Jiangsu Hengrui Pharmaceuticals Initiates Phase 2 Clinical Trial of Adebrelimab for Gastric/Gastroesophageal Junction Cancer.
Adebrelimab Expands Pipeline into Gastric Cancer Area
Jiangsu Hengrui Pharmaceuticals (600276), a developer of the PD-L1 inhibitor Adebrelimab (brand name: 艾瑞利®), has commenced a Phase 2 clinical trial (NCT06808971) targeting gastric/gastroesophageal junction adenocarcinoma. This study, led by the Peking University Cancer Hospital, is a single-arm clinical trial that began on February 28, 2025, and is currently recruiting patients. Adebrelimab received approval from China's National Medical Products Administration (NMPA) in March 2023 as a first-line treatment for small cell lung cancer (SCLC), and this trial aims to diversify its pipeline into the gastric cancer market.
Unique Perioperative Combination Therapy Design
This trial evaluates a perioperative regimen in patients with locally advanced, resectable disease (cT3-4N+M0) who have not received prior treatment. Patients will receive two cycles of neoadjuvant Adebrelimab in combination with AOS (nab-paclitaxel, oxaliplatin, tegafur/gimeracil/oteracil potassium), followed by a multidisciplinary team (MDT) evaluation. If there is no disease progression, one additional cycle will be administered before surgery, followed by surgery. Post-surgery, patients will receive three cycles of the combination therapy and up to one year of maintenance therapy with Adebrelimab alone. This design aims to minimize tumor size before surgery and eliminate microscopic residual disease after surgery to reduce recurrence rates.
Comparison with Global Standard Treatment and Competitors
Currently, the standard treatment for resectable gastric/gastroesophageal junction cancer in the United States and Europe is perioperative FLOT (fluorouracil, leucovorin, oxaliplatin, docetaxel) therapy. In Asia, SOX or DOS therapy based on S-1 is the standard. The AOS combination design in this trial is optimized for the Asian patient population. In the global market, BMS's Opdivo (Nivolumab) and Merck's Keytruda (Pembrolizumab) are leading gastric cancer clinical trials. Jiangsu Hengrui Pharmaceuticals is competing for market share in China with Junshi Biosciences' Toripalimab and Innovent's Sintilimab.
Commercial Opportunities in China and the Global Gastric Cancer Market
China has the largest gastric cancer market globally, with over 40% of the world's patients, and a high incidence rate. The global gastric cancer treatment market is estimated at approximately $5.7 billion to $7.05 billion in 2025-2026, and the Chinese market is projected to grow at a compound annual growth rate of 10.5% to approximately $1.51 billion by 2030. If Jiangsu Hengrui Pharmaceuticals obtains meaningful data in the clinical trial, it can secure a significant share of the large domestic market and create opportunities for revenue growth. Furthermore, data on Asian populations will be a valuable negotiating tool for pursuing overseas licensing agreements with global multinational pharmaceutical companies (MNCs).
Investment Perspective: Risks and Clinical Trial Completion Outlook
However, this Phase 2 trial is a single-arm design without a comparator group, which limits the possibility of obtaining approval without a Phase 3 trial. Maintaining patient compliance and managing adverse events during the intensive perioperative chemotherapy and the year-long maintenance therapy will be critical for success. The final results of the trial are expected to be announced no earlier than 2027, considering the patient recruitment rate, and it will take time to obtain long-term survival data. Investors should carefully monitor the early indicators, such as objective response rate (ORR) and pathological complete response rate (pCR), that will be announced in the future, rather than focusing on short-term momentum.
Jiangsu Hengrui Pharmaceuticals (600276) has taken a significant step towards capturing a portion of the approximately $1.51 billion annual gastric cancer treatment market in China by expanding the indications of its small cell lung cancer treatment, Adebrelimab, to include a Phase 2 clinical trial for gastric/gastroesophageal junction cancer. In the short term, the success of the trial will be judged by the demonstration of superiority in early indicators, such as pathological complete response rate (pCR), which will determine the stock's momentum. In the medium to long term, this trial will serve as an opportunity to narrow the gap with global standard treatments such as BMS's Opdivo and Junshi Biosciences' Toripalimab, a domestic competitor, and to explore the possibility of technology transfer to global multinational pharmaceutical companies (MNCs). The single-arm clinical design limits regulatory approval, and the long duration of maintenance therapy poses challenges in managing patient adverse events, which are key risks to be monitored during development. In conclusion, this trial represents a strategic move by Jiangsu Hengrui Pharmaceuticals to leverage the high prevalence of gastric cancer in Asia and maximize the commercial value and global expansion potential of its oncology pipeline.
Source: ClinicalTrials.gov (api_ct)