It’s been a big day for Junshi Biosciences as it nabs China’s first snap approval for a homegrown PD-1 after reportedly closing a $394 million IPO in Hong Kong.
Conditionally approved under priority review, toripalimab is indicated for fast-growing cases of melanoma, according to the National Medical Products Administration.
“Clinical trial results of this product shows that in treating patients with unresectable or metastatic melanoma who have failed previous systemic therapies, it reaches an objective response rate of 17.3%, disease control rate of 57.5%, and 1-year survival rate of 69.3%,” the NMPA writes in a note. “The product’s marketing approval has a positive impact on the selection of clinical drugs for cancer patients.”
With 68 checkpoints crowding the pipeline, this is likely to be first of many OKs from China’s rapidly evolving regulatory agency. Data provider PharmCube previously told Endpoints News that Innovent Biologics, BeiGene (Celgene’s partner) and Jiangsu Hengrui are all being tipped for a market launch in the first half of 2019.
The approval, which took nine months to process and technically goes to Junshi’s subsidiary TopAlliance, follows those of Opdivo and Keytruda, the two pioneers in the field that’s been dominating sales globally.
While the majority of Junshi’s IPO proceeds will go toward the continued development and commercialization of PD-1, parts will fund its other programs, including a PCSK9 drug and a Humira biosimilar, according to an earlier filing.
Pricing at the bottom of the range, Junshi are selling their shares at $2.48 (HK$19.38) each, Reuters reported. It’s set to begin trading on December 24.
CICC is the sole sponsor for the float while Credit Suisse acts as a joint bookrunner.
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