China's bio-similar drug development to meet the "golden age" Fuhong Hanxuan took the lead in the breakout!

Herceptin, ®'s original drug, developed by Roche, is a humanized monoclonal antibody derived from recombinant DNA derived from human skin growth factor 2 (Her2), which has become the cornerstone of her2-positive breast and stomach cancer treatments since its launch.
has been hit by bioso-like drugs, sales of Hercetin in the global market are declining, but the domestic market growth momentum continues unabated.
In 2016, Hessetin's sales at domestic sample hospitals amounted to 737 million yuan, up 12.8% YoY, and in 2017 it was negotiated into category B of the National Health Insurance Directory, dropping from 21,613 yuan per bottle to 7,600 yuan per bottle.
the listing of hanquoia ® has brought new drug options to HER2-positive patients in China and the European Union.
domestic biosynthic pharmaceutical industry boom Biosynthic drugs first emerged in Europe.
in response to the increasing burden of health expenditure, the European Union first issued and implemented the Biosynthics Guidelines in 2005 and approved the first biosynthics in April 2006.
The U.S., the world's largest pharmaceutical market, has been cautious about biosynthics despite its large share of spending, and although the Biopharmaceutical Price Competition and Innovation Act was enacted as early as 2010, the FDA did not approve the first biosypolyte until March 2015.
China issued and implemented the Technical Guidelines for the Development and Evaluation of Biosynthic Drugs (Trial) in 2015, and four years later (February 2019), Fuhong Hanxuan's Lytoxi single anti-injection (commodity name: Hanlikang ®) was approved for listing, officially opening the Chinese biosynthic drug market.
approval and commercialization of biosynthic drugs can reduce patient burdens and save health care, and the global biosynthic drug scale is at a rapid growth stage.
, according to Frost Sullivan, the global biosypolisic drug was $1.7 billion in 2014, $7.2 billion in 2018 and expected to reach $164.4 billion in 2030.
, the market size of biosynthic drugs in China will explode in the next few years and is expected to reach 58.9 billion yuan by 2030.
: Frost Sullivan reports that objective market size and strong growth momentum mean huge demand in the domestic market, so several pharmaceutical companies are looking at the development of biosynthic drugs.
china currently approves a limited number of biosypolytes, but the number of research and development pipelines is the largest in the world.
-related statistics show that the domestic layout of biosynthic drugs have about 180 enterprises, nearly 400 drugs, the main targets include CD20, EFGR, VEGF, TNF, RANKL, HER2 and so on, involving lyxi monoantigen, curto bead monoantigen, beva bead single resistance, Adamo single resistance and other more than 50 original research drugs.
Fuhong Hanxuan took the lead with two approved drugs on February 22, 2019, Fuhong Hanxuan's Lytoxi monoantigen injection (Hanlikang ®) was approved for the market, becoming the first biosypolytic drug approved in China.
, which was approved for listing,® has also pioneered a number of biosynthic drugs in China throughout the development and listing process. Professor Xu Binghe, lead researcher of the
HanquYou® International Multi-Center Clinical Phase 3 study and director of the National Center for New Drugs (Anti-Oncology) Clinical Research of the Oncology Hospital of the Chinese Academy of Medical Sciences, said hanquyou ® is the first international multi-center Phase 3 clinical study in China and the first biosypolytic drug to be submitted for listing and accepted in the European Union. The phase 3 clinical study of
Hanquyou® included 649 patients with HER2-positive relapsed or metastasis breast cancer who had not been treated in 89 research centers in China®, Philippines, Poland and Ukraine.
as a developing country, high prices are the main factors in the low penetration of the original drugs in China, while the relatively low cost of research and development of biosic drugs determines its more price advantage.
, for example, the price of Hanlikang is 1398 yuan / 100mg: 10ml, compared with the original study of 2418 yuan / 100mg: 10ml, a drop of up to 42.2%.
in order to meet the global patient demand for high-quality, affordable drugs, Fuhong Hanxuan for Hanqu ® launched a commercial layout of domestic and foreign markets.
for the domestic market, Fuhong Hanxuan has completed the development of commercialization strategy and the construction of the core management team of commercialization, a comprehensive layout of the country's six major sales areas in more than 260 cities.
, according to Sina Pharmaceuticals, Hanqu ®'s domestic price is 1688 yuan / bottle (150mg / bottle).
The original health care price for Hessetin in 2017 was 7,600 yuan per bottle (440 mg/bottle), and in 2019 the National Health Insurance Administration renegotied and again reduced the price to complete the renewal of health insurance, the current unit price is about 7,270 yuan per bottle (440 mg/bottle).
, for example, with complementary treatment for breast cancer, the use of terroid monotherapy can be started after all chemotherapy has been completed.
patients who had taken the drug for the first time, intravenous drips at an initial load of 8 mg/kg were then converted to a maintenance dose of 6 mg/kg every 3 weeks, with a total of 17 doses (52 weeks of treatment).
This calculation, a patient weighing about 50-60 kg, the cost of using Hessetine treatment for a year is about 130,000 (before medical insurance reimbursement), and the use of Hanquyou ®, the cost can be reduced to up to about 60,000 yuan (before medical insurance reimbursement).
In order to benefit more HER2-positive patients and improve the level of prevention, diagnosis and treatment of HER2-positive breast and stomach cancer, Fu Honghanhui also launched the "Don't Let a HER2-positive patient fall" public welfare project, through a joint multi-partner, including the Institute, to create a holistic solution ecosystem for HER2-positive patient treatment, forming an integrated medical ecosystem of patients and family members, doctors and medical institutions, pharmaceutical companies, medical insurance companies, professional associations and government agencies.
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