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Recently, East Sunshine Pharmaceutical's product line has been dynamic: Class 1 new drug HEC138671 tablets have been approved for clinical trials, insulin aspart injection has been approved for marketing, and the first generic patent challenge of fingolimod capsules has been successful.
.
.
At present, there are 33 Class 1 new drugs in the approved clinical stage or above, and 5 are in the phase III clinical stage, and the market can be expected; Deeply cultivate the 68 billion diabetes market, with small molecule and large molecule innovative drugs; 42 varieties have been evaluated (14 firsts), and 10 new classified products are under review
.
.
.
At present, there are 33 Class 1 new drugs in the approved clinical stage or above, and 5 are in the phase III clinical stage, and the market can be expected; Deeply cultivate the 68 billion diabetes market, with small molecule and large molecule innovative drugs; 42 varieties have been evaluated (14 firsts), and 10 new classified products are under review
.
33 Class 1 new drugs are eye-catching! These 5 models can be expected to be listed
Recently, East Sunshine Pharmaceutical's Class 1 new drug HEC138671 tablets has obtained implicit approval for clinical trials and is intended for the treatment
of non-alcoholic steatohepatitis (NASH).
Since the beginning of this year, three Class 1 new drugs have been approved for clinical trials, including antitumor drug HEC169096 tablets, migraine drug HEC137076MsOH tablets, and NASH drug HEC138671 tablets
.
of non-alcoholic steatohepatitis (NASH).
Since the beginning of this year, three Class 1 new drugs have been approved for clinical trials, including antitumor drug HEC169096 tablets, migraine drug HEC137076MsOH tablets, and NASH drug HEC138671 tablets
.
In recent years, East Sunshine Medicine has accelerated its innovation and transformation, and innovative projects have continued to emerge
.
At present, East Sunshine Medicine has more than 200 R&D projects, covering small molecule and large molecule innovative drugs, biosimilars, high-end generic drugs and improved new drugs, of which 33 Class 1 new drugs are in the approved clinical stage and above, focusing on infection, tumor, metabolism, psychiatric nerves and other therapeutic areas, involving NS5A, c-MET, RET, EGFR, SGLT2, PI3K, SGLT2 and other targets
.
.
At present, East Sunshine Medicine has more than 200 R&D projects, covering small molecule and large molecule innovative drugs, biosimilars, high-end generic drugs and improved new drugs, of which 33 Class 1 new drugs are in the approved clinical stage and above, focusing on infection, tumor, metabolism, psychiatric nerves and other therapeutic areas, involving NS5A, c-MET, RET, EGFR, SGLT2, PI3K, SGLT2 and other targets
.
East Sunshine Medicine is mainly developing Class 1 new drugs
Source: China Drug Clinical Trial Publicity Database on Intranet
Among the 33 Class 1 new drugs, emetavir phosphate capsules are the first completely independently developed anti-hepatitis C new drugs in China, which were approved for marketing in December 2020 and entered the national medical insurance directory through negotiation in December 2021; Moficedin, llotinib, crefatinib, Jungagliflozin, HEC113995PA· H2O, etc.
are in the phase III clinical stage, and the market can be expected; Ningertinib, HEC96719, ifinidone, etc.
are in phase II clinical stage
.
are in the phase III clinical stage, and the market can be expected; Ningertinib, HEC96719, ifinidone, etc.
are in phase II clinical stage
.
Among the small molecule innovative drugs with advanced research and development, Moficedin, the world's first-in-class hepatitis B virus capsid inhibitor, is the fastest developed compound in the world with the same target, and is also the world's first small molecule compound that can be clinically confirmed to clearly inhibit the s antigen, and is expected to be submitted to NDA in 2023; Lelotinib (EGFR inhibitor) is expected to become the world's only small molecule new drug targeted for the treatment of esophageal cancer, and is expected to be launched in 2024; Crefatinib (FLT3 inhibitor) is a new drug for the treatment of acute myeloid leukemia and is expected to be available in
2025.
2025.
As the company's first Class 1 biological drug, HEC88473 injection is the first approved clinical GLP-1/FGF21 dual agonist in China, and the indications to be developed include non-alcoholic steatohepatitis, type 2 diabetes, and weight loss, and no drugs with the same target have been approved
in China.
In addition, there are 7 macromolecular new drugs in the preclinical stage
.
in China.
In addition, there are 7 macromolecular new drugs in the preclinical stage
.
Onslaught the 68 billion market! Full layout of diabetes product line
On October 18, East Sunshine Pharmaceutical issued an announcement that the company's self-developed product insulin aspart injection was approved for marketing, making it the fifth domestic company
.
Insulin aspart is the third generation of rapid-acting mealtime insulin, which is currently a commonly used drug in the mainstream intensive insulin regimen, which is mainly used to control postprandial blood glucose in diabetic patients, and is suitable for patients
who receive oral hypoglycemic drugs but still have poor blood sugar control.
.
Insulin aspart is the third generation of rapid-acting mealtime insulin, which is currently a commonly used drug in the mainstream intensive insulin regimen, which is mainly used to control postprandial blood glucose in diabetic patients, and is suitable for patients
who receive oral hypoglycemic drugs but still have poor blood sugar control.
Diabetes is a chronic metabolic disease
characterized by high blood sugar.
According to the 10th edition of the Global Diabetes Map published by the International Diabetes Federation (IDF), there were 537 million people with diabetes among adults aged 20-79 years worldwide in 2021, equivalent to 1 in 10 people with
diabetes.
