Chinese B7-H3 ADC Data Debuts at WCLC, Setting New Standard for Lung Cancer Treatment
At the World Conference on Lung Cancer in Seoul, Professor Zhang Li presented Phase III data for YL201, marking the first global publication of clinical results for a B7-H3 target Antibody-Drug Conjugate. The drug demonstrated significant efficacy over topotecan hydrochloride in recurrent small cell lung cancer, reducing death risk by 54%. This achievement highlights the growing influence of Chinese biotech firms like Innovent Bio and Hansoh Pharma, supported by record-breaking license-out deals and favorable national policies.
Professor Zhang Li from Sun Yat-sen University Cancer Center shared the results of the Phase III registration study TAISHAN-302 at the Chairman's Forum of the World Conference on Lung Cancer (WCLC) held in Seoul. The study compared the B7-H3 target Antibody-Drug Conjugate (ADC) YL201 (Tam-Peli) against topotecan hydrochloride for treating recurrent small cell lung cancer.
This presentation marks the first time globally that Phase III clinical research data for a B7-H3 target ADC has been published. The results showed that YL201 provided a statistically significant benefit over the control group, reducing the risk of death by 54% and the risk of disease progression by 71%. Additionally, the objective response rate for YL201 was recorded at 59.1%.
Safety profiles also favored the new treatment, with Grade 3 or higher treatment-related adverse events occurring significantly less frequently in the YL201 group (46.4%) compared to the control group (74.7%). Anne Chiang, Associate Professor at Yale School of Medicine, stated in the official summary that these findings indicate a new standard treatment regimen for recurrent small cell lung cancer has emerged.
The success of YL201 underscores the leading role of Chinese biotechnology companies in this therapeutic field. Approximately 80% of the more than twenty B7-H3 ADC pipelines currently in global clinical stages are led or participated in by domestic Chinese enterprises. At the same conference, Hansoh Pharmaceutical's B7-H3 ADC HS-20093 (Ruilianlifutota单抗) also had its related research selected for the Chairman's Forum latest breakthrough abstracts.
Financial milestones further highlight the industry's momentum. Innovent Bio achieved a global exclusive license agreement with Roche, with upfront payments and near-term milestones totaling $570 million. This deal sets a new record for upfront payments in single-target ADC out-licensing for domestic drugs. Since its establishment less than six years ago, Innovent Bio's total external licensing cooperation amount has exceeded $10 billion.
Broader market data reflects this surge in innovation. From January to June 2026, China's innovative drug License-out deals reached 81 transactions with a total value of approximately $110 billion, reaching 80% of the full-year 2025 total. Furthermore, in the first half of 2026, China approved 38 Class 1 innovative drugs, including 11 new target/new mechanism drugs, all of which were independently developed domestic innovative drugs.