cancer immunotherapy, with drugs like Merck’s Keytruda generating annual sales of over $20 billion and being among the best-selling medications globally. However, they have two major drawbacks: some patients develop resistance to them, and their effectiveness is not optimal.
Yivoxi is a “bispecific antibody,” which targets two targets simultaneously: PD-1 (to prevent tumors from evading the immune system) and VEGF (to cut off the tumor’s blood supply). This trial is the first in the world to show that a bispecific antibody combined with chemotherapy outperforms PD-1 combined with chemotherapy in lung cancer. Previously, Yivoxi had already outperformed Keytruda in single-drug comparisons, and now it has also proven more effective when used in combination with chemotherapy, suggesting that bispecific antibodies could potentially replace PD-1 as the new standard of care. This is a huge boost for the entire bispecific antibody sector.
The “Rollercoaster” of the Bispecific Antibody Sector: From Hot to Cold to Warm Again
The progress of Yivoxi has significantly impacted the industry’s perception of this field:
- 2024: Boom After Yivoxi outperformed Keytruda as a single drug, major pharmaceutical companies invested heavily—Sansheng Guojian and Pfizer signed a $6.06 billion partnership, while Bristol-Myers Squibb and BioNTech invested $11.1 billion.
- 2025: Cool Down When the OS data for Yivoxi versus Keytruda did not meet expectations, the market began to doubt the potential of bispecific antibodies, leading to a slowdown in partnership deals.
- 2026: Rebound With the release of these OS data showing that Yivoxi outperforms PD-1 combined with chemotherapy, the industry sees renewed hope—after all, PD-1 combined with chemotherapy is currently the most widely used treatment approach, so proving its superiority confirms the value of bispecific antibodies.
What Other Challenges Remain? – Beyond Chinese Data
Despite the impressive results, Yivoxi still needs to overcome several hurdles to become a global leader:
1. Global Applicability: The trial data are from a Chinese population, and different ethnic groups may respond differently to the drug. Multicenter trials worldwide are necessary to verify this.
2. Effectiveness in Other Cancers: Yivoxi is being tested in over 40 types of cancer (such as bile duct cancer and breast cancer), but only lung cancer data have been positive so far; its effectiveness in other cancers remains uncertain.
3. Commercialization: Yivoxi was launched in China in 2024, but to be sold globally, it must obtain regulatory approvals from various countries (e.g., the FDA), which requires additional global data support.
What Does This Mean for Kangfang Biotech? – A Boost for Capital Markets and Commercialization
For Kangfang Biotech, these results are highly valuable:
- Stock Price Increase: The company’s stock price is likely to rise after the trial results are announced, as the market values clinical data significantly.
- Accelerated Commercialization: In the Chinese market, Yivoxi can capture a larger share of the PD-1 market due to its superior effectiveness. Globally, these data will help it obtain faster approval in other countries.
- Leadership in the Sector: As the world’s first marketed PD-1/VEGF bispecific antibody, Kangfang Biotech has established a leading position, making it harder for other companies to catch up.
In summary, Yivoxi’s success not only brings new hope to patients but also reignites interest in the bispecific antibody sector. However, whether it will truly become the “next big drug” depends on its performance in global markets.