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Editor´s Picks
Production of Trustworthy Real World Data and Evidence in China(11/7/2018 )  (Premium)
  This BMJ Opinion article by Xin Sun, Youping Li and Gordon Guyatt call for that colleagues from the research community and stakeholders in China will work together to use these strategies, and ultimately improve the generation of real world data and subsequent evidence for better healthcare practice and policy decisions in the country.
The Market
Faster Aging of Population Boosts China's Human Vaccine Industry(11/6/2018 )  (Premium)
  With the implementation of two-child policy, the aging of population and the launch of new-type vaccines, China's human vaccine industry will grow steadily in future, with the expected market size of CNY 35.2 billion by 2022, according to a new report, China Human Vaccine Industry Report, 2018-2022, from ResearchAndMarkets.com.
Industry News
Merck KGaA Paves the Way for its Innovation Hub in Southern China(11/11/2018 )  (Premium)
  Merck KGaA, the vibrant science and technology company, signed on November 12 an agreement with the Guangzhou Development District on innovation development in Southern China. Pursuant to this agreement, Merck will establish an innovation hub in Guangzhou scheduled to open September 2019.
Performance of Chinese Pharmaceutical Industry on Steady Growth in 3Qs/2018(11/9/2018 )  (Premium)
  Revenues and profits of the broad Chinese pharmaceutical manufacturing industry were up 13.3% and 13.0% respectively in the first three quarters of 2018, reaching totals of CNY 1,948,640 million and CNY 248,360 million respectively, according to official statistics of the National Statistics Bureau (NSB).
Amyris Further Expands Relationship with Yifan Pharma(11/8/2018 )  (free)
  This new multi-million-dollar collaboration between Amyris and Yifan deepens the partnership between the two companies, with immediate revenue from developing products and expected product commercialization as early as 2021, as well as plans for additional products in the future.
Ascendis Forms Chinese JV for Endocrinology Rare Disease Therapies(11/8/2018 )  (Premium)
  Ascendis Pharma A/S announced on November 8 the formation of VISEN Pharmaceuticals, a joint venture with an investor syndicate led by Vivo Capital, to develop, manufacture and commercialize the company's endocrinology rare disease therapies in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
Leading Chinese Pharma Companies by R&D Spending in 3Qs/2018(11/8/2018 )  (Premium)
  224 A Share-listed Chinese medical/pharmaceutical companies reported their performance results for the first three quarters of 2018, according to SMEI quoting the Orient Fortune Network.The top ten such companies by R&D spending incurred an average CNY 300 million R&D investment in the period. Two of them had spent more than CNY 1 billion.
GE to Produce Single-Use Consumables in China thru Collaboration with Wego(11/7/2018 )  (free)
  GE Healthcare is to manufacture single-use consumables for bioprocessing in Weihai, China in collaboration with Wego Pharma. The collaboration will provide shorter lead times, enhanced customer support and security of supply for Chinese biomanufacturers.
Eisai Commences Full-Scale Operation of New Suzhou Plant in China(11/7/2018 )  (Premium)
  Aiming to further expand business in China, Eisai has been working to establish the new Suzhou plant which has the largest production capacity under the Eisai Group on a new industrial site more than five times larger than the former Suzhou plant.
Pfizer Makes Bold Moves to Maximize China Business under New Leadership(11/7/2018 )  (Premium)
  Perhaps the boldest move revealed by Pfizer and discussed in its Q3 analyst conference call will see the company¡¯s Established Medicines Division relocate its headquarters from the US to China and to make it fully autonomous in an effort to expand its strong position in China.
Roche Expects to Launch Five More Drugs in China in the next two years(11/7/2018 )  (Premium)
  Swiss pharmaceutical giant Roche Holding AG expects as many as five of its drugs will be approved by China in the next two years as the government accelerates the roll-out of new medicines to meet demand from a rapidly aging population.
Lilly and NextCure Announce Collaboration to Discover and Develop Novel Immuno-Oncology Medicines(11/7/2018 )  (free)
  Eli Lilly and NextCure. announced a multi-year collaboration focused on the discovery and development of immuno-oncology therapies. The collaboration seeks to discover novel cancer targets utilizing NextCure's proprietary FIND-IO platform.
Zambon Boosts Export of Fluimucil to China in Partnership with AstraZeneca(11/7/2018 )  (Premium)
  Zambon announces an investment of EUR 30 mln for the expansion of its production site in Italy to increase the production of Fluimucil to be exported to China. The investment is coupled with a collaboration agreement signed with AstraZeneca under which AZ is responsible for the import, promotion, distribution and sale of the Fluimucil portfolio in China.
