China's self-developed and innovative biopharmaceutical listing application was accepted by the FDA for the first time and entered the review stage

On May 17, U.
S.
time, the U.
S.
Food and Drug Administration (FDA) officially accepted the innovative drug PD- which was jointly developed by Cinda Biopharmaceutical Group (abbreviated as Cinda Bio) and Eli Lilly Pharmaceuticals Group (abbreviated as Eli Lilly).
1 The new drug application (BLA) for the first-line treatment of non-squamous non-small cell lung cancer (NSCLC) with monoclonal antibody daboshu combined with pemetrexed and platinum, which marks the complete listing of innovative biological drugs independently developed by China The application was accepted by the US FDA for the first time and entered the formal review stage.
Daboshu (generic name: sintilimab injection, sintilimab) also became the first complete listing application to be accepted by European and American regulatory agencies and entered the formal review stage China’s independent research and development of innovative biological drugs
.

Sintilimab (Daboshu) is an early development by Cinda Biotech.
In 2015, it reached a licensing agreement with Eli Lilly and started to jointly develop a PD-1 inhibitor with international quality
.

Previously, with the support of China's special policy for innovative biological drugs and new drugs, Sintilimab injection successfully achieved a major breakthrough in China’s independent research and development of innovative drugs in the field of immunotherapy, and became the first international top academic journal "Liu Ye The Chinese PD-1 monoclonal antibody on the cover of "Knife Hematology" was officially approved in China in December 2018 for the treatment of relapsed/refractory classic Hodgkin's lymphoma, and was approved in China in February 2021 Combine pemetrexed and platinum for the first-line treatment of non-squamous non-small cell lung cancer

In 2020, the U.
S.
Food and Drug Administration (FDA) granted Daboshu (sintilimab injection) orphan drug designation for the treatment of esophageal cancer and T-cell lymphoma
.

In the same year, Daboshu also obtained the orphan drug designation granted by the European Medicines Agency (EMA) for the indication of peripheral T-cell lymphoma

The acceptance of Daboshu's listing application by European and American regulatory agencies is a substantial progress made by China's new drug going overseas and on the international stage
.

In recent years, many local biopharmaceuticals have risen, foreign companies have gradually recognized the innovative achievements of local pharmaceutical companies, and authorized cooperation has gradually become an important way for domestic biopharmaceuticals to go overseas

       It is reported that the United States is the country with the most stringent regulations on new drug approvals in the world, and it usually takes 10 years and 1 billion U.
S.
dollars of cycle and investment to get a new drug from the laboratory to the market
.

At the same time, it has to go through multiple links such as early development, preclinical trials, new drug clinical research applications, phase I clinical trials, phase II clinical trials, phase III clinical trials, new drug marketing applications, and approval for marketing

       "Being accepted is the first step for Cinda Bio to go overseas.
After everyone's efforts, we have completed the early run-up
.

To truly realize this historical leap in the overseas approval of domestically-made innovative biologics, Cinda Biological is going all out to complete the US FDA’s audit and verification of us to obtain our final pass

       Dr.
Liu Yongjun pointed out, “The official acceptance by the FDA also indicates that the cooperation between Cinda Biotech and Eli Lilly has reached a new level.
In the future, the two parties will continue to strengthen cooperation and explore in depth the use of Sintilimab injection as a PD with international quality.
-1 Inhibitors, application in other tumor treatment fields and the possibility of more potential overseas markets, in order to bring new treatment options to more tumor patients around the world
.

In the future, we will continue to uphold the development of affordable high The original intention of high-quality biopharmaceuticals brings hope of life to more patients and contributes to the benefit of patients around the world