Founded in 2016, we are a science-driven, clinical-stage biotechnology company. We have two Core Products and 14 other pipeline product candidates.
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According to the written confirmation issued by FDA in February 2019 and by NMPA in February 2020, FDA and NMPA agreed that this global MRCT Phase II trial would be the registrational trial and appropriate to support drug registration if the clinical results demonstrate good efficacy and safety profile.
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We had not received any relevant regulatory agency’s concerns or objections to our clinical development plans as of the Latest Practicable Date, nor did any material unexpected or adverse changes had occurred since the date of issue of relevant regulatory approvals for LAE005.
Our Core Product, CU-20401, is a recombinant mutant collagenase that targets obesity, overweight, or other localized adipose accumulation associated metabolic diseases.
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As of the Latest Practicable Date, we had built a broad portfolio of nine products and product candidates.
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We enrolled the first patient in the Phase I clinical trial in September 2022 in China, and we expect to complete the Phase I clinical trial in the second quarter of 2024.
As of the Latest Practicable Date, our product pipeline consisted of three clinical-stage product candidates, including our Core Product LZ901, and four pre-clinical-stage product candidates.
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We expect to complete the Phase II clinical trial in the second quarter of 2023, initiate a Phase III clinical trial in the second quarter of 2023, and file the BLA in the third quarter of 2024 for LZ901 to the NMPA.
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In addition, we have received IND approval from the FDA in July 2022 for LZ901 and initiated a Phase I clinical trial in the U.S. in February 2023.