Among them, China is 140 million, which is still the country
with the largest number of diabetics.
characterized by high blood sugar.
According to the 10th edition of the Global Diabetes Map published by the International Diabetes Federation (IDF), there were 537 million people with diabetes among adults aged 20-79 years worldwide in 2021, equivalent to 1 in 10 people with
diabetes.
Among them, China is 140 million, which is still the country
with the largest number of diabetics.
According to data from Intranet, in 2021, the sales scale of diabetes drugs in China's three major terminal markets (see the end of this article for the statistical scope) will be close to 68 billion yuan, a year-on-year increase of 2.
58%.
58%.
Sales of diabetes drugs in China's three major terminal markets (10,000 yuan)
Source: Intranet database
The huge patient population and huge drug market have attracted East Sunshine Medicine to deeply enter the field of
diabetes medicine.
diabetes medicine.
In terms of oral hypoglycemic drugs, East Sunshine Medicine has won metformin hydrochloride tablets, glipizide capsules, linagliptin tablets, sitagliptin phosphate tablets, alogliptin benzoate tablets, linagliptin metformin tablets, sitagliptin metformin tablets and other products, involving commonly used clinical biguanides, sulfonylureas and DPP4 inhibitors
.
.
In terms of insulin analogues, Dongguang Pharmaceutical's recombinant human insulin injection and insulin glargine injection have been approved for marketing and won the bid for the sixth batch of centralized procurement (insulin special), and insulin aspart injection is the third insulin product approved by the company; The marketing applications of insulin aspart 30 injection and protamine human insulin mixture injection (30R) are under review; Liraglutide injection, insulin degludecide injection, etc.
are in the phase III clinical stage, and 14028 injection (dulaglutide) has been approved for clinical trials
.
are in the phase III clinical stage, and 14028 injection (dulaglutide) has been approved for clinical trials
.
The research and development of innovative diabetes drugs continues to advance, and the pyroglutamic acid jungagliflozin capsules (SGLT2 inhibitor) of East Sunshine Medicine are in the phase III clinical stage; HEC73077 tablets for the treatment of diabetic nephropathy and HEC88473 injection for the treatment of type 2 diabetes are both in the phase I clinical stage, and a number of macromolecular new drugs are in the preclinical stage
.
.
42 varieties have been evaluated! 10 new products on the way
Up to now, 42 varieties of East Sunshine Medicine have passed/deemed to have passed the consistency evaluation
.
Among them, 14 varieties are the first in China to be evaluated, such as linagliptin metformin tablets (I.
), linagliptin metformin tablets (II.
), linagliptin metformin tablets (III.
), sitagliptin metformin tablets (III.
) and other varieties are exclusively evaluated
.
.
Among them, 14 varieties are the first in China to be evaluated, such as linagliptin metformin tablets (I.
), linagliptin metformin tablets (II.
), linagliptin metformin tablets (III.
), sitagliptin metformin tablets (III.
) and other varieties are exclusively evaluated
.
East Sunshine Medicine passed/deemed to pass the consistency evaluation variety
Source: MED2.
0 China Drug Evaluation Database
0 China Drug Evaluation Database
From the perspective of treatment areas, the 42 varieties cover 8 therapeutic categories, mainly focusing on digestive system and metabolic drugs (11), systemic anti-infective drugs (9), and nervous system drugs (8).
According to data from Intranet, in 2021, the sales scale of terminal digestive system and metabolic drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) exceeded 170 billion yuan, the sales scale of systemic anti-infective drugs exceeded 150 billion yuan, and the sales scale of neurological drugs exceeded 100 billion yuan
.
.
In the six batches of chemical medicine centralized procurement carried out by the state, East Sunshine Medicine won the bid for 0, 3, 2, 4, 2 and 2 varieties respectively, and a total of 13 varieties won the bid
.
Most varieties are approved for listing in the newly registered classification, and the market share is low, which will help the company's products to quickly increase after
centralized procurement.
.
Most varieties are approved for listing in the newly registered classification, and the market share is low, which will help the company's products to quickly increase after
centralized procurement.
The newly registered classification of East Sunshine Drug is reported for the production of generic drugs under review
Source: MED2.
0 China Drug Evaluation Database
0 China Drug Evaluation Database
At present, East Sunshine Medicine still has 10 newly registered generic drug marketing applications under review, which will be regarded as passing the consistency evaluation
after being approved for production.
Among them, fingolimod hydrochloride capsules are the world's first oral drugs for the treatment of multiple sclerosis, and the global sales of the original drug in 2021 will be 2.
787 billion US dollars, and no generic drugs have been approved for marketing
in China.
In 2019, the product won the first imitation in the United States, was the first to be produced in China and was included in the priority review by CDE, with a high probability of being approved as the first imitation
in China.
after being approved for production.
Among them, fingolimod hydrochloride capsules are the world's first oral drugs for the treatment of multiple sclerosis, and the global sales of the original drug in 2021 will be 2.
787 billion US dollars, and no generic drugs have been approved for marketing
in China.
In 2019, the product won the first imitation in the United States, was the first to be produced in China and was included in the priority review by CDE, with a high probability of being approved as the first imitation
in China.
Data source: Intranet database, company announcement
Note: Intranet's "Competition Pattern of China's Three Major Terminals and 6 Major Markets", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
based on the average retail price of the product at the terminal.
