Week In Review: James Watson To Lead New Shenzhen Biopharma Research Center

Trials and Approvals

Chugai Pharma (TYO: 4519) reported that the CFDA accepted its New Drug Application for eldecalcitol, an oral active vitamin D3 derivative for osteoporosis (see story). A Japanese pharma, Chugai is majority-owned (62%) by Roche (ROG: SIX). In a China Phase III trial, patients treated with eldecalcitol showed greater bone mineral density (BMD) compared to alfacalcidol-treated patients after 12 months. Chugai has marketed eldecalcitol in Japan since 2011.   

Avita Medical (ASX: AVH; OTCQX: AVMXY) of Melbourne has started aChina clinical trial of ReCell® to treat second-degree (deep partial-thickness) burns (see story). ReCell is a device that harvests autologous cells, combines them with a proprietary enzyme formulation, and forms a spray to accelerate healing. The procedure, which takes about 30 minutes, does not require lab culturing. Compared to a skin graft, ReCell uses less skin from a patient. The China trial is supported by China's National Health and Planning Commission. 

Company News

Cellular Biomedicine (Nasdaq: CBMG) will develop its stem cell and CAR-T projects exclusively in China, closing down its California operations (see story). The company said a combination of lower costs for clinical trials and a faster path to commercialization prompted the turn toward China. News of the change in its business plan came as CBMG reported early signs of success in a China Phase I trial of AlloJoin™, its off-the-shelf mesenchymal progenitor cell therapy for Knee Osteoarthritis (KOA). CBMG has operations in Shanghai and Cupertino, California.   

Government and Regulatory

As part of an initiative to open its economy to other countries, China plans to eliminate tariffs on some imported drugs, especially those for cancer (see story). The move is aimed partly at China's own population, which struggles to pay the high prices of imported drugs. However, the proposed changes may be more symbolic than real cost-savers. According to one source, drugmakers pay a maximum of 6% as an import tax. If the exporting country has "most-favored nation" status (the US and other western countries are favored), the tax is just 2%.   

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