Lotus Pharmaceuticals’ asthma drug Laevo-Bambutero will receive fast-track approval from China’s State Food & Drug Administration (SFDA) to begin clinical trials.
Laevo-Bambutero completed the SFDA special review process, which allows faster approval for investigative new drug applications to enter clinical trials.
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Laevo-Bambutero completed the SFDA special review process under Category Two, which covers clinical trials and new production for drugs that have not yet been approved in the domestic and overseas market.
Lotus developed the drug in ten years and owns its patent rights until 2022.
China has an estimated 30-40 million asthma patients.
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