The Market Situation of Pembrolizumab


Posted on: 12 November 2020 by chen shanshan

The Market Situation of Pembrolizumab

On July 25, Merck’s PD-1 monoclonal antibody drug Keytruda (Pembrolizumab) was formally approved by the CFDA for the Chinese market, becoming the second PD-listed in China after Opdivo (nivolumab).

Keytruda, also known as K drug, pembrolizumab injection. It is a humanized PD-1 antibody that can block the binding of PD-1 receptors on the surface of T cells to their ligands to activate T cells enable them to attack tumors.

As a "star product" of Merck, Keytruda has been receiving attention since it was approved for listing in 2014. This blockbuster tumor immunotherapy has shown gratifying effects in a number of cancers, and can be used to treat melanoma, head and neck cancer, non-small cell lung cancer, classic Hodgkin's lymphoma, bladder cancer, and gastric cancer. On February 11, the marketing application of K drug was accepted by the State Food and Drug Administration with the acceptance number JXSS1800002. It took less than 6 months from submission to approval, setting a record for the fastest approval of imported anti-tumor biological agents in China.

Good news for melanoma patients

The K drug registration in China is mainly for advanced malignant melanoma. It is currently the only PD-1 inhibitor approved for this patient group. Melanoma is a type of malignant tumor derived from melanocytes. It is commonly found in the skin, but also in mucous membranes, eye choroids and other parts. Melanoma is the most malignant type of skin tumor, and it is prone to distant metastasis. Once the immune transfer occurs, the overall 5-year survival rate of the patient is only about 5%.

Drug K has repeatedly created miracles since its listing. The most widely spread in the treatment of melanoma is that it cured former US President Carter who was suffering from advanced melanoma. On August 20, 2015, former US President Jimmy Carter, nearly 91 years old, announced that he had been diagnosed with advanced melanoma. His treatment options include surgery, radiotherapy and the new anti-cancer drug PD-1 antibody Keytruda. Eventually the tumor completely disappeared!

"Comprehensive" anti-cancer, unlimited potential

The incidence of melanoma in China is generally low and is a rare disease. Data show that the incidence of melanoma in China is about 0.6 per 100,000. Therefore, the listing of K drug in China makes the Chinese people excited more than this.

On May 10, 2017, the FDA accelerated the approval of Merck’s PD-1 antibody Keytruda combined with chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer, and is not limited by PD-L1 expression, achieving "all-in-one-take-all".

On May 23, 2017, Keytruda "re-upgraded"-the FDA accelerated approval for the treatment of solid tumor patients with high microsatellite instability (MSI-H) or mismatch repair defects (dMMR), becoming the first non-tumor based. The location of onset is the cancer treatment method based on tumor markers, which has epoch-making significance in the history of cancer. At the same time, the applicable population has also expanded significantly, including colorectal cancer, endometrial cancer, gastric cancer, liver cancer, ampulla cancer, thyroid cancer, and sebum cancer, melanoma, ovarian cancer, cervical cancer, esophageal adenocarcinoma, soft tissue sarcoma, head and neck cancer, kidney cancer, Ewing's sarcoma and other 15 types of solid tumor patients.

However, with the continuous improvement of the domestic new drug research and development environment, my country's PD-1 antibody market is also extremely competitive, and many high-quality innovative research and development pharmaceutical companies have emerged.

With the successive launch of O drugs and K drugs, and the surging competition in the domestic PD-1 antibody market, it is hoped that the price of anti-cancer drugs can be lower to benefit more cancer patients.

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