News & Analysis as of

Life Sciences China

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: FCPA Enforcement

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the seventh episode of When Your Life Sciences Are on...more

DLA Piper

Navigating China's Healthcare Compliance Landscape: New Guidelines to Mitigate Commercial Bribery Risks

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China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...more

Goodwin

Life Sciences M&A Trends for 2023 and 2024 (Through End of Q3) in Greater China

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Goodwin is presenting a two-part publication series covering life sciences trends involving license deals, M&A, and financing for Greater China’s life sciences sector. ...more

Morrison & Foerster LLP

China’s Compliance Guidelines for Healthcare Companies Signal Areas of Future Enforcement

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On October 11, 2024, China’s State Administration for Market Regulation (“SAMR”) issued the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Draft Guidelines”). These guidelines...more

Morgan Lewis

Shanghai’s 2024 Enforcement Framework on Healthcare Practices – Key Takeaways and How to Prepare

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The Shanghai Health Commission, together with 13 other governmental authorities in Shanghai, jointly published on October 10, 2024 the Shanghai version of the 2024 Notice on Issuing the Key Points of Correcting Improper...more

Morgan Lewis

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

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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

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

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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

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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

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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

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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

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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

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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

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