[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of iguratimod tablets (25 mg) in healthy Chinese subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择海南先声药业有限公司为持证商的艾拉莫德片（商品名：艾得辛，规格：25mg）为参比制剂，对成都硕德药业有限公司生产并提供的受试制剂艾拉莫德片（规格：25mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂艾拉莫德片（规格：25mg）和参比制剂艾拉莫德片（商品名：艾得辛，规格：25mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Hainan Xiansheng Pharmaceutical Co., Ltd. was selected as the reference preparation of Aguratimod Tablets (trade name: Edexin, specification: 25mg), and the test preparation Aguratimod Tablets (specification: 25mg) produced and provided by Chengdu Shuode Pharmaceutical Co., Ltd. was conducted on the human bioequivalence test of fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Aguratimod Tablets (specification: 25mg) and the reference preparation Aguratimod Tablets (trade name: Edexin, specification: 25mg) by healthy volunteers.

Start Date27 Apr 2024

Sponsor / Collaborator

Chengdu Shuode Pharmaceutical Co.,Ltd.

CTR20240234 / CompletedNot Applicable

艾拉莫德片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期、双交叉对照空腹及餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover controlled bioequivalence study of iguratimod tablets in healthy subjects under fasting and fed conditions

研究空腹及餐后状态下单次口服受试制剂艾拉莫德片（规格：25mg，浙江高跖医药科技股份有限公司持证）与参比制剂艾拉莫德片（艾得辛®，规格：25mg，海南先声药业有限公司持证）在健康成年受试者体内的药代动力学，评价空腹及餐后状态下口服两种制剂的生物等效性

[Translation]

To study the pharmacokinetics of the test preparation iguratimod tablets (specification: 25 mg, licensed by Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd.) and the reference preparation iguratimod tablets (Edixin®, specification: 25 mg, licensed by Hainan Xiansheng Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations in fasting and fed state

Start Date28 Feb 2024

Sponsor / Collaborator

Zhejiang Gaozhi Pharmaceutical Technology Co., LtdStartup

CTR20240380 / CompletedNot Applicable

艾拉莫德片在健康人体的单中心、开放、随机、单剂量给药的生物等效性临床试验

[Translation] A single-center, open-label, randomized, single-dose bioequivalence clinical trial of iguratimod tablets in healthy subjects

主要目的：以四川国为制药有限公司生产的艾拉莫德片（25mg/片）为受试制剂，以海南先声药业有限公司生产的艾拉莫德片（25mg/片，艾得辛）为参比制剂，考察两制剂的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Using Iguratimod tablets (25 mg/tablet) produced by Sichuan Guowei Pharmaceutical Co., Ltd. as the test preparation and Iguratimod tablets (25 mg/tablet, Edexin) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. as the reference preparation, the bioequivalence of the two preparations was investigated. Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date29 Jan 2024

Sponsor / Collaborator

Sichuan Guowei Pharmaceutical Co., Ltd.

100 Clinical Results associated with Iguratimod

100 Translational Medicine associated with Iguratimod

100 Patents (Medical) associated with Iguratimod

184

Literatures (Medical) associated with Iguratimod

01 Jan 2024·International immunopharmacology

SLAMF3 promotes Th17 differentiation and is reversed by iguratimod through JAK1/STAT3 pathway in primary Sjögren's syndrome

Article

Author: Song, Haining ; Xu, Lingling ; Cai, Juan ; Yang, Pingting ; Ma, Siyang ; Hu, Peini ; Yang, Chunshu

OBJECTIVE:

The signaling lymphocytic activation molecule family of receptors (SLAMF) is involved in the activation of T cells and plays important roles in the pathogenesis of autoimmune diseases. The purpose of this study is to observe the expression of SLAMF3 on CD4 + T cells and its effect on the differentiation of T helper 17 (Th17) in primary Sjögren's syndrome (pSS). Furthermore, we found iguratimod (IGU) could effectively reverse the aberrant Th17 differentiation through JAK1/STAT3 signaling.

