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Biotech Advances Potential 'Billion-Dollar Drug' with New Trial Launch in China
Research Report

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Maxim Group analyst Jason Kolbert discussed what the launch of a clinical trial in China means for this developer of immuno-oncology therapies.

In a Nov. 30 research note, Maxim analyst Jason Kolbert reported that BeyondSpring Pharmaceuticals Inc. (BYSI:NASDAQ) strengthened its "foothold" in China with the launch of a Phase 2/3 clinical trial of its small molecule plinabulin, which offers "chemotherapy-induced neutropenia prevention, anti-cancer efficacy and immune-related side effect reduction with a favorable adverse event profile."

Study 106, led by co-principal investigator Dr. Qingyuan Zhang, began enrollment on Nov. 29 at the Harbin Medical University Cancer Hospital. Participants are patients who receive combination chemotherapy of taxotere, doxorubicin and cyclophosphamide, as it often causes severe neutropenia. The trial aims to "demonstrate plinabulin's superiority compared with Neulasta" in this population, noted Kolbert.

Other plinabulin studies underway are in individuals with non-small cell lung cancer. They include a Phase 3 trial in the U.S. and China with the chemotherapy agent docetaxel and a Phase 1 study in the U.S. with the PD-1 antibody nivolumab. Plinabulin, wrote Kolbert, has "the potential to become the new standard of care for chemotherapy patients across multiple indications."

The analyst added that "a significant opportunity in China" exists for plinabulin for those two indications alone: chemotherapy-induced neutropenia and non-small cell lung cancer. China is home to more than 4 million people with cancer, lung cancer being the most common. The therapeutic could "create a new therapy paradigm in the large oncology markets now opening in China, which is not at all reflected in the company's current valuation, in our opinion," Kolbert indicated.

Maxim estimates approvals and launch of plinabulin in China by 2020. Recently enacted regulatory reforms there could mean "an accelerated review (shorter time to the marketplace)" for plinabulin, Kolbert deduced. Further, "based on historical, high approval rates of oncology drugs developed by Chinese companies, there is higher probability for plinabulin to succeed in obtaining market approval by the China Food and Drug Administration."

As for the potential overall market for plinabulin, it "extends beyond the $8 billion ($8B) biologics market and could be upwards of $30B," estimated Kolbert. "As such, plinabulin, even conservatively, should be a billion-dollar drug, which points to upside at the current valuation."

BeyondSpring is currently trading at around $31.59 per share versus Maxim's $52 per share target price on it, which it rates a Buy.

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