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Industry News
CFDA Approves Expanded Indication of Eisai's Aricept to Severe AD(12/14/2017 )  (Premium)
  Eisai Co., Ltd. announced on December 13 that Aricept (donepezil hydrochloride) has been approved for the additional indication of severe Alzheimer's disease (AD) in China. Aricept is the first AD treatment with a broad indication that covers mild to severe AD in China.
Ipsen, Zhejiang MedTech Enter Strategic Alliance for Tanakan in China(12/14/2017 )  (Premium)
  Beaufour Ipsen has recently reached an agreement with Zhejiang Medical Science Technology. Under the deal, Ipsen grants the exclusive rights to sell its Tanakan (Gingko biloba extract tablets and oral liquids) in China to Zhejiang MedTech as of December 1.
Shanghai Establishes Regional Ethics Committee for Clinical Research(12/13/2017 )  (Premium)
  The committee was jointly established by the SHFPC and Shanghai¡¯s Xuhui District Government as an affiliate of Shanghai Pharmaceutical Clinical Research Center.
Bayer Announces CFDA Approval of Stivarga as Second Line Treatment for HCC(12/13/2017 )  (Premium)
  Bayer announced on December 12 that the CFDA has approved its Stivarga (regorafenib) for marketing in China for patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib.
Galderma to Spin Off Drug Business in China(12/13/2017 )  (Premium)
  According to Chinese press reports, Galderma, a dermatology company and joint venture of Nestle and L'Oreal, is going to spin off its prescription and non-prescription drug businesses in China as a part of its reorganization to focus more on non-drug strategic brands.
Boai NKY Pharma to Buy BioVision for $290M(12/11/2017 )  (Premium)
  Boai NKY Pharma, a Chinese public pharmchem manufacturing firm known as NKY, is planning to buy San Francisco Bay Area-based biotech firm BioVision for up to $290 mln, with the aim of focusing on precision medicine, the Shanghai Securities Journal reported.
BGI Genomics to Set Up JV with TCM Player Kangmei Pharma(12/11/2017 )  (free)
  BGI Genomics has expanded into a new business: helping to standardize and modernize traditional Chinese medicine. BGI has agreed to set up a joint venture with Kangmei Pharmaceutical Co. Ltd., a TCM developer that cultivates several herb plantations in China.
Ardelyx Announces License Agreement with Fosun for IBS Drug Candidate Tenapanor in China(12/11/2017 )  (Premium)
  Ardelyx, Inc. (NASDAQ: ARDX) announced on December 11 a license agreement with Shanghai Fosun Pharma for the exclusive rights to develop and commercialize Ardelyx's lead product, tenapanor, in China for the treatment of patients with irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia related to chronic kidney disease.
Bayer's Pharma Chief Praises China for Progress in New Drug Clinical Research and Development(12/11/2017 )  (Premium)
  China's emphasis on innovation in recent years has led to more opportunities for global clinical development and research programs to be carried out in the country, which has benefitted its people, according to China Daily quoting Dieter Weinand, president of Bayer AG's pharmaceuticals division.
Regulatory News
CFDA Solicits Comments on Two Clinical Guidelines for Special Medical Purpose Formula Foods for IBD and Diabetes(12/13/2017 )  (Premium)
  The CFDA released two draft documents, the Clinical Study Guidelines for Special Medical Purpose Formula Foods for Inflammatory Bowel Disease (IBD) and the Clinical Study Guidelines for Special Medical Purpose Formula Foods for Diabetes.feedbacks shall be returned before December 31, 2017.
CFDI to Initiate Clinical Data Inspection of Five Drug Products (#16)(12/12/2017 )  (Premium)
  The Center for Food and Drug Inspection (CFDI) under the CFDA announced on December 12 its latest plan (#16) for onsite clinical data inspection of five drug applications following the publication period, which lasts ten working days from the date of announcement between December 11 to 22, 2017.
General Health
Fujian Introduces New Policy to Differentiate Drug Products into Three Categories(12/15/2017 )  (Premium)
  It is provided that a dynamic and open hospital drug purchase platform shall be established with enhanced product screening methods and uniformed drug list coding, under which drug products will be grouped into three categories, namely therapeutic, supplemental and nutritious products. BMI reimbursement policies will be differentiated for products of different categories.
Product/R&D News
CFDA Accepts Innovent Biologics' NDA for PD-1 Candidate IBI308(12/14/2017 )  (Premium)
  The CFDA has reportedly accepted the new drug application (NDA, CXSS1700038) of Innovent Biologics for its anti-PD-1 mAb IBI308 (brand name: Xin Di) for the treatment of Hodgkin lymphoma.
CFDA Approves Genscript's Clinical Trial Application for CAR-T Blood Cancer Therapy(12/11/2017 )  (Premium)
  Genscript Biotech, one of the world¡¯s largest providers of gene synthesis services primarily to university researchers and pharmaceutical firms, said the CFDA had accepted its clinical trial application for its CAR-T blood cancer treatment.
People in the News
Recent Executive Moves(12/15/2017 )  (Premium)
  Recent Chinese pharma-related executive movements at companies including Eli Lilly China, Bayer China, Bayhelix, SinoPharm, Shanghai Fosun Pharma and Wuxi PharmaTech.
Other News
Upcoming Event: 8th Annual Generic International Asia Summit 2018(12/12/2017 )  (free)
  8th Annual Generic International Asia Summit 2018 will be held on April 19-20, 2018 at New Century International Hotel, Shanghai China.
Upcoming Event: Wellness China 2018(12/11/2017 )  (free)
  Wellness China 2018 will be held on June 27-29, 2018 at Poly World Trade Exhibition Centre, Guangzhou, China.
Upcoming Event: Asia Clinical Trials Innovation Summit 2018(12/11/2017 )  (free)
  Asia Clinical Trials Innovation Summit 2018 will be held on April 25 ¨C 26, 2018 at Wyndham Bund East Shanghai, China.
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