BeyondSpring Initiates New Drug Application Rolling Submission for Plinabulin in China for Chemotherapy-Induced Neutropenia

- Potential to be First Superior Therapy to Standard of Care for Chemotherapy-Induced Neutropenia in 30 Years -

- Targeting CIN After All Chemotherapies in All Cancer Types in Combination with All G-CSFs -

- Strong Patent Protection Through 2036 -

NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company headquartered in New York focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has initiated the rolling submission of its New Drug Application (NDA) with the Company’s lead asset, Plinabulin, for the chemotherapy-induced neutropenia indication to China’s National Medical Products Administration (NMPA).

“Commencing the NDA rolling submission in China marks a significant milestone for BeyondSpring, bringing Plinabulin one step closer to commercialization to enhance the lives of cancer patients,” said Dr. Lan Huang, BeyondSpring’s co-founder and CEO. “Our clinical results clearly demonstrate that there is a significant need for improvement in the prevention of CIN. CIN is a common side effect of chemotherapy and can have a devastating impact on cancer care. Plinabulin has the potential to not only reduce infections and other clinical consequences associated with CIN, but also help patients to maintain their optimal chemotherapy care, which potentially prolongs their lives.”

If approved, Plinabulin in combination with G-CSFs can potentially be the first superior therapy to the standard of care (G-CSF alone) for chemotherapy-induced neutropenia in 30 years, with a broad label for the prevention of CIN after all chemotherapies in all cancer types in combination with all G-CSFs. The Company expects to submit an NDA for the same indication to the U.S. Food and Drug Administration (FDA) in the second half of 2020.

About Plinabulin in CIN Studies

Study 105 and Study 106 trials are both multicenter, double blind Phase 3 trials to support Plinabulin’s broad application in preventing CIN to be used with all chemotherapy and for all cancers. 

Study 105 was designed to evaluate the safety and efficacy in NSCLC, breast cancer, and prostate cancer patients with risk factors, treated with docetaxel (Day 1 dose) in a 21-day cycle with a single dose of Plinabulin (40 mg, Day 1 dose) vs. a single dose of Neulasta™ (6 mg, Day 2).  Docetaxel is one example of an intermediate risk chemotherapy.  This is a non-inferiority study in CIN efficacy comparing Plinabulin and Neulasta. Study 105 Phase 3 interim data had achieved statistical significance based on the primary end point of the Duration of Severe Neutropenia (DSN) in the first cycle.

Study 106 was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin, and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with Plinabulin (40 mg, Day 1 dose) + Neulasta (6 mg, Day 2 dose) vs. a single dose of Neulasta (6 mg, Day 2).  TAC is one example of high-risk chemotherapy. Plinabulin and G-CSF have complementary mechanisms in preventing CIN.  This is a superiority study in CIN efficacy comparing the combo head-to-head against Neulasta and is currently enrolling. In the Phase 2 study, the combo had demonstrated superiority in CIN efficacy. 

About BeyondSpring

BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first in class agent Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation ( and , 2019). Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About CIN

Neutropenia is an abnormally low blood concentration of neutrophils, a type of white blood cell, which may result from an abnormal rate of destruction or a low rate of synthesis of white blood cells in bone marrow. Chemotherapy-induced neutropenia, or CIN, is a significant cause of morbidity and mortality in cancer patients receiving chemotherapy as well as a significant factor in the interruption of chemotherapy. Annual global neutropenia treatment is over $11 billion with addressable population of 4 million chemotherapy cycles per year currently world-wide. Additionally, chemotherapy use is expected to grow by more than  50% from now to 2040 (Wilson et al. Lancet Oncology 2019; 20(6): 769-780).  G-CSFs are the predominant therapies in the CIN space but are limited by their inability to adequately address CIN and burdensome side effects. In preclinical studies, Plinabulin increased the survival of neutrophils, a type of white blood cell important in the prevention of bacterial infections.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts

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KCSA Strategic Communications

212.896.1241 / 212.896.1276

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