METHODS:

Peripheral blood mononuclear cells from 40 pSS and 40 healthy control subjects were enrolled for analysis of expression of SLAMF3 on CD4 + T and Th17 cells by flow cytometry. Serum IL-17 and SLAMF3 were detected by ELISA assay. Labial biopsies from 20 pSS patients and 20 non-pSS controls were performed immunohistochemical for staining expression of CD4, IL-17, and SLAMF3. Under the priming conditions with anti-CD3/CD28 or CD3/SLAMF3 antibodies on CD4 + T cells extracted from pSS and controls, the proportion of Th17 cells in CD4 + T cells and the amount of soluble IL-17A were assessed by flow cytometry and ELISA. Furthermore, RNA sequencing was performed for the transcriptomics study. Additionally, RNA level of RORγt and IL-17A and the protein level of RORγt, p-JAK1 and p-STAT3, were detected by real-time PCR and western blot.

RESULTS:

The expression levels of SLAMF3 on CD4 + T and Th17 cells in the peripheral blood and salivary glands in pSS patients were significantly elevated than that in control groups. The serum IL-17A and SLAMF3 in pSS patients were much higher compared with the control group. Although co-stimulation of CD3/SLAMF3 could promote CD4 + T cells differentiate into Th17 cells both in pSS and controls, the CD4 + T cells from pSS have a more sensitive response in Th17 differentiation with the SLAMF3 stimulation. Transcriptomics results showed the CD3/SLAMF3 stimulation caused the activation of Th17 signaling and JAK1/STAT3 pathway. Quantitative PCR and western blotting confirmed the IGU (iguratimod), which is a safe clinical drug in treatment of autoimmune diseases, effectively reversed the increased Th17 proportion, the expression levels of RORγt, pJAK1, and pSTAT3 caused by CD3/SLAMF3 stimulation.

CONCLUSION:

SLAMF3 upregulates Th17 cell differentiation of CD4 + T cells and IL-17A secretion through enriching RORγt and activating the transcriptomics participating in the pathogenesis of primary Sjögren's syndrome. IGU could inhibit the process through this therapeutic target in pSS.

01 Jan 2024·Clinical rheumatology

The clinical characteristics and prognosis of patients with SAPHO syndrome——a real-world cohort study

Article

Author: Zhang, Lihua ; Deng, Xiaoli ; Gao, Shuang ; Duan, Hongji ; Zhai, Jiayu ; Song, Le

OBJECTIVES:

We aimed to analyze the clinical characteristics and outcomes of patients with synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome.

METHODS:

The clinical records of 64 patients with SAPHO syndrome were collected, and the treatment and outcomes of 27 patients were followed up. The patients were divided into three groups according to the site of bone lesions: only anterior chest wall (ACW) involvement, only spinal involvement, and bone lesion involvement at both sites. The clinical characteristics and outcomes were compared. The clinical characteristics of the patients with and without peripheral joint involvement were compared.

RESULTS:

Among all patients, 31.25% (20/64) had only ACW involvement, 15.63% (10/64) had only spinal involvement, and 53.12% (34/64) had both ACW and spinal involvement. Peripheral joint involvement was observed in 25.00% (16/64) of the patients. Patients with only spinal involvement were older than those with only ACW involvement (p = 0.006). Patients with both ACW and spinal involvement were older than those with only ACW involvement (p = 0.002) and had a longer diagnosis delay (p = 0.015). Patients with peripheral joint involvement were younger than those without peripheral joint involvement (p = 0.028). During follow-up, 88.89% (24/27) of patients had good outcomes. Twenty-two patients were treated with non-steroidal anti-inflammatory drugs + Iguratimod (IGU), and the outcomes of 90.91% (20/22) improved.

CONCLUSIONS:

A relationship may exist between the sites of bone lesions and clinical characteristics of patients with SAPHO syndrome. The clinical outcomes of these patients may be good, and IGU may be effective in treating SAPHO syndrome. Key Points • This study is the first long-term follow-up on the effectiveness of iguratimod in treating patients with SAPHO. • This study revealed that patients with SAPHO and different bone lesion sites may present with different clinical characteristics.

18 Dec 2023·Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences

[Effectiveness of tofacitinib combined with iguratimod in the treatment of difficult-to-treat moderate-to-severe rheumatoid arthritis].

Article

Author: Zou, Xue ; Bai, Xiao Juan ; Zhang, Li Qing

OBJECTIVE:

To investigate the efficacy and safety of iguratimod combined with tofacitinib in patients with difficult-to-treat moderate-to-severe rheumatoid arthritis (RA).

