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SHANGHAI - Junshi Biosciences (HKEX:1877; SSE:688180), a prominent biotech player with impressive gross profit margins of 76.2%, announced Thursday that the U.S. Food and Drug Administration has approved its investigational new drug application for a Phase 2/3 clinical study of its recombinant humanized anti-PD-1/VEGF bispecific antibody (JS207). InvestingPro data shows the company’s market capitalization stands at $5.07 billion, with the stock delivering a remarkable 130.74% return year-to-date.
The study will compare JS207 to nivolumab for neoadjuvant treatment of patients with stage II/III, resectable, actionable genomic aberration-negative, non-small cell lung cancer (NSCLC).
According to the company, JS207 is the first PD-1/VEGF dual-target drug approved for a confirmatory study in surgery-eligible patients. The trial will be an open-label, two-arm, randomized, active-controlled international multi-center study led by Professor Yilong Wu from Guangdong Provincial People’s Hospital.
NSCLC accounts for approximately 85% of all lung cancer cases, with 20-25% being surgically resectable at first diagnosis. Even after radical surgery, 30-55% of patients experience recurrence.
"By harnessing cutting-edge innovative therapies, we aim to offer more patients better treatments," said Dr. Jianjun Zou, CEO of Junshi Biosciences, in the press release statement.
JS207 is designed to simultaneously bind to PD-1 and VEGFA with high affinity, combining the effects of immunotherapy and anti-angiogenic treatments. The company reports that the antibody is currently being explored in multiple Phase 2 clinical studies for various cancer types including NSCLC, colorectal cancer, and triple-negative breast cancer.
Lung cancer remains the malignant tumor with the highest prevalence and mortality rate globally, with approximately 2.48 million new cases and 1.82 million deaths worldwide in 2022, according to GLOBOCAN data cited in the announcement. Investors following this development should note that Junshi Biosciences will report its next earnings on October 29, 2025. Get comprehensive earnings analysis and real-time updates with InvestingPro.
In other recent news, Shanghai Junshi Biosciences has experienced a series of analyst downgrades despite its notable stock performance this year. UBS downgraded the company’s stock from Buy to Neutral, citing valuation concerns after the shares rose 167% year-to-date. UBS also adjusted its price target for the stock to HK$34.70 from a previous HK$55.00. Similarly, JPMorgan downgraded the stock from Neutral to Underweight, although it increased its price target to HK$18.00 from HK$12.00. This downgrade followed the company’s financial results, which were largely in line with expectations. The results showed that higher-than-expected partnership income helped offset a slight weakness in product sales. These developments highlight the cautious stance analysts are taking despite the company’s recent stock performance.
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