Simcere Pharmaceutical Group or Simcere Pharmaceutical (, ) is an

innovation Innovation is the practical implementation of ideas that result in the introduction of new goods or services or improvement in offering goods or services. ISO TC 279 in the standard ISO 56000:2020 defines innovation as "a new or changed enti ...

and R&D-driven

pharmaceutical company The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympt ...

with a mission of “providing today’s patients with medicines of the future.” It has established a National Key Laboratory of Translational Medicine and Innovative Drug Development. The company focuses on three therapeutic areas including

oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...

central nervous system The central nervous system (CNS) is the part of the nervous system consisting primarily of the brain and spinal cord. The CNS is so named because the brain integrates the received information and coordinates and influences the activity of all p ...

and

autoimmune diseases An autoimmune disease is a condition arising from an abnormal immune response to a functioning body part. At least 80 types of autoimmune diseases have been identified, with some evidence suggesting that there may be more than 100 types. Nearly a ...

with forward-looking layout of disease areas that may have significant clinical needs in the future. Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading innovative companies and research institutes. The company has been continuously recognized as one of the “Top Innovative Pharmaceutical Enterprises in China” and “Top 100 Pharmaceutical Manufacturing Enterprises of China”.

History

1995 - 2005: Manufacturer and supplier of branded

generics Generic or generics may refer to: In business * Generic term, a common name used for a range or class of similar things not protected by trademark * Generic brand, a brand for a product that does not have an associated brand or trademark, other ...

* 1995 Company established * 2001 Became a pharmaceutical company with independent R&D capability 2006 - 2015: Engaged in Generic and Innovative Drug Development * 2006 Endostar^® (Recombinant human

endostatin Endostatin is a naturally occurring, 20-kDa C-terminal fragment derived from type XVIII collagen. It is reported to serve as an anti-angiogenic agent, similar to angiostatin and thrombospondin. Endostatin is a broad-spectrum angiogenesis inhibi ...

) launched * 2007 NYSE listing * 2012 Iremod^® ( Iguratimod) launched 2015 - present: Innovative Drug Driven Company * 2018 Shanghai Innovation Center established * 2019 Boston Innovation Center established * 2020 Sanbexin^® (

Edaravone Edaravone, sold under the brand name Radicava among others, is a medication used to treat stroke and amyotrophic lateral sclerosis (ALS). It is given by intravenous infusion and by mouth. The most common side effects include bruising (contusion ...

and Dexborneol) and Orencia^® (

Abatacept Abatacept, sold under the brand name Orencia, is a medication used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the immune activity of T cells. It is a modified antibody. Abatacept is a fusion protein composed ...

) launched; HKSE listing * 2021 Enweida^® (Envafolimab) launched

Products

The company strategically focuses on 3 Major Therapeutic Areas including oncology, central nervous system, autoimmune disease, with forward-looking layout of disease areas that may have significant clinical needs. Simcere currently has a portfolio of dozens of market leading pharmaceutical products. Over 10 products are recommended in more than 40 clinical practice guidelines and pathways issued by government authorities or prestigious professional associations in China, and over 40 products are included in the Chinese national reimbursement drug list (NRDL).

Sanbexin^®

Edaravone and Dexborneol Concentrated Solution for Injection, independently developed by Simcere with proprietary

intellectual property Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, co ...

right is indicated to alleviate neurological symptoms and dysfunction of daily activities caused by acute

ischemic stroke A stroke is a medical condition in which poor blood flow to the brain causes cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. Both cause parts of the brain to stop funct ...

. Sanbexin has been the only pharmaceutical for the treatment of stroke which has obtained the approval for sale since 2015 worldwide. As a Chinese category 1 innovative drug, Sanbexin can improve the neurological function of patients with strokes by inhibiting the dual mechanisms of oxidative stress damage and inflammatory damage. Data from Phase III clinical study has been published in

Stroke (journal) ''Stroke'' is a peer-reviewed medical journal published monthly by Lippincott Williams & Wilkins on behalf of the American Heart Association. It covers research on cerebral circulation and related diseases, including clinical research on assess ...

