Core Viewpoint - Anshi Biotechnology Co., Ltd. has applied for a listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board, with a fundraising target of 2.45 billion yuan, and is currently in the "inquiry" stage of the review process [1] Company Overview - Anshi Biotechnology is an innovative biopharmaceutical company focused on addressing significant unmet clinical needs in oncology, aiming to provide high-quality innovative anti-tumor drugs through efficient self-research [1] - The company has established a competitive and commercially viable multi-level pipeline of innovative drugs targeting key tumor driver gene pathways such as MET, EGFR, ROS1, NTRK, HER2, and RAS [1] Product Pipeline - The main products include Wanbiri® (Bertinib) and Andai Aitini, which have shown superior treatment effects and safety advantages in clinical trials compared to existing therapies [2] - The company has developed several innovative drug molecules with significant clinical value, including: - A next-generation MET-TKI (ANS01) targeting the treatment gap for MET-TKI resistant patients - An innovative ROS1/NTRK-TKI (ANS03) aimed at overcoming common drug resistance mutations - A next-generation EGFR-TKI (ANS02) designed to tackle various primary and secondary resistance mutations - A highly selective HER2-TKI (ANS05) intended to address HER2 abnormalities [2] Financial Performance - The company reported net profits of approximately -164 million yuan, -283 million yuan, -479 million yuan, and -91.65 million yuan for the years 2022, 2023, 2024, and the first quarter of 2025, respectively [2] - Total assets as of December 31 for the years 2022, 2023, 2024, and projected for March 31, 2025, were 9.86 billion yuan, 21.07 billion yuan, 17.35 billion yuan, and 16.37 billion yuan, respectively [3] - The company's asset-liability ratio has shown a significant decrease from 22.97% in 2023 to 7.44% in the first quarter of 2025 [3] - Research and development expenses accounted for 119.68%, 455.18%, and 1418.89% of operating revenue for the years 2022, 2023, and 2024, respectively [3]

Core Viewpoint - Ansh Biotech is facing significant financial challenges despite rapid revenue growth from its core product, Beruatinib, which has been listed and included in the medical insurance catalog. The company is heavily reliant on external financing to sustain operations due to ongoing losses and cash flow pressures [1][12]. Financial Performance - Ansh Biotech's revenue has shown a sharp increase, from 12.96 million yuan in 2023 to 71.66 million yuan in 2024, and 64.04 million yuan in the first quarter of 2025. However, the company has reported continuous net losses, with figures of -1.64 billion yuan, -2.83 billion yuan, -4.79 billion yuan, and -916.53 million yuan for the respective periods [2][3]. - Cumulative losses reached 7.82 billion yuan by the end of the first quarter of 2025, indicating a severe financial strain [2][4]. Cost Structure - The company has been experiencing high costs in both research and sales. R&D expenses increased from 145 million yuan in 2022 to 326 million yuan in 2024, with a significant portion of costs attributed to clinical trial services and employee salaries [6][10]. - Sales expenses surged from 3.61 million yuan in 2022 to 102 million yuan in 2024, reflecting aggressive marketing strategies [6][10]. Cash Flow and Financing - Operating cash flow has consistently been negative, with figures of -166 million yuan, -294 million yuan, -356 million yuan, and -74 million yuan over the reporting periods, indicating reliance on external financing [10][12]. - As of March 2025, the company had cash reserves of 529 million yuan, which may only sustain operations for one to two years at the current loss rate [10]. Inventory and Sales Efficiency - The company faces challenges in sales efficiency, with a sales expense of 102 million yuan in 2024, significantly exceeding the revenue of 71.66 million yuan for that year. The accounts receivable turnover rate was only 3.94 times, below the industry average of 7.02 times [11][12]. - High inventory levels have been noted, with inventory amounting to 74.65 million yuan by the end of 2024, representing 4.3% of total assets, compared to just 0.3% in 2022 [13][14]. Market Strategy and Risks - The company's strategy of "price for volume" has led to a significant price reduction of over 60% for Beruatinib, which has resulted in increased sales volume but has also compressed profit margins, with gross margins declining from 84.93% to 80.28% [13][14]. - Ansh Biotech is also facing competition from multiple approved MET-TKI drugs in the market, which could further impact its market share and revenue potential [15]. Goodwill and Financial Health - The company has a substantial goodwill of 927 million yuan, which constitutes 56.64% of total assets. This raises concerns about potential impairment risks that could adversely affect financial performance [15].

