Closing deals, winning drug approvals, receiving patents, announcing financial results, marketing drugs – these are the markers of progress in a biopharma enterprise, and each was in evidence last week in the world of China biopharma.
China Yongxin Pharmaceuticals Inc. (CYXN.OB), for example, announced that it has completed its previously announced reverse merger with Nutradyne Group, Inc. (see story). To celebrate the event and announce itself to the world, the company has changed the name and ticker symbol of the enterprise, broadcasting the changed business of the venture. In the first quarter of 2008, China Yongxin booked $15 million in revenue from the three divisions of its business: a chain of retail drug stores, a wholesale drug distribution business and a ginseng-based TCM drug manufacturing operation.
The two China-based minority participants in the Shanghai Schering-Plough JV will put up for sale their 45% stake in the 14-year old venture (see story). The asking price is $9.6 million. Schering-Plough (NYSE: SGP), the majority owner with a 55% share, will retain its ownership and has the right of first refusal on the rest. The sellers are Shanghai Pharmaceutical Group, with a 30% stake, and Shanghai Pharmaceutical Industry Corp., with the remaining 15%. In 2007, the JV reported a profit of more than $500 thousand, after two years of losses. Depending on your point of view, that fact may make 2008 a good time to sell or a good time to keep a venture. Shanghai Pharmaceutical Group said it was making the move to consolidate its operations in fewer subsidiaries.
Moving on from biopharma deals, Lotus Pharmaceutical [LTUS.OB] said its Q1 revenues rose 41% to $11.7 million, and net income climbed 19% to $1 million (see story). Its third-party manufacturing business experienced a 50% downturn from year-earlier levels, but its other operations – pharmaceutical production and wholesale distribution – did well. To continue the growth, Lotus paid $7 million to buy a new asthma medicine, Laevo-Bambutero, which must still be approved by the SFDA. Lotus expects a 2012 launch for the drug, if all goes well.
China Sky One (CSKI.OB) announced that it will migrate from the OTC Bulletin Board to the American Stock Exchange (see story). When the move takes place, the company will adopt a new ticker symbol: CSY. China Sky One said the new listing will open the company to an expanded number of investors.
In the world of Intellectual Property, Calando Pharmaceuticals of Pasadena, CA, a majority owned subsidiary of Arrowhead Research Corp. (NSDQ: ARWR), was granted a patent in China for delivery of RNA interference drugs (see story). The patent has broad coverage of all methods of using any RNA interference construct formulated in a supramolecular complex, (formulations formed with a polymer). The patent also covers any pharmaceutical compositions of matter containing RNAi constructs adapted for pulmonary or nasal delivery to the lungs. In the US, Calando has begun the first clinical study using targeted, systemic delivery of siRNA and the first siRNA trial in oncology.
India-based Suven Life Sciences Ltd. was granted patents in China and South Africa for two new chemical entities (NCEs) that treat disorders associated with neuro-degenerative diseases (see story). Both NCEs belong to the class of selective 5-HT compounds. The compounds, which are in pre-clinical development, are being developed as therapeutic agents for the treatment of cognitive impairment in diseases such as ADHD, Alzheimer's, Parkinson’s, schizophrenia and Huntington’s.
SFDA approval news was led by China Sky One Medical, Inc. (CSKI.OB), which announced it received marketing approval for two new drugs: Oxymetazoline Hydrochloride Nasal Drops, a treatment for rhinitis and sinusitis, and approval for Taurine Eye Drops, a treatment for conjunctivitis (see story). The approvals lift China Sky One’s product offerings to a total of 98 drugs overall, 49 of which are administered externally. By the end of 2008, the company expects to have submitted 37 additional new drugs to the SFDA for approval.
Oculus Innovative Sciences (NSDQ: OCLS) of Petaluma, CA announced a commercialization plan for its Microcyn products in China (see story). Microcyn was approved by the SFDA two months ago for use in healing acute and chronic wounds, including ulcers, cuts, contusions and burns. This is a more comprehensive indication than Microcyn enjoys in the US, where the product is approved as a medical device for wound dressing.. The company’s distribution partner, China Bao Tai, will distribute samples of Microcyn to key opinion leaders in the field, asking them to test the clinical effect of the product by conducting post-approval trials. The data from the trial will be used to help secure reimbursement from insurance institutions.
In general corporate news, Tongjitang Chinese Medicines Company (NYSE: TCM) released news that the manufacturing plant for its main product, the osteoporosis treatment Xianling Gubao, would resume production after a two-day shutdown following the severe central China earthquake (see story). In the aftermath of that cataclysmic event, Tongjitang management was worried that the quality of water inside its Xiuwen facility had been compromised. They ordered a shutdown until the water could be proven safe. Tongjitang also said it received a tax rebate totaling 16 million RMB ($2.3 million), which it will use to expand its China operations.