5 billion yuan "white medicine" market pattern changes Hengrui 19K into the big

On July 15th, Hengrui Pharmaceuticals' new sulphur-pei non-Gestin injection (commodity name: Ado) was held in Beijing. It is worth noting that, with a more stable new polyglycol modification technology, Hengrui Pharmaceutical's next-generation PEG-rhG-CSF has been awarded the world's first new generic name.Global Trends: Dosage Form Iteration, Biosynthetic Drug Disturbance
Thiebide Non-Gestin is a polyethyl glycol recombinant human granulocytic stimulation factor developed by Hengrui, which is suitable for non-bone marrow cancer patients receiving bone marrow inhibitory anti-cancer drug therapy to reduce the incidence of infection as a result of fever-neutral granulocyte reduction.
Amgen, which was approved by the FDA in February 1991 for its non-Gestin (commodity name: Neupogen), is the world's first recombinant human granulocyte stimulation factor, and in 2002 it introduced the non-Gestin long-acting dosage form, The Pfeisting (product name: Neulasta). In addition, the main products in the field of ascending white medicine are Sanofi's Sagsting (commodity name: leukine) and Novarma's generic drugmaker Sandoz's non-Gestin (biosimilar, commodity name: Zarxio), but Neupogen and Neulasta have a clear competitive advantage and a monopoly.
from overseas experience, long-acting dosage forms have become a mainstream trend. According to Amgen's sales data, Neupogen has been growing weakly for years and sales have been falling rapidly since 2014, while sales of Neulasta, a long-acting dosage form, have risen rapidly since their launch, peaking at $4.715 billion in 2015, making it a well-deserved heavyweight star product. In the same year, short-acting dosage forms achieved sales of $1,049 million, or only 22% of long-acting dosage forms. Even after peak sales of long-acting dosage forms, it achieved sales of $4,534 million in 2017, 8.3 times the short-acting dosage forms of the same year.
iterations, competition for biosynthic drugs is also a key disrupter. Zarxio, the first biosyporoxir in the U.S., grabbed nearly 25 percent of Neupogen's market share when it went on sale in 2015, with sales of nearly $200 million in 2016.china's 5 billion yuan white drug market
domestic white drug market prospects are broad. According to the 2017 statistics of the National Cancer Center, the number of cancer patients in China has increased by 4.29 million per year. In China, the average five-year survival rate for all tumors is only 31%, the average five-year survival rate for breast cancer is about 73%, and in the United States, the average five-year survival rate for all tumors is 66%, of which thyroid, prostate, testicular and skin cancers are over 95%, and breast and skin cancers are about 90%.
In fact, China's tumor market drug categories, traditional Chinese medicine and traditional anti-tumor chemical drugs occupy more than half of the market, targeted drugs (including new drugs and generic drugs) although increasing trend year by year, but the use of anti-tumor drugs in China is still a small proportion.
, chemotherapy is still one of the main ways to treat cancer, so as an anti-cancer-assisted drug, the domestic market for whitening drugs is far from saturated. According to the experience after the listing of neulasta, the long-term characteristics of the second generation of white medicine products are very competitive, the current domestic G-CSF sample hospital market sales of 998 million yuan, long-acting drugs only 12.62 percent, so the product long-term replacement short-acting space is equally huge.
"There is a huge gap between the therapeutic effect of cancer patients in China and the United States, and innovation is the only way to solve the current clinical drug dilemma in China," said Yan Jianjun, deputy general manager of Hengrui Pharmaceuticals in China. Professor Li Guohui of the Oncology Hospital of the Chinese Academy of Medical Sciences pointed out that thiopental is a long-acting G-CSF preparation using a new generation of PEG modified protein technology developed independently, which solves the potential problems of low synthesis efficiency of similar products, unstable binding of G-CSF subjects, accelerated in vivo removal and high ADA rate affecting clinical efficacy, and has the characteristics of Best-in-Class drugs.Hengrui entered the market, Qilu, Shi medicine two male pattern change
At present, The Pfeisting has been listed in the United States, Japan, the European Union and other countries and regions, but not listed in China. Obviously, compared with the long-acting G-CSF commonly used abroad, the traditional short-acting preparations in the domestic mainstream can not meet the needs of drug safety management and tumor standard treatment.
From the domestic competition pattern, there is no long-acting dosage form imported products listed, domestic varieties only stone pharmaceutical group Baig (Shandong) biopharmaceutical and Qilu pharmaceutical production of polyglycol recombinant human granulocyte stimulation factor injection was approved for listing. According to Hengrui Pharmaceuticals, domestic sales of polyethyl glycol recombinant human granulocyte stimulant injections in 2017 were approximately US$759.86 million (approximately RMB515 million).
addition, a number of enterprises such as Beijing Shuangyi, Jiangsu Osaikang, Shenzhen Xinpeng Bioengineering and other enterprises declared polyethyl glycol recombinant human granulocyte stimulation factor injection was approved clinically.
Hengrui Pharmaceuticals adopts a more stable new polyethyl glycol modification technology, develops and creates a new generation of PEG-rhG-CSF, and obtains THE's new generic name, Thipropfei Gestin (commodity name: Edo). Previously, Hengrui Pharmaceuticals has revealed that the company has invested about 98 million yuan in research and development in the research and development project of thiopei non-Gestin injections.
And for the public's most concerned about pricing issues, the listing meeting, Hengrui Pharmaceutical General Manager Zhou Yunshu said that the current price of Ado products has not been finalized, for the future of the product is not convenient to disclose, but China's whitening drug market according to external forecasts of about 5 billion yuan in size, Hengrui will actively participate in the competition. (New Kangjie)