Henri Apatini liver cancer new adaptive disease approved for listing!

Apatinist is a small molecule-targeted new drug developed by Hengrui and approved for market in 2014 to treat patients with advanced or relapsed advanced or relapsed advanced or gastro-esophageal adenocarcinoma who have underwent at least 2 systematic chemotherapy treatments in the past.
On February 14, 2020, Henri completed Phase III clinical trials of Apatinistini in patients with advanced hepatocellular carcinoma (HCC) who had previously received at least one line of systematic treatment and submitted a new adaptation listing application for this upcoming approval.
listing application is based on the results of the Phase III Registered Clinical Research AHELP study, which was released at the 2020 ASCO Annual Meeting.
AHELP study, led by Professor Qin Shuxuan of Jinling Hospital in Nanjing and jointly conducted by 31 cancer centers nationwide, included 393 patients with advanced HCC who had failed or were insatiable after receiving at least first-line systemic treatment.
results showed that apatinib significantly extended the patient's total medium lifetime (mOS) to 8.7 months, compared with 6.8 months in the placebo group, and 4.5 months in the middle progression-free lifetime (mPFS), which was significantly higher than the 1.9 months in the control group.
, the objective mitigation rate (ORR) in the Apatini group was 10.7%, significantly higher than the 1.5% in the control group.
show that apatinib treatment is not only more objective and efficient, but also has significant survival benefits.
same time, Apatinist has good tolerance, safety and control in patients with advanced HCC, and there are no new safety issues compared to previous clinical studies and practices of apatini.
Based on the exciting results of AHELP research, in the second-line treatment section of the late HCC, the 2020 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Primary Liver Cancer formally incorporated Apatini monodone drugs into the second-line treatment recommendation, with a recommended level of Class I and an evidence level of Class 1A. according to the
Insight database, Henri has conducted 24 clinical trials against apatinists to date, 19 of which are still in progress, 10 of which are Phase III clinical, mostly combined drugs, primarily with PD-1 monoanti-clolliju monoantigens.
from insight database () Currently, Bayer's Sorafoni, Pfizer's Shoni tinini and Novarma's Peropani have been approved for domestic listing.
2019, global sales of Solapini, Shonitini and Peropani are approximately $2,159 million.
according to Hengrui's disclosure, sales of apatinist are about RMB 1.7 billion in 2018.
the new adaptation is approved, the market is expected to open further, driving sales up again.
as of the listing of the New Adaptation Report for Liver Cancer, the Apatini project has invested approximately RMB332.34 million in research and development.
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