TM C O N T E N T S ○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○ ○○○ I s s u e Editorial Mentholatum sues XiAn Meichen over Market Dynamics Brew New Order for trademark infringements 14 Chinese Pharma 2 API/Bulk Drugs 32 News in Focus Huaxing expands capacity of Amoxicillin MOH releases results of the 4th and 6-APA 14 APRIL National Health Service Survey 4 NCPG/DSM likely to build major The Market antibiotic API facility in Changchun 14 2 0 0 9 Data Snaptshot: Chinese OTC Shandong Antibiotics granted Germany healthcare market 5 GMP certification 15 Nicholas Hall reports slower growth Hisun sees profits up sharply in 2008 15 of OTC GI market in China 5 Changzhou Yabang-QH builds new In This Issue Industry News cGMP API plant with help from J&J 15 Chinese pharma industry perfor- Shijiazhuang Pharma receives EDQM MNCs report another year of mance in 2008 and outlook in 2009 5 certification for Vitamin B12 15 sharp revenue growth in China MNCs report another year of sharp India likely to investigate China’s 6-APA 15 Many MNCs experienced growth 20% revenue growth in China 6 MOC issues list of authorized exporters or more in China last year amid global MNCs positions for the huge diabetes of ephedrine drugs 15 slowdown P6 market potential in China 6 Data Snapshot - COS certifications and Harbin Pharma reconsiders Chinese producers likely to emerge DMFs held by Chinese companies 16 overseas IPO as global players of recombinant Chinese API in 2008 – Output and Export In preparation, Harbin Pharmaceutical human insulin 6 Volumes Down 16 Group is working on major and minor M&A is likely to intensify for retail Product and R&D News acquisitions this year P8 pharmacy sector in 2009 7 AOB to initiate clinical trials of TCM drug Pfizer opens new sterile facility Guangzhou introduces online for UI in the U.S. 17 in Dalian prescription surveillance system 8 General Health Pfizer unveiled recently its new sterile China forms alliance organization for Health Minister outlines emphasis of facility for cephalosporin power AIDS vaccine research 8 medical administration in 2009 17 injection P9 Local Company News 8 Health Minister talks about government China to introduce DMF system Foreign Company News 9 healthcare funding 18 for APIs and packaging Service Provider News 11 Rules of essential drug system likely to The SFDA has secured fiscal funding Regulatory News be adjusted in implementation 18 the plan which is expected to Tianjin introduces centralized hospital New working procedures for drug accelerate implementation P12 drug purchase through internet bidding 18 registration second review issued 11 Practical Tips for Pharma MOH reports prevalence of infectious NDRC initiates production cost and Companies on Patent Litigation diseases in 02/2009 18 market price survey of drug products 12 in China Prevalence of renal disease high in Shanghai 18 China to introduce DMF system for Legal counsel Geoffrey Lin examines APIs and packaging 12 People in the News / Other News 19 options and strategies in the Chinese patent litigations P20 China to implement the system of Feature Articles “authorized person” 12 Practical Tips for Pharma Companies on Chinese Pharmaceutical National drug registration conference Patent Litigation in China 20 Distribution Landscape to lay out plans for 2009 13 Review of systemic anti-infective con- Zuellig Pharma China CEO Elsie Lim SFDA News 13 sumption in Chinese hospitals 1H/2008 22 demonstrates the models and solutions of pharma distribution in Legal/IPR News Review of gyn infection market in China 26 China P28 SFDA issues #133 and #134 drug Chinese Pharma Distribution Landscape 28 administrative protection 14 Stop Press 23, 24, 25 ○○○○○○○○○○○○○○○○○○○○○○○ WiCON | Pharma China○○○○○○○○○○○○○○○ April 2009 Issue 32 PUBLISHER’S INFORMATION Editorial Publisher: James J. Shen Changing Market Dynamics Brew New Order Chief Editor: James J. Shen for Chinese Pharma Deputy Editor: Joanne Xiao-Hua Zhou Correspondents: Jenny Wang, Fengling Cheng James J. Shen Editorial Consultant: David Xue, Luke Treloar Following Pfizer’s announcement in late January to acquire Wyeth, the trend Advisory Board: Ten distinguished industry leaders of mega deals further intensified in March with Merck’s planned US$41 billion acquisition of Schering Plough and Roche finally winning full ownership of US Head Office: Genentech at a price tag of US$47 billion. 