METHODS:

In this prospective clinical study, 30 patients with difficult-to-treat moderate-to-severe RA who attended the Department of Rheumatology and Immunology of Shanxi Province Fenyang Hospital from September 2021 to June 2022 were selected. Twenty-three patients enrollment had been treated with 2 or more conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) for more than 6 months. At least, methotrexate or leflunomide was included. Seven patients were treated with conventional synthetic DMARDs combined with tumor necrosis factor antagonists. Because all the patients had not reached the target of treatment, the combination treatment regimen of DMARDs was changed to iguratimod and tofacitinib. The observation period was 12 weeks. Clinical data were collected before and after treatment. At the end of 4 weeks, 8 weeks and 12 weeks, the clinical data were collected such as swollen joints count (SJC), tender joints count (TJC), time of morning stiffness, clinical disease activity index (CDAI), health status assessment questionnaire (HAQ), and 28-joint disease activity score (DAS28) were included. We collected laboratory indicators, recorded the patient's medication, and observed some changes to see if any adverse drug reactions occurred during the treatment.

RESULTS:

There were significant differences in erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), platelet (PLT), SJC, TJC, DAS28 based on ESR(DAS28-ESR), time of morning stiffness, HAQ, CDAI, and anti-cyclic citrullinated peptide antibody before and after treatment. The differences had statistical significance (P < 0.05). There was no statistical differences in globulin before and after treatment (P>0.05). During the treatment of iguratimod combined with tofacitinib, there was no serious adverse reactions such as leukopenia, significant elevation of liver enzymes, allergy or thromboemblolic events that occurred in all the patients.

CONCLUSION:

Iguratimod combined with tofacitinib in the treatment of difficult-to-treat moderate-to-severe RA may have efficacy. The machanism was improving the patients' recent clinical symptoms by reducing inflammatory indexes. This combination treatment regimen with iguratimod and tofacitinib has a good safety profile.

