Any delays caused by unpredictable regulatory reviews related to the export of genetic materials threaten to derail the inclusion of China in international clinical trials, caution two trade groups representing the pharma industry in the country.

Chinese firms Shanghai Henlius Biotech and Essex Bio-Technology have announced a key milestone in their Chinese Phase I clinical study for the HLX04-O biosimilar bevacizumab candidate to treat wet age-related macular degeneration.

China’s Henlius has received international recognition of Phase I and III clinical trial results for its bevacizumab biosimilar, HLX04, providing “strong evidence for the efficacy and safety similarity between HLX04 and the reference bevacizumab.” The company has submitted its NDA for the product to the NMPA for various indications.

India's Sun Pharma is to foray into biosimilars, targeting first approval status for “third wave” products. It trails several peers and the changed stance comes as biosimilars gain traction in markets including the US, where experts have predicted a “coming out party” in the next few years.