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BeyondSpring Inc. (BYSI) has submitted its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's focus on developing Plinabulin, a clinical-stage biopharmaceutical product, for multiple cancer indications, including non-small cell lung cancer (NSCLC) and chemotherapy-induced neutropenia (CIN).
The report highlights that Plinabulin has completed a Phase 3 trial for NSCLC, showing statistically significant improvement in overall survival when combined with docetaxel compared to docetaxel alone.
BeyondSpring is also developing Plinabulin for the prevention of CIN, although the FDA issued a Complete Response Letter in November 2021, indicating that additional trials are required.
The company has partnered with Jiangsu Hengrui Pharmaceuticals for the commercialization of Plinabulin in Greater China and is seeking additional partners for other regions.
BeyondSpring's subsidiary, SEED Therapeutics, is developing a Targeted Protein Degradation platform and has collaborations with Eli Lilly and Eisai.
The filing outlines BeyondSpring's strategy to advance Plinabulin through global clinical trials, seek regulatory approvals, and establish commercialization partnerships.
The company acknowledges the need for additional financing to continue its operations and development programs.
BeyondSpring's intellectual property portfolio includes 164 patents in 33 jurisdictions, with 22 issued U.S. patents related to Plinabulin.
The report also notes the regulatory challenges and competitive landscape in the pharmaceutical industry, emphasizing the importance of obtaining market acceptance and adequate reimbursement for its products.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the BeyondSpring Inc. annual 10-K report dated March 27, 2025. To report an error, please email earnings@qz.com.