China Biotech Week In Review: Regeneron Pharma, Bayer Start New Trial For DME Treatment

Includes: BAYZF, REGN
by: ChinaBio Today

Deals and Financings

Reckitt Benckiser, a British maker of OTC drugs and home products, has bought Golong Medicine of Anhui, a TCM company known for its sore-throat treatment Man Yan Shu Ning. The British company wants to expand its distribution foothold in China as a way to increase revenues from its extensive list of products. It does not intend to take Man Yan Shu Ning to the west. Financial details of the transaction were not disclosed.

Government and Regulatory

China's SFDA has announced a set of newly-revised regulations for the country's drug distributors. These new Good Supply Practices (GSP) for drugs, which comprise 187 articles, will promote higher standards of protection for the country's drug supply among wholesalers and retailers. An SFDA spokesperson also said the government wants to reduce the number of China's drug wholesalers from a current 13,000 to just 3,000, a draconian rollup of the country's highly fragmented distribution system.

Trials and Approvals

Sihuan Pharma (HK: 0460) received permission from the SFDA to begin clinical trials of pinoxacin hydrochloride, a Category 1.1 innovative drug. The drug is a DPP-4 inhibitor that is intended for type 2 diabetics. Sihuan, a Beijing-based company, intends to start the Phase I trial during the first half of 2013. In January, Sihuan announced approval to begin clinical trials of another Category 1.1 drug, an innovative carbapenem antibiotic known as benapenum. So far, four of Sihuan's Category 1 drugs have received approval for human testing.

Regeneron Pharma (NSDQ: REGN) and Bayer (OTCPK:BAYZF) have started a new Phase III trial to test Eylea® (aflibercept) Injection as a treatment for Diabetic Macular Edema (DME) (see story). The trial will be conducted in China, Russia and other Asian countries. In its global Phase II DME program, Eylea showed promising results.

Luye Pharma Group (SGX: A61) reported its Xuezhikang drug, a TCM used to lower cholesterol, proved efficacy in a US Phase II clinical trial. According to the company, the drug "significantly" lowered low-density lipoprotein cholesterol while elevating beneficial high-density lipoprotein cholesterol. The company did not disclose specific results from the trial. Xuezhikang is the only TCM included in the National Basic List as a treatment for blood lipids.

Company News

Beijing Double-Crane Pharma (SHE: 600062) will invest 271 million RMB ($43 million) to build a fluid infusion manufacturing facility in Shanghai's Jinshan Development Park. The plant will be operated by a subsidiary of Double-Crane, Shanghai Changzheng Fumin Jinshan Pharmaceutical Co.

Disclosure: none.