This pharmaceutical company is amazing!

Recently, Simcere Pharmaceuticals announced that it has reached a project cooperation with Shanghai Institute of Medicine and others on the global development, production and commercialization of the new coronavirus drug candidate SIM0417 series

Sales of innovative drugs accounted for nearly 60%, and medical insurance boosted the volume of Class 1 new drugs

Simcere, which is committed to rapid transformation to R&D and innovation-driven, has become a pharmaceutical company dominated by innovative drug business, and is one of the typical representatives of innovation and transformation of many traditional pharmaceutical companies

The interim results report shows that in 2021 H1 Simcere Pharmaceuticals achieved revenue of approximately 2.

Simcere's innovative drug revenue as a proportion of total revenue

Source: Listed company announcement

In recent years, Simcere's innovative drug revenue as a proportion of revenue has increased year by year.

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

Source: Listed company announcement

In 2021, H1 Simcere's R&D investment is about 627 million yuan, an increase of 38% over the same period last year, accounting for 29.

Simcere currently has 4 innovative drugs approved for marketing, namely edaravone and dextran injection, recombinant human endostatin injection, iramud tablets and abatacept injection

Edaravone dextrocampanol injection approved in July 2020 is the only new stroke drug approved in the world in the past five years

Also approved in 2020 is the innovative drug abatacept injection introduced by Simcere.

A new class 1 drug for rheumatoid arthritis, Iramud tablets, is the world’s first and only domestically marketed Iramod drug.

Recombinant human endostatin injection is the only endostatin approved for marketing at home and abroad, and it is also the first domestic targeted anti-angiogenesis drug

The sound sales promotion system is superimposed on medical insurance to increase the volume, and the revenue of Simcere's innovative drugs has increased rapidly, which has promoted the continuous growth of the company's performance

60 innovative drugs are under development, and 4 class 1 new drugs are expected to be on the market

Relying on the "cooperation + self-research" dual-drive model, Simcere has created an innovative drug pipeline with significant differentiation and great commercial potential

Simcere Pharmaceuticals is developing some innovative drugs

Source: China Drug Clinical Trial Publicity Library of Meinenet

In the field of anti-tumor, Envolimab, which is cooperating with Sidi Di and Corning Jerry, has been submitted to NDA and has recently entered the administrative approval stage.

In terms of BD, in March this year, Simcere and Kazia reached a cooperation on Paxalisib (SIM0395), which is a PI3K/mTOR pathway inhibitor for the treatment of glioblastoma.

In the field of central nervous system, edaravone dextrocampanol sublingual tablets (Y-2 sublingual tablets) cooperating with Yantai Yinuoyi is undergoing phase III clinical trials.

For BD, in June this year, Simcere and Vivoryon reached an agreement on two products targeting the toxic amyloid N3pE, including varoglutamstat (PQ912) in global clinical phase IIb and preclinical PBD-C06

In the field of autoimmunity, the company’s self-developed SIM0335 is the world’s first national class 1 new drug candidate that regulates fatty acid metabolism and acts on IL-17A-related pathways.
It aims to treat mild to moderate plaque psoriasis through external use.
Phase I clinical trials are currently underway
.

In other therapeutic areas, SIM1909-13 tablets (SIM0295), a highly selective and potent urate transporter 1 (URAT1) inhibitor, in cooperation with JW, are used in the treatment of gout with hyperuricemia, worldwide Phase IIb clinical trials have been completed within
.

15 varieties have been reviewed, 5 major varieties sprint the first imitation

In the field of generic drugs, Simcere closely follows national policies, actively conducts consistency evaluations, and participates in national centralized procurement
.

Review of Simcere Pharmaceuticals

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

At present, 15 products of Simcere Pharmaceutical have passed or deemed to pass the consistency evaluation.
Lenvatinib Mesylate Capsules, Edaravone Injection, Cefaclor Dry Suspension, Meloxicam Tablets, Amoxicillin Xilin granules and montmorillonite powder are the first/exclusive reviews
.

In the research and development of generic drugs, Simcere's owners have taken the lead in imitation, especially the world's best-selling star products
.
At present, the company has 10 new classified products under review, and 5 of them have not yet been approved for listing (including the first imitation of dosage forms)
.

Simcere Pharmaceuticals has already reported for production and there is no new product under review that has been approved for the first imitation

Source: Mi Nei Net Database

Cabozantinib, developed by Exelixis and Ipsen, is a multi-target small molecule tyrosine kinase inhibitor.
Due to its broad effectiveness against a variety of cancers, cabozantinib is known as the most effective drug among targeted drugs.
"Palm Oil"
.
At present, the original products have not yet been approved to enter the domestic market.
Three domestic companies including Hausen, Osaikon, and Simcere have submitted listing applications under the new registration classification
.

Apomilast (apmilast/apmilast) is a new oral, small molecule phosphodiesterase 4 (PDE-4) inhibitor developed by New Base (acquired by Amgen), in 2014 Approved by the FDA for listing, global sales in 2020 will reach 2.
195 billion U.
S.
dollars
.
The original research product was approved for import in August 2021.
At present, 8 domestic companies have submitted applications for the listing of Apster tablets under the new classification
.

Adoxaban is a selective factor Xa inhibitor developed by Daiichi Sankyo.
It was first approved for venous thromboembolism in Japan in 2011, and has been approved for multiple new indications.
Global sales in 2020 154.
1 billion yen
.
The original research products were approved for import at the end of 2018.
Simcere and Nanjing Chia Tai Tianqing submitted applications for the listing of idoxaban tosylate tablets under the new registration classification, and Simcere was the first to submit for production
.

Ibrutinib, which was approved for marketing in the United States in 2013, is the only drug that has been designated by the FDA for three breakthrough treatments.
It is also the world's first Bruton's tyrosine kinase (BTK) inhibitor approved for marketing.
In 2020 Global sales reached 9.
442 billion U.
S.
dollars
.
The original research product was approved for import in August 2017, and the domestic sales in 2020 will exceed 1 billion yuan
.
At present, only Simcere has submitted an application for the marketing of Ibrutinib capsules in the category 4 imitations
.