SL Pharma Wins SFDA Approval for New Drug and a Clinical Trial

Beijing SL Pharmaceutical Co. Ltd. (SZSE: 002038) received SFDA approval to begin producing a hepatitis drug and a second SFDA authorization to begin clinical trials of drug for male infertility.

Adefovir dipivoxil, the drug newly approved for marketing, is aimed at hepatitis B. It is currently available from more than 10 China pharmaceutical companies, though most of them produce the compound as tablets. SL Pharma will market it as a capsule, the third company in China to have permission to make the drug in this form.

SL Pharma already manufactures and sells products that target hepatitis B. Adefovir dipivoxil will be marketed by the company’s existing hospital-based sales staff.

SL Pharma’s male infertility product is thought to be modafinil, the stimulant drug that is marketed as Provigil by Cephalon (NSDQ: CEPH). The drug is given to treat excessive daytime sleepiness, especially among people suffering from narcolepsy. It has also been used to improve patients’ moods, but it has never before been tested for male infertility.

The drug’s patent at one time extended to 2015, but Cephalon settled a patent dispute with four generic drug manufacturers, which will allow generic versions of the drug to appear in 2012. SL Pharma said the clinical trials of the drug would require about four years to complete.

SL Pharma is working with a research institution on modafinil. The company will receive 100% of the profits from the drug inside China and 25% of the earnings ex-China.

Earlier, SL Pharma announced its first half revenues climbed 65% to 159 million RMB ($23.3 million), producing net income of 96 million RMB ($14 million), an 83% increase. Despite those very high profit margins, the company invested an unusually high 9% of revenue – 14 million RMB ($2 million) – in R&D during the period.

SL Pharma’s product portfolio focuses on three major areas – cancer, hepatitis and cardiovascular.

Disclosure: none