. A total of approximately 1,200 acute ischemic stroke patients were included in a randomized, double-blind, positive controlled trial for head-to-head comparison of Sanbexin and edaravone monotherapy. Data shows that Sanbexin^® has the efficacy advantage and is fairly safe. It has received national special support for "Major New Drug Creation Projects" by the Ministry of Science and Technology and been awarded as one of “China’s Milestone Medical Achievements During the 13th Five-Year Plan Period”. It is included in NRDL since 2020;

Iremod^®

(Iremod^® (iguratimod) tablet) independently developed by Simcere is the first iguratimod approved for sales in the world and the only iguratimod approved for sales in China. It has been included in the NRDL since 2017 and is recommended as the primary therapy drug for the treatment of active rheumatoid arthritis by a number of clinical practice guidelines and pathways issued by the National Health Commission, Chinese Medical Association,

Asia Pacific League of Associations for Rheumatology Asia Pacific League of Associations for Rheumatology (APLAR) is a federation of organisations of rheumatology. It was established in Sydney in 1963 and the first congress was held in 1968 in Mumbai at the Taj Mahal Palace Hotel. History In 1961, th ...

and the

Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ...

of Japan. In March 2021, the results of the phase IV prospective real-world study on Iremod^® were published online in The Lancet Regional Health-Western Pacific, a sub publication of

The Lancet ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles ...

. 1,759 patients were enrolled in this study, which made up for the lack of evidence of large-sample IGU in China and provided a new guiding basis for clinical safe and rational drug use.

Endostar^®

Indicated for treatment of non-small cell lung cancer, Endostar^® is the first proprietary anti-angiogenic targeted drug in China and the only endostatin approved for sale in worldwide. Endostar inhibits tumor growth by its

antiangiogenic An angiogenesis inhibitor is a substance that inhibits the growth of new blood vessels (angiogenesis). Some angiogenesis inhibitors are endogenous and a normal part of the body's control and others are obtained exogenously through pharmaceutical dr ...

effect, and has won the Second Prize of National Scientific and Technological Progress Award, and China Patent Gold Award. Endostar^® has been included in the NRDL since 2017 and is recommended as a first-line treatment for patients with advanced

non-small-cell lung carcinoma Non-small-cell lung cancer (NSCLC) is any type of epithelial lung cancer other than small-cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitive to chemotherapy, compared to s ...

(NSCLC) by a number of oncology clinical practice guidelines.

Envafolimab

Approved to the market in China since Nov 2021, Envafolimab (Enweida^®)is the world's first single-domain

PD-L1 Programmed death-ligand 1 (PD-L1) also known as cluster of differentiation 274 (CD274) or B7 homolog 1 (B7-H1) is a protein that in humans is encoded by the ''CD274'' gene. Programmed death-ligand 1 (PD-L1) is a 40kDa type 1 transmembrane protei ...

antibody formulated for

subcutaneous injection Subcutaneous administration is the insertion of medications beneath the skin either by injection or infusion. A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, c ...

(SC) and the first

immunotherapy Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherap ...

approved in China indicated for

MSI-H Microsatellite instability (MSI) is the condition of genetic hypermutability (predisposition to mutation) that results from impaired DNA mismatch repair (MMR). The presence of MSI represents phenotypic evidence that MMR is not functioning norm ...

tumor regardless of tumor type, with the advantages of short administration time and good safety. It is indicated for adult patients with advanced

solid tumors A neoplasm () is a type of abnormal and excessive growth of tissue. The process that occurs to form or produce a neoplasm is called neoplasia. The growth of a neoplasm is uncoordinated with that of the normal surrounding tissue, and persists ...

who have unresectable or metastatic microsatellite instability-high (MSI-H) or

DNA mismatch repair DNA mismatch repair (MMR) is a system for recognizing and repairing erroneous insertion, deletion, and mis-incorporation of bases that can arise during DNA replication and recombination, as well as repairing some forms of DNA damage. Mismatch ...

