Domestic "super" insulin came two leading confrontation industry "black horse" with a class 1 new drug.

Since September, the insulin market has seen the dynamics of two heavyweight new products: Tonghua Dongbao's class 2.1 new drug "super-fast-acting insulin injection" declared clinical, Noor and Nord in China submitted a clinical application for Icodec insulin injection ... In recent years, with the increase in the number of disease groups, the market size of diabetes drugs has been increasing year by year, under the increase of the national collection halo, oral anti-sugar drugs are getting more and more attention, new approved generic drugs springing up.
For people with type 1 diabetes, insulin treatment is necessary to obtain satisfactory results, although in recent years by multinational pharmaceutical companies firmly occupy the market leader position, but domestic pharmaceutical companies in the research and development of new products are still spared no effort, in 2020 these seven domestic new products are expected to join the war.
Transnational pharmaceutical companies topped the list, the three major domestic brands shine TOP list Figure 1: the share of diabetes drugs in various small categories of changes Source: Minet key provincial and municipal public hospital terminal competition pattern Minet data show that in recent years in key provinces and cities public hospital terminals, non-insulin-type blood sugar-lowering drugs are still the main force of diabetes drugs, but insulin and similar drugs market share is also gradually rising.
the first half of 2020 affected by the outbreak, the frequency of patient visits to the hospital declined, but the market share of this small category remains optimistic, the proportion rose to about 38%.
diabetes is a common "drug can't stop" disease, patients reduce the frequency of going to the hospital to the pharmacy to buy, thereby stimulating the sale of insulin products in retail terminals. Data collected by about 5,000 stores in 26 provincial and municipal capitals and municipalities within
meters showed that sales of insulin glycerin and tetratin increased by more than 5% in the first half of 2020, while the growth rate of mendon insulin and refined zinc recombinant insulin also showed positive growth.
Table 1: Changes in the share of insulin and similar drugs TOP5 enterprises Source: Minet key provincial and municipal public hospital terminal competition pattern Has been, multinational pharmaceutical companies firmly control insulin and similar drugs market leadership position, No. Total market share of more than 80%, but in recent years, the domestic leader Ganli Pharmaceuticals, Tonghua Dongbao Pharmaceuticals continued to make efforts, the total market share gradually rose to 11.44% Table 2: TOP10 brand market share changes Source: Minnet key provinces and cities public hospital terminals Competition pattern From the TOP10 brand, domestic brands occupy three seats: Gan Li Pharmaceuticals' recombinant insulin glycelin injection directly impact is Sanofi's heavy product insulin glycelin injection, from the variety of competitive enterprises' share, Sanofi from 2018 76.99 per cent fell to 74.48 per cent in the first half of 2020, while Ganli Pharmaceuticals rose from 22.65 per cent in 2018 to 24.30 per cent in the first half of 2020.
Tonghua Dongbao Pharmaceuticals directly impacted by No. and Nord's refined protein recombinant human insulin injections, from the market share of the variety of competing enterprises, No. No. 1 Ander from 69.40 percent in 2018 to 64.77 percent in the first half of 2020, while Tonghua Dongbao Pharmaceuticals rose from 20.16 percent in 2018 to 23.95 percent in the first half of 2020.
protein zinc insulin injection currently has no import approval, the domestic approved enterprises include Shanghai Pharmaceutical First Biopharmaceuticals, Jiangsu Wanbang Biopharmaceuticals Group and Jiuquan Dadley Pharmaceuticals, of which Wanbang in the variety in the market leader.
The world's first dual insulin preparation, oral insulin preparation heavy attack Table 3: 2018 to date approved imported insulin products Source: Minet MED2.0 China Drug Review Database Minernet data show that Novo Nord The world's first soluble bi-insulin preparation, Degumen Winter Double Insulin Injection, was approved for import in May 2019, effectively balancing the control of peri-abdominal and after-dinner blood sugar, with low rates of confirmed hypoglycemia and night-time confirmed hypoglycemia.
due to the short time to market, the current sales scale has not yet been formed, the first half of 2020 in key provinces and cities in the public hospital terminal sales of 140,000 yuan.
