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Lunsheng Pharmaceutical, a Chinese biopharmaceutical company that focuses on innovative biomedical research and development in China, and Nabriva Therapeutics, a biopharmaceutical company engaged in the commercialization and development of innovative anti-infectives to treat severe infections, today announced that Lunsheng has acquired bacterial pneumonia in the community ( The Phase 3 bridging trial of Lefamorin in Chinese adult patients of CABP has achieved positive preliminary results
.
Lunsheng’s multi-center randomized double-blind trial was designed to evaluate the safety and efficacy of 125 CABP patients receiving intravenous (IV) from Lefamolin versus oral versus intravenous/oral moxifloxacin
.
The subjects were randomly divided into groups of 2:1, taking Lefamolin and Moxifloxacin respectively, and stratified according to their previous antibiotic exposure, pneumonia severity index (PSI) risk level, and renal impairment
In the modified intention-to-treat (mITT) population, Lefamorin achieved the primary endpoint of non-inferiority to moxifloxacin in the Investigator’s Clinical Response Assessment (IACR-TOC), and Lefamorin and Moxifloxacin were successful.
The rates were 76.
8% (n=63/82) and 71.
4% (n=30/42)
.
The results of this survey showed consistent performance in each group
Lefamorin is generally safe and well tolerated, consistent with previously reported clinical trial results, and the total incidence of emergency adverse events (TEAE) during treatment is comparable to that of moxifloxacin
.
The severity of most TEAEs in the two groups was mild to moderate.
Dr.
Rae Yuan, Chief Executive Officer of Lunsheng, said: “We are pleased with the results of this trial
.
These data strongly support the use of Famorene as an empirical monotherapy for CABP, which affects millions of people every year.
In addition, Lunsheng also signed an agreement with Sumitomo Pharmaceutical (Suzhou) Co.
, Ltd.
, a wholly-owned subsidiary of Sumitomo Dalibang Pharmaceuticals, to obtain the development and commercialization rights of Lefarmore in Greater China
.
According to the terms of the agreement, Lun Sheng will transfer its license agreement to Farmolin to Sumitomo Pharmaceutical (Suzhou), and the other terms of the agreement remain unchanged
Naoki Noguchi, Chairman and CEO of Sumitomo Pharmaceuticals (Suzhou), said, “We are very looking forward to expediting the provision of Famolin to Chinese patients after approval
.
These data indicate that Famolin may become a type of CABP patients.
"We are eagerly looking forward to joining the next phase of Lafarmorin's development cycle in China," said Steve Gelone, President and COO of Nabriva
.
"As we continue to expand the global access to Famorim, Sumitomo Pharmaceutical (Suzhou) has mature commercial infrastructure, especially in the field of anti-infection, making it an ideal partner for Nabriva
