CHRS - Will Junshi Bio's Loss-Making Headaches Ease With Landmark U.S. Drug Approval? | Benzinga
Key Takeaways:
- Junshi Bio will receive milestone payments and 20% of sales of its PD-1 drug Toripalimab in the U.S., following the drug’s recent approval by the FDA
- The drug maker’s revenue fell 19% year-on-year in the first nine months of 2023, as its net loss narrowed to 1.41 billion yuan
By Molly Wen
In its ongoing quest to take its drugs overseas, China passed a major milestone late last month when Shanghai Junshi Biosciences Co. Ltd. (1877.HK; 688180.SH) announced the U.S. approval of its self-developed cancer drug Toripalimab, also known as Loqtorzi. With that nod, Toripalimab became not only the first drug approved by the U.S. FDA to treat nasopharyngeal carcinoma, but also the first China-developed treatment approved by the U.S. from an emerging class of targeted drugs called anti-PD-1 monoclonal antibodies.
The approval capped a long and arduous "overseas journey” for Junshi, whose U.S. clinical trials began in 2017. It submitted its biologics license application to the Food and Drug Administration (FDA) in early 2021, only to meet a setback when FDA officials couldn’t complete their review due to inability to visit Junshi’s production facilities in China during the pandemic. But it endured with its application, finally yielding the coveted FDA approval.
But for Junshi, the milestone was tempered with a slightly bitter taste, because it previously licensed U.S. pharmaceutical company Coherus (NASDAQ: CHRS) to sell Toripalimab in the U.S and Canada as early as 2021. Under their agreement, Coherus made a one-time down payment of $150 million to Junshi and, upon reaching agreed milestones, will make up to $380 million in additional payments. Junshi will also receive 20% of Coherus’ Toripalimab sales.
Junshi’s shares got a boost after the announcement, closing up 5.5% in the domestic Chinese A-share market, and rising by an even bigger 8.2% in Hong Kong.
Toripalimab is ...