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The Week in Review: Company Profiles and Drug Advancement

publication date: Aug 2, 2008
 | 
author/source: Richard Daverman, PhD

In ChinaBio® Today, we profiled two China biotechs last week. One, Shenogen Pharma Group, recently won one of the two “Most Promising Company” awards at the ChinaBio® Investor Forum, held in early July in Shanghai (see story). Shenogen combines facets of Western and Eastern pharmaceutical practices. It uses a molecule from traditional Chinese medicine to target a novel receptor that Shenogen has discovered, which the company expects will prove to play a significant role in breast cancer. The Shenogen compound could eventually become as important as tamoxifen. With this ambitious goal, and its novel target, Shenogen is a shining example of innovation in China, as the company aims at a new target to greatly improve medical treatment of a dread disease.

The other profiled company, Beike Biotechnology, is also at the leading edge of scientific inquiry, but Beike provokes much more controversy than Shenogen (see story). Beike was in the news because it hosted the first annual 2008 China Stem Cell Stem Cell Technology Forum, a gathering that was attended by over 300 of the world’s most renowned stem cell researchers. The company’s controversy derives from its practice of treating patients with injections of stem cells (usually a combination of umbilical cord cells and stem cells derived from each patient), even though its therapies have not undergone clinical trials. Beike responds by saying that out of more than 3,000 patients so far, 70% to 80% said they were satisfied with their treatments. 86% of them experienced some therapeutic effect, according to Beike. Because these patients have exhausted other alternatives and find help with Beike’s therapy, the company believes it is doing absolutely the right thing.

Bridge Laboratories announced plans to build a second preclinical facility in China, a 150,000 square foot facility that will be next to the company’s existing laboratory in the Zhongguancun Life Science Park in Beijing (see story). Like the present lab, the new facility will be built to meet FDA and worldwide standards. It will provide GLP toxicology, immunology, vaccine, and bioanalytical services. When Bridge completed a $35 million funding in early 2007, the company said it planned to build a second vivarium in China. Those plans seemed to have changed, however. Construction, which will begin in Q4 of 2008, is expected to be completed in approximately one year.

Lotus Pharmaceuticals (OTCBB: LTUS) also announced its intention to invest in new facilities. The company bought land rights to property in Inner Mongolia on which it will construct a manufacturing plant (see story). Liang Fang Pharmaceutical Company, a China subsidiary of Lotus, paid 108 million RMB ($15.5 million) for the rights, of which 39 million RMB ($5.8 million) was paid to Cha You's Cha Ha Er Industrial Garden District. The first products planned for manufacture at the new factory include saline for intravenous use and blood plasma substitutes.

In terms of individual products last week, Zhejiang Huahai Pharmaceutical Co. (SHSE: 600521) signed a landmark agreement to provide finished product to Merck (NYSE: MRK) (see story). Traditionally, Zhejiang Huahai has provided APIs to western pharmaceutical companies, as well as finished drugs in China. In October 2007, Huahai was granted FDA approval for a generic version of the AIDS drug nevirapine, a Boehringer Ingelheim product that it markets under the name Viramune. It was the first time the FDA awarded approval to a China biopharma for a finished product.

In China, Tianyin Pharmaceutical, Co. (OTCBB: TYNP) was given SFDA approval for a generic version of a statin drug, simvastatin tablets (see story). Simvastatin was developed by Merck (NYSE: MRK), which markets the drug as Zocor. The US patent for the drug expired in 2006. Simvastatin is used to control hypercholesterolemia and treat coronary heart diseases, the only statin approved by the SFDA for these conditions. Tianyin is able to produce $2 million of the drug annually. 

CompuMed (OTCBB: CMPD) received approval from the SFDA to market its OsteoGram software system in China for screening, diagnosing and monitoring of osteoporosis (see story). CompuMed said it would work with China digital x-ray OEMs to market its product. OsteoGram is a software system that is used with ordinary digital (that is, filmless) x-ray equipment. CompuMed said its competitor requires dedicated x-ray machines.

Bayer Pharmaceuticals and Onyx Pharmaceuticals (NYSE: ONYX) were awarded SFDA approval for their blockbuster cancer drug, Nexavar® (sorafenib) (see story). The drug was indicated for unresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer. The approval was based on two international Phase III trials, which showed Nexavar improved overall survival in liver cancer patients. Liver cancer is a major problem in China because of the country’s high incidence of hepatitis B. 

Huifeng Bio-Pharmaceutical Technology (OTCBB: HFGB) said it remains on track to gain COS (European Certificate of Suitability) approval in September to provide Diosmin to Safic-Alcan, a French chemical company (see story). Diosmin is a semisynthetic phlebotropic drug, a member of the flavonoid family that can be isolated from various plant sources or derived from the flavonoid hesperidin. It is used as a supplement to treat chronic venous insufficiency, hemorrhoids, lymphedema and varicose veins. In November 2007, Huifeng signed an agreement with Safic-Alcan under which it will supply at least 50 tons of Diosmin to Safic-Alcan in the first year of the contract. That amount increases yearly to 500 tons over the five years of the contract.

NovaMed Pharmaceuticals added a sixth drug to the list of pharmaceutical products it distributes in China for Sanofi-Aventis (NYSE: SNY) (see story). Starting immediately, NovaMed will promote and distribute Depakine®, an epilepsy drug that is the most widely prescribed anti-convulsant in China. NovaMed also distributes the Sanofi-Aventis drugs Xatral®, Perenan®, Rulide®, Tritace® and Stilnox®.

There was also a small funding that took place last week. Sinobiomed Inc. (OTCBB: SOBM) received a portion of the $500,000 in new convertible debenture funding that Accelera Ventures Ltd has committed to invest in Sinobiomed (see story). Unfortunately, $500,000 is just about the amount of money Sinobiomed needs to stay afloat each quarter. Sinobiomed said it would use the money to further current initiatives, and that it would bring investors up to date on these initiatives in coming weeks.

Disclosure: none.


 

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