The news in China biotech last week revolved around two major topics: trial results/approvals and deals. On the test results front, Bridge Laboratories made a long-awaited announcement: the FDA accepted its China-developed data for review (see story). Bridge submitted data from primate toxicology tests conducted in its Beijing animal lab for an unnamed US biotech client. The data was in support of an IND package. Bridge said the acceptance validates its business plan (and, even though Bridge didn’t say this, the business plan of a large part of the China CRO industry): providing a fully GLP compliant facility in China capable of conducting GLP studies in support of worldwide regulatory submissions at a lower cost than labs in the West.

Simcere Pharma (NYSE: SCR) reported positive interim results from a Phase IV trial of its patented anti-cancer drug Endu (see story). The drug displayed both safety and efficacy results that were in line with Endu’s Phase III trial. An anti-angiogenesis drug, Endu is a modified version of recombinant human endostatin. It is already approved for use in China against non-small cell lung cancer; however, the SFDA asked for a post-approval trial to further validate the drug’s usefulness. The interim data came from the initial 648 patients. Simcere has treated 2,000 patients in the test, but full results will not be available until 2010.

In other regulatory news, Roche (OTC Pink Sheets: RHHBY) announced that Xeloda, an oral chemotherapy drug, was granted SFDA approval for an additional indication: gastric cancer (see story). Xeloda, which is inactive in pill form, becomes active when it comes into contact with a naturally occurring protein called thymidine phosphorylase (TP). TP transforms the ingredients into 5-FU, a widely used chemotherapy. Because some tumors contain higher concentrations of TP than normal tissue, the cell-killing effect of the drug is focused in the tumor. Roche’s China subsidiary, Shanghai Roche Pharmaceutical Co. Ltd, a joint venture with Sunve Pharmaceuticals, manufactures the drug in China.

Moving on to the subject of deals and financings, Huifeng Bio-Pharmaceutical Technology (OTCBB: HFGB) signed a Letter of Intent to assume operational control of Xi'an Qinba Xintong Medical Ltd. in exchange for a management fee that equals all of Qinba’s profit (see story). Huifeng manufactures plant extracts and pharmaceutical raw materials, while Qinba is focused on finished medical devices. This may not seem like a natural fit, but Huifeng’s interest in the deal derives from Qinba's relationships with customers. Huifeng wants to transform itself from a pharmaceutical ingredients company into a vertically integrated, full-service company offering drugs to customers, and it sees the relationship with Qinba as a first step in that transformation.

In an item that is notable for its “man bites dog” theme, the US-based company NeoStem, Inc. (AMEX: NBS) placed $1.25 million worth of units with an Asian private equity firm (see story). The money came from RimAsia Capital Partners, a pan-Asia private equity firm that is making its first investment in a Western company. According to Dr. Robin Smith, Chairman and CEO of NeoStem, RimAsia is a “regional network of strategic investors drawn from leading Asian families and companies.” NeoStem, a company that provides stem cell banking services, said it would use the money to expand overseas and make international acquisitions.

In an earnings announcement with heavy M&A overtones, Mindray Medical (NYSE: MR) reported much higher results for its second quarter, the first quarter that included its acquisition of Datascope’s patient monitoring business (see story). The acquisition was completed on May 1, so Mindray’s Q2 report reflects two months of combined operation. In Q2, revenues climbed 100% to $145.7 million and net income was up an even greater 139% at $36.7 million. Mindray did not break out separate numbers for its Datascope assets, as they are already a part of the Patient Monitoring division. However, as a very un-rigorous estimate, the Datascope acquisition seems to have increased Patient Monitoring by about 30.5% or $16 million over the two months. 

In financial engineering news, Genesis Pharmaceuticals Enterprises (OTCBB: GNPH) completed a 40-to-1 reverse stock split and changed its ticker symbol to GNPH from the previous symbol, GTEC (see story). As before, Genesis Pharma trades on the OTC Bulletin Board Exchange. After the reverse split, Genesis has 10.3 million shares outstanding. Cao Wubo, Chairman and CEO of Genesis, said in a statement that the reverse split was part of a strategic initiative that will culminate in listing its share on a “senior” stock exchange in the US. Before the reverse split, Genesis closed at 24 cents per share, implying a post-split price of $9.60. Investors clearly applauded the move, because, after some hesitation, they pushed the stock up to $13.50.

And finally, following the same financial engineering theme, China Sky One Medical (AMEX: CSY) announced it would list its shares on the NASDAQ Global Market, abandoning the American Exchange after just three short months there (see story). The company’s stock will begin trading on the new exchange on Monday September 15, 2008 under the symbol CSKI, the same symbol it had as a Bulletin Board company. 


Disclosure: none.