Single anti-biopharmacemic patent expiration peak coming Chinese and foreign pharmaceutical companies to seize the market

With the expiration of the patent of the original biological drug and the continuous development of biotechnology, the biosynthic drug developed on the basis of the original biological drug enters the fast track of development. The latest announcement from Fosun Pharma, a listed company on A-shares, said that a biosynthetic drug used in the treatment of non-Hodgkin's lymphoma, Fuhong Hanxuan, a controlling subsidiary, had recently been approved by the State Administration of Food and Drug Administration for drug registration review. In the industry's view, the drug is expected to be the first biosynthic drug to be released in China since the release of the 2015 Biosynthic Drug Research and Evaluation Technical Guidelines (Trial). Chinese and foreign pharmaceutical companies have accelerated their market layout in China, following the dividends of the state's policy of encouraging research and development of biosynthic drugs.National gaps are expected to be broken
According to the above guidelines, biosypolytes are therapeutic biological products that are similar in quality, safety and ability to approved reference drugs (usually original products). Since biosypolytes can better meet public demand for biotherapy products and help improve accessibility and lower prices for biopharmaceers, many countries attach great importance to the development and management of biosypolytes, and more than 20 countries or organizations around the world have developed guidelines on biosypolytes.
However, because biostruct and technology production is far more complex than chemical generics, biosimilars are in their infancy in the world, especially antibody biosimilars, and no more than 10 approved in Europe and the United States remain blank in China.
Recently, Fosun Pharmaceutical Holding Subsidiary Fuhong Hanxuan Bio announced that the company developed lysoxi monoantigen anti-injection (a biosynthic drug, that is, recombinant human mice embedded anti-CD20 monoclonal antibody injection) by the State Administration of Food and Drug Administration drug registration review and acceptance. The drug is a macro-molecular biosynthetic drug developed by Fuhong Hanxuan, which is mainly applicable to the treatment of non-Hodgkin's lymphoma and rheumatoid arthritis.
public information, the incidence of malignant lymphoma was about 668 per 100,000 between 2003 and 2013, ranking eighth among all malignant tumors. In terms of disease classification, lymphoma is usually divided into two broad categories: Hodgkin's lymphoma (10% of all lymphomas) and non-Hodgkin's lymphoma (90% of all lymphomas).
as of October 30, 2017, only Shanghai Roche Pharmaceutical Co., Ltd.'s Merohua has listed lysoxi monoantigen injections listed in China (excluding Hong Kong, Macao and Taiwan). According to IMS, a consulting agency, sales of lysoxi mono-anti-injections in China in 2016 were about 1.5 billion yuan. However, the high cost of lytoxi monoantigen (Ping An Securities Research Report shows that the list price is 3400 yuan / 0.1mg, 16000 yuan / 0.5mg or more) so that many patients can not afford, there are many patient families because of the treatment on the back of a very heavy financial burden.
it is worth noting that once the domestic ritoxidant is on the market, high-quality and low-cost biosygenic drugs will quickly cover patients who have actual drug demand but cannot afford the price of the drug. Qin Shuxuan, president of the China Society of Clinical Oncology Foundation, said that with the continued listing of biosynthic drugs in China, it will not only provide clinicians with better choices, but also allow more patients to receive treatment.Instiface and foreign pharmaceutical companies seize the bio-similar drug market
statistics show that in 2016, the world's top 10 sales of seven biological drugs, six of which are single resistance, single resistance king Shumeile (Adamo single resistance) sales of 16 billion U.S. dollars, such market space attracted the attention of Chinese and foreign pharmaceutical companies.
compared to 2013-2015, when non-mono-anti-biopharmacemic patents are centrally due, 2016-2020 will see a peak in the expiry of mono-anti-biopharmacemic patents, and a large global market for bio-similar drugs is on the horizon. It is worth noting that, in addition to the domestic Fuhong Hanxuan, CITIC Guojian, Xinda Bio and other pharmaceutical companies, Anjin, Novarma (Sanders), Pfizer and other multinational pharmaceutical giants are also important participants in the biosynthic drug market.
