Iguratimod

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

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 .