Simcere broke out with 15 class 1 new drugs and 11 new products

Recently, Simcere Pharma released its 2021 results.
The company's innovative drug revenue is about 3.
12 billion yuan, a year-on-year increase of about 53.
8%, accounting for 62.
4% of the total revenue; research and development expenses are about 1.
417 billion yuan, a year-on-year increase of about 24.
1%, accounting for total revenue.
The proportion is about 28.
3%
.
Simcere focuses on the three major areas of "central nervous system, autoimmunity, and tumor".
Currently, 18 innovative drugs (15 category 1 new drugs) are in the approved clinical stage and above, and 4 innovative drugs are expected to be launched; , 17 varieties have been reviewed (6 first), 5 are planned to be included in the seventh batch of centralized procurement, and the first imitation of $9.
8 billion is exclusively reported for production
.
Innovative drugs sold for over 3 billion yuan, and 15 new class 1 drugs under development are eye-catching.
On March 24, Simcere Pharmaceuticals released its 2021 results.
The company's annual revenue was about 5 billion yuan, a year-on-year increase of 10.
9%; profit was about 14.
99 100 million yuan, a year-on-year increase of 125.
6%
.
Simcere has achieved remarkable results in its innovation and transformation.
Currently, it has 5 innovative drugs, including Edaravone Dex-Cambosol Injection, Envolizumab Injection, Recombinant Human Vascular Endostatin Injection, and Ilarimod Tablets and abatacept injection
.
In 2021, Simcere's innovative drug revenue is about 3.
12 billion yuan, a year-on-year increase of about 53.
8%, accounting for 62.
4% of the total revenue (32.
9% in 2019 and 45.
1% in 2020).
Pharmaceutical business-led pharmaceutical company
.
The composition of Simcere's product revenue in 2021 (unit: 100 million yuan) Source: Listed company announcement From the perspective of sub-sectors, Simcere's product revenue is concentrated in the three major areas of nervous system, tumor and autoimmune system
.
Benefiting from the outstanding performance of the Class 1 new drug Edaravone Dexbornol Injection Concentrated Solution, the company's nervous system business revenue rose 119.
3% to 1.
543 billion yuan
.
Behind the rapid increase in revenue is Simcere's nationwide marketing network and leading commercialization capabilities
.
As of December 31, 2021, the company has a total of nearly 4,000 sales staff, located in 31 provinces, municipalities and autonomous regions in China, covering more than 2,700 tertiary hospitals, about 17,000 other hospitals and medical institutions, and more than 200 large-scale hospitals.
National or regional chain of pharmacies
.
Simcere’s R&D investment (unit: 100 million yuan) Source: Listed company announcement It accounted for about 28.
3% of the total revenue
.
As of December 31, 2021, Simcere has a total of about 950 R&D personnel (including about 120 with Ph.
D.
and about 480 with master's degree), of which the clinical research team has grown rapidly to about 300
.
Simcere focuses on the three major fields of "central nervous system, autoimmunity and tumor", and has created nearly 60 innovative drug R&D pipelines
.
According to data from Minet.
com, Simcere has 18 innovative drugs in China that are in the approved clinical stage and above (excluding new drugs that have been marketed to expand new indications), of which 15 are Category 1 new drugs
.
Sources of some of Simcere's domestic innovative drugs: Minet database, listed company announcements Simcere's innovative drugs under development are concentrated in small-molecule chemical drugs, while biological drugs are mostly monoclonal antibodies; the targets under development include CDK4/6 , VEGF, JAK1, URAT1 and other common popular targets, and also include RAD51, AQP4, MAT2A and other targets with less layout at home and abroad
.
From the perspective of R&D progress, 4 innovative drugs have entered Phase III and above
.
Trilaciclib for injection (Trilaciclib for injection) has made the fastest progress and has now submitted NDA.
It is a CDK4/6 inhibitor co-operated by Simcere Pharmaceuticals and G1 Company of the United States.
It has a comprehensive bone marrow protection effect.
Targeted drugs include Pfizer's Palbociclib, Eli Lilly's Abecili, and Hengrui's Dalsili
.
