China Biotech in Review: Deals, Approvals, Awards and Trials
by: ChinaBio Today July 26,
Xian-Janssen, a division of Johnson & Johnson, announced the China launch of Dacogen (decitabine), a novel treatment for myelodysplastic syndrome. Dacogen received SFDA approval through the Green Channel, an expedited approval process that the SFDA introduced in January 2009. In Dacogenâ€™s case, the SFDA allowed Xian-Janssen to begin marketing the drug in China based on trials done ex-China because MDS remained an unmet need and the incidence of MDS in China is small.
GlaxoSmithKline has partnered up with Dr. Reddys Laboratories in a deal that will allow GSK to sell Dr. Reddyâ€™s generic pharmaceutical products in emerging markets. The targeted countries include China. GSK has the right to select products from Dr. Reddyâ€™s portfolio of over 100 branded pharmaceuticals, which GSK will distribute through its established sales infrastructure.
AlphaRx and Venturepharm China, a subsidiary of Venturepharm Laboratories Ltd., entered into a cooperation agreement under which Venturepharm will provide AlphaRx with research services for its vaccine and anti-cancer drugs. Venturepharm will also help AlphaRx develop adjuvant vaccines for swine flu (A/H1N1). AlphaRx had been seeking local partners with the goal of building R&D and pilot plant facilities in China. AlphaRx uses its proprietary nano drug delivery technology to deliver proven drugs in new ways.
Six weeks after receiving their first samples of the A/H1N1 swine flu virus, two China biotechs have begun clinical trials of vaccines for the potentially fatal version of flu. Sinovac Biotech (SVA) and Hualan Biological Engineering will each test their vaccines in about 2,000 volunteers, a process that will take about two months. Both companies say they expect to announce results in September.
Mindray Medical International issued an update of its medical product offerings last week, announcing it has introduced five new products so far in 2009. Four of them are additions to its patient monitoring and life support business, while the fifth is an upgrade of a medical imaging machine. Mindray expects to meet or beat its 2009 goal of bringing between seven and nine products to market during the full calendar year.
Two China life science companies received industry awards last week. American Oriental Bioengineering (NYSE: AOB) was selected as one of the Top 20 Most Competitive Public Pharmaceutical Companies in China. The honor came after American Oriental was chosen from 132 China public pharmaceutical companies. Criteria for the selection included the companies\' management capabilities, brand recognition, financial strength, resource accessibility and quality of key team members.
Sundia MediTech Company, a Shanghai CRO, was named a Top 100 Fast-growth Outsourcing Service Provider. The criteria used for determining the ranking was company size and growth rate, business income, and per headcount revenue. The list included outsourcing companies in the fields of IT, pharmaceuticals, biotech, and other industrial sectors. In other news, Sundia also announced that the Express Customs Clearance trial service, instituted at Shanghai Pudong Airport one month ago, has reduced customs clearance time to an average of one day from three days previously.