Government and Regulatory

Last month, China's National Health and Family Planning Commission issued updated rules for stem cell clinical trials, offering researchers a clear path for trial approvals (see story). At the same time, the agency warned unscrupulous clinics they will be punished for selling unapproved treatments. Under the new rules, clinical trials must be conducted in Tier IIIa hospitals, records kept for 30 years, an ethics panel must oversee the trial, certified stem cell lines must be used, and patients must be monitored after treatment ends. In addition, patients cannot be charged for treatments administered in a clinical trial. 

Deals and Financings

Mindray Medical (NYSE: MR), the Shenzhen medical device company, reported a management-led group has lowered its offer to take the company private to $27 per ADS, a 10% drop from the $30 bid the group made in June (see story). The revised offer values the company at $3.2 billion. The company's announcement did not give any reasons why the group lowered its offer. However, Mindray's growth rate has slowed to almost zero, and the outlook for China's economy has deteriorated, making the economic logic behind go-private transactions seem increasingly risky. 

DaVita Healthcare (NYSE: DVA), a US owner/operator of dialysis clinics, formed a JV with Shunjing Renal Hospital of China's eastern Shandong province (see story). The company will combine with the private hospital to offer kidney dialysis along with services that delay the need for dialysis by treating hypertension and obesity. The JV plans to build a second hospital in Shangdong. The JV will be owned by DaVita and Xiaoyi Zhang, president of Shunjing Renal Hospital, who will become the CEO of the JV. 

Yabao Pharma (SHA: 600351) established a collaboration with the University of South Australia in Adelaide to develop new cancer drugs (see story). The company will co-support discovery research in the lab of Professor Shudong Wang at the University. Yabao will have China rights to any drug candidates, while the University will retain rights for the rest of the world. Last year, Yabao formed a partnership with Changzhou Le Sun Pharma to develop another cancer drug candidate discovered by Dr. Wang. 

Trials and Approvals

DelMar Pharma (OTCQX: DMPI), a Vancouver-Menlo Park, CA company, together with its China partner, Guangxi Wuzhou Pharma, announced plans to start a China Phase IV trial of VAL-083 in patients with refractory and relapsed non-small cell lung cancer (see story). The drug is already approved for NSCLC in China, but most patients are prescribed newer tyrosine kinase inhibitors. Based on preclinical studies, DelMar believes VAL-083 is effective against TKI-resistant NSCLC, which the trial is designed to prove.