News (Medical) associated with Iguratimod

06 Oct 2022

·www.biospace.com

Simcere closed an out-license deal of 492M USD with Almirall

Nanjing China and Barcelona Spain, September 29, 2022. Simcere Pharmaceutical Group（2096.HK), an innovation and R&D-driven pharmaceutical company, and Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health; announced today that they have entered into an exclusive licensing agreement for Simcere’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278. Under the agreement, Almirall will be granted an exclusive right to develop and commercialise SIM0278 for all indications outside of the Greater China region (Mainland China, Hong Kong, Macau and Taiwan). Simcere will retain all rights to develop and commercialise SIM0278 within Greater China. Within the terms of the agreement, Simcere will receive a $15 million upfront payment, and up to $492 million in development and commercial milestone payments considering successful achievements in several indications, with an important part as sales milestones, as well as up to low double-digit tiered royalties based upon future global sales. “We are very excited to have reached a collaborative agreement with Almirall for the development of SIM0278. This innovative IL-2 mutein is one important molecule of our immune-rebalancing strategy for autoimmune diseases.” Said Renhong Tang, Ph.D., Co-CEO of Simcere, “SIM0278 is one of the key molecules developed based on Simcere's in-house protein engineering platform. This partnership also marks a milestone of Simcere’s globalization effort. We look forward to closely working with Almirall to demonstrate the clinical value of SIM0278. "At Almirall, we always look for new opportunities to strengthen our R&D pipeline. That is why we are very pleased to close this new development and commercialisation agreement with Simcere," stated Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer. "SIM0278 has great potential to treat a broad spectrum of immunological diseases, and we expect that its development will allow us to reinforce our biologic pipeline and our leading position in Medical Dermatology. About SIM0278 SIM0278 is an interleukin 2 mutant fusion protein (IL-2 mu-Fc) that activates regulatory T cells developed in-house by utilizing Simcere’s protein engineering platform. This IND ready subcutaneous injection will potentially be developed to treat various autoimmune diseases. SIM0278 exhibits improved PK pro selective activation of Treg cells with no activation of effector T cells or NK cells to restore immune balance which has been demonstrated in multiple preclinical disease models. About Simcere： Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovative R&D and committed to synergistic innovation. It has established the State Key Laboratory of Translational Medicine and Innovative Drug Development and currently boasts four R&D centers in Shanghai, Nanjing, Beijing and Boston. With the commitment to "providing today's patients with medicines of the future", the Company focuses on three therapeutic areas: oncology, central nervous system diseases, and autoimmune diseases, while actively expanding its strategic presence in prospective disease areas with significant clinical needs in the future. Simcere now has six global first-in-class innovative drugs, and is holding leading market shares for its key products in China with its excellent R&D and commercialization capabilities. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with international and domestic leading innovative pharmaceutical enterprises, medical institutions and research institutes. Moreover, Simcere has been recognized as one of the “Top 10 Innovative Pharmaceutical Enterprises in China” and “Top 100 Pharmaceutical Manufacturing Enterprises of China” for several consecutive years. I. Global Innovative Drugs Simcere prioritizes the R&D of innovative drugs and generic drugs with high technical barriers based on ever-increasing and unmet clinical needs. To date, it has launched 6 global first-in-class innovative drugs, over 10 products have been included into the guidelines and pathways issued by more than 50 governmental agencies or authoritative professional associations in China, and more than 40 products have been included in China's National Reimbursement Drug List. The 6 global first-in-class innovative drugs include: 1. Sanbexin: the world's only innovative drug approved for stroke since 2015, which can significantly reduce CNS damage caused by acute ischemic stroke 2. Iremod: the first iguratimod drug product in the world, which is the only small molecule DMARD, or disease-modifying anti-rheumatic drug, developed in China that has been approved over the past decade 3. Endostar: the first recombinant human endostatin in the world and the first innovative biologic product approved in China as first-line treatment for patients with NSCLC 4. Cosela: the world's first and only "Chemo Guard" with multi-lineage myeloprotection 5. Enweida: the first subcutaneous PD-(L)1 antibody-based drug in the world and the first pan-tumor immunotherapy drug in China 6. Orencia: the first CTLA-4-Fc fusion protein in the world, providing another small molecule treatment option for rheumatoid arthritis As of December 31, 2021, Simcere's annual revenue has amounted to approximately CNY 5 billion. Specifically, the revenue of innovative drugs increased by more than 50% over the same period, occupying 62.4% of the total revenue that hits a record high. II. Global R&D Professionals Simcere has been continuously expanding its R&D investments. In 2021, its R&D investment was more than CNY 1.4 billion, accounting for 28.3% of the sales revenue. Additionally, it has established a whole-process R&D system integrating drug discovery, pre-clinical development, clinical trials, and drug registration, owns a R&D pipeline project of nearly 60 new drugs, and is conducting 20 clinical studies for registration of 16 potential innovative drugs. As of August 2022, the Company has established a R&D team comprising over 1000 professionals, of whom more than 60% are professionals with a master's or doctoral degree and more than 10% are professionals with an international education background. III. International Standard-Based Pharmaceutical Bases Simcere possesses 5 pharmaceutical bases in China, which can perform pharmaceutical practices by integrating drug substances and drug products, engage in the late-stage development and commercial manufacturing of macromolecular and micro-molecular drugs, and perform manufacturing and quality control as per the stringent international standards. All production workshops have passed GMP certification, the base in Hainan has passed EU GMP certification for multiple times in succession, and the manufacturing base for small-molecule drugs in Nanjing has passed FDA's on-site inspection with "zero 483" (zero defect). The Company has established a management system overseeing the entire production cycle from raw material procurement to drug product delivery, so as to ensure the whole-process compliance, continuously improve quality specifications, and safeguard patient safety. IV. Academic Marketing Simcere's marketing system consists of four business units, namely, neuroscience, oncology, autoimmune & general disease, and grassroots retail. It boasts a professional academic promotion team comprising more than 4000 professionals, with members spanning across 31 provinces, municipalities, and autonomous regions. It has a portfolio of products serving more than 3000 tertiary hospitals, 37,000 non-tertiary hospitals and medical institutions, and over 280 large chain pharmacies, and can leverage the commercialization capability to quickly maximize the sales of its innovative drugs. In pursuit of the principle of "Patient First", Simcere always conducts academic promotion activities in compliance with laws and regulations, promotes compliance culture, and implements compliance requirements, providing professional academic information for medical and health professionals. V. Synergistic Innovation Simcere remains dedicated to synergistic innovation, and is committed to achieving mutually beneficial cooperation with leading innovative pharmaceutical enterprises, medical institutions, and research institutes in China and beyond. It has successively reached a series of strategic cooperation agreements with numerous globally leading multinational pharmaceutical groups and biotechnology companies including Bristol-Myers Squibb, G1 Therapeutics, Kazia, and Vivoryon, so as to introduce the latest R&D achievements of global life sciences into China and facilitate the availability of highly effective treatment options for Chinese patients, thereby contributing to building a healthy China. By virtue of its solid independent R&D strength, successful experience of commercially developing global innovative drugs, and synergistic innovation philosophy rooted in corporate culture, Simcere has gained widespread recognition from its innovative pharmaceutical partners at home and abroad, and has been recognized by global pharmaceutical and biotechnology companies as the "Preferred Partner". Simcere website： linkedIn： 2021 Forbes report on Simcere: About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need. The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70. Website ： almirall.com LinkedIn： ### For media inquiries, or to request an interview, please contact: RSVP PR Agency Victoria Fei victoria.fei@rsvpshanghai.com Simcere Pharmaceutical Group Limited Li Yiling liyiling@simcere.com

