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Introduction: The biopharmaceutical industry is gradually moving towards the center of the stage of the pharmaceutical industry.
2016-2019, china's biopharmaceutical market grew from 329.928 billion to 371.386 billion U.S. dollars, with a compound annual growth rate of 4.02%, ranking first in the pharmaceutical industry, far ahead of established industries such as chemicals and Traditional Chinese medicine.
the market is expected to exceed 400 billion shares by 2020-2021.
(data sources: National Bureau of Statistics, public data, annual reports of enterprises, etc.) at the same time, because of the biopharmacemic drug market, biogenic research drugs due to its first-in-the-post and patent advantages, its revenue ratio over the years have shown an absolute leading level, "single anti-product" is in recent years in all sub-categories of the leader.
with the expiration of several heavy-weight mono-drug patents, biosynthic drugs are gradually entering the fast track of development, the global growth rate of more than 40%, and the market size increase is also very obvious.
As far as domestic terms are concerned, at present, Fuhong Hanxuan, Qilu, Baiotai, Haizheng, Xinda and other related enterprises are different degrees of layout of bio-similar drug research and development, becoming a strong competitor in the global Top10 drug sales.
the industry, to a large extent, China's bio-similar industry to achieve internal and external double cycle, overseas competitiveness has been effectively enhanced.
same time, as China's biopharmace product market is still in a period of structural instability, increased demand and frequent technological substitution, the rapid growth and lagging development of the market segment also brought a broader space for growth.
September 10, 2020, the 2020 China Pharmaceutical and Health Industry Development Conference and the 4th China Pharmaceutical Research and Development Innovation Summit (PDI) announced the "2020 China Biopharmaceutical Research and Development Strength Ranking TOP50" (hereinafter referred to as Biopharmaceuticals List" ), compared with last year, the top 20 enterprises in the biopharmaceutical list, the degree of change is not small, the top five Fosun Pharma, Jiangsu Hengrui and Cyntharma Bio still cover the top three, Junshi Biological, Shenzhou cells and other enterprises rose to the top.
notable for its rise and fall, six of the top 20 companies made the list for the first time, largely representing the rise of emerging forces in the industry.
list C, innovative biological medicine into the "top necessary conditions" this time into the list of "biopharmaceutical list" TOP20 enterprises, in the field of biological medicine last year more or less have made a success, to a large extent can be said to represent China's biologics industry's top strength, industry leaders say they are.
According to the Pharmaceutical Registration and Acceptance Database, a total of 16 biological products have been approved for market in China in 2019 (see figure below), including four new drugs developed independently, namely, Cindi li single anti-injection, Kang Hong's "Compassip eye injection", HengRui's "injection karili pearl monoanti" and Jindik's "flu virus lysate vaccine (four prices).
addition, 2019 is the first year of the listing of biosics in China, and on February 22, 2019, Fuhong Hanxuan's independently developed product "Hanlikang ®" was successfully approved for sale in China, becoming the first biosicide drug approved in China.
Data Source: Pharmaceutical Intelligence Data Enterprise Data Source: Pharmaceutical Intelligence Data Enterprise Edition China's first biosynthic drug approved, to help Fosun Biopharmaceutical layout 2019 for Fosun Pharma is undoubtedly full of turning points of the year, the focus of the direction of change The main business of the main business structural shift, gradually increased the small molecule innovation drugs, monoclonal antibody bio-innovative drugs and bio-similar drugs, CAR-T cell drugs research and development investment, Is Fosun Pharma's unstable acceleration period, but also its opportunity to surpass themselves.
won the top spot in the Biopharmaceuticals List at this PDI summit, which shows that it made a big deal in the field of biopharmaceuticals last year.
2019 annual report shows that Fosun Pharmaceuticals achieved operating income of 21.76 billion yuan, an increase of 16.51 percent over 2018, with a total investment of 3.463 billion yuan in research and development, an increase of 38.15 percent over 2018.
research and development investment in the pharmaceutical business was 3.131 billion yuan, accounting for 14.38 percent of the pharmaceutical business revenue.
(source: Fosun Pharma's 2019 Annual Report) invested heavily in bioinnovating drugs and biosynthic drug declaration projects as many as 12 and 21.
2019, Lytoxi monoantigen injection (Hanlikang) became the first biosypolytic drug to be approved for sale in China, and was quickly approved by the market in mid-May 2019, with annual sales of about 150 million yuan.
In addition, monoclonal antibody biosynthetic drugs (injected crater bead monoantigen, Adamo monoantigen injections) have also been approved for marketization of new drugs in China and have been included in the priority review process, with 12 monoclonal antibody products and 8 joint treatment programs conducting more than 20 clinical trials worldwide.
data fully show the huge layout of Fosun Pharma in the field of biopharmaceuticals, but also reflect Fosun Pharma's determination to firmly follow the path of innovation and internationalization.
believe that with the strengthening of its research and development strength, with its "4IN" strategic guidance, both product strength and innovation capabilities in the next few years will be qualitatively improved.
Hengrui Karelli pearl single-year sales of more than 1 billion, dozens of clinical trials potential development in recent years, gradually shift the focus from "chemical drugs" to "biopharmaceuticals" Hengrui medicine, biopharmaceuticals in the field of performance is equally outstanding.
this year's Hengrui Pharmaceutical "Biopharmaceuticals List" ranking slightly lower than last year, but in the field of biopharmaceutical achievements, compared with last year is only higher than last year.
