Zambon Gets Approval to Launch Fluimucil IV in China for Respiratory Treatment

Zambon Approval and Entry into China

Image Credits: Farmacia Rubino

Announcement

A multinational chemical pharmaceutical company, Zambon, known for its innovative care and cure, has received approval from Chinese regulatory authorities. Zambon received approval due to its vigorous local clinical development program, which ensured the drug’s efficacy, tolerability, and safe profile. Zambon’s intravenous formulation of Fluimucil's launch in the Chinese market has strengthened the presence and has initiated a step towards innovation in the global therapeutic market. The presence will contribute to the innovation in respiratory diseases. It’s an expansion at the early stage, which will accelerate the approach of this treatment. The green signal and the new launch will foster growth in China’s healthcare market.

Intravenous Formulation of Fluimucil

Though the treatment is available in various international markets, Fluimucil IV has introduced a new option and alternative for Chinese patients. It will enable an important hospital-based therapeutic option for curing respiratory diseases containing excessive mucus secretion. The treatment underwent clinical studies for confirmation and launch in China.

Study Before Approval

The phase 1 tolerability and pharmacokinetics was the 1st study of fluimucil IV in fit individuals that took place at Ruijin Hospital, led by Prof. Yaozong Yuan. The hospital affiliated with the Shanghai Jiao Tong University School of Medicine, the result showed that single and multiple 600 mg doses of Fluimucil are tolerable and safe.

The phase 3 clinical trial started in June 2019 and entered to conclusion in February 2021. The study involved 333 adult patients suffering from abnormal mucus secretion and respiratory diseases in 28 hospital centers in China. The study was conducted by Prof. Jieming Qu, and the results showed that Fluimucil IV 600mg twice a day was superior to placebo and equivalent to intravenous ambroxol hydrochloride. This will help minimize sputum viscosity and ease expectoration after treatment for 7 days. The data confirms the safety and tolerability of drugs.

Views and Statements

Chief Medical Officer and Head of R&D at Zambon, Paola Castellani, said, “The approval of fluimucil IV in China has strengthened the scientific rigor along with the clinical trials and showed an effective quality collaboration with local research centers. We would like to thank investigators and patients who participated in our clinical studies.”

CEO of Zambon, Giovanni Magnaghi, said, “We proudly celebrated our 60th anniversary of Flumicil and the launch of intravenous formulation in China. The approval was possible because of the joint efforts of the local scientific communities and our commitment towards improving patients' quality of life.”