Deals and Financings
ZAI Lab of Shanghai in-licensed China rights to a liver cancer drug candidate from Bristol-Myers Squibb (NYSE: BMY) (see story). Brivanib is an oral kinase inhibitor that is in Phase III trials for oncology indications including hepatocellular carcinoma, which is especially prevalent in China. ZAI Lab will be responsible for developing, manufacturing and commercializing brivanib in China, though BMS will have an option to co-promote the drug. ZAI will pay BMS development milestones and tiered royalties if brivanib is approved in China.
Concord Medical Services (NYSE: CCM), a China radiotherapy and diagnostic imaging company, will acquire a small Singapore hospital from Fortis Healthcare for $40 million (see story). The 31-bed facility, known as Fortis Surgical Hospital, offers nearly 100 different minimally invasive procedures. Concord, which plans to change the Singapore hospital's focus to oncology, has previously announced plans to build three high-end cancer hospitals in China.
Sinophi, a UK healthcare consultancy and investor in China hospitals, announced that it will be the exclusive distributor of Advanced Oncotherapy's (LON: AVO) LIGHT proton beam systems in China and other Southeast Asian countries (see story). Advanced Oncotherapy, also of the UK, makes the systems which are similar in function to radiation therapy devices. In addition, Sinophi paid $40 million to purchase a LIGHT proton system for its $130 million regional oncology hospital in Huai'an City, Jiangsu province.
Trials and Approvals
A China Ebola vaccine developed by Beijing Institute of Biotechnology and Tianjin CanSino Biotechnology completed a successful Phase I trial in Jiangsu, with results published in The Lancet (see story). The vaccine is the first candidate tested that was developed to fight the current 2014 Zaire Guinea Ebola strain of the virus. The candidate was safe and provoked an immune response, though it still needs to prove that it can protect against the virus. The vaccine is delivered by a virus-like structure.
CASI Pharma (NSDQ: CASI), a US biopharma with strong China connections, has begun a China Phase II trial of its lead molecule, ENMD-2076, in triple-negative breast cancer (see story). The trial is a China arm of an on-going Phase II test in the US. The China trial, which is being conducted at the Cancer Hospital of Chinese Academy of Medical Sciences in Beijing, will assess the safety and efficacy of ENMD-2076 in a Chinese population along with analysis of a bio-marker.
Critical Diagnostics, a San Diego diagnostics company, received CFDA approval for China marketing of its Presage ST2 Assay as a risk predictor in patients who have suffered heart failure (see story). ST2 is a soluble protein that is expressed following heart disease or injury, reflecting ventricular remodeling and cardiac fibrosis. Patients whose assays record high scores are at greater risk for death or heart transplants.
CardioKinetix, a California medical device company, reported positive results from a three-month China trial of its minimally invasive heart failure treatment, the Parachute® Ventricular Partitioning Device (see story). The device, which blocks off non-functioning areas of the left ventricle following a heart attack, helps the damaged heart provide adequate blood flow. In a China trial that enrolled 31 patients, the Parachute device reduced the volume of the left ventricle by one-third at three months, a result that CardioKinetix called "highly significant."
WuXi PharmaTech (NYSE: WX), China's largest CRO/CMO, announced that the CFDA accepted an IND filing to begin clinical trials of WuXi MedImmune's novel anti-IL6 monoclonal antibody, a potential treatment for rheumatoid arthritis (see story). In 2012, WuXi and MedImmune, the biologics subsidiary of AstraZeneca (NYSE: AZN), formed a JV for China development of the drug, which had already started a Phase I dose-escalation trial in the US and Europe. The JV filed the IND with the Jiangsu provincial FDA as a Class 1 therapeutic biologic.
UniTao Pharmaceuticals postponed plans to open a US manufacturing plant in Petersburg, Virginia, where it was expected to make APIs for the ex-China market (see story). The company cited adverse business conditions for the setback, though it did not provide details. In October 2014, UniTao, a division of China's Tenry Pharma, announced it would invest $22.5 million to buy and refurbish a Boehringer Ingelheim facility that was about to be shut down. Apparently, UniTao paid $2.4 million to acquire the plant, but decided to postpone any updates.
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