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Editor´s Picks
Breaking News on New Policies of Innovative Drugs in China(4/19/2018 )  (Premium)
  This article by CCPIT Patent and Trademark Law Office concludes that "undoubtedly, the above is good news for pharmaceutical companies. But the specific rules on how to determine the duration of the data exclusivity period and patent term extension have not been available. We will keep you informed of the updates in the future."
Chinese Money Floods U.S. Biotech as Beijing Chases New Cures(4/18/2018 )  (Premium)
  This Bloomburg article by Rebecca Spralding and Emma Ockermann reports that "Chinese investors are pumping money into U.S. drug startups as Beijing seeks to become a global leader in new medicines, adding to a flood of cash flowing to groundbreaking health firms."
China Announces New Initiatives to Level the Playing Field for Innovative and Generic Drugs(4/18/2018 )  (Premium)
  This article by Katherine Wang of Ropes & Gary suggests that "while many hurdles for regulatory approval of innovator drugs have been eliminated, commercial success will require a sophisticated market access strategy that can fend off pressure from high quality generics."
U.S. Businesses Worried over Chinese Policy Initiative(4/17/2018 )  (Premium)
  This Kera News article by Jennifer Pak quotes The European Union Chamber of Commerce's 2017 report as saying: "[Made in China 2025] is in fact a large-scale import-substitution plan aimed at nationalizing key industries, or at least severely curtailing the position of foreign business in them, both as suppliers both of key components and finished products."
China Will Always Be Bad at Bioethics(4/17/2018 )  (free)
  This Financial Times article by Yangyang Cheng concludes that "it's no accident that the Chinese government is leading the world in medical advances ¡ª and in dangerous ethical lapses."
Why Immuno-Therapy Is Leaving Markets Abuzz Across the World(4/17/2018 )  (Premium)
  The achievement is being viewed as a landmark example for Beijing's ambitious ¡°Made in China 2025¡± plan, which strives to garner the acceptance of Chinese innovation globally, she added.
Goldman Sachs: China Is Beating the U.S. in the Gene Editing Arms Race(4/17/2018 )  (Premium)
  This Fortune article by SY MUKHERJEE suggests that "But China is currently winning that race, outpacing the U.S. when it comes to developing new wave CAR-T and CRISPR treatments."
Industry News
Tocagen Licenses Greater China Rights for Phase III Cancer Immunotherapy to ApolloBio(4/19/2018 )  (Premium)
  Tocagen has granted ApolloBio exclusive rights to its Phase III two-part cancer immunotherapy candidate Toca 511 (vocimagene amiretrorepvec) and Toca FC in the greater China region, in a deal that could generate up to $127 million-plus for Tocagen.
Pfenex and NT Pharma Agree over Bioequivalent Generic of Forteo(4/19/2018 )  (Premium)
  Pfenex and China NT Pharma Group announced on April 18 an agreement under which Pfenex granted NT Pharma non-exclusive development and exclusive commercialization rights to PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly & Company's Forteo, in Mainland China, Hong Kong, Singapore, Malaysia and Thailand.
WuXi AppTec Expands Site in the U.S. for Drug Development Testing Services(4/19/2018 )  (free)
  WuXi AppTec announced on April 18 the opening of its expanded Laboratory Testing Division (LTD) facility in New Jersey. The grand opening event was honored by the presence of state and local officials including State Senator Linda Greenstei.
Takeda Launches Multiple Myeloma Drug Ninlaro in China(4/18/2018 )  (Premium)
  Takeda announced on April 17 that it had launched its Multiple Myeloma drug Ninlaro (ixazomib) in China after completion of the China continuation study of a phase III trial named TOURMALINE-MM1 which investigates ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Morphotek Licenses Its Eribulin-Linker Payload To Bliss Bio(4/18/2018 )  (Premium)
  The licensing agreement grants China's Bliss Biopharmaceutical the exclusive right to use the eribulin-linker payload to develop a therapeutic ADC against an undisclosed oncology target for the China market.
Alliance Pharma Sells Chinese JV and Rights of Pregnancy Supplement for GBP 2.9M(4/17/2018 )  (Premium)
  Alliance Pharma plc (LON:APH) announced on April 17 is selling the Chinese rights of Forceval, a micro-nutrient supplement used in pregnancy, for ¡ê2.9mln. It doing so via the disposal of its 60% stake in its Chinese JV called Unigreg Ltd. to JV partner Pacific Glory Development.
China Performance of Korean Pharma Cos Mixed in 2017 with Hanmi and Il-yang Up Sharply(4/17/2018 )  (Premium)
  Beijing Hanmi Pharm, Yangzhou Yiyang, GC China, and Sichuan Daewoong Bio are the Chinese offshoots of Hanmi Pharmaceutical, Il-yang Pharmaceutical, GC Pharma, and Daewoong Pharmaceutical, respectively. Among them, Beijing Hanmi Pharm posted the largest sales of $200 mln last year.
