News & Analysis as of

China Life Sciences

Faegre Drinker Biddle & Reath LLP

New Investment Opportunity in China’s Health Care Sector Following Recent Legal Reforms

Policy Announcements - On September 6, 2024, the People’s Republic of China’s (PRC) National Development and Reform Commission and the PRC Ministry of Commerce issued the “Special Administrative Measures for Foreign...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...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

Foley & Lardner LLP

Global Growth In GenAI Patenting Activity

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Between 2014-2023, China has filed more patent applications (38,000) covering Generative AI (GenAI) technology than another other country, six times more than second place United States, as reported by the World Intellectual...more

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

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This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more

Morrison & Foerster LLP

DOJ National Security Division Issues First-Ever Declination Under Voluntary Self-Disclosure Policy

On May 22, 2024, the Department of Justice’s (DOJ) National Security Division (NSD) announced its first-ever prosecution declination under its corporate voluntary self-disclosure (VSD) policy for sanctions and export controls...more

The Volkov Law Group

Life Sciences Company Escapes Criminal Charges for Employee’s Illegal Export Scheme

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Sigma-Aldrich, Inc., d/b/a MilliporeSigma (“MilliporeSigma”), a U.S. life sciences company based in Massachusetts, escaped criminal charges for export control violations, despite a former sales person’s scheme to illegally...more

Hogan Lovells

U.S. BIOSECURE Act: Key considerations for global cell, tissue, and gene therapy stakeholders

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Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more

Hogan Lovells

China update: Human Genetic Resources Administration Rules support HGR Implementing Rules

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After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration Rules (Implementing Rules) on 1 June 2023,...more

Pillsbury Winthrop Shaw Pittman LLP

Congress Sets Sights on Limiting Access to Chinese Biotech Companies

The BIOSECURE Act would prohibit federal agencies from contracting with, extending loans to, or awarding grants to, any company with existing or pending agreements with identified biotechnology companies. This limits funding...more

Fenwick & West LLP

The BIOSECURE Act: Too Early to Call?

Fenwick & West LLP on

A congressional proposal to sever ties between United States and Chinese biopharmaceutical companies is far from a done deal, but its bipartisan support is a concrete reminder to consider options for supply chain...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

Lowenstein Sandler LLP on

The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...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

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Hogan Lovells

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

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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

Morgan Lewis

Life Sciences Industry: Key Trends and Developments for Asia-based Investors

Morgan Lewis on

With the consequences of the global pandemic still reverberating throughout the Asia-Pacific region, governments and businesses in the area continue to focus on the life sciences industry. From startups to global...more

Latham & Watkins LLP

8 Key Takeaways From the CFIUS 2022 Annual Report

Latham & Watkins LLP on

The Report shows that CFIUS reviewed a record number of filings in 2022 and also required more mitigation as a condition of clearance. On July 31, 2023, the Committee on Foreign Investment in the United States (CFIUS)...more

Morgan Lewis

Protecting Assets: Employer Guide for Life Sciences Startups in Japan, China, and the US

Morgan Lewis on

The life blood of many life sciences startups is their assets—employees, ideas, and innovations. A key focus for these companies is how to best protect those assets. In Japan, China, and the United States, there are...more

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

Morgan Lewis on

China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

Linda Liu & Partners

CNIPA’s Requirements on Supplementary Experimental Data and Inventiveness Evaluation of CN Patent Application in Biology and...

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On December 14, 2020, the China National Intellectual Property Administration released “Announcement about Amendments to the Guidelines for Patent Examination (Announcement No. 391)” on its website, showing that the amended...more

Hogan Lovells

Spotlight on Greater China: antitrust and regulatory risks in life sciences distribution channels

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As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan Lovells is hosting a special...more

Morrison & Foerster LLP

China Eyes New Export Controls for Life Sciences Technologies

China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to...more

Hogan Lovells

Spotlight on Greater China: navigating a shifting patent landscape

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As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan Lovells is hosting a special...more

Foley Hoag LLP

CFIUS Year in Review

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CFIUS reviewed a record number of transactions in 2021 according to its most recent annual report – and shows no signs of slowing down. High technology (including quantum computing), life sciences, and green energy...more

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