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Press Release

Sep 26, 2017
Amgen And Simcere Announce Strategic Collaboration To Co-Develop And Commercialize Biosimilars In China

THOUSAND OAKS, Calif. and NANJING, China FIFA 2026开球时间 (Sept. 26, 2017) – Amgen (NASDAQ:AMGN) 世界杯直播频道 and Simcere Pharmaceutical Group 世界杯直播频道 today announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars FIFA 2026开球时间 in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.

Under the terms of the agreement, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of 世界杯直播频道 the 世界杯直播频道 biosimilars. Simcere will be responsible for distribution and 世界杯直播频道 FIFA 2026开球时间 commercialization in China, 观看比赛直播 while Amgen will have a limited right to co-promote the products. 世界杯直播频道 The biosimilars included in the agreement are a 世界杯直播频道 part of Amgen’s existing biosimilars portfolio.

“We are pleased to enter this strategic collaboration with Simcere as we continue to enhance patient access through 世界杯直播频道 broader adoption of more competitive therapeutic options worldwide,” said Scott Foraker, vice FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 president and general manager of Biosimilars at Amgen. “This agreement brings together Amgen’s long-standing development and biologics manufacturing expertise with Simcere’s local development experience FIFA 2026开球时间 FIFA 2026开球时间 and strong commercial presence in China in the areas of inflammation and oncology.”

“This agreement furthers Amgen’s efforts to reach more patients in Asia by bringing high quality biosimilars medicines to patients suffering from debilitating and FIFA 2026开球时间 potentially life-threatening conditions,” said Penny Wan, regional vice president and general 观看比赛直播 manager of Amgen’s Japan and Asia-Pacific Region. “We look forward to working with Simcere on these four biosimilar programs where 观看比赛直播 FIFA 2026开球时间 we can build on their network FIFA 2026开球时间 and experience in China to make a big difference for patients.”

“This strategic partnership between a world-renowned biotechnology company and a leading Chinese pharma will help to accelerate development and launch of United States and European approved biosimilars in China. FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 By leveraging our sales network, it will also help to FIFA 2026开球时间 improve the accessibility of high quality therapeutic antibodies for Chinese patients,” said Honggang Feng, president of Simcere. “This collaboration will allow 观看比赛直播 both companies to further penetrate inflammation and oncology markets in China.”

Dr. Hua Mu, chief scientific officer of 观看比赛直播 Simcere said, “Recently, China Food and Drug Administration (CFDA) has formally joined the International Council FIFA 2026开球时间 for Harmonisation of Technical Requirements for Pharmaceuticals 观看比赛直播 FIFA 2026开球时间 for Human FIFA 2026开球时间 Use (ICH) and implemented major reforms on drug evaluation and approval systems, encouraging and supporting research 观看比赛直播 and development of innovative, high quality medicines. This strategic alliance 世界杯直播频道 FIFA 2026开球时间 combines Amgen’s leading global research and FIFA 2026开球时间 development capabilities in biosimilars and Simcere’s domestic drug development and registration experience. It aims to bring more high 观看比赛直播 quality and effective medicines to Chinese patients to meet the pressing unmet medical needs. It is also another important milestone in our international collaboration strategy to enrich Simcere’s biologics pipeline.”

Specific financial terms of FIFA 2026开球时间 the agreement were not disclosed.

About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients suffering from serious illnesses. Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its more than 35 years of experience in FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 世界杯直播频道 观看比赛直播 biotechnology FIFA 2026开球时间 to create high-quality biosimilars and 世界杯直播频道 reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human FIFA 2026开球时间 世界杯直播频道 therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of 世界杯直播频道 human biology.

Amgen focuses on areas of high unmet medical need 观看比赛直播 and leverages its expertise to strive for solutions that 观看比赛直播 improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, FIFA 2026开球时间 FIFA 2026开球时间 Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of 观看比赛直播 medicines with breakaway potential.

For more information, visit www.amgen.com and follow 世界杯直播频道 us on www.twitter.com/amgen.

About Simcere Pharmaceutical Group
Simcere is a research and development-driven Chinese pharmaceutical company committed to bringing high quality and more effective therapies to patients 世界杯直播频道 观看比赛直播 by 观看比赛直播 combining in house R&D with partnerships. Simcere focuses its efforts on therapeutic areas of oncology, neurology, inflammation/immunology, cardiovascular and infectious diseases.

