Tina Wu joined Ropes & Gray's life science practice group in the Shanghai office in 2017.
Prior to joining Ropes & Gray, Tina worked at a leading international law firm, advising multi-national companies on regulatory, intellectual property and compliance matters, with a particular focus on the healthcare and life science industry.
Tina has extensive experience in advising pharmaceutical, biotechnology, medical device and healthcare clients on a wide variety of matters arising from the entire product life cycle, including regulatory issues concerning M&A, collaboration, partnership and licensing deals, market access and commercialization strategies, post-market compliance and enforcement actions, and telemedicine services.
Tina passed the PRC Bar Exam in 2006 and the New York State Bar Exam in 2014.
- Assisted a leading US pharmaceutical company with the divestiture of certain business units in China, and provided legal advice on relevant pharmaceutical regulatory matters;
- Assisted a PRC innovative drug research and development company with the transaction in connection with the importation of investigational products, collaboration development and product localization, and provided legal advice on relevant pharmaceutical regulatory matters;
- Assisted a venture fund with its investment in a PRC pharmaceutical company to assess the product portfolio and regulatory risks;
- Assisted a Taiwan drug company with co-development of an innovative drug with a US pharmaceutical company worldwide and provided legal advice on relevant regulatory pathways and options;
- Assisted a PRC pharmaceutical company with the acquisition of foreign generic drug business, and provided legal advice on relevant pharmaceutical regulatory matters;
- Assisted a leading US medical devices company with M&A transactions in connection with PRC-related products, and provided legal advice on relevant regulatory affairs;
- Advised a leading US pharmaceutical company on its drug development collaboration with a China based CAR-T biotech company, and provided legal advice on relevant pharmaceutical regulatory affairs;
- Advised several renowned US medical centers on the feasibility and legal risks of telemedicine services targeted toward PRC patients;
- Advised multinational pharmaceutical companies and investment companies on the collection, use, transfer and cross-border transfer of healthcare data and patient data;
- Advised multinational pharmaceutical companies on the collection, use and importation and exportation of human genetic resources and biological samples;
- Advised several leading medical devices companies on potential business models and implications under the Market Authorization Holder system;
- Advised a leading US medical devices company on the marketing model and legal risks associated with the two-invoice system and other matters; and
- Advised a leading US medical devices company on NMPA’s post-market surveillance of its products, including its strategies of communication with law enforcement agencies and legal risks associated with relevant matters.
- Quoted, “Attorneys Urge Chinese Regulator to Engage More With Industry,” International Devices & Diagnostics Monitor (September 7, 2018)
- Co-author, “Public Private Collaboration to Advance Medtech Regulation Reform,” (September 5, 2018)