Pharmaceutical Business review

SFDA approves Lotus Pharma asthama drug clinical trial

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.