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. However, 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.
In this video, experts Hamish King, CEO of Cisema, and Toby Mak, Patent Attorney with the China IP SME Helpdesk, explore the specificities of this sector and share their recommendations. This event was organised in June 2024 in partnership with Genopole and the China IP SME Helpdesk.
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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