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Editor´s Picks
Update on Antitrust Legislative Development in China(11/15/2017 )  (Premium)
  This Lexology article by legal experts of Mayer Brown LLP highlights a number of anticipated changes to the key antitrust legislative instruments and rules that are expected to come in the near future.
Competition Impact Review to Be Required for All New Chinese Regulations(11/15/2017 )  (Premium)
  This Lexology article by legal experts of Wilmer Cutler Pickering Hale and Dorr LLP concludes that "the Rules promise benefits for foreign companies which are often hampered by sub-central government requirements to establish local subsidiaries or discriminated against in their efforts to do so".
Ongoing Healthcare Reform in China(11/14/2017 )  (Premium)
  This Lexology article by legal experts of Bird & Bird provides a round-up review and update of the recent Chinese drug regulatory system reform.
U.S. Employs Rarely Used Tool to Probe China IP Practices(11/14/2017 )  (Premium)
  This Lexology article by legal experts of Pillsbury Winthrop Shaw Pittman LLP provides a summary update of the issues raised in the ongoing USTR investigation of China's technology transfer/intellectual property practices and next steps.
The Market
McKinsey: Chinese Healthcare Market to Reach $1 Trillion by 2020(11/13/2017 )  (Premium)
  China's healthcare market is projected to grow at a whopping CAGR of about 12% from $357 billion in 2011 to USD 1 trillion by 2020, driven by the country¡¯s favorable demographic trends, continued urbanization, growing disease burden, economic expansion, and rising income levels providing access to treatments.
Industry News
Listed Chinese Pharma Cos Remains Major Advertisers in H1/2017(11/19/2017 )  (Premium)
  Among the 61 listed Chinese companies with over CNY 100 million advertising expenditures in the first half of 2017, 18 are pharmaceutical companies, according to Chinese pharma industry digital media Saibailan.
Domestically-listed Companies Maintains Growth in First 3Qs of 2017(11/19/2017 )  (Premium)
  By November 2, 253 domestically A-share listed companies in the broad pharmaceutical industry have released their performance results in the first three quarters of 2017, according to Chinese pharmaceutical digital media Saibailan.
Shanghai Pharma Eyes Acquisitions in the U.S. and Europe Following Cardinal Deal(11/16/2017 )  (Premium)
  Shanghai Pharma is interested in deals in the U.S. and some European countries including Germany and Switzerland,which are related to specialty drugs, including treatments for cancer and cardiovascular conditions, as well as branded generics, Liu said.
Is Alliance Boots Pulling Out of Chinese JV Guangzhou Pharma(11/15/2017 )  (Premium)
  Guangzhou Baiyunshan Pharmaceutical Group announced a plan to purchase an unspecified stake of Guangzhou Pharmaceutical Co. Ltd., its drug distribution joint venture with Alliance BMP, giving rise to speculations that Alliance Boots might be exiting China after Cardinal Health.
Reckitt Benckiser, Alibaba Join Hands to Market Quality Health Products to China(11/14/2017 )  (free)
  The cooperation aims to build a big health strategy in China by bringing more quality and innovative products to China¡¯s consumers. RB plans to use Alibaba¡¯s big data to gain deep insight into health consumption trends in China and introduce newer, safer and more innovative products.
Shanghai Pharma Buys Cardinal Health's China Business for $1.2B(11/14/2017 )  (Premium)
  The transaction is expected to close by the end of Cardinal Health's fiscal year, subject to closing conditions and regulatory clearances. The deal includes Cardinal Health's pharmaceutical and medical products distribution business in China.
XiAn Janssen Launches IMBRUVICA (ibrutinib) in China(11/13/2017 )  (Premium)
  XiAn Janssen announced on November 12 the launch in the country of IMBRUVICA (ibrutinib), a BTK inhibitor for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or Mantle Cell Lymphoma who have received at least one prior therapy.
Pfizer Divests from Chinese JV with Hisun(11/13/2017 )  (Premium)
  Pfizer will exit from Hisun-Pfizer Pharmaceuticals, its Chinese joint venture (JV) for generic drugs, by divesting 49% stake to Sapphire I (HK) Holdings for an undisclosed price.
