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Editor´s Picks
Shanghai Regulator: Speaking Fees to Physicians Constitute Bribery(8/14/2018 )  (Premium)
  This Lexology article by Todd Liao of Morgan Lewis & Bockius LLP concludes that "this decision¡¯s binding effect is currently limited to one district (Shanghai), and is not legally binding on future decisions of authorities in other municipalities or provinces. However, it is still a possible indication of future trends in the enforcement of the AUCL."
SCMP: Fierce Competition in China's Nascent Immuno-therapy Cancer Drugs Market Could Compromise Safety(8/14/2018 )  (Premium)
  As the Chinese immuno-therapy cancer drug market grows, it will inevitably fragment into tiers of treatments with varying degrees of effectiveness and safety, according to this SCMP article by Eric Ng quoting the latest report from Nomura.
China National Drug Administration Sets Guidelines for Overseas Drug Trial Data(8/14/2018 )  (Premium)
  In an effort to increase the availability of pharmaceutical treatments, the CNDA has recently released guidelines to allow drugs that have already undergone clinical trials in other countries to enter the Chinese market without undergoing domestic clinical trials, according to this Lexology article by Morgan Lewis, which reviews the key features of this document.
Big Pharma Opportunities Aplenty in China(8/14/2018 )  (Premium)
  Following a review of the Chinese pharma industry background and emerging trends, this Kr-Asia article by Elain Huang boasts that the "China is poised to create pharmaceuticals that can overtake their traditional counterparts."
The Market
SMEI: Chinese Drug Terminal Market Up 6.9% in H1(8/13/2018 )  (Premium)
  The growth of three major Chinese terminal drug markets slowed slightly more at 6.9% in the first half of 2018, reaching a total of CNY 859 billion, according to the SMEI. The data does not include drug sales through private hospitals, private clinics and village clinics.
Industry News
Adlai Nortye Opens R&D Site in Boston(8/17/2018 )  (free)
  Adlai Nortye Ltd., a globally-focused biopharmaceutical company dedicated to becoming a leader in developing effective therapies for cancer treatment and unmet medical needs, announced the opening of its first US site in Boston, which will focus on novel target identification, validation, and translational medicine research.
China Grand Given More Time for Acquisition Offer to Sinclair Pharma(8/16/2018 )  (Premium)
  Sinclair Pharma said on August 16 that Britain'sTakeover Panel had agreed to allow privately owned China Grand Enterprises and its affiliate company Huadong Medicine Co more time to make an offer for the British firm.
CNDA Approves Hengrui¡¯s Breast Cancer Drug Pyrotinib Conditionally(8/16/2018 )  (Premium)
  The CNDA announced on August 16 that it has granted conditional approval of Hengrui Medicine¡¯s anticancer Pyrotinib (Ai Rui Ni) through its priority review path for the treatment of recurrent or metastatic breast cancer.
Kintor and Frontier Reportedly Seeking IPOs in Hong Kong(8/16/2018 )  (Premium)
  Suzhou Kintor Pharmaceuticals Inc. and Frontier Biotechnologies are planning Hong Kong stock offerings that could each raise about $300 million, according to people with knowledge of the matter. The companies could list as soon as this year, the people said, asking not to be identified because the information is private.
Chinese Pharma Growth Continues to Slow as Shares of Online Pharmacies and CHCs Go Up(8/16/2018 )  (Premium)
  Sales of drugs in China have slowed down in the first six months this year while online pharmacies and local health centers have increased their market shares. The sales grew 6.9% to CNY 859 billion, which was 0.7 percentage point less than last year, according to Yicai Global quoting official data from the CNDA.
Chinese Online Drugstore 111 Inc. Files For $200M US IPO(8/15/2018 )  (Premium)
  Shanghai-based 111 Inc., which runs an online retail drugstore and healthcare platform in China, has filed for U.S. initial public offering to raise US$200 million under the name YI, according to its prospectus. J.P. Morgan, Citi and CICC are the joint bookrunners of the deal, but the pricing terms were undisclosed.
Blackstone Invests $400M in YiChang HEC Change(8/15/2018 )  (Premium)
  U.S. private equity firm Blackstone Group LP has signed a deal to invest $400 million in Hong Kong-listed YiChang HEC ChangJiang Pharmaceutical Co. <1558.HK> via convertible bonds, HEC said on August 15.
IQVIA: Peeking Into China's Healthcare Deals(8/14/2018 )  (Premium)
  China's hospital landscape is rapidly changing as operators and owners respond to shifting policy incentives, an aging population, the opportunity to serve Tier 2 and 3 cities, and shifts in consumer preferences, according to an article posted on www.healthinvestorasia.com by Jude Uzonwanne, a principal with IQVIA.
EU: Zhejiang Tianyu the Second Chinese Producer of Tainted Heart Drug(8/14/2018 )  (Premium)
  The European Medicines Agency (EMA) said on August 10 that a second Chinese pharmaceutical company, Zhejiang Tianyu, had produced a common blood pressure and heart drug with an impurity that could cause cancer.