Phase III clinical trials are being carried out, such as sivacizumab for injection (BD0801 for injection), edaravone dextrocamphenol sublingual tablet (Y-2 sublingual tablet), etc.
, among which Y-2 sublingual tablet is a new type of sublingual tablet The mode of administration is more convenient, and the patient compliance is better.
It is also more suitable for expanding other central nervous system disease indications in the future
.
5 varieties to be collected and 11 new products are on the way.
In terms of consistency evaluation, currently 17 varieties of Simcere have passed or are deemed to have passed the consistency evaluation, and more than half of them will be approved in 2021
.
The first/exclusive review of 6 varieties, of which Lenvatinib Mesylate Capsule is the first imitation + the first review
.
Simcere Pharmaceuticals has reviewed varieties Source: Minet MED2.
0 China Drug Evaluation Database In the forthcoming seventh batch of centralized procurement, Simcere Pharmaceuticals has 5 reviewed varieties to be included
.
From the perspective of competition, the competition pattern of mycophenolate mofetil oral normal-release dosage form and cefaclor oral liquid dosage form is relatively good; The market for phenolic ester oral normal-release dosage forms, lenvatinib mesylate capsules, and cefaclor oral liquids is yet to be developed, and it is expected to achieve increased volume through centralized procurement
.
Sources of varieties that Simcere Pharmaceuticals intends to include in the seventh batch: among the varieties under review by Minet database and Shanghai Sunshine Pharmaceutical Purchasing Network (excluding withdrawn or unapproved varieties), 3 varieties submitted supplementary applications for consistency evaluation; 11 varieties are reported for production under the new classification, and 3 of them have not been approved for the first imitation (including the first imitation of the dosage form)
.
Consistency evaluation varieties under review by Simcere (including new classification declaration) Source: MED2.
0 China Drug Evaluation Database of Minet Report production
.
Edoxaban is a selective factor Xa inhibitor developed by Daiichi Sankyo, with global sales of 154.
1 billion yen in 2020; ibrutinib is the only drug that has received three FDA breakthrough therapy designations, and is also a global The first BTK inhibitor approved for marketing, with global sales of $9.
777 billion in 2021
.
The first Sino-US double-reported product has been approved, and innovative drugs have made new progress in overseas clinical trials.
At the beginning of this year, Simcere Pharma announced that the clinical application of the company's self-developed innovative drug SIM0235 (SIM1811-03 injection) has been approved.
FDA-approved, this is a human immunoglobulin G1 (IgG1) type humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody, intended for clinical trials in advanced solid tumors and cortical T-cell lymphoma
.
In addition, Simcere's Y-2 sublingual tablet is undergoing Phase I clinical trials in the United States, with indications including intracranial hemorrhage and ischemic stroke
.
Its main component is similar to the concentrated solution of edaravone and dexbornol for injection, which can effectively penetrate the blood-brain barrier and exert central anti-inflammatory and anti-free radical effects
.
Compared with injection, the innovative sublingual delivery method is safer, more accessible and more convenient
.
Source of global clinical research and development progress of Y-2 sublingual tablet: new version database of Minet.
com In addition to innovative drugs, Simcere's generic drugs have also made new breakthroughs in "going overseas"
.
In May 2020, Simcere Pharma received a notification that the ANDA of Celecoxib Capsules declared to FDA by Nanjing Simcere TECO Pharmaceuticals, a subsidiary of the group, has been approved
.
Celecoxib belongs to a new generation of non-steroidal anti-inflammatory analgesics.
It mainly inhibits the production of prostaglandins by selectively inhibiting cyclooxygenase-2 (COX-2) to achieve anti-inflammatory and analgesic effects
.
Pfizer's global sales peak of celecoxib is close to 3 billion US dollars.
At present, the FDA has approved a number of celecoxib generic drugs, including Simcere, Yiling, Shiyao, Tianjin Tianyao, Qingdao Baiyang and other domestic pharmaceutical companies 's products
.
Source: Minet database, announcements of listed companies, etc.
Note: The statistics are as of March 30.
If there are any omissions, please correct me!