Dive Brief:
- Tocagen Inc. on Thursday inked a licensing agreement with an affiliate of Chinese biotech ApolloBio Corp. handing over exclusive rights in China to a late-stage combination immunotherapy called Toca 511 & Toca FC.
- ApolloBio will pay $16 million upfront, with up to $4 million in near-term contingent payments. Further milestones could be worth up to $111 million for Tocagen.
- Toca 511 & Toca FC is a cancer-selective immunotherapy currently in Phase 3 testing for recurrent high grade glioma and currently holds a Breakthrough Therapy Designation in the U.S. and PRIME designation in Europe.
Dive Insight:
China is the second-largest pharmaceuticals market in the world. But investment from foreign drugmakers has been mixed, slowed by concerns over patent protection and challenges associated with working with Chinese regulators.
That environment, however, appears to be changing rapidly.
In December 2017, China's Food and Drug Administration (CFDA) published a variety of major regulatory reforms, designed to accelerate regulatory review of drugs and improve the options for manufacturing. These include opening up fast track approval for drugs developed and approved outside China but manufactured in China, or manufactured at plants approved by the U.S. or European regulatory authorities.
While these changes could benefit 'foreign' companies in China, there are still benefits to working with local companies such as ApolloBio, which bring to the table regional expertise in product development, regulation and healthcare access.
ApolloBio also has a deal with Inovio Pharmaceuticals Inc. for a treatment designed for prevention of pre-cancerous HPV infections and HPV-driven dysplasias.
It's not just the biotech though. AstraZeneca plc has seen rapid growth in China sales, notching an increase of 15% in 2017 and an even more impressive 30% in the fourth quarter.
As well as having a local team, the British drugmaker has partnered with Chinese Future Industry Investment Fund (FIIF) to launch a stand-alone joint venture in China, called Dizal Pharmaceutical. Dizal will develop candidates from AstraZeneca's pipeline as well as its own.