Fu Hong Hanxuan's first domestic "qutozhuzumab biosimilar drug" will soon be approved.

Qutozhu monoantigen research is Roche's Herceptin, is a recombinant DNA-derived humanized monoclonal antibody that binds to the extracellular domain of human epidermal growth factor receptor 2 protein (HER-2) to inhibit tumor cell growth, while at the same time inducing antibody-dependent cell toxicity (ADCC) to kill tumor cells.
, querceon monotophoid has been approved in China for a number of indications, including HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer assisted, new complementary treatment, HER2-positive advanced gastric cancer, and hyperadaptive drugs in HER2-positive non-small cell lung cancer.
the species is Roche's ace drug, long on the list of top10 drug sales, and was first approved by the U.S. FDA on September 25, 1998.
sales have grown steadily since the launch, but sales have declined steadily since 2018 due to the patent period, with global sales of nearly CHF 6 billion in 2019, down 13.5% year-on-year.
domestic, Heseltine was approved for import in 2002, and domestic sample hospital sales in 2016 were 737 million yuan, up 12.8% year-on-year.
2017, when Heseltine was included in the health insurance, it was reduced from 21,613 yuan per bottle to 7,600 yuan, a 65% price reduction, and then there have been a number of hospitals in the country out of stock.
public lying shows that in 2019, Herceptin's sales in China will be about 3.5 billion yuan.
13 successful lying in the research and development of the company's biosimilars, as patents in the European Union expired in July 2014 and U.S. patents expire in June 2019. according to the
Insight database, there are currently 13 enterprises in the research, a total of 7 enterprises have entered phase III clinical, respectively, Shanghai Institute of Biological Products, Jiahe Biology, Zhengda Qing, Hualan genetic engineering, Haizheng Pharmaceuticals, Anke Bio, SAMSUNG BIOEPSIS like-like drugs in Phase 3 clinical.
April 2020, Fu Honghanxuan successfully passed the EU GMP on-site verification of the HLX02 quorbead single antigen solution (DS) and preparation (DP) line, and obtained two EU GMP certificates issued by the Polish health supervisory authority, becoming the first EU GMP-certified "Chinese" monoanti-biosimilar drug.
May 2020, the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) issued an active review recommending approval of HLX02 (injection of qural suprema) for the treatment of 2 positive early-stage breast cancer, HER2-positive metastatic breast cancer, and untreated HER2-positive metastatic gastric cancer or gastric/esophagus junction adenocarcinoma.
based on positive review stakes, "HLX02 is highly similar to the reference drug herceptin (quorbead monobin), and the study data support hlX02 with no significant differences in quality, safety and efficacy from Heceptin."
" On June 30, 2020, fuhong Hanyu HLX02 (injection of querceta monotagated) was shipped to the European market.
, after being officially approved by the European Union, the batch HLX02 is released after final testing and packaging procedures, and can be marketed in all EU member states as well as the European Economic Area countries Norway, Iceland and Liechtenstein, becoming the first "Chinese national" monoanti-biosimilar to enter the European market.
huge market potential HER2-positive breast cancer accounts for about 20% to 30% of all breast cancers, with high degree of malignancy, rapid progression of the disease, prone to lymph node metastasis and so on.
at present, qutozumab has been recommended by domestic and foreign breast cancer diagnosis and treatment guidelines for HER2-positive breast cancer patients at all stages of treatment, has become THE WHOLE process of STANDARDIZED treatment of HER2-positive breast cancer patients recognized as a "golden standard" drug.
in addition to breast cancer, HER2 expression is also common in stomach cancer or gastric/esophageal adenocarcinoma.
about 22% of metastatic stomach cancer patients are WHO2 positive.
quralmon monotometreadone combined chemotherapy can significantly reduce the risk of death in patients with HER2-positive metastatic gastric cancer, prolong the total survival of patients, and become the cornerstone of first-line treatment of HER2-positive metastatic gastric cancer. According to the latest data from the
, the domestic bid for Herceptin is 7270 yuan/440 mg, still expensive and affordable patients are limited, and according to Frost Sullivan, only about 25% of eligible patients in China will be able to afford Herceptin in 2018.
, the number of new breast cancer cases in China is expected to increase from about 320,700 in 2018 to about 373,200 in 2030.
for stomach cancer, the number of new cases in China is expected to increase from 442,300 in 2018 to 613,800 in 2030.
Given the large number of undertreated patients, there is a huge market opportunity for Herceptin biosimilars to be less expensive than the original study.
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