CollaborateAntibodyInnovative DrugGeneric DrugFirst in Class

14 Nov 2011

·www.biospace.com

Simcere Pharmaceutical Group Reports Preliminary Unaudited Third Quarter 2011 Results

NANJING, China, Nov. 14, 2011 /PRNewswire-Asia/ -- Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported preliminary unaudited financial results for the quarter ended September 30, 2011. Highlights Total revenue was RMB501.0 million (US$78.5 million) for the third quarter of 2011, representing a decrease of 8.9% from RMB550.1 million for the same period in 2010. For the first nine months of 2011, total revenue was RMB1,529.5 million (US$239.8 million), representing a decrease of 1.5% from RMB1,553.4 million for the same period in 2010. Gross margin for the third quarter of 2011 was 84.6%, compared to 84.8% for the same period in 2010. For the first nine months of 2011, gross margin was 84.5%, compared to 84.0% for the same period in 2010. Income from operations was RMB32.4 million (US$5.1 million) for the third quarter of 2011, representing a decrease of 47.4% from RMB61.6 million for the same period in 2010. For the first nine months of 2011, income from operations was RMB141.9 million (US$22.3 million), representing a decrease of 8.5% from RMB155.1 million for the same period in 2010. Net incomeattributable to Simcere was RMB34.0 million (US$5.3 million) for the third quarter of 2011, representing a decrease of 37.8% from RMB54.7 million for the same period in 2010. For the first nine months of 2011, net income attributable to Simcere was RMB135.6 million (US$21.3 million), representing an increase of 19.2% from RMB113.7 million for the same period in 2010. "While Endu, Sinofuan and Jiebaishu continued to see healthy growth in the third quarter, changes in government pricing policies, as well as issues related to the tender process in certain provinces impacted the sales of Simcere's branded generic products, including Zailin," said Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere. Mr. Ren continued, "In August, we were pleased to receive new drug approval for Iremod, Simcere's independently developed new drug in the category of Disease Modifying Anti-rheumatic Drugs (DMARDS). In addition, Shanghai Celgen Bio-Pharmaceutical Co., Ltd. recently began the production and sale of Qiangke, a biosimiliar product. Going forward, we plan to continue to focus sales efforts on our anti-tumor and new drugs, while adjusting our marketing strategy for branded generic drugs in response to the regulatory environment and pricing policies." 2011 Third Quarter Financial Results Total revenue for the third quarter of 2011 was RMB501.0 million (US$78.5 million), which represented a decrease of 8.9% from RMB550.1 million for the same period in 2010. The decrease in total revenue was primarily due to the decrease in revenue from some branded generic products, as a result of changes in government pricing policies and issues related to the tender process in certain provinces. For the first nine months of 2011, total revenue was RMB1,529.5 million (US$239.8 million), which represented a decrease of 1.5% from RMB1,553.4 million for the same period in 2010. Revenue from edaravone injection productsunder the brand names Bicun and Yidasheng decreased by 5.3% to RMB192.0 million (US$30.1 million) for the third quarter of 2011 from RMB202.8 million for the same period in 2010. Revenue from edaravone injection products constituted 38.3% of the Company's total revenue for the third quarter of 2011. For the first nine months of 2011, revenue from edaravone injection products totaled RMB598.7 million (US$93.9 million), which represented an increase of 5.1% from RMB569.5 million for the same period in 2010. Revenue from Endu,the Company's patented anti-cancer biotech product, increased by 21.9% to RMB78.0 million (US$12.2 million) for the third quarter of 2011 from RMB64.0 million for the same period in 2010. Revenue from Endu constituted 15.6% of the Company's total revenue for the third quarter of 2011. For the first nine months of 2011, revenue from Endu totaled RMB197.6 million (US$31.0 million), which represented an increase of 27.4% from RMB155.2 million for the same period in 2010. Revenue from Sinofuan, a 5-FU sustained release implant for the treatment of cancer, increased by 9.9% to RMB53.0 million (US$8.3 million) for the third quarter of 2011 from RMB48.2 million for the same period in 2010. Revenue from Sinofuan constituted 10.6% of the Company's total revenue for the third quarter of 2011. For the first nine months of 2011, revenue from Sinofuan totaled RMB135.4 million (US$21.2 million), which represented an increase of 17.0% from RMB115.7 million for the same period in 2010. Revenue from other branded generic products including Zailin and Yingtaiqing decreased by 20.1% to RMB177.9 million (US$27.9 million) for the third quarter of 2011 from RMB222.8 million for the same period in 2010. Revenue from other branded generic products constituted 35.5% of the Company's total revenue for the third quarter of 2011. For the first nine months of 2011, revenue from other branded generic products totaled RMB597.6 million (US$93.7 million), which represented a decrease of 6.7% from RMB640.9 million for the same period in 2010. Gross margin for the third quarter of 2011 was 84.6%, compared to 84.8% for the same period in 2010. For the first nine months of 2011, gross margin was 84.5%, compared to 84.0% in the first nine months of 2010. Research and development expenses for the third quarter of 2011 totaled RMB45.4 million (US$7.1 million), which represented an increase of 39.7% from RMB32.5 million for the same period in 2010. This increase was due primarily to the increased expenditure and milestone achievements on on-going research and development projects. As a percentage of total revenue, research and development expenses increased to 9.1% for the third quarter of 2011 from 5.9% for the same period in 2010. For the first nine months of 2011, research and development expenses totaled RMB128.1 million (US$20.1 million), compared to RMB94.3 million for the same period in 2010. Sales, marketing and distribution expenses for the third quarter of 2011 were RMB291.3 million (US$45.7 million), which represented a decrease of 2.5% from RMB298.7 million for the same period in 2010. As a percentage of total revenue, sales, marketing and distribution expenses increased to 58.1% for the third quarter of 2011 from 54.3% for the same period in 2010. This percentage increase was due primarily to the effect of a decrease in revenue and relatively stable marketing and distribution expenses. For the first nine months of 2011, sales, marketing and distribution expenses were RMB844.5 million (US$132.4 million), which represented a decrease of 1.3% from RMB855.5 million for the same period in 2010. General and administrative expenses were RMB69.6 million (US$10.9 million) for the third quarter of 2011, which represented a decrease of 6.0% from RMB74.0 million for the same period in 2010. As a percentage of total revenue, general and administrative expenses increased to 13.9% for the third quarter of 2011 from 13.5% for the same period in 2010. For the first nine months of 2011, general and administrative expenses were RMB212.4 million (US$33.3 million), which represented an increase of 6.2% from RMB199.9 million for the same period in 2010. Share-based compensation expenses, which were allocated to research and development expenses, sales, marketing and distribution expenses, and general and administrative expenses, based on the nature of the work that the relevant employee was assigned to perform, totaled RMB7.9 million (US$1.2 million) for the third quarter of 2011, which represented an increase of 3.6% from RMB7.6 million for the same period in 2010. For the first nine months of 2011, share-based compensation expenses totaled RMB23.0 million (US$3.6 million), which was almost equal to the same period in 2010. Income from operations was RMB32.4 million (US$5.1 million) for the third quarter of 2011, which represented a decrease of 47.4% from RMB61.6 million for the same period in 2010. For the first nine months of 2011, income from operations was RMB141.9 million (US$22.3 million), which represented a decrease of 8.5% from RMB155.1 million for the same period in 2010. Income tax expense for the third quarter of 2011 was RMB0.7 million (US$0.1 million), compared to RMB5.9 million for the same period in 2010. For the first nine months of 2011, income tax expense was RMB6.5 million (US$1.0 million), compared to RMB17.5 million for the same period in 2010. The effective income tax rate was 5.2% for the first nine months of 2011, decreased from 12.6% for the same period in 2010, which was primarily due to the improved financial results in one of the subsidiaries during the first nine months of 2011, resulting in the reversal of valuation allowance previously made against the deferred tax assets of such subsidiary and the impact of a non-taxable other operating income of RMB35.0 million (US$5.5 million) arising from the receipt of settlement in respect of the acquisition of Jiangsu Quanyi in 2009 from certain former shareholders of Jiangsu Quanyi. Net income attributable to Simcere was RMB34.0 million (US$5.3 million) for the third quarter of 2011, which represented a decrease of 37.8% from RMB54.7 million for the same period in 2010. Net margin, representing net income attributable to Simcere divided by total revenue, was 6.8% for the third quarter of 2011, compared to 9.9% for the same period in 2010. For the first nine months of 2011, net income attributable to Simcere