Approval of Sintilimab's new indication application for frustrated potential is still optimistic

On November 3, the listing application (CXSS2100007) for a new indication of Cinda Bio's PD-1 antibody Sintilimab received a drug notification from the National Medical Products Administration (NMPA), but the application was not approved Passed

Temporary setbacks in listing applications for new indications

From a global perspective, lung cancer is the leading cause of cancer deaths.

In April 2021, in the online meeting of the American Association for Cancer Research (AACR) Annual Meeting, the Cancer Hospital of the Chinese Academy of Medical Sciences announced the Phase III clinical ORIENT- 3 Data, for the second-line treatment of advanced/metastatic squamous non-small cell lung cancer, Sintilizumab compared with the chemotherapy drug docetaxel, in terms of overall survival (OS), progression-free survival (PFS), etc.

However, due to unpredictable circumstances, Sintilimab received a drug notification for the first time in China, and the listing application for a single-drug second-line treatment of squamous non-small cell lung cancer was not approved

4 indications superimposed on medical insurance advantages and outstanding performance

In late December 2018, Sintilimab injection, a PD-1 antibody drug under Cinda Biologics, passed the priority review and obtained the marketing approval of the National Medical Products Administration (NMPA) of China in 255 days for treatment Relapsed or refractory classic Hodgkin's lymphoma after at least second-line chemotherapy

Since February of this year, Sintilizumab has been approved in China and has been approved for 3 new indications: the treatment of first-line non-squamous non-small cell lung cancer, first-line squamous non-small cell lung cancer, and first-line hepatocytes.

In addition, as the first PD-1 monoclonal antibody drug included in the National Medical Insurance Catalogue, Cinda Biotech has implemented a competitive comprehensive marketing strategy, expanded its sales promotion team through multiple lines, and ultimately improved The coverage rate and market impact in cities and hospitals

Thanks to the various benefits mentioned above, under the fierce competition in the domestic PD-1 drug market environment, Sintilimab still performs well, with good sales performance: sales in the third quarter were approximately RMB 800 million.

Follow-up efforts are optimistic about the new indications that will be approved soon

It is worth noting that, in addition to the single-agent second-line treatment of squamous non-small cell lung cancer that has encountered twists and turns in the listing application, the listing application of Sintilimab for the treatment of first-line esophageal squamous cell carcinoma has been approved by the National Medical Products Administration (NMPA).

It is a high probability event that Sintilimab will continue to be approved for new indications.