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"Pharma in China Being Held to Higher Standard, Says Greg Scott, ChinaBio"
Week in Review: Zhejiang Medicine to Develop Ambrx Breast Cancer Drug
Deals and Financings
Zhejiang Medicine Co. (SHA: 600216) formed a collaboration with Ambrx of San Diego to develop an Ambrx molecule that targets Her2-positive breast cancer (see story). Ambrx genetically engineers proteins that contain new amino acids with different properties than those of the 20 natural-occurring amino acids. In return for China rights, Zhejiang will underwrite the costs of development, which will be carried out by WuXi PharmaTech (NYSE: WX).
Suzhou Ribo Life Sciences and Life Technologies (NSDQ: LIFE) of California have stuck a deal giving Ribo exclusive China rights to develop and manufacture siRNA therapeutics using Life's Invivofectamine® Rx delivery technology (see story). Life Technologies will receive milestones and royalties for each drug that Ribo develops. Ribo’s first product will be a treatment for hepatitis B.
Shanxi CY Pharmaceutical (SHE: 300254) will purchase a stake of at least 80% in Hangzhou Baoling Group Co., Ltd. (see story). Baoling Group’s main asset is a 75% ownership of Zhejiang Baoling Pharmaceutical Co., which produces healthcare and drug products for pregnant women. The purchase price was not disclosed.
BioClinica®, a clinical trial services company headquartered in the US, has formed a strategic partnership with TEDA International Cardiovascular Hospital (TICH) in Tianjin, China. The partnership will offer the company’s cardiac safety monitoring services in Asia (see story). BioClinica recently completed the first CFDA-requested Thorough QT (TQT) cardiac safety study in China for a domestic China company at the hospital.
Sichuan BoXin LaiTe Biotechnology and its major shareholder, Heracles International Investment Inc., have signed a memorandum of understanding to form a partnership with the Center for Blood Research (CBR) at the University of British Columbia (see story). BoXin LaiTe and Heracles use their ability to validate the commercial and clinical of novel discoveries made at the CBR and accelerate their development for the China market.
Government and Regulatory
China’s chief drug safety regulator, the CFDA, recently felt compelled to have a meeting with Johnson & Johnson (NYSE: JNJ) about product recalls (see story). The problem was an article in a China newsletter alleging J&J has recalled 51 products globally since 2005. But 48 of those products were not recalled in China, according to the publication. The apparent double standard required an explanation.