Regulatory News
CFDA Solicits Comments on Draft Amendment to the Rules for CFDA Legislation Procedures(11/17/2017 )  (Premium)
  The China Food and Drug Administration released a draft amendment to the Rules for CFDA Legislation Procedures on November 17 and is now seeking public comments which must be received before December 18, 2017.
CFDA Solicits Public Comments on Provisions for Regulation of Internet Drug Business(11/14/2017 )  (Premium)
  The CFDA released a draft of the Provisions for Regulation of Internet Drug Business on November 14 and is now seeking public comments which must be faxed or emailed to the Drug and Cosmetic Registration Department of CFDA before November 30, 2017.
CFDA Issues New Announcement to Adjust Drug Registration Acceptance Rules(11/13/2017 )  (Premium)
  The CFDA issued a new announcement (CFDA Announcement 2017#134) on November 13 to adjust drug registration acceptance process and rules. As of December 1, all drug registration applications previously accepted by the provincial level food and drug departments for review and approvals by the CFDA will be accepted by the CFDA centrally in future.
CDE Seeks Comments on First List of Essential Drugs Eligible for BE Exemption and Simplified BE Studies(11/13/2017 )  (Premium)
  The CDE released a draft document which includes the first proposed list of 44 essential (generic) drugs which are eligible for exemption from human bioequivalence studies and 13 such drugs which are eligible for simplified bioequivalence studies.
General Health
CIRC Releases Draft Amendment of Health Insurance Regulation(11/16/2017 )  (Premium)
  The China Insurance Regulatory Commission (CIRC) released on November 15 a draft amendment of the Provisions for Health Insurance for public comments. This is the first time the Chinese government proposes to amend the regulation after its initial version was issued in 2006.
Fujian-led Inter-provincial Drug Purchase Alliance Imminent(11/15/2017 )  (Premium)
  A document of the Healthcare Reform Office of Fujian government, which seeks comments for a plan of joint centralized drug purchase alliance from the governments of Fujian, Jiangsu, Zhejiang and Anhui provinces plus Shanghai, was recently leaked to the Chinese press. The comment seeking deadline is November 20.
The National Cancer Center Joins Hands with WHO on the Fight against Cancer(11/13/2017 )  (Premium)
  The National Cancer Center under the NHFPC revealed that the accord was reached with WHO's International Agency for Research on Cancer (IARC) at the International Conference for Cancer Prevention and Control in Beijing on November 2.
Legal/IPR News
China Issues New Measure to Ensure Fair Competition(11/15/2017 )  (Premium)
  A document jointly issued by the National Development and Reform Commission , Ministry of Finance, Ministry of Commerce and State Administration for Industry and Commerce said that local authorities cannot issue regulations that treat companies unequally or limit market access.
Product/R&D News
Ascentage Announces U.S. FDA Acceptance of Its IND for Novel IAP Inhibitor APG-1387(11/15/2017 )  (free)
  Ascentage Pharma announced on November 15 that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for APG-1387, a novel small molecule IAP inhibitor for the treatment of advanced solid tumors and hematologic malignancies.
RiboQuark Enrolls First Patient in China for a Global Pivotal Trial for siRNA Drug(11/13/2017 )  (Premium)
  Kunshan RiboQuark Pharma, a Chinese-foreign JV, announced on November 14 the enrollment of the first patient in China in QRK207, a global pivotal Phase II/III study of the ocular neuroprotectant QPI-1007.
People in the News
Recent Official and Executive Moves(11/16/2017 )  (Premium)
  Recent Chinese pharma related official and executive movements at government agencies and companies including CFDA/CDE, Cardinal Health, Median Tech, CRC Oncology and McCann Health Greater China.
Guo Guangchang to Resign Executive Posts at All Fosun Subsidiaries(11/13/2017 )  (Premium)
  Guo Guangchang, the billionaire known as "China's Warren Buffett" who is also chairman of the HK-listed Fosun International, is to quit all his executive posts at group companies to "make room for young people", he told a conference call with investors on November 13.
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