U.S. Pharma Giant Amgen Expands in China With Local Partner

Chinese drugmaker Simcere Pharmaceutical Group has signed an exclusive contract with U.S. biopharma giant Amgen Inc. to co-develop and commercialize four medicines in China.

All four agents are “biosimilars,” or nearly identical to existing biologic medical products that have been greenlighted by a drug authority, and thus have no clinically meaningful differences in terms of safety and effectiveness from the existing medications.

The companies did not specify what the four products were, but in a joint statement said they “are a part of Amgen’s existing biosimilars portfolio,” and would be used in the treatment of inflammation and cancer.

Financial details also were not disclosed, but Amgen “will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars,” while Simcere will focus on distribution and commercialization in China, the statement said.

Amgen has created several pioneering biotechnological agents for the treatment of diseases such as cancer, stroke and diabetes. Its newly developed drug Mvasi — based on Avastin, a medication from F. Hoffman-La Roche AG’s Genentech Inc. — is the first anti-cancer biosimilar ever approved by the U.S. Food and Drug Administration.

The Amgen-Simcere deal comes as China develops increasingly ambitious plans for its drug sector, especially in biopharmaceuticals, an area that is gaining ground on traditional chemically synthesized medicines.

“This agreement furthers Amgen’s efforts to reach more patients in Asia by bringing high quality biosimilars medicines to patients suffering from debilitating and potentially life-threatening conditions,” said Penny Wan, regional vice president and general manager of Amgen's Japan and Asia-Pacific Region.

The China Food and Drug Administration (CFDA) has implemented reforms on drug approvals, encouraging research and development of innovative, higher-quality medicines, according to Simcere Chief Scientific Officer Mu Hua. In June, the CFDA became a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, which allows China to share technical standards with developed regions like the U.S. and Europe.

In January, the country’s national economic planning body forecast that China’s biopharma output will hit the equivalent of 600 billion yuan ($90.5 billion) by the end of 2020.

Following political trade winds, venture capital funding in Chinese biopharma companies surged more than sixteenfold from 2012 to 2016, to more than $1 billion, according to BioCentury’s online intelligence service BCIQ.

Shares of Nasdaq-listed Amgen declined 0.37% to $185.6 per share on Tuesday. Simcere was among the first Chinese drugmakers to list in New York, but was privatized in 2013 by a consortium that included Hony Capital and a subsidiary of Shanghai Fosun Pharmaceutical Group Co. Ltd.

Contact reporter Coco Feng (renkefeng@caixin.com)