WEEKLY e-ALERT  [ PREMIUM EDITION ]
Pharma China (www.pharmachinaonline.com) is the most influential English media and source of business intelligence covering the Chinese pharmaceutical sector. Pharma China caters for the growing needs of the international pharmaceutical industry for up-to-date and insightful information and intelligence on China’s burgeoning but increasingly complex healthcare marketplace, and is subscribed by most MNC pharma companies, leading CROs, investment banks, consulting firms active in China as well as relevant industry associations and government agencies.

Note: To view full text of free articles, you need to register as a basic member first and then log in. To view premium articles, you need to subscribe to Pharma China as a premium member. For more information or subscription, please contact info@pharmachinaonline.com. If you wish to unsubscribe from this e-Alert, please reply this e-mail with "Remove" in the subject line.
Editor´s Picks
Pharmaceutical Innovation in the APAC Region(11/13/2019 )  (Premium)
  This PMLive article concludes that "the APAC region is a rich source of innovation, but in most countries/regions - Japan being the exception - this is not translating into a strong global footprint."
As Trade War Continues, Pharma Companies Prepare for Alternatives(11/13/2019 )  (Premium)
  This Supply Chain Brain article by Bill Connell concludes that "While that hasn*t happened yet, the government, military and pharmaceutical industry have all acknowledged the extreme risk involved. Pharma must prepare."
A Summary of The Latest Amendments to the Guidelines for Patent Examination In China(11/12/2019 )  (Premium)
  This Mondaq article by Jason Yang and Jian Xu of Gowling WLG provides a summary of the latest key changes to China's Guidelines for Patent Examination and impacts of these revisions.
Industry News
Outlook on Chinese Pharma Distribution Market 2019-2025(11/14/2019 )  (Premium)
  In 2018, the Chinese pharma distribution market was worth CNY 2,194.5 bln, up 9.6% from CNY 2,001.6 bln in 2017, according to the "China Pharmaceutical Distribution Industry Report, 2019-2025" report from ResearchAndMarkets.com.
Thermo Fisher opens Customer Solution Center in China(11/13/2019 )  (Premium)
  Thermo Fisher Scientific has officially opened a Customer Solution Center in Shanghai to support pharma and biopharma laboratories. This follows the recent announcements of a Biosciences Customer Exploration Center in Shanghai and the expansion of the company's clinical trials logistics facility in Suzhou.
CDE Solicits Comments on the Working Procedures for Risk Control, Suspension & Termination in Drug Clinical Trials(11/13/2019 )  (Premium)
  The Center for Drug Evaluation under the NMPA (CDE) issued the draft of a new document, the Working Procedures for General Risk Control, Ordered Suspension and Termination in Drug Clinical Trials, on November 13.
LEO Pharma, HitGen to Develop Novel Class of Derma Drugs(11/13/2019 )  (Premium)
  Denmark headquartered LEO Pharma A/S and China based HitGen announced that HitGen and LEO Pharma expands their collaboration with a license to develop a novel class of drugs for a dermatology indication.
Qpex Biopharma, Brii Biosciences Ink Anti-infective Alliance for China(11/13/2019 )  (Premium)
  Qpex Biopharma, Inc., a biopharmaceutical company dedicated to anti-infective therapies, has entered into a multi-product collaboration in China with Brii Biosciences to develop and commercialize Qpex's portfolio of potentially best-in-class therapies to treat a range of multi-drug resistant gram-negative infections.
GSK Announces Chinese Approval of Triple COPD Therapy Trelegy Ellipta(11/12/2019 )  (Premium)
  GSK announced on November 11 the NMPA approval of its once-daily triple COPD Therapy Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol, 100/62.5/25 米g), which is used long term to treat COPD, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.
GE Healthcare and Akeso Expedite Antibody Manufacturing in China(11/12/2019 )  (free)
  GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate the production of antibody drugs in the Guangzhou region and is expected to be operational by end of 2020 creating up to 150 jobs upon opening.
Novaliq, Hengrui Enter China licensing Deal for EyeSol-based NOV03 and CyclASol(11/11/2019 )  (Premium)
  Novaliq GmbH and Jiangsu Hengrui Medicine announced the closing of an exclusive license agreement to develop, manufacture and commercialize the innovative, water-free drugs NOV03 and CyclASol for the treatment of dry eye disease in the Greater China region.
