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Industry News
Merck's MilliporeSigma Opens its Largest M Lab Collaboration Center in Shanghai(7/9/2020 )  (Premium)
  Merck KGaA's MilliporeSigma opened on July 10 its M Lab Collaboration Center in Shanghai. The new M Lab Collaboration Center in Shanghai includes an integrated lab with customizable solutions, validation services, training and hands-on applications to help advance drug development.
Roche Launches Collaborative Program in China for Digestive Tract Immunotherapies(7/9/2020 )  (Premium)
  Roche China announced on July 6 that it has launched in China a collaborative program for combination immunotherapies for digestive track tumors, which invites Chinese partnerships in the therapeutic area.
Clover Biopharma Receives $66M from CEPI for COVID-19 Vaccine Candidate(7/9/2020 )  (free)
  Chinese drugmaker Clover Biopharmaceuticals received a $66 million investment from the Coalition for Epidemic Preparedness Innovations (CEPI) to support clinical development and manufacturing of its COVID-19 vaccine candidate.
Turning Point and Zai Lab Announce Exclusive License Deal for Repotrectinib in Greater China(7/7/2020 )  (Premium)
  Turning Point Therapeutics and Zai Lab announced on July 8 an exclusive license agreement for the development and commercialization of Turning Point's lead drug candidate, repotrectinib, in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
SinoPharm Completes New Vaccine Plant in Wuhan, Doubling Capacity(7/7/2020 )  (free)
  Sinopharm has completed construction of a plant in Wuhan for mass production of a coronavirus vaccine candidate now under development, doubling its capacity to more than 200 million doses a year.
Regulatory News
CDE Launches Updated Drug Clinical Trial Registration and Information Publication System(7/10/2020 )  (Premium)
  The CDE announced on July 10 the launch of an updated version of the Drug Clinical Trial Registration and Information Publication System on its website.
CDE Launches Online Application Systems for Breakthrough Medicines and Priority Review(7/10/2020 )  (Premium)
  The CDE announced on July 10 the launch of two new online application systems under the Applicant Window on the CDE website, the Breakthrough Medicine Process Application System and the new edition of the Priority Review and Approval Application System.
CDE Issues the Guidelines for Format/Style and Collation of Drug Administration Application Dossiers(7/9/2020 )  (Premium)
  The CDE issued on July 9 an announcement (2020#12) to introduce the Guidelines for Format/Style and Collation of Drug Administration Application Dossiers.
NMPA Issues the Working Procedure for Priority Review and Approval of Drug Marketing Authorizations (Interim)(7/8/2020 )  (Premium)
  The NMPA published an announcement (2020#82) to issue the Working Procedure for Priority Review and Approval of Drug Marketing Authorizations (Interim) on July 8. A thorough summary, which is prepared by WiCON|Pharma China exclusively for our subscribers, is enclosed.
NMPA Issues Working Procedures for Drug Marketing Evaluation and Approval with Attached Conditions (Interim)(7/8/2020 )  (Premium)
  The NMPA published an announcement (2020#82) to issue the Working Procedure for Drug Marketing Evaluation and Approval with Attached Conditions (Interim) on July 8. Thorough summary prepared by WiCON|Pharma China exclusively for our subscribers included.
NMPA Issues Working Procedures for Evaluation and Approval of Breakthrough Medicines (Interim)(7/8/2020 )  (Premium)
  The NMPA published an announcement (2020#82) to issue the Working Procedure for Evaluation and Approval of Breakthrough Medicines (Interim) on July 8. Thorough summary prepared by WiCON|Pharma China exclusively for our subscribers included.
CDE Solicits Comments on the Draft Writing Guide and Common Format of Drug Production Processes, Quality Specifications and Package Inserts(7/6/2020 )  (Premium)
  The CDE released the draft Preparation Guide and Common Format of Drug Production Processes, Quality Specifications and Package Inserts, on July 6. It is now soliciting public comments on the draft document within two weeks from the date of release
CDE Solicits Comments on the Draft Technical Guidelines for Marketing Registration of Non-prescription Chemical Drugs(7/6/2020 )  (Premium)
  The CDE released the draft Technical Guidelines for Marketing Registration of Non-prescription Chemical Drugs, which was developed following internal discussions and comment seeking among experts and OTC drug companies, on July 6. It is now soliciting public comments on the draft document within one month from the date of release.
