科创板“新五套”再破冰：必贝特过会两年半终获批文

Group 1 - The core viewpoint of the article is that Guangzhou Bibet Pharmaceutical Co., Ltd. has finally received its IPO approval after a lengthy process, reflecting the challenges and changes in the regulatory environment for biotech companies in China [1][2][3] - Bibet's IPO journey began during the "golden window period" of the STAR Market's fifth set of standards, which allowed unprofitable biotech companies to go public, but the overall IPO pace tightened in 2023 [2][3] - The approval of Bibet's IPO may signify a substantial restart of the fifth set of standards, with other similar companies also awaiting review [2][3] Group 2 - Bibet focuses on innovative drug development for major diseases such as cancer and autoimmune diseases, with six core products currently in clinical trials, including BEBT-908, which has submitted a Pre-NDA application [4][5] - The company has incurred significant R&D expenses totaling 342 million yuan from 2020 to 2022, with a continuous expense ratio above 90%, leading to cumulative losses of 422 million yuan by the end of 2022 [5][6] - The company plans to issue up to 70 million shares, raising approximately 2.005 billion yuan, with a post-listing valuation likely between 9 billion to 11 billion yuan [6]