Biotech in China: Assessing Market Opportunities for European SMEs

  • Date
    13 June 2024
  • Beijing Time
    16:00 - 18:00
  • Brussels Time
    10:00 - 12:00
  • Location
  • Venue
  • Open to
    All European SMEs
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The biotech sector in China is booming. With supportive government policies towards biotech development and a massive patient base, China presents a relevant opportunity for smaller European companies looking to scale up and access new revenue streams. Participating in this market can not only open doors to extensive R&D resources and potential partnerships. It can also provide SMEs with the chance to establish a foothold in one of the world’s fastest-growing biotech ecosystems. Understanding and adapting to the regulatory and business landscape in China can greatly enhance an SME’s ability to compete on a global scale and capitalise on emerging biotechnological advancements.

While the Chinese market for biotech is promising, entering it involves navigating a set of complex risks. Regulatory challenges are substantial, with stringent and often rapidly changing rules that require careful attention and adaptability. Intellectual property protection poses another significant risk, as differing legal frameworks can complicate the safeguarding of innovations. Additionally, the competitive landscape in China is intense, with domestic companies often receiving strong governmental support, which can place foreign entrants at a disadvantage. Cultural and language barriers further complicate effective communication and business practices. Understanding these risks is crucial for European SMEs to develop robust strategies that mitigate potential setbacks while capitalising on the opportunities within China’s dynamic biotech sector.

To explore the specificities of this sector, the EU SME Centre and Genopole, in collaboration with the China IP SME Helpdesk and Cisema, are organising on 13 June 2024 an online workshop to help European SMEs in the process of assessing their opportunities.

Agenda (Brussels Time)


Opening remarks


China Drug, Medical Device & IVD Marketing Approvals: Top Tips and Latest Updates
Mr. Hamish King, CEO, Cisema

This keynote presentation will include the following topics:

  • Key China regulatory bodies for life science products
  • Product Classification & Categorisation: From Drugs to Medical Software
  • High Level Timelines to Achieve Marketing Approvals for Drugs, MD & IVD
  • China Local Agent (Authorized Representative) Requirements
  • Alternative Pathways: Hong Kong through to Greater Bay Area

Q&A session


IPR Protection for the Medtech Sector
Toby Mak, Patent Attorney, China IP SME Helpdesk


Q&A session

Keynote speakers
Hamish King
CEO, Cisema

Hamish King, LLB, RAC is CEO at Cisema, a regulatory and compliance consultancy for China founded in Munich and Beijing in 2002. Cisema is a 100-strong family-owned company providing regulatory and compliance services for China and Hong Kong, including product registration, in-China testing, clinical studies and writing, regulatory communications, local agent, post market surveillance, quality control and audits.

A lawyer by training – admitted in Hong Kong and NSW, Australia – Hamish previously worked with UK Magic Circle Firm Linklaters in Hong Kong, and has over 10 years’ experience in the legal and regulatory fields. He has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China regulatory pathways and registration points, he currently lives in Hong Kong and specialises in NMPA registrations and compliance.

Toby Mak
Patent Attorney, China IP SME Helpdesk

Toby Mak is a patent attorney and expert at the China IP SME Helpdesk. He served as co-chair of the AIPLA’s IP Practice in China committee and IP Practice in the Far East committee and is currently AIPLA’s representative at the US Bar Association/CNIPA Liaison Council. He is Vice Chair of the Asian Practice committee of the IPO, as well as a member of the Membership Committee of the IPO. He is one of the authors of Patent Law in Greater China.

Born and educated in Hong Kong with a PhD in chemistry, he is the only Chinese patent attorney working in a Beijing Chinese patent firm from Hong Kong. Trained under the UK system, he took the UK CIPA examinations and passed some of the papers. He is responsible for publishing articles on China IP update for the UK CIPA Journal. He is also a member of AIPLA, IPO, UK CIPA, and INTA.

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