News · PR

  • HOME
  • News · PR
  • Amgen and Bushu Pharma Announce An Expanded Supply Chain Management Across Japan and Asia-Pacfific Region

News · PR

Amgen and Bushu Pharma Announce An Expanded Supply Chain Management Across Japan and Asia-Pacfific Region

  • Press Releases
Asset 3Logo

November 9, 2021
Tokyo, Japan

Amgen Inc., Amgen K.K. and Bushu Pharmaceuticals Ltd. (“Bushu Pharma”), Amgen’s contract manufacturing organization (CMO), today announced the expanded Gateway-to-Asia partnership to four countries across the Asia Pacific region.

Since 2016, Bushu Pharma has been an integral part of Amgen’s business growth in Japan. The two companies have partnered together to assure pharmaceutical drug product supply continuity and quality excellence for Amgen patients in Japan. Further reinforcing the value of this great partnership, Amgen has awarded Bushu Pharma the expanded Gateway-to-Asia contract for supply in Amgen’s biggest markets with our most innovative products. These markets include China, Taiwan and South Korea for Repatha, Evenity, Prolia, and Xgeva. The decision is expected to double the current volume of Amgen products already going through the Bushu Pharma manufacturing and packaging facilities. The scope of the work under Bushu Pharma’s Gateway-to-Asia services will be to assemble, label, package and inspect the products for those markets. We expect first supplies from Bushu Pharma to commence within 2021.

Som Chattopadhyay, Vice President of Global Supply Chain of Amgen said, “Amgen awarded Bushu Pharma with its first contract, and we are extremely pleased to share a common mission of delivering safe, compliant and on-time medicines to patients. The partnership has grown over the years and we look forward to a long and trusted relationship. Amgen remains committed to serving patients across Japan, and the whole Asia-Pacific region with high-quality medicines and seamless supply chain processes.”

Tadao Takano, Chief Operational Officer and President at Bushu Pharma said, “We have built a strong partnership through successful launches of Amgen’s four innovative drugs (Repatha, Evenity, Blincyto, and Aimovig) in Japan and scaled production to match the growing patient needs. We are pleased to be able to further expand our partnership to the Asia Pacific region with the new Gateway-to-Asia services, enabling further effectiveness in importing bulk products to Japan for quality inspection, labeling, packaging and distributing them throughout Japan and the Asia Pacific region.”

My Linh Kha, Amgen JAPAC Senior Vice President and General Manager, said, “The decision to award Bushu Pharma a packaging contract is further evidence of Amgen’s commitment to investing for growth in the Asia Pacific region. Partnering with Bushu Pharma will give us the additional packaging capacity necessary for us to serve patients across the region with improved quality and speed.”About Amgen Inc.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, 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 medicines with breakaway potential.

For more information, visit and follow us on

About Amgen K.K.

Amgen K.K. is a wholly owned Japanese affiliate of Amgen Inc., one of the largest independent biotechnology companies in the world. Amgen K.K., formerly Amgen Astellas BioPharma K.K., was established in October 2013 as joint venture between Amgen and Astellas Pharma Inc., and changed its corporate name when it became a wholly owned subsidiary of Amgen Inc. in April 2020. Under the mission, “To serve patients,” Amgen K.K. focuses on the development of innovative medicines, and addressing severe unmet medical needs of patients in Japan by bringing Amgen’s global pipelines, ranging from therapeutic areas such as cardiovascular, cancer, bone, inflammation and immunology through neurological diseases.

About Bushu Pharmaceuticals Ltd. Japan:

Bushu Pharma was established in August 1998 as an independent pharmaceutical contract manufacturer. Bushu Pharma, capitalized at 1 billion yen, carries out pharmaceutical drug product contract manufacturing and packaging of clinical trials and commercial products in accordance with the latest cGMP standards. Through the utilization of know-how and the latest industry information, Bushu Pharma prides itself in being able to offer added-value solutions to customers. For more information, visit and

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking 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 our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as 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 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 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 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 regulatory 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 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 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, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and 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, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be 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 integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products 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 collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

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, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.


As a company specializing in contract manufacturing of pharmaceutical drugs, we offer a wide range of contract services tailored to clients’ needs based on our extensive experience and know-how accumulated over many years.