China Biotech Week in Review: Safety Regulation Improves

Two familiar themes ran through China life science news last week: drug/device safety and the onward progress of biopharmas. Because no new scandals have emerged to fan drug safety fears, the noise about them has become less strident in recent months. But regulators nevertheless keep hammering out new arrangements in an effort to provide reassurance to a public that may have already moved on to other worries.

During the past week, U.S. and China officials agreed to a list of drugs and devices that would be subject to supervision from both countries. China will receive information on manufacturing facilities, registrations and recalls on six drugs and two devices. For its part, the U.S. has listed eight drugs and two devices for which companies must register with the SFDA before they are allowed to export to the US. Reviewing its upgraded regulatory efforts, China announced that it had shut down 300 drug and device companies in the second half of the year, since the crackdown began, for manufacturing products of inferior quality. Inspectors have examined 29,000 types of drugs, reviewed 148,000 drug registration files, checked 26,000 files for medical devices and found 1,100 approvals that were not properly completed.

And, finally, 180 drugs and medical instruments were banned for improper advertising -- a slippery concept on both sides of the Pacific Ocean. At the same time, China’s appetite for pharmaceuticals is predicted to grow between 12% and 13% to $90 billion in 2008, according to a report from China’s Chamber of Commerce (see story). In terms of China pharmaceutical buying, about one yuan out of every five will be spent in the three monster cities of Shanghai, Beijing and Guangzhou. The domestic market is important, but so is trade, and not surprisingly, China seems to do better at exporting ($19.8 billion) than importing ($11.4 billion).

However, in medical devices, the order was reversed: $2.9 billion of medical devices went to China from the US, while $2.2 billion flowed the opposite direction. GlaxoSmithKline (NYSE: GSK) said it was increasing the size and pace of its investment in China biopharma (see story). The Shanghai neurological R&D center, previously announced as a $40 million venture, now will be the beneficiary of $100 million by the end of 2008 with the goal of employing 1,000 staff in 2010. By concentrating on neural stem cells and libraries of natural products, GSK will build a “one-stop shop” that will develop drugs for neurodegenerative illnesses such as Alzheimer’s and Parkinson’s disease.

Massachusetts-based Organogenesis partnered with the National Tissue Engineering Center (NTEC) of Shanghai, which will sell its Apligraf product in China (see story). Approved in the U.S. in 1998, Apligraf is a regenerative medicine product using human dermal cells to treat venous ulcers on the leg and diabetic foot ulcers that do not heal normally. In the second phase of the agreement, NTEC will build a plant to manufacture Apligraf in Shanghai. Eventually, NTEC will market Apligraf® throughout Asia.

Sinvoac (SVA) announced that its hepatitis A vaccine, Healive, was added to the list of officially approved products in Beijing (see story). Healive is one of two inactivated hepatitis A vaccines in pre-filled syringes that will be used in Beijing’s hepatitis A vaccination program. Separately, Sinovac reported that, partially because of improved sales of Healive, its financial results have improved dramatically so far this year. Revenues more than doubled in Q3 to $10.8 million while earnings came in at $2.2 million.

And, finally, Helicon, an Australian biopharma, reached a deal with Jewim Pharma to distribute oncology drugs in China (see story). Helicon is in the business of looking for drugs and medical products that supply unmet needs in China, including putting these drugs/products through the SFDA approval process. Helicon does not currently list any oncology drugs in its portfolio, but its tie-up with Jewim suggests it may be in the hunt for some.

Disclosure: none.