India's Pharmexcil to sign MoU with China Trade Body for Expedite Drug Approvals(8/14/2018 )  (Premium)
  In a bid to boost the India-China pharmaceutical trade, the Pharmaceuticals Export Promotion Council of India under the Indian Ministry of Commerce, will be signing a MOU with the China Chamber of Commerce for Import and Export of Medicines and Health Products to speed up drug approval processes.
Haisco and Pneuma Enter Equity Investment and China Distribution Deal(8/13/2018 )  (Premium)
  Pneuma Respiratory, which has developed PNEUMAHALER, announced that Haisco Pharma has agreed to make a $10 million equity investment in the firm. Under the agreement, Haisco is to receive rights to distribute Pneuma Respiratory's pharmaceutical products in China and will fund Chinese regulatory filings.
Regulatory News
CDE Solicits Comments of Draft Guidelines for Aluminum Adjuvant in Preventative Vaccines(8/17/2018 )  (Premium)
  The Center for Drug Evaluation under the CNDA (CDE) released its draft Technical Guidelines for Aluminum Adjuvant in Preventative Vaccines, which was developed referencing relevant international guidelines and following expert panel discussions, on August 17 and is now seeking public comments.
Chinese Pharmacopoeia Commission Announces Proposed Addition of 40 Biologics in ChP 2020(8/14/2018 )  (Premium)
  The Chinese Pharmacopoeia Commission (ChPC) announced on August 13 that it has drafted a list of 40 biological products which are proposed for addition to the Part III of the Chinese Pharmacopoeia (ChP) 2020 Edition.
General Health
NHC and SATCM Issue Notice for Building of Tiered Medical Service System(8/14/2018 )  (Premium)
  Further to the guidance opinion documents issued by the State Council in 2015 and 2017 respectively for advancing tiered medical service system and for advancing medical consortiums, the NHC and the SATCM recently issued an official notice to further facilitate the building of tiered medical service system.
State Council Issues Notice to Divide Fiscal Responsibilities of Central and Local Governments for Healthcare(8/14/2018 )  (Premium)
  The State Council on Aug 13 released an official notice to provide the fiscal duties of central and regional authorities in medical services, as part of more structural reform, according to the official website of the National Health Commission.
Legal/IPR News
Trump Lashes Out on China and Mexico for Opioid and Fentanyl "Warfare"(8/16/2018 )  (Premium)
  President Trump lashed out August 16 at China and Mexico for illegal opioids entering the US from the two countries ¡ª and called on Attorney General Jeff Sessions to file a federal lawsuit against unnamed pharmaceutical companies that make them.
Gilead's Key Sovaldi Patent Claims Partially Invalidated in China(8/16/2018 )  (Premium)
  A par-tial patent in-val-i-da-tion by Chi-nese au-thor-i-ties has shaken the case Gilead has been build-ing for its hep C star So-valdi by re-mov-ing a key bar-rier to generic entry, according to Endpoint News. The de-ci-sion means knock-offs of the highly ef-fec-tive hep C treat-ment can ar-rive as early as next year.
Product/R&D News
CANbridge Approved to Commence CAN017 Ib/III Trial for ESCC in China(8/14/2018 )  (free)
  The Phase Ib/extension study is a multicenter, open label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CAN017 in combination with chemotherapy as the second line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Sihuan Pharma's Self-Developed Anticancer Pirotinib Commenced Phase II Trial in China(8/14/2018 )  (free)
  Sihuan Pharma, the largest CCV drug manufacturer in China's prescription drug market, announced that its self-developed oncology innovative drug Pirotinib commenced Phase II Clinical Trial in China, subsequent to the completion of Phase I Clinical Trial in the U.S..
API/Bulk Drug News
Indian Drugmakers Hit by Rising Prices of Chinese Intermediates(8/16/2018 )  (Premium)
  The spurt in prices of raw materials and intermediates being imported from China has adversely impacted Indian drug-makers. Many firms engaged in production of raw materials in China are being closed down due to strict implementation of pollution control norms leading to dip in production resulting in price increase.
FDA Warns Four Manufacturers from China, India and Canada(8/14/2018 )  (Premium)
  The US FDA's Center for Drug Evaluation and Research on released August 14 four warning letters sent to prescription drug, API and OTC drug manufacturers in China, India and Canada, including Yicheng Goto Pharma.
People in the News
Recent Executive Moves(8/17/2018 )  (Premium)
  Recent Chinese pharma-related executive moves at companies including BMS China, Sanofi China, Hanmi Pharma, China Biologic Products, Zai Lab, CBT Pharma, Leica Bio and Jimin Kexin Pharma.
Top Drug Regulators and Senior Local Officials Punished over Vaccine Scandal(8/16/2018 )  (Premium)
  China¡¯s powerful Politburo announced investigation and disciplinary actions on August 16 against more than 40 officials including top and local drug regulators, state media said, in the latest fallout over a vaccine scandal that has undermined trust in the ruling Communist Party.
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