Incorporate biological drugs into centralized procurement! The market for monoclonal antibodies and insulin fluctuates

With the gradual maturity of centralized procurement of drugs, the arrival of the normalization of collection, biological products into the scope of centralized procurement, is expected to happen, but did not expect to come so soon, recently, the State Health Insurance Administration held biological products (including insulin) and Traditional Chinese medicine into the collection of the symposium, on biological products (including insulin), concentrated procurement of traditional Chinese medicine to listen to expert opinions and suggestions, research and improve the relevant areas of procurement policy, promote procurement reform.
news broke, shaking the entire medical circle.
heat is not gone, July 28 industry on July 24 thin national collection meeting of the main content of the content of the content of the circulation, the collection varieties will be in accordance with the purchase amount of the first 80% of the drugs, the proposed 500 drugs, including a number of biological drugs and insulin products included.
biologics have developed rapidly in recent years and has been the focus and hot spot of innovative drug research and development.
broad biological drugs include biosimilars (monoantines, recombinant proteins), blood products, vaccines, insulin and other categories.
, according to Huarong Securities pharmaceutical industry analyst Zhang Keran pointed out that the biological drug vaccine and blood products into the volume of procurement is less likely, a class of vaccines have been free, two kinds of vaccines are self-funded varieties, the contribution of medical insurance is very small;
and most likely to enter the collection of biological drugs are highmaturity, market competition pattern is more adequate insulin;
domestic has accumulated 5 biosimilar drugs on the market, two varieties have formed a "1 plus 2" competitive pattern at present, the domestic heavy varieties of biosimilar drugs have reached the night before the dense listing.
according to pharmaceutical data statistics, up to now, the domestic layout of biologically similar drugs have about 180 enterprises, nearly 400 drugs, in the research of biological-similar drugs are mainly CD20, EFGR, VEGF, TNF, RANKL and HER2.
of which is most notable is the monoclonal antibody biosimilar stake with better anti-tumor effect.
according to pharmaceutical data, up to now, the domestic listed biosimilar drugs accumulated 5, respectively, Bai Otai and Haizheng Pharmaceuticals' Adamu mono-anti-injection, Qilu Pharmaceuticals and Cinda Bio's Bevala pearl monotoidagain, and Fuhong Hanxuan's Litoxi monotoidagain.
and notable on July 28th, the documents included 500 drugs in the biosimilar drug litoxiin, querceon, and bevalo-serobarbitagain.
, the FDA has approved a total of six Aadamzumamono-resistant biosimilar drugs, involving Concord Kirin, Pfizer, Samsung Bio, Sanders, BI, Amgen and original research firm AbbVie.
only the original research Adamu monoidat (Sumeile) was approved for listing in China, but it is worth mentioning that the domestic enterprises BaiOtai and Haizheng Pharmaceuticals' Adamu mono-anti-injection injection to priority review qualification in 2018 in the domestic rapid approval of the listing.
Adamu single anti-domestic declaration listing details
, in addition, Zhengda Tianqing, Suzhou United, Fuhong Hanxuan and Cinda Bio's Adamu Singanti has been declared for listing, as shown in the figure above.
according to the pharmaceutical zhi China clinical trial data show that the cumulative clinical registration of Adamu monoantimo has 41, of which 3 clinical 11, in addition to the original research enterprises of the product and listed enterprises, Cinda Biopharmaceuticals, TonghuaBao, Shenzhou cell three enterprises of the product has also entered the third phase of clinical trials.
it can be seen that Adamu single resistance at present initially meet the qualifications of collection, the formation of a 2-1 competitive pattern, domestic substitution of the distance of primary research further closer.
Adamu single anti-domestic enterprises phase 3 clinical trial details
data sources: pharmaceutical data Belava zhu singular anti-belvex monotonicaination enterprises for Roche, in 2017 domestic imports, 2018 the drug in the domestic patent expiration.
in December 2019 Qilu Pharmaceuticals won the first imitation, the first domestic-made Bevala bead sing-injection was approved for listing, in June this year, Cinda bio has been approved, domestic beival beads sing-it-against the import of raw drugs intensified, the competition pattern has been formed.
in addition, Green Leaf Pharmaceuticals, Haizheng Bio, Bai Otai similar products have also been reported.
Bevalzhu single anti-domestic declaration listing details table
data source: Drug intelligence data According to the pharmaceutical zhi China clinical trial database shows that up to now, bevalju singdron clinical registration has 74, of which 3 clinical trials have 24, including Hengrui Pharmaceuticals, Junshi Biologics, Shenzhou cells and other local enterprises 10, the specific details can be seen in the following : Beva Zhu singular anti-domestic enterprises phase 3 clinical trial details
data source: pharmaceutical data Litoxi singantism-based monoantithem for Roche Pharmaceuticals, in 2016 domestic imports, 2019 domestic enterprises Fuhong Hanxuan was approved for listing, the domestic competitive landscape is at a level of 1 .
according to pharmaceutical data, Cinda Bio's litoxin monotoxhashas has also been declared on the market, and has been included in the priority review, is expected to be quickly approved to join the ranks of the competition.

data sources: Drug intelligence data In addition, Baiji Shenzhou, Hualan Biology, Zhengda Tianqing and other enterprises of litoxisimonol resistance has entered the 3rd clinical phase: Lituxi monosar3 clinical trial related details table
data source: pharmaceutical intelligence data insulin substitution import in that, this kind of collection competition pattern has been fully in addition to focus on the focus of the single anti-drug, large amount of dosage, high gross margin, national focus on the two diseases (hypertension), diabetes
and in December 2019, Wuhan City in 2019 the first batch of drug centralized volume procurement implementation rules and procurement catalog released, insulin is listed, become a regional collection products, and for the pilot of the city of insulin collection.
insulin has developed to the third generation, the first generation of animal insulin due to adverse reactions gradually withdrew from the historical stage, the current competition is the second generation of insulin - genetically synthesized human insulin, the third generation of insulin is currently the most advanced new insulin-insulin analogue.
at the same time according to the action time classification, insulin can be divided into quick-acting, short-acting, medium-effect, long-acting and pre-mixed insulin and other categories.
According to Guoxin Securities report, the current domestic insulin market nearly 70% by Novo Nordisk, Lilly, Sanofi occupied, and whether it is second-generation insulin or three generations of insulin multiple products only original research imports, and is not currently declared listed enterprises produced, such as, Lai Lu insulin injection, De insulin valley, dit especial insulin, etc. ;
insulin details overview
data source: drug intelligence data, but it is worth mentioning that, although the degree of insulin localization is not high, but a variety of products have formed a full competitive pattern, especially the second generation of insulin, relatively domestic has matured, if the collection to promote the landing, will not promote domestic insulin replacement research, wait and see. in addition,
, the main content sin of the July 24 National Gathering Conference, which circulated on 28 July, contained 500 drugs (set in quantity on a case-by-case basis) contained a number of insulin varieties, such as: recombinant insulin glargine, endothein insulin, terioinsulin, sperm protein biosynthetic human insulin (30R) injections Dosage form, mendong insulin 30, sperm protein zinc recombinant human insulin (70/30) injection, sperm protein zinc recombinant insulin (25R) injection form, sperm protein biosynthetic human insulin (50R) injection form, sperm protein zinc recombinant insulin (50R) injection form.
on the current policy trends, whether it is national collection or local collection will be normal, including the scope of collected drugs will be more and more extensive, chemical drugs, biological drugs, traditional Chinese medicine into the collection is also early and late, since now the state has begun to prepare for the collection of biological drugs and traditional Chinese medicine, for enterprises only to be fully prepared to meet the opportunities and challenges.
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