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Editor´s Picks
Can Tax Breaks Boost Private Health Insurance in China?(8/15/2017 )  (Premium)
  National tax incentives have produced a surge in inquiries, but eligible policies hold little appeal for most individuals, according to this Sixth Tone article by NI Dandan.
New Research Compares Drug Regulators Around the Globe(8/15/2017 )  (Premium)
  Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of the regulators¡¯ budgets, staff, new drug approvals and timelines for approvals.
Beijing Courts Issued Consequential Judgments On Life-Science Patents(8/15/2017 )  (Premium)
  The Beijing Higher People's Court (BHPC) and Beijing Intellectual Property Court (BIPC) recently issued their judgments in a number of high-profile validity cases in the life science area. The courts' reasoning in the judgments, unless negated in future appeal or retrial proceedings, will have general consequence beyond the specific cases.
The Market
Chinese Human Vaccine Market To Rise Quickly Before 2021(8/14/2017 )  (Premium)
  Pushed by the two-child policy, population aging, and launching of new vaccines, the vaccine industry in China will grow rapidly with an estimated market size of up to CNY 31.2 billion in 2021, according to a new report from Research and Markets, China Human Vaccine Industry Report, 2017-2021.
Industry News
CFDA Approves BMS's Baraclude as First Pediatric HBV Drug in China(8/18/2017 )  (Premium)
  Bristol-Myers Squibb announced on August 16 that the CFDA has expanded approval of BARACLUDE (entecavir tablet) to treatment of chronic hepatitis B virus (HBV) infected and nucleoside-inhibitor-treatment-naive patients with compensated liver disease who are aged between two and 18 years.
Ascletis In-licenses Medivir's Novel HCV Drug Candidate(8/18/2017 )  (Premium)
  Medivir AB and Ascletis announced on August 18 that Ascletis has licensed the exclusive rights to develop, manufacture and commercialize Medivir's nucleotide polymerase inhibitor for hepatitis C, MIV-802 (Ascletis code: ASC21), in Greater China.
50 Domestically-listed Chinese Pharma Companies Report H1 Performance(8/18/2017 )  (Premium)
  By August 17, 50 domestically-listed Chinese pharmaceutical companies had released their performance guidance for the first half of 2017, according to pharma industry social medial Saibailan. 18 of the 50 companies reported revenues above CNY 1 billion.
WuXi Biologics and Gloria Pharma Outlicense PD-1 Antibody to Arcus Biosciences(8/17/2017 )  (Premium)
  Gloria contracted WuXi Biologics to discover and develop GLS-010, a novel anti-PD-1 antibody, using Ligand's transgenic rat platform OmniRat. GLS-010 is currently being evaluated in cancer patients in phase I clinical studies in China. Arcus has licensed the exclusive development and commercialization rights of GLS-010 in North America, Europe, Japan and certain other territories.
GSK, AliHealth Join Hands to Build Vaccine Promotion Channel with Initial Focus on Cervarix(8/17/2017 )  (Premium)
  Most recently on August 15, GSK and AliHealth jointly announced a cooperative project, Ruizhi ¨C Adult Vaccine Service Project, which will provide relevant consultations, education and offline vaccination appointments focusing on Cervarix at the present stage, but does not involve in sales of any vaccines.
Prometic Seals Joint Venture and Licensing Deal with Chinese Partner(8/16/2017 )  (Premium)
  Quebec-based Prometic Life Sciences Inc. has reached a deal with Shenzhen Royal Asset Management (SRAM), licensing rights to three of its fibrosis drugs to a new joint venture set up together with SRAM.
Zai Lab Files for NASDAQ IPO(8/16/2017 )  (Premium)
  Zai Lab has filed an F-1 form with the U.S. SEC regarding its IPO. No pricing details were given in the filing, but the offering is valued up to $115 million. The company intends to list its American depositary shares on the Nasdaq under the symbol ZLAB.
Antengene Raises $21M in Series A Financing Led by Qiming Ventures(8/15/2017 )  (free)
  Antengene Corporation, a Chinese clinical-stage biopharmaceutical company, has raised US$21 million in a series A financing round led by Qiming Venture Partners. Chinese investment firms TF Capital and HG Capital, as well as Tigermed Investment, also participated in the deal.
HitGen, Aduro Form New Drug Discovery Partnership(8/15/2017 )  (Premium)
  HitGen will use its DNA-encoded library (DEL) design, synthesis and screening to discover novel small-molecule leads and license them out exclusively to Aduro for an undisclosed amount.
Regulatory News
CFDI to Initiate Clinical Data Inspection of 32 Drug Products (#13)(8/18/2017 )  (Premium)
  The Center for Food and Drug Inspection (CFDI) under the CFDA announced on August 18 its latest plan (#13) for onsite clinical data inspection of 31 drug applications following the publication period, which lasts ten working days from the date of announcement between August 18 and 31, 2017.
CFDA Issues Announcement to Clarify Over Published Reference Drugs for BE Studies(8/18/2017 )  (Premium)
  The CFDA has so far published eight batches of reference formulations for generic drug quality and efficacy studies.On August 18, the agency released an announcement to make a number of clarifications over the published reference drugs.
NDRC Solicits Comments on Pricing Guideline for Shortage Drug and API Businesses(8/15/2017 )  (Premium)
  The NDRC issued a draft document, Guidelines for Pricing Behaviors of Shortage Drug and API Businesses, on August 14. The agency is now seeking public comments on the draft document before September 13, 2017.
CFDA Issues National Drug Abuse Monitoring Annual Report (2016)(8/14/2017 )  (Premium)
  China Food and Drug Administration issued the National Drug Abuse Monitoring Annual Report (2016) on August 14.China Food and Drug Administration issued the National Drug Abuse Monitoring Annual Report (2016) on August 14.
General Health
Smoking-unrelated Lung Cancer Jumps in China(8/16/2017 )  (Premium)
  Air pollution is a serious issue in China, especially in cities such as Beijing. China recorded nearly 4.3 million new cancer patients in 2015. More than 730,000 of them had lung cancer, accounting for nearly 36 per cent of the world's total.
Legal/IPR News
China Sets Up New IP Rights Center for Manufacturing and Biopharma Industries(8/17/2017 )  (free)
  China has launched an Intellectual Property Rights Protection Center to provide fast and coordinated protection of rights for the manufacturing and biopharmaceutical industries.
China Issues Interpretations for Application of Criminal Laws for Faking Drug and Medical Device Registration Data(8/15/2017 )  (Premium)
  The Supreme People's Court and the Supreme People's Procuratorate issued a new document, Interpretations of the Supreme People's Court and the Supreme People's Procuratorate for Application of Criminal Laws over Cases Relating to Faking Drug and Medical Device Registration Data, with effect from September 1, 2017.
USTR Promises Thorough Investigation of China's IP Practices(8/14/2017 )  (Premium)
  U.S. Trade Representative Robert Lighthizer on August 14 promised a "thorough investigation" of China's actions relating to copyright and intellectual property following a directive from President Trump to investigate piracy by the Asian nation.
People in the News
Recent Executive Moves(8/17/2017 )  (Premium)
  Recent Chinese pharma-related executive moves at companies including Eli Lilly, Shire and Phoebus Medical.
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