China's first querto-pearl mono-anti-biosymedic drug on the market, Central Europe two-batch layout of the world.

Guide: Hanqu Yuzhu ® can automatically enter the national medical insurance catalog according to the generic name Quto Zhu single resistance.
. . . . . . . . . ® in China and the European Union approved for the adaptations are consistent with the original research varieties.
hanqu excellent ® according to the generic name Quto Zhu single resistance automatically into the national health insurance directory.
Xuhui base officially became the first GMP factory in China to obtain EU GMP certification for the production of independent research and development of antibody biologic drugs.
August 14, Fu Hong Hanxuan announced that the company's independent development and production of injection quercetin mono-Hanquyu ® (research and development code HLX02, EU commodity name: Zercepac ®) was officially approved by the State Drug Administration for listing.
July this year, HLX02 was officially approved by the European Commission (EC) to be listed in the European Union, as the first domestic querto-bead monoantigen and "Chinese" mono-anti-biological similar drugs successfully landed in the European market.
It is understood that Hanqu You® in China and the European Union approved indications are consistent with the original research varieties, that is, HER2-positive early breast cancer, HER2-positive metastatic breast cancer, HER2-positive metastatic gastric cancer, and will be consistent with the original research of the generic name automatically entered the national health insurance directory.
domestic development of Quto Zhu single anti-biological similar drugs enterprises have more than 10, what factors make Fuhong Hanxuan win the first opportunity, in the domestic first place at the same time, and then successfully enter the international market? Entering the European Union's first Chinese mono-anti-biosimilar drugs in recent years, Chinese pharmaceutical companies into the international market more and more products.
By the end of 2019, China's pharmaceutical companies have obtained more than 300 U.S. ANDA numbers, of which about 100 have been commercialized;
notably, complex and high-end preparations are beginning to emerge from export products.
In 2019, Zebutine, the first new cancer drug developed entirely by Chinese pharmaceutical companies, was approved for listing by the FDA, and a number of complex preparation products were approved in the United States for the first time, indicating that the research and development and internationalization strength of China's pharmaceutical companies has been enhanced.
But in the field of biopharmaceuticals, because of its own high technical threshold, can be recognized in the mainstream market in Europe and the United States, there is no independent research and development of antibody biologic drugs of Chinese enterprises in the list.
The European Union, the world's first region to develop guidelines for bioseco-like drugs, has relatively well-developed systems and is therefore the world's leading arena for biosycamed drugs, how did HLX02 qualify for this arena step by step? This goes back to the beginning of product development in 2010.
china's guidelines on the development and evaluation of biosysmedicine drugs have not yet been issued, the lack of reference standards is the first problem it faces.
Fu Hong Hanxuan decided to take a longer-term view, directly against the EUROPEAN standards.
It turned out that this was a forward-looking decision, and in 2015 China's Guidelines for the Development and Evaluation of Biosycides (Trial) stipulated that the amino acid sequences of biosynthic drug candidates should in principle be the same as those of reference drugs.
Then China joined ICH, the drug review system gradually in line with international standards, which for many enterprises may face some challenges, or even be eliminated, but has always adhered to the highest international standards of Fuhong Hanxuan is good.
refocus on the quality of the drug, both in terms of the quality of the product itself (e.g., the high similarity of biosycrusts and original drugs) and the quality of the GMP production system.
In 2017, HLX02's Head-to-Head International Multi-Center Phase III clinical trial was fully conducted as the first domestic biosamed drug to conduct clinical Phase III trials overseas, in accordance with the relevant norms and regulations of ICH, EMA and NMPA, and a total of 649 cases were conducted in 89 research centers in China, Ukraine, Poland and the Philippines.
From the results of the 1:1 group study, the optimal objective mitigation rate (ORR24) for 24 weeks at the end of the main efficacy was 71.0% (HLX02) and 71.4% (European commercially available original acetobetic monosection), the differences between the two groups were not statistically significant, and the differences between orR groups were also within the preset equivalent range.
health care, including the rate of adverse events associated with heart disease, was similar (P?gt;0.05), with no clinical differences.
And to cross the global mainstream market on the quality of GMP production system threshold is more difficult, complete, can meet international standards of biopharmaceutical production quality system to establish at least 7 to 10 years, which is the key to multinational pharmaceutical companies monopolizing the global biopharmaceutical market, but also domestic enterprises need to complement the short board.
In April 2020, Fuhong Hanxuan successfully passed the EU GMP on-site verification of the HLX02 Quto Zhu monoantigen liquid (DS) and preparation (DP) line, and officially obtained two GMP certificates from the European Union, and obtained the "pass" to land in the international market.
Fuhong Hanxuan co-founder and CEO Dr. Liu Shigo said: "The company began early clinical GMP production in 2012, when the relevant SOP (standard operating procedures) only more than 400, after continuous improvement and strengthening, by the end of 2019 EU inspectors for HLX02 GMP on-site verification, SOP has more than 2000."
the quality culture of 'continuous improvement', our GMP system has been a different place for seven years.
