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On October 23, Hengrui Pharmaceuticals announced that it had recently received NMPA's Notice of Approval for Clinical Trials of Drugs, approving its PD-1 monoantigenic single-anti-carriju monoantigenated apatinist for complementary treatment in people with high risk of recurrence after hepatocellular carcinoma (HCC) root surgery or ablation.
will conduct this Phase III clinical trial in the near future.
hepatocellular carcinoma is the world's most common solid tumor, the third most common cause of cancer and stomach cancer in cancer-related deaths.
Surgical liver cancer patients have a high rate of postoperative recurrence, 3 and 5 years recurrence rate of up to 50% and 70%, respectively, seriously hindering the long-term survival of liver cancer patients, complementary treatment has no recognized standard treatment plan, clinical failure to meet high demand.
is a small molecule-targeted new drug developed by Hengrui, which was approved for sale in 2014.
, at home and abroad, Bayer's Solafoni, Pfizer's Shoni tinini, Novarma's Peropani and other similar products have been approved for the market.
three multi-target inhibitors have been approved for listing in China.
2019, global sales of Solapini, Shonitini and Peropani are approximately $2,159 million.
injection with Karelli pearl monoantigen is a humanized anti-PD-1 monoclonal antibody, can bind to human PD-1 receptor and block the PD-1/PD-L1 path, restore the body's anti-tumor immunity, thus forming the basis of cancer immunotherapy.
, there are 3 PD-1 monoclonal antibodies approved for listing abroad, of which Pabli Pearl Monoanti and Navuliyu Monoanti have been approved for listing in China.
In addition to Hengrui Pharmaceuticals, there are 3 PD-1 monoclonal antibodies approved for listing in China, namely, Ripley Monoanti (Shanghai Junshi, Commodity Name, approved in 2018), Xindili Monoanti (Zenda Bio, Commodity Daboshu, Approved in 2018) and Reilly Pearl Monoanti (Baiji Shenzhou, Commodity Name Bai Zean, approved in 2019).
2019, global sales of anti-PD-1 antibodies were approximately $18.809 billion.
To date, according to the announcement, Apatini has invested approximately RMB356.25 million in research and development, and the cumulative investment in research and development in Karelli Pearl Monoantitor for injection is approximately RMB127,984 million.
According to the Insight database, Karelli pearl mono-anti-currently has four major adaptations approved, namely advanced/metastatic hepatocellular carcinoma, non-squamous NSCLC, esophageal squamous cancer, classic Hodgkin's lymphoma, and nasopharyngeal cancer adaptations on the market;
from: Insight Database ()