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Editor´s Picks
China's Patent Flood Stifles Foreign Filer Freedom(1/17/2019 )  (Premium)
  Corporate concern is growing over freedom to operate capability in China after a surge of domestic patent applicaitons into the country's IP office, according to this Managing Intellectual Property feature article quoting eight IP lawyers from different industries.
China's Biopharmas Buffeted by Clashing Market Dynamics(1/16/2019 )  (Premium)
  This Bioworld article concludes that "the upshot is that China's biotech industry is suffering from the same push and pull experienced by other markets generally lumped in the "developed" category. Everyone wants more innovation and is willing to devote enough financial and regulatory resources to support it. At the same time, the need to tighten budgets and offer affordable drugs is high on the list of priorities.".
The Market
Chinese mAb Market to Grow 13.7% CAGR between 2017 and 2022(1/16/2019 )  (Premium)
  China's oncology drug market has grown rapidly in recent years. Revenue of the oncology drugs in China grew from CNY 83.4 billion in 2013 to CNY 139.4 billion in 2017, representing a CAGR of 13.7%, according to the "China Monoclonal Antibody Market by Targets Research Report, 2018-2025" report from ResearchAndMarkets.com.
SMEI Predicts Four China Healthcare Sector Trends in 2019(1/15/2019 )  (Premium)
  After a number of central government healthcare conferences in early January with their major tasks for the year outlined, including the National Medical Insurance Working Conference hosted by the SMIA, the Medicine Economy journal of SMEI published a feature article predicting four major trends being shaped for the Chinese healthcare sector in 2019.
Industry News
Boehringer Ingelheim Expands Biopharma Commercial Manufacturing in China(1/17/2019 )  (Premium)
  Boehringer Ingelheim announced on January 17 that it has initiated a capacity expansion at its commercial manufacturing site for biologics in China. The expansion covers an additional bioreactor and includes all needed utility and infrastructure to support the GMP operations of 2x 2.000L single use bioreactor manufacturing lines.
AstraZeneca to Promote Luye Pharma's Cholesterol TCM in Mainland China(1/16/2019 )  (Premium)
  Luye Pharma has announced it has entered an agreement with AstraZeneca China, the terms of which grant AstraZeneca China exclusive rights to promote Luye Pharma's formulated TCM Xuezhikang Capsules in mainland China.
Bio-Thera Partners with Cipla to Market Key Cancer Biosimilar(1/16/2019 )  (Premium)
  Bio-Thera Solutions Ltd announced on January 14 that it has reached a licensing agreement with Cipla for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets.
Ironwood Pharma Announces IBS Drug Linzess Approval in China(1/16/2019 )  (Premium)
  Ironwood Pharmaceuticals, Inc., a US based commercial biotechnology company, has announced that the National Medical Products Administration (NMPA) approved the marketing application for LINZESS (linaclotide) for adults with irritable bowel syndrome with constipation (IBS-C) in China.
Bayer Files IND of Loxo¡¯s Novel Anticancer Vitrakvi in China(1/15/2019 )  (Premium)
  The NMPA has accepted on January 14 the IND of Loxo Oncology's Larotrectinib Sulphate capsule, which was filed by Bayer Healthcare in China. Loxo Oncology and Bayer are engaged in a collaboration for the development and commercialization of Vitrakvi (larotrectinib). Earlier, Eli Lilly announced the acquisition of Loxo Oncology for $8.0 billion.
Celltrion Set to Enter Chinese Pharmaceutical Market(1/15/2019 )  (Premium)
  Celltrion Inc. is going to establish a joint venture company in China within this year to enter Chinese pharmaceutical markets on full-scale. Seo Jeong-jin, chairman of Celltrion Group, made this announcement at the JP Morgan Healthcare Conference held in San Francisco on Dec. 9.
Adagene Announces Collaboration for Discovery of Novel CAR-T with NIH Affiliated Lab(1/15/2019 )  (Premium)
  Adagene announced on January 7 a collaboration with Dr. Richard Childs, Chief of the Laboratory of Transplantation Immunotherapy at the National, Heart, Lung and Blood Institute, part of the NIH, to discover antibodies targeting a novel antigen expressed on the surface of tumor cells.