was RMB135.6 million (US$21.3 million), which represented an increase of 19.2% from RMB113.7 million for the same period in 2010. Net margin for the first nine months of 2011 was 8.9%, compared to 7.3% for the same period in 2010. Basic and diluted earnings per American Depository Share ("ADS")for the third quarter of 2011 were RMB0.64(US$0.10) and RMB0.61(US$0.10), respectively. Basic and diluted earnings per ADS for the first nine months of 2011 were RMB2.54(US$0.40) and RMB2.45(US$0.38) respectively. One ADS represents two ordinary shares of the Company. As of September 30, 2011, the Company had cash, cash equivalents and restricted cash of RMB208.2 million (US$32.6 million), compared to RMB278.7 million as of December 31, 2010. Share Repurchase Program In November 2011, the Company's board of directors approved a share repurchase program, under which the Company may purchase up to US$30 million of its issued and outstanding ADSs. The repurchases will be made from time to time on the open market at prevailing market prices or in block trades and subject to restrictions relating to volume, price and timing. The Company may effect repurchase transactions pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended. The timing and extent of any repurchases will depend upon market conditions, the trading price of its ADSs and other factors. The Company expects to implement this share repurchase program in the next 12 months, in a manner consistent with market conditions and the interest of its shareholders. The Company's board of directors will review the share repurchase program periodically, and may adjust its terms and size accordingly. The Company plans to fund repurchases made under this program from its available cash balance. Financial Information The preliminary unaudited condensed consolidated statements of income and balance sheets accompanying this press release have been prepared by the management using U.S. GAAP. This preliminary financial information is not intended to fully comply with U.S. GAAP because it does not present all of the financial information and disclosures required by U.S. GAAP. Safe Harbor Statement This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "project," "predict," "should" and "will" and similar expressions. In particular, the quotations from management in this press release contain forward-looking statements. These forward looking statements are based upon management's current views and expectations with respect to future events and are not a guarantee of future performance. Furthermore, these statements are, by their nature, subject to a number of risks and uncertainties that could cause actual performance and results to differ materially from those discussed in the forward-looking statements as a result of a number of factors. Further information regarding these and other risks is included in Simcere's filings with the U.S. Securities and Exchange Commission at . Simcere does not undertake any obligation to update any forward-looking statement, except as required under applicable law. Conference Call Simcere Pharmaceutical Group will host a conference call to discuss the Company's results for the third quarter of 2011 on Monday, November 14, at 8:00 a.m. Eastern Time (Monday, November 14 at 9:00 p.m.Beijing/Hong Kong time). The management team will be on the call to discuss the results for the third quarter of 2011 and to answer questions. To access the conference call, please dial:United States toll-free:+1.866.519.4004United States toll:+1.718.354.1231China Domestic:800.819.0121China Domestic mobile400.620.8038Hong Kong:+852.2475.0994 Please ask to be connected to Q3 2011 Simcere Pharmaceutical Group Earnings Conference Call and provide the following passcode: 21357022. Simcere will also broadcast a live audio webcast of the conference call. The broadcast will be available by visiting the "Investor Relations" section of the company's web site at . Following the earnings conference call, an archive of the call will be available by dialing:United States toll-free: +1.866.214.5335United States toll: +1.718.354.1232 The passcode for replay participants is 21357022. The telephone replay also will be archived on the "Investor Relations" section of the company's web site for seven days following the earnings announcement. About Simcere Pharmaceutical Group Simcere Pharmaceutical Group ("Simcere") (NYSE: SCR) is a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China. Simcere concentrates its research and development efforts on the treatment of diseases with high incidence and/or mortality rates and for which there is a clear demand for more effective pharmacotherapy such as cancer, strokes, cardiovascular disease, infectious diseases and pain. For more information about Simcere Pharmaceutical Group, please visit .