-deficient (dMMR), including those patients with advanced colorectal cancer who have experienced disease progression after being treated with

fluorouracil Fluorouracil (5-FU), sold under the brand name Adrucil among others, is a cytotoxic chemotherapy medication used to treat cancer. By intravenous injection it is used for treatment of colorectal cancer, oesophageal cancer, stomach cancer, panc ...

oxaliplatin Oxaliplatin, sold under the brand name Eloxatin among others, is a cancer medication (platinum-based antineoplastic class) used to treat colorectal cancer. It is given by injection into a vein. Common side effects include numbness, feeling ...

and

irinotecan Irinotecan, sold under the brand name Camptosar among others, is a medication used to treat colon cancer, and small cell lung cancer. For colon cancer it is used either alone or with fluorouracil. For small cell lung cancer it is used with cispl ...

previously, as well as other patients with advanced solid tumors who have experienced disease progression after previous treatment and no satisfactory treatment alternatives. On March 30, 2020, Simcere entered a tripartite cooperation agreement in relation to Envafolimab with 3D (Beijing) Medicines and Jiangsu Alphamab and obtained the exclusive right to promote Envafolimab for all oncology indications in

mainland China "Mainland China" is a geopolitical term defined as the territory governed by the China, People's Republic of China (including islands like Hainan or Chongming Island, Chongming), excluding dependent territories of the PRC, and other territorie ...

Other marketed products

Simcere collaborated with

Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...

(BMS) to develop and commercialize Orencia^® (abatacept injection) in China since 2013. The drug is approved by NMPA in 2020 and became the first and only soluble

CTLA4 CTLA-4 or CTLA4 (cytotoxic T-lymphocyte-associated protein 4), also known as CD152 (cluster of differentiation 152), is a protein receptor that functions as an immune checkpoint and downregulates immune responses. CTLA-4 is constitutively expre ...

-Fc fusion protein approved for sale in China as treatment of

rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are inv ...

. Other branded products of Simcere include Jepaso^®: Nedaplatin for Injection, JIEBAILI^®:

Pemetrexed Pemetrexed, sold under the brand name Alimta among others, is a chemotherapy medication for the treatment of pleural mesothelioma and non-small cell lung cancer (NSCLC).. It is available as a generic medication. Medical use In February 2004 ...

Disodium for Injection, Enlength^®:

Bortezomib Bortezomib, sold under the brand name Velcade among others, is an anti-cancer medication used to treat multiple myeloma and mantle cell lymphoma. This includes multiple myeloma in those who have and have not previously received treatment. It is ...

for Injection, AIJIEWEI^®:

Tofacitinib Tofacitinib, sold under the brand Xeljanz among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Common side effects include diarrhea, headache, and high blood pressure. Serious side eff ...

Citrate Tablets, Softan^®:

rosuvastatin Rosuvastatin, sold under the brand name Crestor among others, is a statin medication, used to prevent cardiovascular disease in those at high risk and treat abnormal lipids. It is recommended to be used together with dietary changes, exercise, ...

calcium tablets, Antine^®:

diclofenac Diclofenac, sold under the brand name Voltaren, among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammatory diseases such as gout. It is taken by mouth or rectally in a suppository, used by injection, or ...

sodium sustained release capsules/gel, ZAILIN^®:

amoxicillin Amoxicillin is an antibiotic medication used to treat a number of bacterial infections. These include middle ear infection, strep throat, pneumonia, skin infections, and urinary tract infections among others. It is taken by mouth, or less c ...

granules/dispersible tablets/capsules, BIQI^®: Diosmectite Powder etc.

Pursuit of innovation

In the rapid transitioning towards an innovation driven company, Simcere has established four innovation centers globally, located in Nanjing, Shanghai, Beijing and Boston. For the years of 2019, 2020, and 2021, Simcere's R&D costs accounted for 14.2%, 25.3%, and 28.3% respectively, of its total revenue for the same periods. As of March 2022, the company maintains a new drug R&D pipeline of nearly 60 innovative projects, with 19 innovative drug projects in the clinical stage.

