The latest: BeiGene Ltd. (BGNE.US; 6160.HK; 668235.SH) announced Monday that its Zanubrutinib drug has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which recommended approval for the drug to treat adults with marginal zone lymphoma.

Looking up: Following the positive opinion, the European Commission will consider BeiGene’s marketing application, with a final decision expected within 67 days. If approved for marketing, the drug is expected to enter the world’s largest market with 29 member countries.

Take Note: Marginal zone lymphoma is an extremely rare group of malignancies with an incidence rate of about 20-30 cases per 1 million people per year. That means there is limited market potential for Zanubrutinib for that particular treatment.

Digging Deeper: BeiGene is a global biotechnology company that focuses on the research, development, and production of innovative molecularly targeted and oncology immunotherapy drugs. The company has three self-developed drugs approved for sale, including Zanubrutinib, which is mainly sold in China and the U.S. The drug’s revenue in the first half of the year jumped 261% year-on-year to $233 million, making it the company’s largest contributor. BeiGene achieved a major milestone late last year by listing on the Nasdaq-style STAR Market in Shanghai, making it the first company to list in New York, Hong Kong and mainland China at the same time.

Market Reaction: BeiGene’s Hong Kong shares closed up 1.8% at HK$92.75 at the midday break on Tuesday, at the lower end of its 52-week range. It’s A-shares rose 1.7% to reach 92.54 yuan at the noon close, slightly higher than their historic low reached in April this year.

Translation by Jony Ho

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