(Yicai) Dec. 26 -- China's top drug regulator has approved Chinese pharmaceutical firm Innovent Biologics’ cancer drug Daboxin® (Ipilimumab N01 Injection) for use in combination with another monoclonal antibody as a pre-surgery immunotherapy for colon cancer. The treatment is the world’s first, and so far the only, approved dual-immunotherapy neoadjuvant regimen for patients with resectable stage IIB to III MSI-H/dMMR colon cancer.

Daboxin® (Ipilimumab N01 Injection) is also the first domestically developed anti-CTLA-4 monoclonal antibody approved in China, Suzhou-based Innovent Biologics said yesterday. When combined with Tyvyt® (Sintilimab Injection), an innovative PD-1 inhibitor co-developed by Innovent and the US' Eli Lilly and Company, the short course of preoperative treatment can significantly increase the pathological complete response rate, which measures if any viable tumor cells are still found in the surgically removed tissue, enabling most patients to avoid chemotherapy after the operation.

This dual-immunotherapy neoadjuvant treatment regimen is mainly intended for patients with resectable stage IIB to III colon cancer patients with microsatellite instability-high or mismatch repair deficiency. These patients are generally less responsive to chemotherapy, and even after standard postoperative treatment, about 10 percent to 30 percent of them still experience disease recurrence or metastasis. The side effects of chemotherapy can also significantly affect their quality of life.

The approval will change clinical practice and fill the gap in China’s pre-surgery treatment options for colon cancer, allowing more MSI-H/dMMR patients to benefit, said Xu Ruihua, lead researcher of the project who is also an academic at the Chinese Academy of Engineering and president of the Sun Yat-sen University Cancer Center.

"Radical surgery for locally advanced colon cancer is often difficult, highly invasive and sometimes fails to achieve complete tumor removal, resulting in a poor prognosis,” Wang Feng, assistant to the president and director of the Department of Internal Medicine at the Sun Yat-sen University Cancer Center, told Yicai. “The approval of this dual-immunotherapy neoadjuvant treatment provides a new option for these patients."

Innovent's shares [HKG:1801] did not trade today as the Hong Kong market was closed for the Christmas holiday.

Editors: Tang Shihua, Kim Taylor