Shanghai, 25 March 2022 – Henlius (2696.HK) announced that 汉斯状 (generic name: Serplulimab Injection), its first independently developed innovative biologic and PD-1 inhibitor also referred to as H Drug, has been officially approved by the National Medical Products Administration (NMPA) of China. It is indicated for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) advanced solid tumors that have failed prior standard therapy. This approval offers a new therapeutic option for patients, empowers the development of precise immuno-oncology in China, and fuels the high-quality growth of China's biopharmaceutical industry.
Pan-Cancer Therapy Benefits a Broader Patient Population
This approval was mainly based on a single-arm, multicenter, pivotal Phase II clinical study. The primary endpoint of the trial was the objective response rate (ORR) assessed by an Independent Radiology Review Committee (IRRC) in accordance with RECIST v1.1 criteria.
As of 10 July 2021, 108 patients were enrolled in the trial, of which 68 patients confirmed as MSI-H by central laboratory or study site were included in the primary efficacy analysis set. In this population, the IRRC-assessed ORR was 39.7% (95% CI: 28.03, 52.30; 3 complete responses and 24 partial responses).
The study results showed that H Drug monotherapy provided significant clinical benefits to patients with unresectable or metastatic MSI-H solid tumors who failed prior standard therapy, meeting the predefined primary endpoint, with favorable safety and tolerability. The clinical trial data were first released as an oral presentation at the 24th Chinese Society of Clinical Oncology (CSCO) Annual Meeting 2021.
About H Drug – 汉斯状
汉斯状 (H Drug, generic name: Serplulimab Injection) is a recombinant humanized anti-PD-1 monoclonal antibody injection, and the first innovative monoclonal antibody independently developed by Henlius. The product has been approved for the treatment of MSI-H solid tumors.
Building on H Drug, Henlius has actively advanced its synergy with the Company's other products and combination with innovative therapies. It has obtained clinical trial authorizations from China, the United States, the European Union and other countries/regions successively, and is conducting 9 global clinical trials of immuno-oncology combination therapies, covering a wide range of indications including lung cancer, esophageal cancer, head and neck cancer and gastric cancer, with full coverage of first-line lung cancer treatment.
