News & Analysis as of

Life Sciences China Prescription Drugs

Morgan Lewis

Understanding the NewCo Model: A Trending Approach of Chinese Pharmaceutical Companies

Morgan Lewis on

Inventive deal structures are on the rise within China’s life sciences industry, with the “NewCo” model having garnered significant interest among Chinese pharmaceutical companies in recent years. In 2024, several landmark...more

Fenwick & West LLP

Update on the BioSecure Act

Fenwick & West LLP on

The BioSecure Act is a bipartisan bill introduced in both the U.S. House of Representatives and Senate earlier this year that would effectively stop companies that are doing business with the U.S. government from using...more

Foley & Lardner LLP

The Rise of GenAI in Personalized Medicine and Beyond

Foley & Lardner LLP on

GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more

Akin Gump Strauss Hauer & Feld LLP

The Road Ahead for Private Equity: Reflections and Predictions

The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more

Hogan Lovells

JPM2024: Impact of China’s HGR Rules on clinical trials and scientific studies involving China sites

Hogan Lovells on

Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

Goodwin on

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Jones Day

Patent Linkage and Article 76 Proceedings in China: A Litigator's Perspective

Jones Day on

China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers.  This new system will also create a new form of pharmaceutical patent litigation in...more

Wilson Sonsini Goodrich & Rosati

China Patent Linkage System

Starting in July of this year, China initiated a patent registration platform that bears some similarity to the generic drug framework under the Hatch-Waxman Act in the U.S. The purpose of this alert is to describe this new...more

Perkins Coie

Updates on the Implementation of the Newly Amended PRC Patent Law

Perkins Coie on

The China National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) in the People’s Republic of China (PRC) issued measures to facilitate the implementation of the newly...more

A&O Shearman

China: Patent Law Amendment brings sea change to pharmaceutical patent regime

A&O Shearman on

Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more

Hogan Lovells

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

Hogan Lovells on

On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more

Hogan Lovells

China’s drug regulator seeks comments on updated drug recalls regulation

Hogan Lovells on

On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an...more

Hogan Lovells

China: Survival of the Fittest or Cheapest?

Hogan Lovells on

The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more

Hogan Lovells

China adds 30 drugs to its "urgently needed" list

Hogan Lovells on

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications - On 28 March China's National Medical Products Administration (NMPA) published a list of an...more

Hogan Lovells

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

Hogan Lovells on

On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more

Hogan Lovells

China drug regulator calling on international pharmaceutical companies to bring “urgently-needed” new drugs to China

Hogan Lovells on

On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more

Hogan Lovells

China Drug Administration publishes a key Draft Guidance on data exclusivity

Hogan Lovells on

This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more

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