EyePoint Pharma and Ocumension Sign Exclusive License for Uveitis in Greater China(11/5/2018 )  (Premium)
  EyePoint Pharma and Ocumension Therapeutics announced on November 5 an exclusive license agreement for EyePoint's three-year micro insert using the Durasert technology for chronic, non-infectious posterior segment uveitis in the greater China territory, which is comprised of China, Hong Kong, Macau and Taiwan.
Mapi Pharma Closes $10M Investment by Zhejiang Jingxin Pharma(11/5/2018 )  (Premium)
  Mapi Pharma has completed an equity investment of $10 million by Zhejiang Jingxin Pharmaceutical Co., Ltd. Jingxin is also a current shareholder of Mapi Pharma, following an initial $10 million investment in 2016.
Automation Could Help China Capture Pharma Manufacturing Lead(11/5/2018 )  (Premium)
  Automation could help China to become a world leader in the pharmaceutical industry, competing with companies from America and Europe, according to a recent article of the European Pharmaceutical Review (EPR).
Most Domestically-listed Medical/Pharma Companies Report Positive Results in Q3 of 2018(11/5/2018 )  (Premium)
  By November 1, a total of 270 listed Chinese medical/pharmaceutical companies reported their Q3 performance results. These companies reported combined total revenues of CNY 1 trillion with profits of CNY 93.1 billion and an average profitability of CNY 8.72% in the third quarter of 2018.
Regulatory News
NMPA Issues Guidelines for Clinical Trials of Mental and Bipolar Disorder Drugs(11/8/2018 )  (Premium)
  The NMPA issued two new documents, the Guidelines for Clinical Trials of Mental Disorder Drugs (2018#114) and the Guidelines for Clinical Trials of Bipolar Disorder Drugs (2018#115), on November 8.
NMPA Issues New Announcement (2018#86) for Clinical Data Self-Inspection(11/8/2018 )  (Premium)
  The NMPA issued a new announcement (NMPA Announcement 2018#86) on November 8 about onsite inspection of seven drug applications which completed clinical studies and are seeking production or import approvals. All seven applications are for from domestic players.
Shanghai Promotes Biopharma Innovation with New Measures(11/7/2018 )  (Premium)
  The Shanghai Municipal Government released 32 new measures relating to the city's drug and medical enterprises on November 7, an attempt to further bring out these enterprises' creativity and development, and to improve the city's competitiveness in the drug and medical fields to the highest international level, according to the municipal government.
CDE Issues Notice Over Change of Priority Review Publication Process(11/7/2018 )  (Premium)
  The CDE announced on November 7 that it will begin working on applications of priority review as they are submitted.As such, it will no longer publicize applications to be granted priority review status in batches like now, but rather individually as they are recommended for approval.
NMPA Releases List of Reference Formulations for Generic Drug Equivalence Studies (18th Batch)(11/6/2018 )  (Premium)
  The 18th batch of the list is composed of 15 reference drug products which are sourced from domestically produced originator drugs, imported originator drugs as well U.S. and Japanese Orange Books.
NMPA Launches New Official Website(11/5/2018 )  (Premium)
  The National Medical Products Administration (NMPA), China's drug regulatory watchdog, launched its new official website on November 5 following a reorganization of the central government agencies earlier this year. The internet address of the NMPA website is: www.nmpa.gov.cn.
General Health
China Step Up Crackdown on Medical Frauds by Charities(11/11/2018 )  (Premium)
  The Ministry of Civil Affairs will strengthen oversight of nonprofit organizations that run medical assistance programs, and warned of severe punishments for those profiting from such programs, according to a circular released by the ministry recently.
China Step Up Crackdown on Medical Frauds by harities face severe penalties(11/11/2018 )  (Premium)
  The Ministry of Civil Affairs will strengthen oversight of nonprofit organizations that run medical assistance programs, and warned of severe punishments for those profiting from such programs, according to a circular released by the ministry recently.
Legal/IPR News
Chinese Lawyer Sues Yunnan Baiyao over False Advertising(11/7/2018 )  (Premium)
  The company's current troubles surround its line of eponymous toothpastes. In late October, a lawyer from Hunan province named Liu Gao sued the company, claiming that the list of ingredients on Yunnan Baiyao teeth cleaning products is intentionally misleading.
People in the News
Recent Executive Moves(11/9/2018 )  (Premium)
  Recent Chinese pharma-related executive movements at companies including Pfizer, Lundbeck China, Roche, Biostage and ACM Global Labs.
Other News
China to Launch New Tech Bourse in Shanghai(11/7/2018 )  (Premium)
  China's President Xi Jinping has revealed plans for a new, tech-focused trading venue in Shanghai, in what appears to be a bid to keep key tech firms from going public in Hong Kong or the US.
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