CEO: Ning Li
Junshi Biosciences is another Chinese firm with a marketed PD-1 inhibitor, but its Tuoyi (toripalimab) boasts two firsts: It’s the first homegrown PD-1/L1 to obtain an approval in China—or anywhere—and it’s the first China-made checkpoint inhibitor to win an FDA breakthrough designation.
Being first means a lot to a startup, Junshi's CEO Ning Li told Stat in September. It has a greater opportunity to snag market share, and the publicity helps promote the company’s reputation among doctors, patients, talent, investors and the public, he explained.
Li, previously VP of Asia regulatory affairs at Sanofi, is the only CEO on our list with previous work at the U.S. FDA, having served stints around biostatistics. That experience could come in handy as Junshi breaks out of China and into the U.S. But it first needs to get its home market right.
With its December 2018 Chinese green light in previously treated melanoma, Junshi launched right into the territory of Merck’s Keytruda, which won its first China nod five months before in the same indication. The two drugs even tapped the same principal investigator for their registrational trials.
It’s hard to compare results from the two meds, given they were only carried out in small yet different patient populations. In the phase 1b Keynote-151 trial featuring 103 Chinese patients, Keytruda triggered a response in 17 patients (16.7%). In Tuoyi’s phase 2 Polaris-01 study, tumor shrinkage was observed in 22 of 127 patients (17.3%).
Without control arms in both studies, Tuoyi appears better at extending patients’ lives. Tuoyi’s patients lived a median 22.2 months, while Keytruda helped patients live a median 12.1 months, even though Keytruda enrolled a higher proportion of patients bearing the PD-L1 biomarker, who generally responded better to treatment than PD-L1-negative individuals in both trials.
Sales of Tuoyi during the first half of the year totaled CNY 426 million ($63.5 million), out of which CNY 254 million ($37.9 million) came from the second quarter, with the drug recovering from a sudden slowdown in early 2020.
When the accelerated approval came through, Junshi was among a flurry of Chinese biotechs taking advantage of a relaxed listing rule to go public on the Hong Kong Exchange. The company raised $394 million in its Hong Kong IPO, and in July 2020 dual-listed on the mainland’s Nasdaq-like STAR market after a $692 million IPO.
The breakthrough designation Tuoyi recently won from the FDA carries more symbolic meaning than commercial relevance—it’s for a rare cancer type called nasopharyngeal carcinoma—and has therefore flown under the radar of most people other than close watchers of China’s biotech industry. But another newly discovered antibody drug by Junshi has attracted much attention these days during the COVID-19 pandemic.
In May, Eli Lilly put down $10 million upfront and committed $245 million for ex-China rights to Junshi’s neutralizing antibody against SARS-CoV-2, the novel coronavirus behind COVID-19. Dubbed etesevimab (JS016/LY-CoV016), the drug was jointly developed by Junshi and the Institute of Microbiology at the Chinese Academy of Sciences.
Lilly’s idea was to pair the Junshi drug with another AbCellera-partnered candidate called bamlanivimab (LY-CoV555) in an antibody cocktail. However, the Junshi drug might have a bigger part to play now that bamlanivimab has failed as a monotherapy in hospitalized patients in the ACTIV-3 trial, run by the National Institute of Allergy and Infectious Diseases.
In another Lilly-run trial called Blaze-1, the company reported solo bamlanivimab had lowered the rate of hospitalization in people newly diagnosed with mild-to-moderate COVID-19. But on the trial’s primary endpoint, only the middle dose tested beat placebo at reducing viral load by day 11. In contrast, in the combo arm, Lilly claimed a home run where the pair significantly reduced viral load, improved symptoms, and cut down COVID-related hospitalization and ER visits.
Lilly has won an FDA emergency use application for bamlanivimab monotherapy for mild-to-moderate COVID-19 patients within early days of symptom onset. It is preparing to file the combo for emergency use, too.
Besides those two drugs, Junshi’s in-house pipeline is heavily tilted toward oncology, with drugs targeting PD-L1, BTLA, TIGIT, CTLA-4 and CDK, but it also has candidates in cardiovascular and autoimmune diseases and neurology. Its employees are stationed in Shanghai, Suzhou, China, and the company has R&D centers in San Francisco and Rockville, Maryland (as TopAlliance Biosciences).