Regulatory News
China to Launch Nationwide Vaccine Tracking System Next Year(11/14/2019 )  (Premium)
  The system will cover information on the entire supply chain of products of all domestic vaccine manufacturers and vaccination information from health departments, said Yan Jiangying, Deputy Commissioner of the NMPA.
NMPA Announces Implementation of 15 Series E and 13 Series S ICH Guidelines in China(11/12/2019 )  (Premium)
  The NMPA released two announcements (2019 #88 and #89) on November 12 for implementation of the following ICH E and S series guidelines with different effective dates.
CDE Extends Deadline for Public Comments on Nine Draft Documents(11/11/2019 )  (Premium)
  The CDE announced on November 11 that it has extended the deadline for public comments on nine new draft documents, which were released on November 8, from November 13 to November 22.
CDE Solicits Comments on the Technical Guidelines for Clinical Research Changes of Approved Drugs(11/11/2019 )  (Premium)
  The CDE has drafted a new document, the Technical Guidelines for Clinical Research Changes of Approved Drugs, on November 8. It is now soliciting public comments on the draft document before November 22, 2019 via the following email.
General Health
China Issues the Provisions for Health Insurance Administration(11/13/2019 )  (Premium)
  The China Bank and Insurance Regulatory Commission (CBIRC) issued the newly amended Provisions for Health Insurance Administration on November 12. In this amended regulation, (commercial) health insurance is declared as an important component of China's multi-layered medical insurance system.
NHSA Initiates A New Round of Negotiation for the NRDL Access(11/11/2019 )  (Premium)
  The NHSA will initiate a new round of access negotiation for the NRDL, according to the PhIRDA. Earlier reports show that the NHSA has proposed a total of 128 drug products, including 109 Western medicines and 19 formulated TCMs for this round of negotiation.
Product/R&D News
Hua Medicine's Pivotal Phase III Monotherapy Trial of Dorzagliatin(11/13/2019 )  (Premium)
  Hua Medicine announced on December 12 the 24-week top-line results from HMM0301, the first Phase III trial of a novel first-in-class dual-acting glucokinase (GK) activator, dorzagliatin, which was designed to restore glucose homeostasis in adults with type 2 diabetes.
Chi-Med Announces NDA Acceptance for Novel Drug Surufatinib(11/11/2019 )  (Premium)
  Chi-Med announced on November 11 that its New Drug Application for surufatinib had been accepted for review by the NMPA. Surufatinib, a novel angio-immuno kinase inhibitor, is used for treatment of patients with advanced non-pancreatic neuroendocrine tumors.
Akesobio Presents P1 Data from First-in-class Bispecific Drug Candidate AK104(11/11/2019 )  (Premium)
  Akeso Biopharma presented results of phase 1 study of its first-in-class bispecific drug candidate AK104, in patients with advanced solid tumors in 2019 Society for Immunotherapy of Cancer (SITC). AK104 is a novel, tetrameric bispecific antibody targeting both PD-1 and CTLA-4.
Other News
Upcoming Event: Asia Wellness Expo 2020(11/13/2019 )  (free)
  Asia Wellness Expo 2020 will be held on July 16 每 18, 2020 at China Import & Export Fair Complex, Guangzhou, China.
Upcoming Event: NanoPharma 2020(11/13/2019 )  (free)
  NanoPharma 2020 will be held on May 4 每 5, 2020 in Amsterdam, Netherlands.
Upcoming Event: IDF Congress 2019(11/13/2019 )  (free)
  IDF Congress 2019 will be held on December 2 每 6, 2019 at BEXCO, Busan, Republic of Korea.
Upcoming Event: Phar-East 2020(11/13/2019 )  (free)
  Phar-East 2020 will be held on March 31 每 April 1, 2020 at Resorts World Convention Centre, Singapore.
Upcoming Event: 2019 Pharma CI+MR Asia Conference & Exhibition(11/12/2019 )  (free)
  2019 Pharma CI+MR Asia Conference & Exhibition will be held on December 5 每 6, 2019 at Hilton, Singapore.
© Wicon International Group﹛Support by: www.heightow.com Home | Site map | Contact Us | Links