Regulatory News
CDE Releases Two Draft Clinical Guidelines for Public Comments(4/19/2018 )  (Premium)
  The CDE has released the draft of two new guidance documents, the Clinical Research Guidelines for Recombinant Human Anticoagulant Factor VIII Products and the Clinical Research Guidelines for Recombinant Human Anticoagulant Factor IX Products. Separately, the agency released at the same time another draft guidance document, Guidelines for Grading Standards of Adverse Drug Reactions in Clinical Trials of Preventative Vaccines. Feedbacks need to be submitted before May 18.
CNDA Solicits Comments on Clinical Guidelines for Acute Heart Failure Drugs(4/19/2018 )  (Premium)
  The CNDA issued a new guidance document, Clinical Guidelines for Acute Heart Failure Drugs (2018#10), on April 19.
CNDA Outlines Five Focal Areas of Its Work in 2018(4/18/2018 )  (Premium)
  The newly established China National Drug Administration held its first meeting of officials on April 17 following inauguration earlier this year. The meeting was chaired by CNDA Commissioner JIAO Hong, while Party Secretary and CNDA Deputy Commissioner LI Li delivered a keynote speech.
GlobalData: Chinese Pharma Regulatory Reforms to Help Attract Foreign Investment(4/17/2018 )  (Premium)
  Vikas Bedi, APAC Healthcare Research Director at GlobalData, says that the increased manpower at the CFDA will strengthen the standards for generic drugs approval process, clinical trial review process and the priority review process for innovative drugs.
China to Cut Review Time for Clinical Trial Applications with Plan to Expand Reviewer Force(4/17/2018 )  (Premium)
  Speaking at Hong Kong Exchanges & Clearing Ltd.'s inaugural biotech summit, Ruyi He, chief scientist of the Center for Drug Evaluation under the CFDA (CDE), said the CFDA is aiming to cut the time it takes to review clinical trial applications to just 30 days.
General Health
China Publishes First Health Management Bluebook(4/18/2018 )  (Premium)
  According to the bluebook, the country has about 300 million chronic disease patients and people under the age of 65 accounts for 50% of the chronic disease burden. In addition, the death rates of chronic diseases in urban and rural areas are 85.3% and 79.5% respectively at present.
China to Roll Out New Measures to Boost Internet + Healthcare(4/16/2018 )  (Premium)
  China will greenlight internet healthcare services conducted by medical institutions and explore exchange of drug prescription and retail sales information as parts of a broader push to promote Internet Plus healthcare, a State Council executive meeting chaired by Premier Li Keqiang decided on April 13.
Product/R&D News
Sinovac Announces Preliminary Results of Phase III Trial on sIPV(4/19/2018 )  (Premium)
  Sinovac Biotech Ltd. (NASDAQ: SVA) announced on April 18 preliminary results of a phase III clinical study on Sabin inactivated polio vaccine ("sIPV") developed by Sinovac Biotech Co., Ltd. on the unblinding conference held on April 19, 2018.
BeiGene Presents Clinical Data on Pamiparib in Chinese Patients(4/17/2018 )  (free)
  BeiGene (NASDAQ:BGNE) announced on April 16that preliminary clinical data from an ongoing Phase 1 trial of its investigational PARP inhibitor pamiparib in Chinese patients with locally advanced or metastatic high-grade non-mucinous ovarian cancer (HGOC), including fallopian cancer, or triple-negative breast cancer (TNBC), who had disease progression following at least one line of chemotherapy were
JHL Files Clinical Trial Application for Avastin (Bevacizumab) Biosimilar(4/17/2018 )  (Premium)
  JHL Biotech announced on April 16 that the CFDA has accepted for review JHL's Clinical Trial Application for a proposed biosimilar of Roche's Avastin (bevacizumab), JHL1149, to treat cancer.
Opdivo (Nivolumab) Improves Survival in Pretreated Chinese NSCLC Patients(4/16/2018 )  (Premium)
  BMS announced on April 13 positive results from the pivotal, randomized Phase 3 CheckMate-078 trial evaluating Opdivo (nivolumab) versus docetaxel in a predominantly Chinese population with previously treated advanced non-small cell lung cancer (NSCLC).
People in the News
Recent Executive Moves(4/19/2018 )  (Premium)
  Recent Chinese pharma-related executive movements at companies including Novo Nordisk, China, Takeda China, GSK China, Novartis China, Baxter China, Quan Capital and SciClone Pharma.
Other News
China to Set Up Hainan Free Trade Zone, Further Benefiting Medical Tourism(4/16/2018 )  (Premium)
  China aims to establish a free trade zone in Hainan by 2020 and will encourage multinationals to set up their international and regional headquarters there, as part of plans to open up the province's economy to foreign investors.
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