2020, Sanofi's insulin glycerina injections (1.5ml: 450 units/pre-filled injection pens) were approved for import, and the product currently has 10 import approvals in China.
recombinant human insulin intestinal capsule, which was approved as clinically as early as 2019 and is expected to become the world's first oral insulin preparation, has recently ushered in new developments: Domestic Phase III. Phase III clinical trials are about to begin.
the main purpose of this clinical trial is to assess the effectiveness of oral insulin capsule therapy among patients with type 2 diabetes who have poor blood sugar control of oral hypoglycemic drugs, and to plan to include 470 people in the group.
the product was developed by Israel's Oramed, and in November 2015 Hefei Tianma Bio signed an investment agreement with Oramed, as well as exclusive rights to develop the product in China (including Hong Kong and Macau);
Figure 2: Clinical Trials of Recombinant Human Insulin Intestinal Capsules Source: China Drug Clinical Trials PublicIty Kuno and Nord submitted clinical applications for Icodec insulin injections in China in September this year, and the product is currently under review and approval.
is known to be a long-acting underlying insulin similar, with a half-life of 196 hours, and after injection into the body, Icodec insulin binds to albumin tightly but reversiblely, reducing blood sugar continuously, slowly and steadily over a period of a week.
the amount of Icodec insulin injected once a week is comparable to the amount of insulin glycelin (100 units) injected daily.
domestic insulin to catch up: 1 new drugs, 2 new drugs... There are 7 new products to be released Table 4: 2018 to date approved production of domestic insulin Source: Minet MED2.0 China Drug Review Database Domestic insulin, 2018 to date approved 5 new products, in addition to generalization Dongbao Pharmaceuticals, Ganli Pharmaceuticals, two domestic leaders, has been focusing on the field of antiviral drugs Yichang Dong Sunshine Changjiang Pharmaceuticals has also been approved the first insulin products, after entering the market will further eat into the market share of No.
Table 5: Domestic Insulin Approved clinically from 2018 to date Source: MED2.0 China Drug Review Database 2018 To date, 20 new insulin products have been approved clinically (by product name and enterprise statistics), of which the industry "black horse" Hefei The new class 1 drug recombinant recombinant insulin injection of Tyme Bio has attracted much industry attention, and in recent years, the research and development achievements of Tianmai Bio in the field of insulin have been emerging, and since 2018 there have been refined protein recombinant human insulin injections (premixed 30/70), recombinant human insulin injections have been approved for production.
September 15, Tonghua Dongbao announced that the 2.1 class of new drugs super-speeding insulin injection declaration clinically has been accepted, is currently in review and approval.
Tonghua Dongbao signed a partnership and licensing agreement with Adocia of France in 2018 to obtain exclusive clinical development, production and commercialization rights for the licensed product BC Lispro (i.e., super-fast-acting insulin injections) in designated countries and regions using the company's bio Chaperone patented platform technology.
Super-acting insulin injections belong to a new generation of quick-acting insulin similar products, currently only Noro and Noro's quick-acting men's winter insulin and Lilly's quick-acting insulin, which are characterized by faster and better drug absorption, so that insulin more rapidly effective, and after-dinner physiological insulin secretion is closer to the current domestic market has no similar products approved.
before the listing of Ganli Pharmaceuticals, Tonghua Dongbao was the "first stock of insulin", in this heavy new drug, can return to the glory of the past? In addition, No. and Nord's Degu insulin, tetrade insulin and Lilly's refined protein zinc recombinant human insulin is expected to usher in the impact of domestic brands, at present, Is day-clear pharmaceutical group , LianyunGang Run Crowd Pharmaceutical's Degu insulin injection Phase I clinical is under way.
Table 6:2018-to-date domestic insulin market application insulin glycelin, mendon insulin, lai insulin is the key provincial and municipal public hospital terminal insulin and its similar drug TOP3 varieties, the first half of 2020 total market share of more than 74%.
Figure 3:2020H1 insulin glycelin enterprise competition pattern At present, in addition to Sanofi's insulin glycelin injection in the domestic market, the domestic pharmaceutical company In-Glycerine Pharmaceuticals recombinant insulin recombinant insulin injection market share is also larger, Tonghua Dongbao Pharmaceutical's insulin insulin glycelin injection was approved to join the war situation at the end of 2019.
No and Nord exclusive men's winter insulin market situation in May this year was broken by GanLi Pharmaceuticals, zhuhai Federal Pharmaceuticals, Zhejiang Haizheng Pharmaceuticals, Tonghua Dongbao Pharmaceuticals and other enterprises have related products listed applications in the review and approval, with the addition of domestic brands, the road to replace the original research will be more and more smooth.
Figure 4:2020H1 Lai's insulin enterprise competition pattern Source: Minet key provincial and municipal public hospital terminal competition pattern Lai's insulin is currently only Lilly and Gan Li Pharmaceuticals approved, Jiangsu Wanbang Biopharmaceutical Group submitted a listing application in June 2020.
in July this year, it was reported that insulin in the future will also be included in the national collection, the two domestic leading stock prices fell sharply in an instant.
But the industry believes that the entry of insulin into the collection of multinational pharmaceutical companies have a greater impact, in the face of the current situation of multinational pharmaceutical companies dominate the market, the domestic leader with the power of the collection to seize the market is not irresistible, but the price reduction brought about by the harvest will also arrive as scheduled.
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