Luye Acquires Hanmi's Oncology Drug for $20 Million
Deals and Financings
Luye Pharma (HK: 2186) of China in-licensed a novel oncology drug candidate from Korea's Hanmi Pharmaceutical (KRX: 128940) (see story). Under the terms of the agreement, Luye will have China rights to develop and sell poziotinib, a pan-HER inhibitor. Hanmi will receive up to $20 million in upfront and milestone payments. According to Hanmi, poziotinib has a novel, oral mechanism that blocks EGFR receptors and may be effective against various forms of cancer.
Bao Hao Investment Management of Shanghai made an equity investment in US-based 20/20 GeneSystems, which 20/20 will use to advance China clinical development of its lung cancer diagnostic test (see story). The blood test is designed to be administered yearly to smokers, with the goal of diagnosing lung cancer before it metastasizes. Bao Hao said the investment was the first of several it plans to make in 20/20, though it did not disclose specific details.
Sinopharm (China National Pharmaceutical Group) has signed a Memorandum of Understanding with Provectus Biopharma (NYSE: PVCT), a US clinical-stage drug company, to in-license China rights for Provectus's lead drug candidate: PV-10, an immunotherapy aimed at cancer (see story). If the two entities reach a final agreement, Provectus will manufacture PV-10 in the US, and Sinopharm A-THINK will distribute the drug in China.
Trials and Approvals
Suzhou Amerigen Pharma, the China division of US-based Amerigen, was granted CFDA approval to sell generic mecobalamin tablets, the company's first product to be launched in China (see story). Mecobalamin is equivalent to vitamin B12. In 2013, Sinochem Jiangsu Pharma obtained exclusive China marketing rights to mecobalamin from Amerigen. Amerigen will manufacture the product at its FDA/CFDA certified facility in Suzhou.
A Wuxi PharmaTech (NYSE: WX) subsidiary, Shanghai SynTheAll Pharma, has passed FDA inspection, allowing it to manufacture the active pharmaceutical ingredient of an unspecified commercial drug (see story). In 2013, the same facility was granted FDA permission to produce an advanced intermediate. Drug manufacturing has become an important factor in WuXi's business -- manufacturing revenues rose 19% to $43.5 million in Q2 -- and the company's STA subsidiary provides services ranging from process research to research manufacturing to commercial manufacturing.
Cook Medical, a privately held US medical device maker, has begun enrolling patients in a China clinical trial of its Zilver® PTX® Drug Eluting Peripheral Stent (see story). The stent is seeking China approval as a treatment for peripheral arterial disease (PAD) in above-the-knee arteries between 4 mm and 9 mm in diameter. Cook Medical makes an extensive variety of medical products including catheters, wire guides and stents for use in surgical and minimally invasive procedures.
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