From the major companies in the research pipeline, bio-similar drug research and development focused on Adamo monoanti, Invlixi monoanti, lytoxi monoanti, beval bead monoanti, curt bead monoantigen and other patents have been or are about to expire on the large varieties of monoanti. The market expects the global biosypolyte market to reach $35 billion by 2020.
the technical and investment thresholds of biosimilars are much higher than those of chemical generics. Fosun Pharma announced that as of September 2017, approximately 290 million yuan had been invested in research and development for lysoxi monoantigen. Since its establishment in 2010, Fuhong Hanxuan has invested a total of about 864 million yuan in the development of monoantigen products, in addition to the Lytoxi monoantigen (HLX01 project), the company's HLX02 project (Roche Hessetin biosypolytic drugs) has been in the European Union Poland and Ukraine breast cancer phase III clinical research.
in addition to their own work, there are also domestic pharmaceutical companies choose to join forces with foreign giants. Recently, Synth Pharmaceuticals and Amgen of the United States announced the launch of a strategic alliance of biosynthic drugs, a number of single-resistant varieties of biosynthic drugs introduced to China, for joint research and development and commercialization, this is the first time that Chinese and American pharmaceutical companies in the field of biosynthic drugs to carry out large-scale cooperation.
the two companies, including adamu monoantigen for rheumeumatoid diseases and beva bead monoantigen for the treatment of tumors. The two biosynthic drugs are the first of their kind approved by the FDA in the United States. Zhang Wenjie, general manager of Amgen China, said the partnership combines Amgen's long-standing expertise and strengths in biopharmaceeus research and development and production, as well as the company's local development and registration experience and strong marketing capabilities in the field of rheumatism immunization and oncology diseases.drug review reform continues to stimulate the vitality of market innovation
Biosynthic drugs in the domestic boom, thanks to the domestic continuous promotion of drug review reform.
In recent years, the State Administration of Food and Drug Administration has successively implemented a series of major initiatives, such as the pilot drug listing license holder system, the reform of chemical drug registration classification, the consistent evaluation of the quality and efficacy of generic drugs, the priority review and approval, and the self-examination and verification of clinical trial data, which have set off a wave of reform in the pharmaceutical industry.
biosypolysed drugs are the focus of reform. In 2015, the Technical Guidelines for the Development and Evaluation of Biosynthic Drugs (Trial) were issued, which regulate the registration procedures, registration categories and registration requirements for biosynthic drugs. The 2016 Measures for the Administration of Drug Registration (Amendment) states that "the approval of drug market applications should focus on the similarity of biosypolysed drugs to the quality and efficacy of the original drug".
domestic health insurance also opened the door to biosypolysed drugs. In April 2017, the Ministry of Social Affairs issued a circular defining the scope of negotiations on the 2017 National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalog. Of the 44 drugs involved, 7 involved monoants, indicating that the health insurance sector fully recognized the clinical value of monoanto-drugs.
said it has set up three pharmaceutical research and development laboratories in Silicon Valley, connecting with Shanghai and Chongqing to form a seamless global research and development network. Based on this research and development network, Fosun currently has 11 global clinical approvals for 8 products in the area of tumors and autoimmune diseases. Oncology drug leader Hengrui Pharmaceuticals is also continuing to increase the size of research and development investment, the financial results show that in the first half of 2017 the company invested a total of 780 million yuan in research and development funds, an increase of 60% year-on-year, basically formed an annual innovative drug application clinical benign development trend.
, executive director of the China Pharmaceutical Innovation Promotion Association, noted that the regulatory agency's new policy has stimulated the vitality of the entire pharmaceutical industry, while promoting international cooperation between local and international companies to accelerate their entry into the Chinese market. By promoting the level of supervision in cooperation with the international level, it will enhance the overall level of China's biopharmaceutical industry. (Economic Reference)