Amgen and Zhejiang Beida pharmaceutical announced the establishment of joint venture in China

Source: China Council for the promotion of drugs, May 10, 2013, introduced anticancer drug vectibix? (patomumab) from amjin company to Chinese patients, thousand Oak City, California, USA and Hangzhou, Zhejiang, China (May 9, 2013, us time) - May 10, 2013, China time, AMGN company (NASDAQ: AMGN) ）Zhejiang Beida Pharmaceutical Co., Ltd (Zhejiang Beida Pharmaceutical Co., Ltd.) and Zhejiang Beida Pharmaceutical Co., Ltd jointly announced that the two companies have signed an agreement to establish a joint venture to jointly promote the marketization of anti-cancer drug vectibix? (patomumab) of amjin company in China, so as to introduce vectibix into China as soon as possible and effectively, benefiting Chinese patients Amgen is the world's leading innovative biomedical R & D and production enterprise Zhejiang Beida pharmaceutical is good at developing and marketing molecular targeted drugs, and has established a leading cancer drug marketing network in China The joint venture will combine the advantages of the two companies to promote innovative biomedical research and development and marketization "This joint venture is a step towards our goal of providing Amgen innovative drugs to Chinese patients, as well as supporting our strategy to expand our business in key and emerging markets around the world." Anthony C Hooper, global executive vice president of Amgen, said, "we are pleased to have the opportunity to work with Zhejiang Beida pharmaceutical, a leading enterprise in innovative drug research and development and commercialization, to work together to introduce innovative drugs into China for the benefit of colorectal cancer patients." Ding liming, chairman of Zhejiang Beida Pharmaceutical Co., Ltd., thinks: "Amgen is the pioneer and leader of the global biotechnology industry Our cooperation with Amgen will have long-term strategic significance for Zhejiang and the whole Chinese pharmaceutical industry We and Amgen will work together to develop molecular targeted therapeutic drugs to meet the needs of patients in China, and we are confident to work with Amgen to benefit patients with colorectal cancer in China " "This is an important step in Amgen's commitment to the Chinese market," said Li Yiping, Amgen's global vice president and general manager for Greater China "We are very pleased to have a partnership with Zhejiang Beida pharmaceutical industry and look forward to bringing vectibix to Chinese patients in the near future Amgen's achievements in developing innovative drugs in the past 30 years enable us to provide the best support for the development of China's biotechnology industry The establishment of this joint venture has taken us a step further to achieve this goal " "This cooperation is a pioneering event in the field of China's biopharmaceutical technology industry," said Wang Yinxiang, CEO of Zhejiang Beida Pharmaceutical Co., Ltd "we are very happy to work together with Amgen in the fight between human beings and cancer." Under the agreement, the new joint venture will be named Amgen beta Pharmaceuticals Co., Ltd Zhejiang Beida Pharmaceutical Co., Ltd will own 51% of the equity of the joint venture and the remaining 49% of the equity will be owned by Amgen The establishment of the joint venture company needs to meet certain customary transaction conditions, including the approval of relevant government departments About Amgen company Amgen company was founded in 1980 It is mainly engaged in the research, development, production and sales of innovative drugs It is a pioneer in the field of biotechnology in the world As one of the first companies to realize the transformation of biotechnology into human beings to create well-being, Amgen has continuously brought safe and effective drugs from the laboratory to patients for 30 years The new biological drugs developed by Amgen have changed the world's medical practice and helped many patients around the world to fight against major diseases Looking forward to the future, Amgen, which has a wealth of new drugs under research, will continue to make more contributions to human health through technological progress To learn more about our cutting-edge technologies and important drugs, visit www.amgen.com or follow us at www.twitter.com/amgen About Zhejiang Beida Pharmaceutical Co., Ltd Zhejiang Beida Pharmaceutical Co., Ltd was founded in January 2003 It is a national high-tech pharmaceutical enterprise with innovative drug research and development as the core and integrating R & D, production and marketing, which was founded by the doctoral team in the United States Headquartered in Hangzhou, the company has its own R & D center in Beijing In the past 10 years since its establishment, the company has launched more than 20 new drug projects and successfully developed the first small molecule targeted anticancer drug in China, exetane hydrochloride (Kemena) In July 2011, exetinib hydrochloride was approved to be listed, and the cumulative sales volume has reached 430 million yuan, of which 360 million yuan was sold in 2012, a record of new drug sales in China The company has more than 400 employees, including 6 returned doctors, five of whom have been selected as experts of the national "Thousand Talents Program" Vectibix is a prescription drug for the treatment of metastatic colorectal cancer (mCRC) It is a biological preparation based on human cell therapy Vectibix has been approved in more than 40 countries Vectibix? Is the first fully humanized epidermal growth factor receptor (EGFR) antibody approved by the US Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC) Vectibix was approved in September 2006 in the United States as a single agent for the treatment of advanced metastatic colorectal cancer, or for the late treatment of chemotherapy regimens containing fluorouracil, oxaliplatin and irinotecan The approval was based on a progression free survival study, and there is no data to show that vectibix has the efficacy of slowing disease-related symptoms or improving survival Retrospective