" this time to obtain the EU GMP certification, Fuhong Hanyu Xuhui base officially became the first GMP factory to obtain the EU GMP certification for the production of independent research and development of antibody biologic drugs, HLX02 also became the first in China to obtain the EU GMP certification of "Chinese nationality" mono-anti-biosimilars, meaning that domestic mono-anti-biopharmaceuticals listed overseas GMP barriers have been broken, China's biopharmaceutical industry to the international significance.
the future market, the Blue Sea or the Red Sea? There are about 300,000 new cases of breast cancer in China every year, of which HER2 positive accounts for 20% to 30%.
patients often have rapid progression, high degree of tumor malignancies, but also more prone to recurrence and metastasis, anti-HER2 treatment is the routine treatment they need.
whether it is the NCCN Clinical Practice Guide for Breast Cancer or the China Anti-Cancer Association's Guidelines for Breast Cancer Diagnosis and Treatment, quercosin monotherapy will be used as the gold standard for anti-HER2 treatment.
The original research quarto-bead monotherapy was approved in China in 2002, the price of about 25,000 yuan / branch, a treatment cycle needs to use an average of 14 drugs, cost about 350,000 yuan, which makes the vast majority of families are unbearable.
even if the "buy 6 give 8" charity drug conditions, out-of-the-own costs of six drugs also caused many families to have "catastrophic health expenditure."
that by 2017, less than 20 percent of patients will not receive the treatment they need.
2017 Quto-Zhu mono-resistance was included in the national health insurance list through negotiations, but the conditions for charitable drug giving have also tightened.
According to Professor Zhang Qingxuan of Harbin Medical University Affiliated Oncology Hospital, although Quto zhu monotherapy has been included in the medical insurance, but because of the imbalance between drug supply and demand, uneven level of medical insurance everywhere, there are many patients have not been able to get treatment opportunities.
Therefore, there is still a clinical need for high-quality quercetine monotherapy, on the one hand, to improve drug access, to ensure a more stable supply of drugs, so that more patients get standardized treatment, on the other hand, can also save health insurance funds."
Estimates based on IQVIAMIDASTM data, sales of the original icing and its biosymedicine in the European Union and Norway, Iceland and Liechtenstein reached US$1.37 billion in 2019, which shows that the demand and ability to pay for quercotroma in the EU market is also relatively good.
although hanqu ® market demand is very optimistic, but HER2 as a hot development target, the future market competition must be very fierce.
at present, there are more than 10 domestic development of querto-pearl monobial-like drugs enterprises, many of which have entered the clinical III.
as the first querto-pearl monobio-similar drug, what are the advantages ® the Hanqu Yuju? In clinical applications, the Drug Review Centre has issued a "Notice on Public consultation on the Guidelines for the Evaluation of Biosycientist Similarity and The Extraposent Technology for Adaptation (Draft for Comments)", affirming that if all the evidence of a biosemblance drug application can directly support its clinical similarity to the reference drug in an adaptation, then data and information can be used to scientifically demonstrate other adaptations that have not been directly studied.
Hanquy® is precisely according to the TWO indications of HER2-positive early breast cancer and HER2-positive metastatic gastric cancer, that is, all the indications of the original research varieties approved, and then can be laid out to the corresponding clinical application range.
, anti-HER2 monoantriles declared by innovative drug pathways need to be clinically tested for each adaptation in order to be approved for the corresponding adaptation, which cannot be extraposed.
In terms of market access, Hanqu You® can automatically enter the national health insurance catalog according to the generic name Quto Zhu monoantire, standing on the original research "shoulder" biosemic drugs can gain some inniture advantages in the market.
it is understood that Hanlikang's commercial promotion after the listing is the responsibility of Fosun Group's Jiangsu Fosun.
and this HanquYu ® listing, will be the first time through the Fuhong Hanyu independent team for commercialization, the company has been early layout, efforts to enhance the independent commercialization capacity.
2019, Mr. Zhang Wenjie joined FuHong Hanxuan, responsible for the company's overall business planning and product marketing strategy.
According to Fuhong Hanxuan's annual report, the company plans to build an efficient team of more than 500 professionals in 2020, aiming to cover more than 260 first- to third-tier cities in the country's six major sales areas, more than 2,700 A/B hospitals.
"Our team size grows every day, and we pay close attention to the professionalism and market dynamics of our team to remain competitive."
," Zhang Wenjie said.
the commercialization team will focus on communicating with local health insurance and completing the rollout of hospitals and DTP pharmacies.
Unlike small molecular chemicals, biopharmaceuticals have high molecular weight, complex structure and physical and chemical properties and high environmental sensitivity, so biosimilars are more difficult to develop than chemical generics, more complex production processes, longer research and development cycles, and higher research and development costs.
" based on the limitations of the technical threshold, the domestic will have a relatively benign market environment.
," Zhang Wenjie said.
In addition to the Chinese market, since 2017, Fuhong Hanxuan has been working with Jacobson Pharmaceuticals, Accord, Cipla, Mabxience and other companies on HLX02 to develop an international commercial layout and actively explore overseas markets.
products have been licensed to cover Europe, the Middle East, North Africa, Asia-Pacific, Latin America, South America and other countries and regions around the world.
HLX02 is approved in Europe, the commercialization of HLX02 will be the responsibility of Accord and can be sold in all EU member states as well as the European Economic Area countries Norway, Iceland and Liechtenstein.
.