Financial StatementGeneric DrugAcquisition

100 Deals associated with Iguratimod

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KEGG	Wiki	ATC	Drug Bank
D01146	Iguratimod	M01C	DB12233

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Rheumatoid Arthritis	CN	Simcere Pharmaceutical Group Ltd.	23 Aug 2011

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Sjögren's syndrome	Phase 2	CN	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	22 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05281068 (ASH2023)	Phase 2	Purpura, Thrombocytopenic, Idiopathic	71	Iguratimod plus Danazol	dpwyigrlcv(mfnnzitctu): odds ratio = 1.82 (95% CI, 1.22 - 2.7), P-Value = 0.003	-	10 Dec 2023
				Danazol
EULAR2023	Not Applicable	Axial Spondyloarthritis Add-on TNF-α \| IL-17	302	NSAIDs only	cbqvqobiud(cylpnrssib) = wybnzzkftm tuzdfzqncq (zjcjfyyoil )	Positive	31 May 2023
				NSAIDs combined with SSZ	cbqvqobiud(cylpnrssib) = fyltgugyup tuzdfzqncq (zjcjfyyoil )
EULAR2023	Not Applicable	Scleroderma, Systemic \| Digital ulcer	-	Iguratimod	nclemzlcoj(wgqxialnpd) = buharanlwe mjxdiydtyk (nqxaztjwcn ) View more	-	31 May 2023
NCT03855007 (EULAR2023)	Phase 4	Rheumatoid Arthritis First line	246	IGU combination with csDMARDs	nafxqdczxl(xruxyquizn) = lunvyyjtht rhitfvuylv (wtvajnzgtk ) View more	-	31 May 2023
EULAR2022	Not Applicable	Rheumatoid Arthritis	263	IGU with MTX	tejinsgzyl(wtnjnvyaih) = sholrvsgmx ghmgpkqzfs (pwhipoafdr )	-	01 Jun 2022
				bDMARDs with MTX	tejinsgzyl(wtnjnvyaih) = ftgituvurm ghmgpkqzfs (pwhipoafdr )
ACR2021	Not Applicable	Spondylarthritis	-	Iguratimod	ozbjqjwmak(xbecllowda) = frcphlyrud tgjtwffgbz (esljvmfzlc ) View more	Positive	09 Nov 2021
				Placebo	ozbjqjwmak(xbecllowda) = bihbrxmkxi tgjtwffgbz (esljvmfzlc ) View more
NCT01548001 (EULAR2021)	Phase 4	Enthesitis-Related Arthritis \| Angina, Unstable \| Rheumatoid Arthritis First line	313	IGU monotherapy	jyndyejtkl(eochoxcwjv) = rlwdriiuwi ltwnacopwf (thalmttgma ) View more	Positive	02 Jun 2021
				Combination therapies with methotrexate, hydroxychloroquine, and prednisone	jyndyejtkl(eochoxcwjv) = fyvmounhyo ltwnacopwf (thalmttgma ) View more
NCT01548001 (SMILE, EULAR2021)	Phase 3	Rheumatoid Arthritis	895	Iguratimod 25mg bid	bsnewjckti(dzamvuadpy) = pbzqzvjdsh igednxqchb (phuhanhxay )	Positive	02 Jun 2021
				Methotrexate 10-15mg qw	bsnewjckti(dzamvuadpy) = sbeqcmndcq igednxqchb (phuhanhxay )
EULAR2020	Not Applicable	Rheumatoid Arthritis Bio	107	IGU therapy	twnmamhrry(ekxnefiayo) = xmmxzywyuu wptyoolwoq (exqohcbyal ) View more	Positive	03 Jun 2020
EULAR2020	Not Applicable	Rheumatoid Arthritis First line	-	Iguratimod	tcxfzesngw(tkbabruizq) = okrzwplqmy ymuphkfuxp (lpflyjanjh ) View more	Positive	03 Jun 2020
				Salazosulfapyridine or Bucillamine	tcxfzesngw(tkbabruizq) = nxiaqoqoms ymuphkfuxp (lpflyjanjh ) View more

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