Deals and Financings
China's IPO window will soon open again. There hasn't been an IPO in China since October 2012, when regulators shut the entire process down. One month ago, the China Securities Regulatory Commission (CSRC) issued new rules for regulating the IPO process that adopted a more market-oriented approach. Now, China has approved eleven IPO candidates, a group that includes at least three pharmaceutical/healthcare companies.
Stellar Biotechnologies (OTCQB:SBOTF), located in California, will collaborate with Amaran Biotechnology and its partner OBI Pharma, both of which are Taiwanese companies (see story). Stellar will develop methods to manufacture OBI-822, an active cancer immunotherapy that uses Stellar's GMP-grade KLH. KLH is a protein that is derived from the Giant Keyhole Limpet, a marine mollusk. As part of the deal, Amaran invested $5 million in Stellar's recent $12 million capital raise.
DIH Medical Technologies, a Beijing-based medical device distribution company, gained China rights to market a non-invasive treatment for stroke recovery manufactured by Zynex (OTCQB:ZYXI) of the US (see story). The device, NeuroMove, helps stroke patients regain mobility, even several years after a stroke, through an electronic stimulation process that Zynex calls neuroplasticity. The SFDA recently granted Zynex approval for the device.
A hepatitis B vaccine produced by Shenzhen Kangtai Biological has been cleared of any responsibility for the deaths of nine children. Over the past month, a total of 17 young children have died in China following inoculation with a hepatitis B vaccine. After investigating, China regulators blamed the deaths of the first nine on causes ranging from pneumonia to suffocation. In addition, health officials said the remaining eight deaths also seem unrelated to the vaccines, though they are awaiting autopsies for confirmation.
Chugai Pharma (JP: 4519) will take its China drug marketing/distribution in-house with a $30 million investment in Taizhou's China Medical City. At present, Chugai outsources its China sales activities to local drugmakers and wholesalers. The company said the initiative comes as a result of China's growing pharma market and will provide greater flexibility. A Japanese drugmaker, Chugai is majority-owned (almost 60%) by Roche.
Government and Regulatory
China's FDA has temporarily halted importation of a Pfizer (NYSE: PFE) product, the anti-fungal treatment Diflucan (see story). The problem is late paperwork: the French facility responsible for producing Diflucan failed to file a supplementary application on time. While Pfizer said it strives to comply with all China regulations, it stressed that the paperwork problem does not affect the quality or safety of Diflucan.