The international profile of the China CRO industry, which is already well established, was raised even further last week when HD Biosciences Co., Ltd., the Shanghai-based biotech CRO, was given the “2008 Top Research Service Partner” award by big pharma Pfizer (NYSE: PFE) (see story). Specifically, the award recognized the quality, productivity, and value that HD Biosciences delivered in its collaboration with Pfizer during the past year. Last week, to mark the giving of the award, we profiled the company—its history, its offerings—including an exclusive interview with CEO and Founder Dr. Xuehai Tan. HD Biosciences is focused entirely on biology service in drug development, a fairly unusual niche that differentiates the company from most China CROs. “We stay focused on the things we do the best,” said Dr Tan. “We will not try to do everything. But, we are the leaders in what we do.”

Frontage Laboratories Inc., a CRO with facilities in the US and China, announced a collaboration with Beijing Second Pharmaceuticals, the ethical drug division of Beijing Pharmaceutical Group (see story). Frontage will provide help in developing new generic drugs that will be marketed in China, Europe and the US. The goal is to file 12 abbreviated new drug applications (ANDAs) in the next 3-5 years. As part of the deal, Frontage will obtain a new 1,800 square meter R&D center in Beijing, and it will have access to Beijing Pharma’s GMP manufacturing areas. Frontage’s present China lab is located in Shanghai.

Beijing SL Pharmaceutical Co. (SZSE: 002038) will expand its portfolio of products by establishing a JV in Liaoning to produce in vitro products (see story). The JV will be capitalized with 20 million RMB ($4.4 million). SL Pharma will contribute 10.2 million, and two private investors will add the remaining 9.8 million RMB, giving SL Pharma a controlling 51% stake. Up to this point, SL Pharma has derived its revenue from biotech drugs and a number of treatments for cancer and hepatitis. 

Biocomposites, a UK medical device company, reported that is synthetic bone graft substitute, geneX®, was approved for use by the SFDA (see story). geneX® uses a proprietary bi-phasic composition process to create a negative surface charge. According to the company, this negative charge attracts key proteins and directs the adhesion of osteoblasts, accelerating the formation of new bone. geneX® is fully resorbable. Biocomposites will market the product through its already established sales subsidiary, located in Shanghai. 

Obio Pharmaceutical Holdings issued a progress report of its current crop of drug candidates (see story). The company, which claims a focus on diabetes and influenza, reports that it has six drugs in development, two of them patented. The company plans to develop these drugs and then partner them with larger companies to bring them to market. Obio is headquartered in Hong Kong, but its research facilities are in Beijing. It also outsources some of its R&D work to outside groups.

China Sky One Medical (NSDQ: CSKI) (中国天字一号医药公司) has signed up Shaanxi Buchang Group to distribute Naftopidil Dispersible tablets for China Sky One (see story). China Sky One said its treatment for benign enlargement of the prostate gland is expected to generate sales of 100 million RMB ($14.6 million) over the next 5 years. Normally, China Sky One seeks drugs from other companies to distribute through its system, but this time the company elected to out-source distribution to a company with experience in the prostate specialty.

And finally, there was an unfortunate story last week about a China company falling afoul of regulatory rules. Three officials of Dalian Jingang Andi Bio-products (JGAD), the China operating subsidiary of China Bio-Immunity Corporation (OTCBB: CHHB), have been charged with intentional fraud for adding an unapproved nucleic acid to the company’s human rabies vaccine (see story). Although nucleic acids are used to increase the effectiveness of vaccines, the addition was not approved by the SFDA. The company’s general manager, the vice general manager, and a purchasing agent have been detained. The Dalian Food and Drug Administration will confiscate all the illegal products and profits from the vaccine. It will also assess a punitive fine of three times the value of illegal products.

Disclosure: none.