Henlius Biotech, Inc. announced that its first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments, providing an alternative treatment option for patients.

Furthermore, it also empowers the domestic precision immunotherapy for tumors and promotes the high-quality development of China’s biopharmaceutical industry.

Zhang Wenjie, Chairman, Executive Director, and CEO of Henlius, said:

I’m very glad to see the first indication of HANSIZHUANG was approved in China. As one of the pioneering PD-1 inhibitors for the ‘pan-cancer’ treatment of MSI-H solid tumors in China, HANSIZHUANG would give full play to its advantages in clinical practice to enable patients to live longer with more comfortable lives and accelerate the development of tumor immunotherapy. In addition, HANSIZHUANG is the fifth product launched by Henlius as well as a significant milestone in the company’s evolution toward Biopharma, which will actively drive Henlius to move forward, and inspire more innovative achievements centered on patient needs.

Professor Qin Shukui, one of the co-leading principal investigators of the pivotal phase II clinical study of HANSIZHUANG on MSI-H solid tumors, from the Tumor Center of Nanjing Jinling Hospital, said:

PD-1 inhibitor is one of the immune checkpoint inhibitors that has been explored in some diseases, which makes breakthroughs in many tumor treatments. The clinical research data of HANSIZHUANG for MSI-H solid tumors is outstanding and will actively improve the clinical efficacy and provide a new mindset and alternative option for the precision treatment for tumors in China.

With HANSIZHUANG as the backbone, Henlius conducts and accelerates various clinical trials with immuno-oncology combination therapies worldwide in a wide variety of high-incidence solid tumors, including lung cancer (LC), esophageal carcinoma, head and neck carcinoma, gastric cancer, etc., and covering the full range of first-line treatments of lung cancers.

Up to date, more than 2,800 subjects have been enrolled worldwide for HANSIZHUANG clinical trials, which makes it a PD-1 inhibitor with one of the largest global clinical data pools and lays a solid foundation for future applications across the world.