Delmaine Donson
Shanghai Junshi Biosciences (OTCPK:SHJBF) signed a licensing agreement with London-based Hikma Pharmaceuticals (OTCPK:HKMPF) (OTCPK:HKMPY) for cancer drug toripalimab in the Middle East and North Africa (MENA).
Under the agreement, Hikma is granted an exclusive license to develop and commercialize toripalimab injection in all its MENA markets. In addition, Junshi will grant the right of first negotiation to Hikma for the future commercialization of three novel oncology molecules under development, in MENA.
On Dec. 24 Coherus BioSciences (CHRS) said that the U.S. Food and Drug Administration was not able to conduct a required site inspection of Junshi’s manufacturing facility in China for toripalimab in the current review cycle due to the ongoing impact of COVID-19 related restrictions on travel in China.
The FDA had previously granted priority review and was expected to make decision on the companies’ biologics license application (BLA) by Dec. 23.
Through the BLA the companies are seeking approval of toripalimab, in combination with gemcitabine and cisplatin, as first-line therapy for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC) and for toripalimab monotherapy as a second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
Coherus added that the companies did not receive an action letter from the FDA and BLA remains under review.
Coherus noted that the companies were engaged in discussions with the FDA about the pre-approval inspection plans.
“Together with our partner Coherus, we are working with the FDA to expedite the facility inspection so it may be conducted safely as soon as possible in order to provide NPC patients with a treatment that has been demonstrated to be safe and effective. Our production operations are well prepared for the inspection,” said Sheng Yao, senior vice president, Junshi.
Image and article originally from seekingalpha.com. Read the original article here.