Zai Lab Ltd – ADR (NASDAQ: ZLAB) announced a significant milestone for one of the key drugs in its oncology pipeline last week.
The Chinese-American biopharmaceutical company has obtained orphan drug designation for its small cell lung cancer therapeutic ZL-1310. Antibody-drug conjugates (ADC) like this deliver chemotherapy agents directly to cancer cells, minimizing damage to surrounding healthy tissue.
This FDA certification aims to promote the development of drugs for rare diseases in small patient populations. The agency designates a condition as rare if it impacts less than 200,000 Americans. Only about 34,000 are diagnosed in the U.S. each year.
Development incentives Zai Lab will now receive include tax credits, fee waivers, market exclusivity and assistance from the FDA with clinical trial protocols.
“These patients have an urgent need for innovative treatment options with improved efficacy, safety and ready access in tertiary care and community settings,” President and research lead, Rafael G. Amado, said in a release on Wednesday.
This approval builds on favourable Phase I clinical trial results released last fall. Most notably, the drug demonstrated a 74 per cent rate of “anti-tumour activity” in a cohort of 19 patients.
Small cell lung cancer is much deadlier than non-small cell lung cancer and accounts for only about 15 per cent of all lung cancer cases.
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Zai Lab’s NDA for schizophrenia drug accepted
A couple of weeks ago, Zai Lab revealed that Chinese regulators had accepted a new drug application for the company’s orally administered “KarXT” drug. It is used for the treatment of schizophrenia and psychosis linked to Alzheimer’s.
“In clinical trials, KarXT demonstrated statistically significant reductions of schizophrenia symptoms along with a tolerable safety profile,” Amado said on Jan. 17.
The orphan drug designation and the acceptance of the NDA are a couple of Zai Lab’s recent successes.
A new partnership with China’s MediLink Therapeutics to develop another ADC used to treat tumours based on the successful model of ZL-1310 is another. Zai Lab also reported 47 per cent year-over-year net product revenue growth in Q3 results at US$101.8 million. The American bank JPMorgan Chase & Co (NYSE: JPM) raised its share target for the company by US$6.00 to US$44.00 in October.
Zai Lab’s primary focuses are oncology, infectious and rare diseases, immunology and neuroscience. The drug developer was founded in 2014 and is based in Shanghai China. It has three offices in the United States and employs about 2,100 people.
rowan@mugglehead.com
