China,

October 2019

With optimism and energy pervading the Chinese healthcare landscape, actors of all stripes see new potential and opportunities on the horizon. The heterogeneity of the Chinese market, with its 31 province-level entities offering a variety of market characteristics and needs; the waves of overseas returnees repatriating decades of experience in top pharma companies and biotechs, known as the so-called ‘sea turtles’; the budding capital markets unfurling their increasing interest in the sector; and the most pro-innovation regulatory environment the industry has seen practically since inception – all have coalesced into a veritable playground for the next generation of global pharma and biotech giants.

All of them, and the network of service providers that surround them, see in China’s vast market not only bountiful opportunities to serve patient needs and so doing, reap rewards, but also an unparalleled platform to test new models of innovation, operational excellence, and service delivery.

Articles

CDE’s China Drug Evaluation Report 2020: Part 1

The following is an overview from Accestra Consulting* of Part 1 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including data on drug approvals for all application types (including Investigational New Drugs (INDs), New Drug Applications (NDAs), and ANDAs), hot topics within new drug approvals for 2020, and reasons for rejected applications. Abstract…

Hong Chow Leaves Roche China for Big New Role at Merck

In a big career move on a personal level and a sign of China’s continuing significance to global pharma, Hong Chow has left her role as General Manager for Roche Pharma in China to take on an expanded role at German giant Merck KGaA. Chow will join Merck’s Healthcare business sector as Head of…

China Enters CAR-T Era with Fosun-Kite Yescarta Approval

A historic approval for Fosun-Kite’s CAR-T therapy Yescarta in China looks set to pave the way for further developments in the Chinese cell and gene therapy space, as multinationals look to bring their new therapies to the rapidly expanding China market Yescarta, originally approved in the US in 2017 and in Europe in 2018,…

China’s New Era of Reform Transforming Regulatory Professionals

Writing in the June edition of DIA’s Global Forum magazine, Harbour BioMed’s Fang Zhou, in conversation with Sanofi China’s Irene Deng, looks at how Chinese pharmaceutical regulations have evolved and what impact this has had on regulatory professionals in the country. The Chinese pharmaceutical industry, through the first five years of China’s National Medical…

China: EpimAb Looks to 2022 IPO & Global Leadership in Bispecific Antibodies

Hot on the heels of a USD 120 million fundraising round, Shanghai-based EpimAb Biotherapeutics is now looking towards a 2022 IPO with the aim of becoming a globally competitive player in the bispecific antibody field. The Series C financing round means that the company has raised over USD 220 million in venture capital from…