Partnering and global alliances

Simcere collaborates extensively with domestic and foreign R&D partners to develop innovative medicines. It is striving to become a strategic "partner of choice" with world leading pharmaceutical companies and biotechnology companies, in an effort to bring more global life science breakthroughs to China. Collaboration highlights: G1 Therapeutics Collaborate to introduce COSELA^TM (Trilaciclib), an innovative anti-tumor and myeloprotection therapy. Bristol-Myers Squibb Co-development of Orencia^® (Abatacept injection), the innovative drug in the field of autoimmune diseases. Kazia Therapeutics Co-development of Paxalisib, which was granted Fast Track Designation for

glioblastoma Glioblastoma, previously known as glioblastoma multiforme (GBM), is one of the most aggressive types of cancer that begin within the brain. Initially, signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality ...

by the US FDA in August 2020. Vivoryon Therapeutics Collaborate to develop and commercialize Varoglutamstat, an orally administered small molecule inhibitor for

Alzheimer's disease Alzheimer's disease (AD) is a neurodegenerative disease that usually starts slowly and progressively worsens. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As ...

. Apexigen Co-development of Suvencitug, a humanized monoclonal antibody directed against

VEGF Vascular endothelial growth factor (VEGF, ), originally known as vascular permeability factor (VPF), is a signal protein produced by many cells that stimulates the formation of blood vessels. To be specific, VEGF is a sub-family of growth factors ...

. Avilex Pharma Collaboration on AVLX-144, an innovative drug for acute ischemic stroke (AIS). Aeromics Co-development of a potent inhibitor of AQP4 water channels for the treatment of novel therapy with Nobel-winning mechanism to treat

cerebral edema Cerebral edema is excess accumulation of fluid ( edema) in the intracellular or extracellular spaces of the brain. This typically causes impaired nerve function, increased pressure within the skull, and can eventually lead to direct compres ...

in China. JW Pharmaceutical Collaboration on URC-102, a selective inhibitor of uric acid transporter (URAT-1) for

gout Gout ( ) is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot and swollen joint, caused by deposition of monosodium urate monohydrate crystals. Pain typically comes on rapidly, reaching maximal intens ...

in China. 3D-Medicines & Alphamab Oncology A strategic collaboration to develop and commercialize Enweida^® (Envafolimab), the world’s first subcutaneously injected PD-L1 antibody. NeuronDawn Collaborate to develop Sanbexin^® (Edaravone and Dexborneol) sublingual tablet for stroke. Daiichi-Sankyo Strategic partnership for the exclusive commercialization of Olmetec Plus^® ( Olmesartan medoxomil, Hydrochlorothiazide) in China. Shanghai Institute of Materia Medica, Chinese Academy of Sciences Co-development of a novel

antiviral drug Antiviral drugs are a class of medication used for treating viral infections. Most antivirals target specific viruses, while a broad-spectrum antiviral is effective against a wide range of viruses. Unlike most antibiotics, antiviral drugs do n ...

targeting

3CL protease The 3C-like protease (3CLpro) or main protease (Mpro), formally known as C30 endopeptidase or 3-chymotrypsin-like protease, is the main protease found in coronaviruses. It cleaves the coronavirus polyprotein at eleven conserved sites. It is a c ...

to treat

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quick ...

. Lynk Pharmaceuticals Partnering to develop and commercialize a highly selective JAK1 inhibitor for the indications of rheumatoid arthritis and

ankylosing spondylitis Ankylosing spondylitis (AS) is a type of arthritis characterized by long-term inflammation of the joints of the spine typically where the spine joins the pelvis. Occasionally areas affected may include other joints such as the shoulders or hi ...

in China.Simcere and Lynk Pharmaceuticals Announced Strategic Commercialization Partnership upon Novel JAK1 Inhibitor LNK01001

References

{{Authority control Civilian-run enterprises of China Pharmaceutical companies of China Manufacturing companies based in Nanjing Companies listed on the New York Stock Exchange Generic drug manufacturers