CDE Solicits Comments on the Draft Technical Guidelines for Clinical Testing of Immune Cell Therapy Products(7/6/2020 )  (Premium)
  The CDE released the draft Technical Guidelines for Clinical Testing of Immune Cell Therapy Products on July 6. The CDE is now soliciting public comments on the draft document within one month of release via email.
General Health
State Council Issues Guidance Opinions on Advancing BMI Fund Regulatory System Reform(7/10/2020 )  (Premium)
  The General Office of State Council issued a new document, Guidance Opinions on Advancing BMI Fund Regulatory System Reform, on July 10. The goal is to preliminarily establish the BMI fund regulatory and enforcement systems by 2025.
Swiss Re: Chinese Online Health Insurance Market to Grow 43% Annually Until 2025(7/8/2020 )  (Premium)
  COVID-19 has been found to accelerate the trend of consumers in China purchasing insurance online, particularly for the health sector. This creates a growing opportunity for insurers, according to Swiss Re Institute in its latest sigma report.
Legal/IPR News
NPC Solicits Comments on 2nd Draft of the Chinese Patent Law Amendment (with Summary of Pharma Patent Restoration & Linkage Provision)(7/6/2020 )  (Premium)
  The 20th Meeting of the 13th People¡¯s National Congress of China (NPC) recently reviewed the second draft of the Amendments of the Patent Law of PRC and released the document at the NPC website for public comments before August 16, 2020. The NPC stated that pharma-related IP issues were drafted to implement "trade agreement(s)".
Product/R&D News
Evive Biotech Meets Endpoints in Global PIII Trial for Novel Chemotherapy-induced Neutropenia Drug(7/9/2020 )  (Premium)
  Shanghai-based Evive Biotech announced on July 10 that its pivotal Phase III study (NCT03252431) for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia in breast cancer patients has met its primary and secondary endpoints, demonstrating strong and lasting benefit.
Asieris Received Chinese Approval to Start a Global Phase III Trial of APL-1702 for Cervical Precancerous Lesions(7/9/2020 )  (Premium)
  Asieris Pharma received Clinical Trial Approval from NMPA for the global,multi-centered Phase III clinical trial of its photodynamic drug-device combination product, APL-1702 (Cevira) for the non-surgical treatment of high-grade cervical dysplasia.
Chinese Alzheimer¡¯s Drug Rebuked Again by Top Local Neurologist(7/9/2020 )  (Premium)
  One of China's top neuroscientists has again raised doubts over China¡¯s highly touted self-developed Alzheimer's drug, which was granted conditional approval to be sold on the domestic market last year.
GSK Files New Drug Application for IL-5 mAb Nucala (Mepolizumab) in China(7/8/2020 )  (Premium)
  The CDE accepted the Chinese NDA for import of GSK's Nucala (mepolizumab injection), according to its publicized website records. The relevant acceptance number is JXSS2000021.
Sinovac Begins Phase III Trial of Its Coronavirus Vaccine in Brazil(7/8/2020 )  (Premium)
  Sinovac Biotech said on July 6 it is starting Phase III trials of its potential coronavirus vaccine in Brazil, becoming among three companies to transfer to the late stages at the race to develop an inoculation against the disorder.
Ascentage and MSD in Clinical Trial Partnership to Evaluate APG-115 in Combo With KEYTRUDA in Advanced Solid Tumors(7/6/2020 )  (Premium)
  Ascentage Pharma announced a clinical collaboration with MSD to evaluate the combination of APG-115, Ascentage's MDM2-p53 inhibitor, and KEYTRUDA (pembrolizumab), MSD's anti-PD-1 therapy, for the treatment of patients with advanced solid tumors.
People in the News
Recent Executive Moves(7/10/2020 )  (Premium)
  Recent Chinese pharma-related executive movements at companies including Biogen China, GE Healthcare China, Antengene and Ocumention Therapeutics (Shanghai).
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