News & Analysis as of

China Pharmaceutical Industry

CFDA’s New Draft Policy Introduces the Chinese Version of Patent Linkage

by Allen & Overy LLP on

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more

China FDA Calls for Comments on Key Policy Proposals

by Ropes & Gray LLP on

On May 11-12, 2017, the China FDA (CFDA) issued four new draft policies for public comments, proposing further reforms in the current drug and medical device regulatory regime. The four draft policies aim to accelerate the...more

USTR Report Highlights Foreign Barriers to U.S. Exports

by Polsinelli on

U.S. companies should review a recent USTR (United States Trade Representative) report providing insight into the various country-specific issues that may take center stage in future trade negotiations. Companies should then...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

China’s FDA Accepts JHL Biotech’s Clinical Trial Application for Rituximab Biosimilar in NHL

by Goodwin on

JHL Biotech announced today that China’s FDA has accepted its application for the use of JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients. JHL1101 is a rituximab biosimilar candidate that JHL...more

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

Alteogen Reportedly Transferring Biosimilar to Qilu Pharmaceutical

by Goodwin on

Korean Biomedical Review is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly...more

Importance of patents in Chinese pharmaceutical tendering

by Allen & Overy LLP on

China has a complicated and unique tendering system for drugs – and patents play an important role in almost every tender. What adds to the complexity is that tendering rules vary between provinces. Providing necessary patent...more

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Winter 2017

by Hogan Lovells on

FTC takes another look at merger remedies - On 3 February 2017, the U.S. Federal Trade Commission (“FTC”) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to...more

China’s State Council Announces Major Policies to Reform the Pharmaceutical Industry

by Ropes & Gray LLP on

China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the...more

Boletín Mensual de Comercio Internacional: Enero - Información con Énfasis en la Regulación Comercial y de Arbitraje Internacional

by Holland & Knight LLP on

Durante el mes de Enero destacan los siguientes temas: Acceso, Compras, Propiedad Intelectual, Comercio, Inversión, Solución de Diferencias, Competencia, Subvenciones, Arbitraje Inversión....more

China Solicits Comments on Drug GCP

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently proposed revisions to the Good Clinical Practices for Pharmaceuticals (“GCP”), the most comprehensive revision in 13 years. The revisions (“Revisions”) are now open to...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

A new trading link dropping next week will give international investors access to more than 800 stocks listed on China’s Shenzhen stock market, the boom/bust venue best known for its “rampant speculation”....more

Top Ten International Anti-Corruption Developments for October 2016

by Morrison & Foerster LLP on

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

The CFTC’s reportedly investigating the interest rate swap activities of Citigroup and others. Swaps allow companies to “hedge against a rise or fall in interest rates on the debt that they issue or hold, with banks usually...more

Top Ten International Anti-Corruption Developments for September 2016

by Morrison & Foerster LLP on

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

China tightens regulations for vaccine distribution and issues new product registration measures

by DLA Piper on

In the wake of a case of illegal trading of vaccines that implicated more than 300 people, ranging from businesses operating without proper licenses to hospital personnel, China's State Council has released amendments to the...more

GSK Settles SEC FCPA Case for $20 Million

by Michael Volkov on

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

The Oscar Meyer Wiener Theme and Revisiting GSK in China

by Thomas Fox on

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

Donations and Grants in China: Compliance Controls Beyond T&E

by Ropes & Gray LLP on

While travel and entertainment expenses have presented significant compliance challenges for life sciences companies operating in China, donations and grants can also pose notable compliance risks. China’s escalated...more

Second Circuit: “C” is for Comity; Price Fixing Judgement Against Chinese Vitamin C Sellers Reversed

by Mintz Levin on

Last week, in In re Vitamin C Antitrust Litigation, the US Court of Appeals for the Second Circuit (“Second Circuit”) vacated a $147 million jury award against Chinese vitamin C sellers Hebei Welcome Pharmaceutical Co. and...more

Top Ten International Anti-Corruption Developments for August 2016

by Morrison & Foerster LLP on

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

by Thomas Fox on

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

by Michael Volkov on

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Your daily dose of financial news - The Brief - 9.2.16

by Robins Kaplan LLP on

Turns out that the Anbang Insurance Group—the powerful Chinese insurer that’s made plenty of Brief appearances for its massive bids on US hotels, among others—really does live up to its air of mystery, with many of its...more

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