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news.The State Food and Drug Administration (SFDA) Ethics Committee in China has approved Lotus Pharmaceuticals to initiate the Phase I human clinical trials of R-Bambuterol Hydrochloride, the company's proprietary drug candidate for the treatment of asthma.
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R-Bambuterol Hydrochloride is categorized as a Class I new drug.
In preclinical studies, R-Bambuterol Hydrochloride demonstrated a promising efficacy and safety profile.
Obtaining permission from the SFDA Ethics Committee is required for advancing the Phase I clinical program.
Lotus plans to initiate Phase I trials, including drug tolerance and pharmacokinetics studies, in the near term.
Phase I trials will be conducted by Beijing Zenith International Medical Science and Technology Development Company, a full-service clinical research organisation, and will be carried out in the Third Hospital of Peking University in China.
Lotus has patent protection for the drug until 2022.