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从必贝特医药IPO发行看中国一类创新药的破晓之路
Core Insights - The IPO of Bibet Pharmaceuticals on the Sci-Tech Innovation Board reflects a significant shift in the Chinese capital market towards evaluating future potential, intellectual property, and national strategic importance rather than historical performance [1][9] - Bibet Pharmaceuticals serves as a case study for investors to assess the value of "hard technology" in the biopharmaceutical sector [1] Group 1: FIC Drug Development - FIC (First-in-Class) drugs represent a scientific breakthrough with unique mechanisms targeting unmet clinical needs, setting a high innovation threshold [2] - The proportion of FIC drugs approved by the NMPA is less than 5%, compared to 36% to 54% by the FDA from 2020 to 2024, indicating a significant gap in source innovation between China and the U.S. [2] - Bridging this "innovation quality gap" is crucial for China's transition from a pharmaceutical manufacturing powerhouse to an innovation-driven leader [2] Group 2: Financial Aspects of Bibet Pharmaceuticals - The average cost to develop a new drug ranges from $1.4 billion to $2.6 billion, with a success rate of only 12%, explaining the substantial R&D investments by companies like Bibet before generating revenue [3] - Bibet's R&D expenses for 2022, 2023, and 2024 were approximately 166.74 million, 157.65 million, and 120.29 million CNY, respectively, with net losses of approximately -188.34 million, -172.76 million, and -55.99 million CNY, reflecting ongoing investment in high-value R&D pipelines [4] Group 3: Product Pipeline and Market Potential - Bibet has one FIC drug, BEBT-908, approved for relapsed/refractory diffuse large B-cell lymphoma, showing a high response rate in difficult-to-treat patient populations [5] - Two additional FIC drugs, BEBT-209 and BEBT-109, are in Phase III clinical trials, indicating reduced risk and potential for significant market impact [5] - The company is also developing siRNA drugs, expanding its technological capabilities and market reach [6] Group 4: Valuation Methodology - Traditional valuation metrics like P/E or P/S are unsuitable for pre-revenue biotech firms; instead, the risk-adjusted Net Present Value (rNPV) model is used to assess future potential [7] - The rNPV of BEBT-908 contributes significantly to the company's overall valuation, alongside the rNPV of drugs in later clinical stages [8] Group 5: Regulatory Environment and Strategic Importance - The success of Bibet's IPO is attributed to the forward-looking and inclusive design of the Sci-Tech Innovation Board's listing standards, which cater to the unique characteristics of innovative drug companies [9][10] - The fifth set of listing standards aims to alleviate financing bottlenecks in strategic emerging industries, aligning with national strategies to foster local innovation capabilities [10]