Tianyin Wins First SFDA Approval

Tianyin Pharmaceutical, Co., Inc. (TYNP.OB) continues the rapid pace of its news flow with an announcement that the SFDA approved the company’s generic form of antibiotic medicine Azithromycin Dispersible Tablets. For Tianyin, the approval was the first the company has received from the SFDA, and the drug will become the third Western-style drug in the portfolio. Most of Tianyin’s products are traditional Chinese medicines. To further diversify its product line, Tianyin has another 10 products awaiting SFDA approval.

Azithromycin is closely related to erythromycin, though it has been shown more effective against certain gram-negative bacteria. The drug was discovered by researchers at the Croatian firm Pliva, and the US and Western European rights were out-licensed to Pfizer (PFE), which markets the drug under the trade name Zithromax. The drug had sales of $350 million in China in 2007.

Tianyin says Azithromycin is especially effective for treating upper and lower respiratory tract infections and other bacterial infections in the skin and the reproductive system.

To market its Azithromycin, Tianyin has entered a distribution deal with the largest Chinese distributor of Azithromycin, Anhui Huayuan Pharmaceutical Co., Ltd., which signed a $3.66 million distribution contract for 2008 covering most of China for Azithromycin and other products. Tianyin said the agreement will produce margins that are in line with its blended average during the past year.

Tianyin has its own distribution division, but said it opted to work with Huayuan to speed up the market entry of its Azithromycin product and gain market share throughout China.

Tianyin earned a net $3.95 million on revenues of $20.4 million is its fiscal 2007, which ended June 30, 2007. Last week, Tianyin Pharma announced it new name and ticker symbol, completing the details of a reverse-merger process that was announced in January.

Disclosure: none.