449 Sayre Drive, Princeton, NJ 08540, USA As such gigantic deals happen, big pharma companies continue to pick up Tel: +1 609-919-0898 smaller assets here and there. With healthcare reform looming and anticipated Fax: +1 702-995-3905 rise of generics in the U.S., R&D-based MNCs are now showing strong interest E-mail: [email protected] in acquisition of generic drug businesses, particularly generic product portfolios Internet: www.pharmachinaonline.com of Indian companies. Pfizer acquired various generic drug rights from Indian firm Aurobindo in March, as it and its competitor Sanofi Aventis are also eyeing China Editorial /Sales Office: the biotech business of Wockhardt, another Indian drug major. B-17D, Oriental Kenzo Plaza, 48 Dongzhimenwai Impacts of overseas deals on China Dajie, Dongcheng District, Beijing 100027, China. Tel: +86 10 8447-6010 Fax: +86 10 84476110 While smaller licensing deals of MNCs will help broaden their pipelines in China, the rising trend of generic drug acquisitions are likely to make it easier China Representative and Agent: for these companies to enter the Chinese generic drug business. David Xue, PharmaGuys Info Meanwhile, mega mergers between Pfizer and Wyeth as well as between Tel: +86 10 8530-0937 Fax: +86 10 8530-0938 Merck and Schering Plough will make the combined companies much bigger Cell: 13911325130 e-mail: [email protected] and more influential in China. Pfizer is already the third largest MNC company in the Chinese hospital market, Subscriptions (2009): and its acquisition of Wyeth is likely to make it the biggest, replacing Bayer Subscription Rate for Journal Edition: US$1,650 for Healthcare. In addition, Wyeth will open up for Pfizer the potential in China’s Print or PDF inclusive of S&H (additional print copy OTC healthcare market, an area Pfizer is currently not active in. The in the same envelop is US$1,000). combination of the two companies will result in a new company with much Gold Package: US$2,750 (includes single subscriptions bigger revenues and diversified business lines. The challenge will lie with to both Pharma China Journal Edition and Web Edition, successful integration of the two companies and the learning curve of Pfizer Weekly Alert, Breaking News Alert, Pharma China executives in OTC healthcare. Archive and Online Databases). Meanwhile, Merck and Schering Plough share a similar business model in China and both concentrate on their ethical drug businesses. Their product Request order forms from: lines are quite complimentary to one another with Merck being a leading player WiCON International Group in vaccines, cardiovascular, anti-infective, urinary, NSAID, osteoporosis and 449 Sayre Drive, Princeton, NJ 08540, USA. respiratory areas, and Schering Plough being active in Oncology, Allergy, Tel: +1 609-919-0898 Fax:+1 702-995-3905 Hepatitis and Dermatology. Besides, Schering Plough has a small OTC E-mail: [email protected] business too. Both Merck and Schering Plough do not have any R&D in China, but the larger revenue base and platform of the combined new company may Conditions of Sale: offer some incentives to Merck in this area. Currently Merck ranks No.7 among © All rights reserved by WiCON International. No part MNCs in the Chinese hospital market, and the merger with Schering Plough of this publication may be reproduced, stored in a re- is likely to bump it to the No. 5 place, overtaking Roche and Novartis. trieval system, or transmitted in any form or by any other NPC and CPPCC become a new platform of rising importance for means, electronic, mechanical, photocopying, record- advocating interests of pharma industry ing or otherwise without the written consent of the The “two conferences”, referring to the sessions of the National People’s Publisher. Any abstraction of data for republication and Congress (NPC) and the Chinese People’s Political Consultative Conference sale requires prior written permission from the Publisher (CPPCC), are currently ongoing in Beijing as I am writing this editorial. and provided due acknowledgement is made to the Interestingly, the transformation of NPC and CPPCC offers the world a glimpse source. Without prior written permission of the of how the Chinese style democracy has been evolving in the past decade. Publisher, Pharma China may not be circulated outside Instead of turning into the Western-styled legislative bodies, as hoped by the staff employed at the mailing address to which it is many Western groups and bluntly rejected by the Chinese government, NPC sent by the publisher. Please contact and CPPCC have increasingly become a de facto consultative forum and a [email protected] for details of multiple rather liberal platform for airing all kinds of criticisms, suggestions and sites or global licenses. While due care has been used proposals on Chinese economy, politics and society. in compiling this information, the publisher makes no claim that it is free of error or fit for any particular While NPC and CPPCC representatives are not legislators and continue to follow the party line for most of their votes, many of them have become very purpose, and does not accept liability to anyone for the outspoken and critical to the status quo and government policies. consequence of any decision or action taken in reliance Representatives have the rights by law to submit proposals on subjects of on any information contained herein. their choice and the executive branches of NPC and CPPCC are required to 2 © WiCON International | www.pharmachinaonline.com ○○○○○○○○○○○○○○○○○○○○○○○ WiCON | Pharma China ○○○○○○○○○○○○○○○ April 2009 Issue 32 resolve such proposals with relevant government departments.