Sagent Pharma (NSDQ: SGNT), a US maker of injectable products, opened a National Research Center in Chengdu's Bio-Technology Park (see story). Sagent says the NRC will focus on process and method development of technically difficult injectable pharmaceuticals. Sagent has an FDA/GMP manufacturing facility in Chengdu.
Aslan Pharma of Singapore opened a new office in Taipei, Taiwan, from which it will run clinical trials. In an exclusive interview with ChinaBio Today, Aslan said that Taiwan's regulatory system is both quick to respond and open to innovative clinical trials. Aslan is an in-licensing company. It limits itself to molecules from that have substantially completed their pre-clinical development, which it takes through Phase II proof-of-concept trials, and then finds a partner for them.
GlaxoSmithKline (NYSE GSK) reported its Q4 China revenues dropped 18% year-over-year for its drugs and vaccines. Ordinarily, that would be a disaster. But given that the company's sales were 61% lower in Q3, a decline of only 18% shows recovery (see story). Overall, GSK's China revenues were down 29% for the full year. The company's Q4 report shows the fallout from GSK's China bribery scandal will be something it can weather.
Deals and Financings
Cachet Pharma (SHE: 002462), a China drug and medical device distributor, signed a Term Sheet with Miraculins (MCUID) of Canada to distribute Miraculins' Scout DS Non-Invasive Diabetes Screening Test (see story). Cachet will pay $500,000 in upfront and milestones, and it agreed to place a $15 million order upon China approval of the device. $15 million will continue to be the minimum level of sales over the five years of the contract. Miraculins will be responsible for obtaining CFDA approval of the device.
Trials and Approvals
Abiomed (NSDQ: ABMD) was granted China approval for two versions of its minimally invasive heart pump, the Impella 2.5 and Impella 5.0 (see story). Abiomed is a Massachusetts-based market of cardiac devices. The Impellas, which are designed to provide temporary assistance to the heart, are inserted into the left ventricle via a catheter and pump blood into the aorta. The devices are used as temporary support for patients who are otherwise too weak to undergo an interventional cardiac procedure.
A new - and deadly - strain of avian flu has been isolated by Chinese scientists, according to a report published in the British medical journal, The Lancet. So far, only two cases of H10N8 have been identified, both in Jiangxi province. One of them resulted in death. China will establish a sentinel system in hospitals and clinics to watch for an outbreak of the strain. "The pandemic potential of this novel virus should not be underestimated," warned the Lancet authors, though nothing suggests that any mutation has happened to date that would facilitate human-to-human transmission of H10N8.