500 million research and development, challenge Herceptin Hengrui heavy new drugs listed yesterday
Medical Network August 15th News On August 13th, Hengrui's new drug, the drug formulation of pyrrolidine tablets, was changed to “approval – pending certificationâ€. It is the third chemical innovation drug of Hengrui Medicine after Ericoxib and Apatinib. The listing of pyrrolidine may have an impact on the 40 billion anti-breast cancer drug market.
In the past seven years, "oral Herceptin" was listed.
Pyrrolidine maleate is an oral, irreversible, pan-ErbB receptor tyrosine kinase inhibitor (TKI) developed by Hengrui with anti-EGFR/HER1, HER2 and HER4 activities, also known as oral Herceptin.
On August 3, 2016, Hengrui announced that it had invested Rmb76 million in research and development projects on pyrrolidine maleate. On December 10, 2017, Hengrui announced that it has invested about 520 million yuan in research and development expenses on the pyrrolidine maleate research and development project.
The market environment in China is relatively complicated, and drug research and development is easily affected by many factors such as technology, approval, and policy, and there are many uncertain factors. However, in the case of pyrrolidine, the approval has turned green all the way:
In April 2011, the first application for clinical
In September 2012, China Clinical Phase I Study was officially launched.
In June 2015, China Clinical Phase II Study was launched
Priority review in September 2017
On August 13, 2018, it was officially approved by the State Food and Drug Administration (CFDA).
In just seven years, pyrrolinib completed the first application for clinical to approved listing.
â– shock, new fluctuations in the 40 billion market
According to the medical economic report, in the field of global breast cancer drug treatment, Roche's monoclonal antibody Herceptin (Herceptin, trastuzumab) leads the market, Roche's annual report shows that 2017 global Herceptin sales The amount reached $7.534 billion.
According to the chart below, the top TOP5 sales of global anti-breast cancer drug products in 2017 are trastuzumab, Ibrance, pertuzumab, Abraxane and trastuzumab. DM1 (Kadcyla).
Sales of global anti-breast cancer drug TOP5 products were $15.539 billion.
From a domestic perspective, breast cancer is the highest incidence of cancer among women . According to the WHO, more than 1.67 million people suffer from breast cancer every year. From the perspective of breast cancer population in various countries, the number of rickets in China and the United States is the highest.
According to the statistics of the intranet, the total size of domestic breast cancer medications in 2016 has exceeded 32 billion yuan, an increase of 11.67% over 2015. It is predicted that the market for breast cancer treatment and treatment will reach 40 billion yuan in 2018.
At the same time, the data show that in 2017, the amount of anti-breast cancer TOP10 drugs in public hospitals in key cities in China was 5.67 billion yuan, a year-on-year growth rate of 12.10%.
The above figure shows that paclitaxel injection is the first in the TOP10 anti-breast cancer drug in public hospitals in key cities in China. Paclitaxel is a broad-spectrum antitumor drug with unique microtubule stabilization that is widely used in chemotherapy for a variety of common malignancies.
Among them, trastuzumab (Herceptin) has entered the third place from the fourth place in 2015. It is worth noting that after Hershey's price cut into the national medical insurance last year, the demand for medicines in various places also surged in the short term, and Herceptin was out of stock in many places.
The listing of Hengrui's new drug, pyrrolidine, will further expand the market scale and will have a certain impact on the old drug market. Pyrrolidine may have a certain impact on the market of nearly 40 billion breast cancer drugs, and may squeeze Herceptin's market share.
Leading the way, more new drugs are on the road
At the beginning of August, Hengrui Pharmaceutical announced that the company's drug ambroxol hydrochloride tablets passed the consistency evaluation of generic drugs. Ambroxol hydrochloride tablets are used as peony drugs and can be used for the treatment of acute and chronic respiratory diseases and abnormal bronchial secretion.
Ambroxol hydrochloride was developed by Boehringer Ingelheim, Germany, under the trade name Mucosolvan®, and was first approved for marketing in Germany in 1979. In addition to Hengrui Medicine, the main domestic manufacturers of ambroxol hydrochloride tablets are Shanghai Boehringer Ingelheim Pharmaceutical Co., Ltd., Sandoz (China) Pharmaceutical Co., Ltd., Shandong Yuxin Pharmaceutical Co., Ltd., etc.
According to the data from the intranet, in 2013-2017, the sales of ambroxol hydrochloride tablets in Chinese city public hospitals, county-level public hospitals and other terminals exceeded 200 million yuan, in the peony (excluding the compound preparation containing cough medicine) The top of the tablet product TOP20. The leading company is Boehringer Ingelheim, with a market share of over 47% in 2017.
At the same time, the announcement showed that the global sales of ambroxol hydrochloride tablets in 2017 was approximately 87.552 million US dollars, and the sales in China were approximately 7.819 million US dollars. The company's sales of the drug in 2017 was approximately 268,000 US dollars.
As the first approved for the consistency evaluation of ambroxol hydrochloride tablets, the 47% market share of Boehringer Ingelheim Pharmaceuticals has to be broken.
In addition, the company has three new applications for Class 1 new drugs in the “in the review and approval†stage, namely, caldefloxacin, remazuron toluenesulfonate and camrelizumab injection (PD-1).
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