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.

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Editor´s Picks
China's Biopharma Rise: Opportunities and Threats(7/10/2018 )  (Premium)
  This PharmExec article by Peter Young concludes that "the Chinese have clearly gained significant market share in pharmaceutical intermediate/fine chemicals and generics manufacturing. Whether they can do the same over time in the market for more sophisticated drugs is still an open question."
Industry News
Merck and Xian Janssen to Co-launch Type 2 Diabetes Drug in China(7/12/2018 )  (Premium)
  Through this agreement, the two companies will work closely together on future development, distribution, promotion, access, marketing and sales of Invokana (canagliflozin) in the country and Merck will hold the exclusive rights for Invokana (canagliflozin)¡¯s promotion in China.
Ping An Reportedly to Make Rival Offer for China Biologic(7/10/2018 )  (free)
  An arm of Ping An is reported by Bloomburg to be in talks with other investors about a potential joint bid for Beijing-based and U.S.-listed China Biologic. Any offer would be higher than the $110-per-share proposal from Chinese buyout firm Citic Capital, which valued the company at about $3.6 billion.
Transgene Swaps JV Ownership for Stake in Tasly Biopharma(7/10/2018 )  (Premium)
  France's Transgene agrees to swap ownership of its Chinese joint venture and control of their assets for a 2.53% stake in Tasly Biopharma, the biopharma arm of the Chinese medicine giant Tasly.
iBio Establishes Strategic Commercial Relationship with CC-Pharming(7/10/2018 )  (Premium)
  iBio, Inc.announced on July 9 the commencement of a strategic commercial relationship with Beijing-based CC-Pharming Ltd. for joint development of products and manufacturing facilities for the Chinese biopharmaceutical market, utilizing iBio's technology.
China Agrees to Slash Import Duties on Indian Medicines(7/10/2018 )  (Premium)
  India and China have reached an agreement on reduction of tariffs on the import of Indian medicines, particularly cancer drugs, to China, the Chinese Foreign Ministry said on July 9, days after a Chinese movie on a leukaemia patient highlighted the need for paving the way for import of cheap Indian medicines.
Tocagen Closes Licensing Deal with ApolloBio for Immunotherapy Toca 511 & Toca FC in Greater China(7/10/2018 )  (free)
  Tocagen and Beijing Apollo Venus Biomed announced on July 9 the closing of an agreement for exclusive right to develop and commercialize Toca 511 & Toca FC, Tocagen's lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, within the greater China region.
Regulatory News
CNDA Solicits Comments on GMP for Clinical Trial Drugs(7/13/2018 )  (Premium)
  The CNDA published the draft Good Manufacturing Practices for Clinical Trial Drugs on July 13 for public comments. Feedbacks need to be submitted via email to the Drug and Cosmetic Registration Department under the CNDA before August 15.
CDE Solicits Comments on Technical Requirements for Topical Dermatological Generics(7/11/2018 )  (Premium)
  The CDE published a new document, Technical Evaluation Requirements for Topical Dermatological Generic Drugs under the New Registration Classification, on July 11. The document was drafted on the basis of literature research, experiences from cross-specialty evaluation meetings and other expert consultations.
CNDA Issues Technical Guidelines for Acceptance of Foreign Drug Clinical Trial Data (with Summary)(7/10/2018 )  (Premium)
  The new document's provisions are divided into five sections: 1) Scope; 2) Essential Principles for Accepting Foreign Clinical Trial Data; 3) Integrity Requirements for Accepting Foreign Clinical Trial Data; 4) Submission Summary and Essential Requirements of Foreign Clinical Trial Data; and 5) Acceptability of Foreign Clinical Trial Data. Summary of key provisions included.
U.S. FDA and CNDA Officials Meet to Exchange Anticancer Regulatory Experience(7/10/2018 )  (Premium)
  Xu Jinghe, Deputy Commissioner of the CNDA, attended the China US Exchange for Cancer Drug Development and Evaluation held jointly by CNDA and the USFDA in early July. Prior to the exchange meeting, Xu Jinghe met with Dr Richard Pazdur, the Director of the FDA's Oncology Center of Excellence (OCE).
General Health
SMIA Mulls Tender for Anticancers as It Plans New Mechanism for Updating NRDL(7/13/2018 )  (Premium)
  The State Medical Insurance Administration (SMIA) has begun preparing for a national level special tender for anticancers which have been granted tax reduction recently. The goal is to ensure reduction of end market prices of such drugs.
NHC Reports on Growing Sector of Private Healthcare Providers in China(7/13/2018 )  (Premium)
  China has a total of 448,000 private medical facilities at the end of 2017, representing 46.3% of all Chinese medical institutions, according to official statistics released by GUO Yanhong, Deputy Director General of the Medical Administration Department under the NHC.
Shanghai Unveils New Open Policy Measures, Benefiting Pharma/MedTech Industries(7/11/2018 )  (Premium)
  Shanghai introduced 100 new measures as it continues to play a leading role in the latest opening-up efforts of China. Under the measures announced by the city government, Shanghai will encourage foreign investments in the advanced manufacturing sector and plans to become an import center for drugs and medical equipment.
Updated - NHC Issues Drug Prescription Review Guidelines of Medical Institutions (with Summary)(7/10/2018 )  (Premium)
  The NHC, SATCM and the Logistics Security Office of the Central Military Commission issued a new document, the Drug Prescription Review Guidelines of Medical Institutions, on July 10. The document is effective from the date of issuance.
Product/R&D News
Sirona Biochem Announces CNDA Approval of SGLT2 Inhibitor for Phase I Trial(7/12/2018 )  (Premium)
  Sirona Biochem announced on July 12 that its partner, Jiangsu Wanbang Biopharma , has confirmed the IND submission to the CNDA for its SGLT2 inhibitor was approved for clinical trial. Wanbang will be entering a Phase I clinical trial for the treatment of Type 2 diabetes.
CStone's PD-1 Inhibitor CS1003 Gets Clinical Trial Approval in China(7/12/2018 )  (Premium)
  CStone Pharma announced on July 12 that the China National Drug Administration (CNDA) has approved the first clinical trial application (CTA) in China for CS1003, a self-developed and wholly-owned anti-programmed death-1 (PD-1) monoclonal antibody (mAb).
People in the News
Recent Executive Moves(7/13/2018 )  (Premium)
  Recent Chinese pharma related executive movements at companies including Johnson & Johnson China, Marykay China and I-May Biopharma.
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