Tocagen Licenses Greater China Rights for Phase III Cancer Immunotherapy to ApolloBio

Source: Tocagen Licenses Greater China Rights for Phase III Cancer Immunotherapy to ApolloBio

Regulatory Changes

“ApolloBio brings valuable regional expertise in product development, regulation, and healthcare access, positioning our lead product to advance toward patients in the greater China region as quickly and efficiently as possible,” Tocagen CEO Marty Duvall said in a statement. “As an innovative biopharmaceutical company in China, ApolloBio is well positioned to leverage China’s recent regulatory changes supporting the development of new medicines.”

China’s FDA last year began carrying out reforms designed to shorten reviews and approval timeframes for new drugs and devices. The reforms include acceptance of data from clinical trials conducted outside China, quicker reviews of drugs and devices intended to address life-threatening diseases or critical unmet medical needs, and conditional approvals for new rare disease drugs that already have approvals elsewhere in the world.

Last month, China’s State Council proposed creation of a new State Drug Administration that would oversee reviews and approvals of drugs and medical technologies, supplanting the China FDA—in the latest move to align China’s drug regulation with global standards, also reflected in China joining the International Council for Harmonization.

The companies said the number of projected new diagnoses of high-grade glioma this year were about 47,000 in greater China and 180,000 worldwide. Standard treatment includes surgery, radiation therapy, and chemotherapy.

“Toca 511 and Toca FC is a highly promising, best-in-class cancer-selective immunotherapy, and we look forward to working with Tocagen to advance this innovative late-stage product toward commercialization,” added ApolloBio CEO Weiping Yang, Ph.D.

ApolloBio’s license is subject to satisfaction of customary conditions, and is expected to become effective in the second quarter, the companies said.

Published at Thu, 19 Apr 2018 14:37:40 +0000