BeiGene Receives U.S. FDA Breakthrough Therapy Designation for Zanubrutinib in Mantle Cell Lymphoma(1/15/2019 )  (free)
  BeiGene announced on January 14 that the U.S. FDA has granted Breakthrough Therapy designation for its investigational BTK inhibitor, zanubrutinib, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
94 Listed Chinese MedPharm Companies Release 2018 Performance Guidance(1/14/2019 )  (Premium)
  By January 13, 2019, a total of 94 A share-listed pharmaceutical companies disclosed their 2018 full year performance guidance. 72 or nearly 80% of them expect to see improving or steady performance, while the rest 22 predict worse performance.
Bayer Launches Hemophilia A Drug Kovaltry in China(1/14/2019 )  (Premium)
  Bayer Healthcare launched Kovaltry, a full-length recombinant Factor VIII product, in China on January 12. Bayer told the Chinese press that it plans to price Kovaltry at a level similar to that of its earlier generation product, Kogenate FS.
Ascletis and Alphamab Reach Agreement over Anti-PD-L1 for HBV(1/14/2019 )  (Premium)
  Ascletis Pharma and Suzhou Alphamab jointly announced on January 13 that Ascletis' subsidiary and Alphamab have entered into a strategic collaboration and exclusive licensing agreement for anti-PD-L1 KN035 to treat hepatitis B and other viral diseases in Greater China.
Regulatory News
Shanghai Introduces Point System for Physician Irregularities(1/16/2019 )  (Premium)
  Resembling the point system for drivers, the new system for recording irregular practices of physicians in Shanghai assigns points between 1 and 18 to different types of irregularities. Both receiving financial and other improper interests as well as providing prescription data shall be given the maximum 18 points.
A New Scandal Involving Expired Polio Vaccine under Investigation(1/15/2019 )  (Premium)
  Chinese authorities say they have opened an investigation into reports that over 100 children received an expired polio vaccine, the latest scandal over defective medication to roil the country¡¯s embattled pharmaceutical industry.
General Health
The State Council Issues Trial Plan for Nationally-Organized Centralized Drug Purchase and Application(1/17/2019 )  (Premium)
  The State Council Issues a new policy document, Trial Plan for Nationally-Organized Centralized Drug Purchase and Application, on January 17, 2019. Enclosed is a thorough English summary of this document prepared exclusively for WiCON|Pharma China subscribers.
China to Focus Corruption Fighting on Healthcare and Education Sectors(1/17/2019 )  (Premium)
  China's anti-corruption crackdown will focus on education, healthcare, environmental protection and other major areas of concern to the public this year. The Communist Party's Central Commission for Discipline Inspection said on January 13 that this year¡¯s campaign would focus on areas related to "the people¡¯s livelihood".
China Pledges to Advance Poverty Alleviation in Healthcare(1/15/2019 )  (free)
  China will advance poverty alleviation in health care and ensure all medical institutions at county, township and village levels in impoverished areas reach set standards by 2020, according to the National Health Commission (NHC).
Product/R&D News
CMBG¡¯s AlloJoin the First Stem Cell Drug Application Approved in China for Phase II Trials(1/18/2019 )  (Premium)
  Cellular Biomedicine Group announced on January 18 that its off-the-shelf allogeneic adipose-derived mesenchymal progenitor cell AlloJoin therapy for Knee Osteoarthritis has been approved as the first stem cell KOA drug application in China for a Phase II clinical trial.
API/Bulk Drug News
Novo Nordisk Pharmatech A/S signs Asia Pacific distribution agreement with DKSH(1/16/2019 )  (Premium)
  DKSH's Business Unit Performance Materials, a leading ingredients and specialty chemicals distributor, will distribute Novo Nordisk Pharmatech¡¯s pharmaceutical grade compounds (quats) to its large customer base in Asia Pacific markets including China.
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