Over 3 billion!

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%
.

Innovative drugs sold for over 3 billion yuan, and 15 class 1 new drugs under development were eye-catching

On March 24, Simcere announced its 2021 results.
The company's annual revenue was about 5 billion yuan, a year-on-year increase of 10.
9%; its profit was about 1.
499 billion yuan, a year-on-year increase of 125.
6%
.

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
.

Product revenue composition of Simcere 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
.

Behind the rapid increase in revenue is Simcere's nationwide marketing network and leading commercialization capabilities
.

Simcere Pharmaceutical's R&D investment (unit: 100 million yuan)

Source: Listed company announcement

In terms of research and development, Simcere is also willing to "heavy costs".
In 2021, the company's research and development expenses will be about 1.
417 billion yuan, a year-on-year increase of about 24.
1%, accounting for about 28.
3% of total revenue
.

Simcere focuses on the three major fields of "central nervous system, autoimmunity and tumor", and has created nearly 60 innovative drug R&D pipelines
.

Some of the innovative drugs under research by Simcere Pharmaceuticals in China

Source: Mi Intranet database, announcements of listed companies

Simcere’s innovative drugs under development focus on small-molecule chemical drugs, while biological drugs are mostly monoclonal antibodies; the targets under development include common popular targets such as CDK4/6, VEGF, JAK1, and URAT1, as well as RAD51, AQP4, and 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
.

Phase III clinical trials are being carried out, such as sivacizumab for injection (BD0801 for injection) and edaravone dextrocambosol sublingual tablet (Y-2 sublingual tablet), 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 proposed collection varieties are gaining momentum, 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
.

Simcere Pharma has reviewed varieties

Source: MED2.
0 China Drug Evaluation Database

In the upcoming seventh batch of centralized procurement, Simcere 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
.

Simcere Pharmaceuticals plans to be included in the seventh batch of varieties

Source: Minet database, Shanghai Sunshine Pharmaceutical Purchasing Network

Among the varieties under review for consistency evaluation (excluding withdrawn or disapproved varieties), 3 varieties submitted supplementary applications for consistency evaluation; 11 varieties were reported for production under new classification, and 3 of them have not been approved for the first imitation (including the first copy of the dosage form).
imitation)
.

Consistency evaluation varieties under review by Simcere (including new classification declaration)

Source: MED2.
0 China Drug Evaluation Database

Among them, edoxaban tosylate tablets were the first to be reported for production, and ibrutinib capsules were exclusively reported for 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 US$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

In terms of internationalization, at the beginning of this year, Simcere announced that the clinical application of the company's self-developed innovative drug SIM0235 (SIM1811-03 injection) was approved by the FDA, which is a human immunoglobulin G1 (IgG1) human immunoglobulin G1 (IgG1).
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
.

Global clinical research and development progress of Y-2 sublingual tablet

Source: new version database of Minet

In addition to innovative drugs, Simcere's generic drugs "going overseas" have also made new breakthroughs
.
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: Mi Intranet database, announcements of listed companies, etc.