Simcere is dedicated to research & development of innovative pharmaceuticals and branded generic drugs in 世界杯直播频道 China, with a State Key Lab 观看比赛直播 of Translational Medicine and Innovative Drug Development. By leverage of its commercial capability, all top products of the company have leading market share 世界杯直播频道 in China.

By leveraging partnering experience with multinational pharmaceutical companies and innovative biotech companies, Simcere continues to advance [international medical scientific achievements transformation] and 世界杯直播频道 观看比赛直播 create value for partners in China.

For more information, visit www.simcere.com.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs FIFA 2026开球时间 of Amgen. All statements, other than statements 观看比赛直播 of 世界杯直播频道 historical fact, are 世界杯直播频道 statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, 观看比赛直播 FIFA 2026开球时间 FIFA 2026开球时间 FIFA 2026开球时间 arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. 世界杯直播频道 Forward-looking FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including 观看比赛直播 our most recent 观看比赛直播 FIFA 2026开球时间 世界杯直播频道 annual report on Form 10-K and any subsequent periodic reports on 世界杯直播频道 Form 10-Q 世界杯直播频道 and Form 8-K. Unless otherwise 观看比赛直播 noted, Amgen is providing this information as of the date of this news release and does not undertake 世界杯直播频道 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 any obligation to update any forward-looking statements contained in this document as FIFA 2026开球时间 a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing FIFA 2026开球时间 products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing 观看比赛直播 product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body 世界杯直播频道 观看比赛直播 cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain 世界杯直播频道 regulatory FIFA 2026开球时间 approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between FIFA 2026开球时间 the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, 观看比赛直播 sales growth of recently FIFA 2026开球时间 launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales FIFA 2026开球时间 of our products are affected by pricing pressure, political and public scrutiny and reimbursement 观看比赛直播 policies imposed by third-party payers, including governments, private insurance 世界杯直播频道 plans and managed care providers 观看比赛直播 and FIFA 2026开球时间 may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, 观看比赛直播 世界杯直播频道 FIFA 2026开球时间 marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business 世界杯直播频道 may be impacted by government investigations, litigation and product 世界杯直播频道 FIFA 2026开球时间 liability claims. In addition, our business may be 世界杯直播频道 impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate 观看比赛直播 世界杯直播频道 观看比赛直播 世界杯直播频道 integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely FIFA 2026开球时间 obtain patents for our products and technology, the protection offered FIFA 2026开球时间 FIFA 2026开球时间 by our patents and patent 世界杯直播频道 applications may be challenged, invalidated or circumvented by our 观看比赛直播 competitors, or we may fail to prevail in present and future intellectual 观看比赛直播 property litigation. We perform a substantial FIFA 2026开球时间 观看比赛直播 FIFA 2026开球时间 世界杯直播频道 amount of our commercial manufacturing activities at a few key facilities and also depend 世界杯直播频道 on third 世界杯直播频道 parties for a portion 世界杯直播频道 of our manufacturing activities, and limits on supply 世界杯直播频道 may constrain sales of certain of our current products and product candidate development. In addition, we compete with FIFA 2026开球时间 other companies with respect to many of our marketed products as well as for the discovery and development of new products. 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of FIFA 2026开球时间 significant problems with a product similar to one of our products FIFA 2026开球时间 FIFA 2026开球时间 FIFA 2026开球时间 FIFA 2026开球时间 that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or FIFA 2026开球时间 观看比赛直播 世界杯直播频道 products and to integrate the operations of companies we have acquired 世界杯直播频道 may FIFA 2026开球时间 not be successful. We may not be able to access the capital and 世界杯直播频道 credit markets on terms 观看比赛直播 that 世界杯直播频道 are favorable to us, or at all. We 观看比赛直播 are increasingly dependent on FIFA 2026开球时间 information technology systems, infrastructure and data security. FIFA 2026开球时间 Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to 观看比赛直播 declare a dividend or our ability to pay a 世界杯直播频道 dividend or repurchase our common stock.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

CONTACT: Amgen, Thousand Oaks
Kelley Davenport, 202-585-9637 世界杯直播频道 世界杯直播频道 观看比赛直播 (media)
Kristen Davis, 805-447-3008 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 (media)
Arvind Sood, 805-447-1060 观看比赛直播 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 (investors)

CONTACT: Simcere, Nanjing
Alan Yuan, Simcere BD (US and Nanjing) quanwei.yuan@simcereusa.com
Jingzhong Yu, Simcere Media (Nanjing) yujingzhong@simcere.com
Xiaoyu Wu, Simcere Media (Nanjing) wuxiaoyu@simcere.com