Innovent and Lilly Expand Collaboration: Chinese PD-1 Inhibitor Tyvyt® (Sintilimab) to Enter North American and European Markets

　　【Pharmaceutical Network - Industry Trends] On August 18, Innovent Bio and Eli Lilly announced another milestone in their collaboration. The innovative PD-1 monoclonal antibody immuno-oncology drug Tyvyt (sintilimab injection), jointly developed by the two companies, will be launched in North America, Europe, and other regions, benefiting more cancer patients worldwide.
 

In China, lung cancer is a very common malignant tumor, ranking first in both incidence and mortality among all malignancies. Lung cancer poses a serious threat to public health. According to statistics, there are over 730,000 new cases of lung cancer annually in China, with more than 610,000 deaths, while the overall five-year survival rate is only 16.1%. Furthermore, data released by the National Cancer Center in 2019 indicates that patients with non-small cell lung cancer (NSCLC) account for 80%–85% of all lung cancer cases, and approximately 70% of patients present with locally advanced or metastatic disease unsuitable for curative surgery at the time of diagnosis.
 

Tyvyt is a domestically produced PD-1 inhibitor that has been included in the National Reimbursement Drug List, significantly reducing the financial burden on patients compared to similar imported drugs. Innovent Bio recently announced on the Hong Kong Stock Exchange the sales figures for Tyvyt (sintilimab injection) for the first half of 2020. The data showed that sales of the product amounted to approximately RMB 400 million in the first quarter and around RMB 500 million in the second quarter. In the first half of this year, Tyvyt’s sales nearly reached the full-year 2019 total of RMB 1 billion, a figure comparable to the total sales of Opdivo in China in 2019.
 

At the 21st World Conference on Lung Cancer held on August 8 this year, Phase III clinical data for Tyvyt (sintilimab injection) as first-line treatment for non-small cell lung cancer (NSCLC) demonstrated that Tyvyt (sintilimab injection) in combination with chemotherapy significantly delayed disease progression in patients with advanced non-squamous NSCLC. In April this year, the National Medical Products Administration (NMPA) formally accepted the new indication application for Tyvyt as first-line treatment for non-squamous NSCLC, with approval expected by the end of this year or early next year.
 

Notably, Innovent Bio recently announced that another clinical study evaluating sintilimab in combination with chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer (NSCLC) also met its primary endpoint. On August 12, the National Medical Products Administration (NMPA) formally accepted the new indication application for Tyvyt (sintilimab) as first-line therapy for squamous NSCLC. Upon approval of this new indication, it is expected to provide patients with additional treatment options.
 

It is reported that from 2020 to early 2021, Innovent Bio will submit four New Drug Applications (NDAs) for Tyvyt (sintilimab), covering major cancer types with large patient populations, such as lung cancer and liver cancer. Meanwhile, Innovent Bio is conducting global clinical research on sintilimab injection, with more than 20 clinical trials (including over 10 registrational clinical trials) currently underway to evaluate the antitumor efficacy of sintilimab in various solid tumors and hematologic malignancies, which will benefit more cancer patients in the future.
 

Currently, eight PD-1/PD-L1 inhibitors have been approved for marketing in China, including six PD-1 monoclonal antibodies and two PD-L1 monoclonal antibodies. Among them, four domestic manufacturers of PD-1 inhibitors have already launched their products, another four are poised to launch, and several others are in Phase II clinical trials. Data disclosed recently show that in the first half of this year, the PD-1 products of Innovent Bio, Junshi Biosciences, BeiGene, and Hengrui Medicine collectively generated a market share exceeding RMB 2.2 billion.