(Yicai Global) Sept. 11 -- Shanghai Junshi Biosciences announcement it has secured the US Food and Drug Administration's Breakthrough Therapy Designation for its Toripalimab Injection anti-cancer drug caused its stock to close over 4 percent up this morning.

Toripalimab's approved indication is for the treatment of nasopharyngeal carcinoma cancer, Junshi said in a statement yesterday, adding this is the first Chinese anti-PD-1 antibody granted the Breakthrough Therapy designation. The FDA granted orphan drug designation for this indication in May, the firm also said. This award will turbocharge the company's business development in the country, it predicted.

Junshi's shares [HK:1877] closed the morning out in Hong Kong 4.07 higher at HKD47.35 (USD6.11) after rising above 5 percent and up 2.21 percent to CNY84.08 (USD12.29) on the Shanghai Stock Exchange's Nasdaq-style Star Market [SHA:688180].

The full name of PD-1 is programmed death-1, which has been a hot field of tumor immunotherapy in recent years. Toripalimab was the first local PD-1 product China's National Medical Products Administration approved for market entry. It got the nod in December 2018 for the treatment of locally advanced or metastatic melanoma after the failure of systemic treatments.

The Breakthrough Therapy designation expedites the development and review of drugs targeting a serious condition when preliminary clinical evidence indicates the medicine may bring about substantial improvements over and above those of other available therapies at a clinically significant endpoint. A development process that has obtained breakthrough drug therapy certification receives closer guidance and various forms of policy support under the rules, per the statement.

Junshi has carried out more than 30 clinical studies covering more than 10 types of tumors in China and the US many other countries since clinical research and development of its Toripalimab started in early 2016. Aside from the approval for treatment of metastatic melanoma, its new indications for the treatment of nasopharyngeal carcinoma and urothelial carcinoma have also gained NMPA acceptance, the company added.

Editor: Ben Armour