Yesterday (26 July), MSD announced that its pd-1 single anti-keytruda (pd-1 single anti-keytruda) injection was officially approved in China.

 

This is the second monoclonal anti-pd-1 / pd-l1 drug to enter China after bristol-myers squibb's Opdivo for second-line treatment of NSCLC.

 

Up to now, pablizumab is the only pd-1 inhibitor drug approved for the treatment of advanced melanoma in China, marking that the treatment of melanoma in China has entered the era of immunotherapy since then.

 

▍ application to the examination and approval, only 5 months

 

It is understood that Keytruda only took more than five months from submission to approval. That is a significant acceleration from the seven-month time it takes Opdivo.

 

On February 8 this year, the former state administration of food and drug administration issued the basic data requirements for the declaration and listing of anti-pd-1 / pd-l1 monoclonal antibody varieties, proposing clear policy guidance for the development and declaration of anti-pd-1 / pd-l1 monoclonal antibody varieties and supporting support for "pre-nda conference", "priority review" and "evaluation and acceleration".

 

In just 40 days, two broad spectrum anti-cancer drugs, pd-1 / pd-l1, were approved in China. It is because of the implementation of the above policies that the state has truly achieved the qualification of priority review and accelerated approval of innovative therapeutic drugs that can meet China's major medical needs.

 

▍ how important is this medicine?

 

Melanoma is a malignant tumor derived from melanin cells. It is the most malignant cancer in skin cancer and one of the fastest growing malignant tumors in China. With an annual growth rate of 3% to 5%, it has become an important disease that seriously endangers the health of Chinese residents.

 

Melanoma deteriorates rapidly and is prone to distant metastasis. Therefore, once it enters the advanced stage of tumor, previous treatment methods have relatively poor curative effect and patients' prognosis and quality of life are greatly affected. Once metastatic, melanoma patients' 5-year survival rate was just 4.6%, according to the study data.

 

▍ finally don't have to act as purchasing agency!

 

It is understood that pd-1 monoclonal antibody has been on the market in the United States for more than three years, and Keytruda has made a great reputation for its role in the treatment of former U.S. President Jimmy Carter's melanoma brain metastasis. But patients in China have not been able to wait for the release of this "magic anti-cancer drug."

 

Just over a month ago, my alumni group also discussed the topic of this medicine. If you put yourself in the situation, you can really feel the helplessness and pain of patients.