2019, a total of 6 new drugs of class 1 for therapeutic biologics were approved for clinical use and 1 new drug for therapeutic biologics (Carelli pearl monoanti) was approved for production.
Karelli Zhudan is the third domestic PD-1 antibody drug listed in China for the treatment of patients with relapsed/refractic classic Hodgkin's lymphoma (cHL).
is also one of only five PD-1 monoantigen drugs in the country, and although its company's results do not disclose sales for 2019, the industry estimates that the drug will have sales of more than $1 billion in 2019.
and according to corporate announcements, there are as many as 33 clinical trials followed by Henri Pharmaceuticals' Karelli pearl monoantigen, which also provides a strong backing for this antibody.
2020, Henrui Pharmaceuticals' Karelli Zhu single anti-single anti-single anti-successive approval for the field of lung cancer, esophageal cancer treatment, becoming the first approved lung cancer and esophageal cancer adaptation of domestic PD-1 inhibitors.
to a large extent, China's cancer into a new era of immunotherapy, but also let the single anti-competitive or biological agent competition officially entered the white heat stage! Baiji Shenzhou for the first time in the top 10, rookie-shaped Yuanshe who 2019, is destined to be an extraordinary year in the history of Baiji Shenzhou, the most "burning money" company has become Baiji Shenzhou unique "title", since its inception in 2011 has not yet achieved a real sense of profit, but widely favored by investors, this year is the largest equity financing in the field of biotechnology.
, Baiji Shenzhou, relying on its strong research and development strength, entered the 10th place in the 2020 biopharmaceutical list, comparable to the NBA rookie yuan.
Biopharmaceuser, at the end of 2019, the high-profile single-dose injection of Reilly Zhu was approved by China's State Drug Administration (NMPA) for the treatment of classic Hodgkin's lymphoma (cHL) patients with at least second-line system chemotherapy, and the domestic market PD-1 "4-plus-2 model" was initially formed, so that the domestic PD-1 first echelon officially entered the final.
At the same time, in order to meet the disadvantages of single anti-regeneration in Baiji Shenzhou, there are currently 15 potential registered clinical trials for Reilly-Zhu single resistance in China and the world, including 11 Phase 3 clinical trials, 4 key Phase 2 clinical trials, covering lung cancer, liver cancer, esophageal squamous cell carcinoma, stomach cancer and other high-risk cancer species.
If the anti-injection solution for Reilly-Zhu can be designed with differentiated products and excellent clinical performance, in accelerating the expansion of reilly-pearl single-dose injections in solid tumors and blood tumors on the adaptive layout smoothly, or will open a new era of immunotherapy, to achieve later.
addition, once by 2020 Baiji Shenzhou relies on its PD-1 products to achieve commercial revenue, then the domestic first echelon of single-resistance competition or will be converted to domestic PD-1 between the competitive situation.
in the case of obvious price advantage, and adaptive accelerated approval is equally important, whether to enter health insurance is the key to success or failure! List: Concino (vaccine industry) in 2020 under the new crown outbreak catalyzed, vaccines and "special effects drugs" as the focus of the public's attention.
of vaccines as an effective tool for preventing problems has been raised again.
at the same time, a group of vaccine-focused biopharmaceutical companies have quickly become popular in this outbreak, especially as the epidemic spreads around the world, and new crown vaccines and special effects drugs may be a hope for the world.
Net Red" enterprise Concino is one of them, its company has developed a new crown vaccine has now entered the third phase of clinical, in the near future or will benefit the people, its super research and development strength reflected in the most vivid, this PDI summit, research and development strength, the first successful entry into the "biological medicine list", ranked 17th.
In 2019, Concino completed clinical declaration with the new drug 13-price pneumococcal polysaccharide binding vaccine (CRM197, TT vector) for biologics 3 new drugs, and completed the production declaration with the vaccine for the combination of 6 new drugs for biological products, ACYW135 group meningococcal combined vaccine and freezing-dried group C meningococcal vaccine, and recombinant Ebola virus vaccine (adenovirus vector) completed the supplementary application.
heavy product ACYW135 group meningococcal combined vaccine, Minhai biology, Zhifei biology, Lanzhou Institute of Biological Products, Watson biological layout, and in the clinical trial stage, it is expected that there will be greater competition in the future.
also because of its own MCV4 can cover the corresponding serotype of MCV2, the plan MCV2 will enter the national immunization program in the future as an immunization program vaccine, then MCV4 after the market is a non-immune program vaccine.
the immune programme vaccine market is different from the consumer group faced by the non-Immune programme vaccine market.
, concino's MCV2's entry into the national immunization program is largely related to competing with MCV4.
summary with the previous period, the official website of the State Health Insurance Administration issued a message on biological products (including insulin) and Chinese medicine collection to listen to expert advice, research procurement policy.
In the government's health insurance financial pressure, policy enforcement, health insurance bureau negotiation capacity and other aspects of the joint impact of hundreds of billions of sales market and huge investment in research and development, enterprises should see, if the collection extended to biological drugs, worry will follow? Although, due to the complexity and differences of biological drugs, the inclusion of biological products in the harvesting is not a short-term solution, but with the increase in the number of drugs on the market, the inclusion of collecting will still be the final destination of biological drugs.
, sooner or later the enterprise layout time is the key, of course, is also a good time for the up-and-coming show to catch up with the previous.
attached: List of Biological Medicines.