subgroup analysis of clinical trials of metastatic colorectal cancer did not show that vectibix had an advantage in the treatment of tumors with KRAS mutations in codon 12 or 13 Therefore, vectibix is not recommended for the treatment of colorectal cancer (CRC) with these mutations Vectibix? Is a single agent targeting epidermal growth factor receptor (EGFR expressing), which is mainly used for the treatment of metastatic colorectal cancer (mCRC) in progress or for the later treatment of chemotherapy containing fluorouracil, oxaliplatin and irinotecan The efficacy of vectibix in the treatment of metastatic colorectal cancer with EGFR expression is based on its progression free survival study At present, there is no data to show that vectibix has the effect of reducing disease-related symptoms or improving survival rate Vectibix is not suitable for the treatment of metastatic colorectal cancer (mCRC) patients with positive KRAS mutation or unknown KRAS status Retrospective subgroup analysis of clinical trials of metastatic colorectal cancer did not show that vectibix had an advantage in the treatment of tumors with KRAS mutations in codon 12 or 13 Warning: skin toxicity and infusion reaction skin toxicity: 89% of the patients who received vectibix? Single drug treatment had skin poisoning reaction, and 12% of the patients who had serious reaction (NCI-CTC Level 3 or above) [see dosage and Administration (2.1), warnings and precautions (5.1), and adverse reactions (6.1)] infusion reaction: the incidence of serious infusion reaction is about 1% After the drug was put on the market, some patients had fatal transfusion reaction [see dosage and Administration (2.1), warnings and precautions (5.2), and adverse reactions (6.1, 6.3)] vectibix? The most common adverse reactions (≥ 20%) include: various types of rashes, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, diarrhea, dehydration induced diarrhea, etc The most serious adverse reactions of vectibix? Include pulmonary fibrosis, pulmonary embolism, severe skin poisoning with infection sequelae and septicemia, as well as infusion reaction, abdominal pain, hypomagnesemia, nausea, vomiting, constipation, etc For more information on the U.S vectibix? Prescription, please visit: www.vectibix.com Amgen's forward-looking statements This press release contains forward-looking statements based on management's current expectations and beliefs, and is subject to a number of risks, uncertainties and assumptions that may cause actual results to be significantly different from those described In addition to statements of historical facts, all statements can be considered forward-looking statements, including estimates of operating income, operating profit, capital expenditure, cash and other financial indicators, expected legal, arbitral, political, regulatory or clinical results or norms, customer and agency models or practices, reimbursement activities and consequences, and other such estimates and results The forward-looking statements relate to significant risks and uncertainties, including the following, as well as the significant risks and uncertainties described in more detail in Amgen's report to the securities and Exchange Commission (SEC), which includes the latest annual report (statement 10-K) and the latest periodic report (statement 10-Q and statement 8-K) For other information on uncertainties and risk factors related to our business, please refer to Amgen's report 10-K and its subsequent reports and reports 10-Q and 8-k Unless otherwise noted, the deadline for information provided by Amgen is May 9, 2013, and Amgen expressly disclaims any responsibility for updating these forward-looking statements in the future We do not commit to any forward-looking statements, and the actual results may be quite different from what we expect Whether it is the discovery or identification of new candidate products or the development of new indications of existing products, there is no guarantee; in addition, there is also uncertainty from a certain concept to the implementation of products Therefore, there is no guarantee that the development of any specific candidate product or new indications of existing products will be successful and eventually become commercial products In addition, preclinical results can not guarantee the safety and effectiveness of candidate products in human body Computer, cell culture system or animal model can not perfectly simulate the complexity of human body, sometimes even can not fully simulate The time required to complete clinical trials and obtain product registration licenses for different drugs is different before, and we expect that there will be such differences in the future We not only develop candidate products independently within the company, but also develop candidate products through authorized collaboration, partnership and joint venture However, candidate products jointly developed by multiple parties may be subject to disputes between the parties, or may not be as effective or safe as we think when we reach the above cooperation relationship Similarly, after our products are on the market, we or others may find that they have safety problems, adverse effects or production problems Government investigations, litigation and product liability claims can all impact our business A large part of our manufacturing capacity relies on third parties to supply some of our current and future products, and supply restrictions may restrict the sales of some of our current products and the development of candidate products In addition, our product sales are influenced not only by reimbursement policies imposed by third-party payers (including governments, private insurance schemes and managed healthcare providers), but also by regulatory, clinical and guideline development, domestic and international managed healthcare trends and cost control of health care, as well as by US legislation Regulations and reimbursement policies of governments and other agencies may affect the development, use and pricing of our products In addition, for some of our commercial products