Core Viewpoint - Ansh Biotechnology is facing significant financial challenges despite rapid revenue growth from its core product, Beruatinib, which has been listed and included in the medical insurance catalog. The company is heavily reliant on external financing to sustain operations due to ongoing losses and high cash flow pressure [2][3][9]. Financial Performance - The company reported a revenue of 12.96 million yuan in 2023, projected to increase to 71.66 million yuan in 2024, and 64.04 million yuan in Q1 2025. However, net losses have been substantial, with figures of -1.64 billion yuan, -2.83 billion yuan, -4.79 billion yuan, and -916.53 million yuan for the respective periods [3][4]. - Cumulative losses reached 7.82 billion yuan by the end of Q1 2025, indicating a worsening financial situation [5]. Cost Structure - Research and development expenses have surged from 145 million yuan in 2022 to 326 million yuan in 2024, with Q1 2025 expenses at 76.64 million yuan. Sales expenses also increased dramatically, from 3.61 million yuan in 2022 to 102 million yuan in 2024 [5][8]. - The R&D expense ratio was extraordinarily high at 1418.89% in 2023 and 455.18% in 2024, while sales expense ratios were 350.47% and 141.74% respectively, indicating severe cost pressures [5][8]. Cash Flow and Financing - Operating cash flow has consistently been negative, with figures of -1.66 billion yuan, -2.94 billion yuan, -3.56 billion yuan, and -740 million yuan over the reporting periods, necessitating reliance on external financing [7][9]. - The company completed a 900 million yuan Series B financing, with a post-financing valuation of 5.25 billion yuan, highlighting the need for continued external funding to maintain operations [9]. Market Strategy and Risks - The company adopted a "price-for-volume" strategy, significantly reducing the price of Beruatinib from 17,200 yuan to 6,700 yuan, leading to a surge in sales volume but also a decline in gross margin from 84.93% to 80.28% [10][11]. - High inventory levels have emerged, with stock reaching 74.65 million yuan by the end of 2024, indicating potential risks of inventory devaluation and cash flow issues [10][11]. Competitive Landscape - Ansh Biotechnology faces intense competition with five other MET-TKI drugs approved for the same indication, which could impact market share and revenue growth [12]. - The company is heavily reliant on Beruatinib, with no product diversification to mitigate risks associated with market fluctuations and competitive pressures [12]. Goodwill and Financial Health - The company has a significant goodwill of 927 million yuan, accounting for 56.64% of total assets, raising concerns about potential impairment risks that could adversely affect financial performance [12].

Core Viewpoint - Anshi Biotechnology Co., Ltd. has received acceptance for its IPO application on the Sci-Tech Innovation Board, aiming to raise funds for its innovative biopharmaceutical pipeline focused on unmet clinical needs in oncology [2]. Company Overview - Anshi Biotechnology is an innovative biopharmaceutical company entering the commercialization phase, specializing in diseases with significant unmet clinical needs, particularly in oncology [2]. - The company has developed a multi-layered pipeline of innovative drugs targeting key tumor driver gene pathways such as MET, EGFR, ROS1, NTRK, HER2, and RAS [2]. Product Pipeline - The company has one product, Wanbirei® (Bairuitin), approved for market in China, and another product, Andai Aitini, under review for new drug approval. Two additional products are in clinical research [2][4]. - Wanbirei® is a selective and potent MET tyrosine kinase inhibitor (MET-TKI) and is the first in its class for treating MET amplified non-small cell lung cancer (NSCLC) and MET abnormal glioma [4]. - Wanbirei® received its first approval in November 2023 for MET ex14 skipping mutation NSCLC, with subsequent approvals for glioma and MET amplified NSCLC in April and June 2024, respectively [4]. - Sales revenue for Wanbirei® increased from 12.96 million yuan in 2023 to 71.66 million yuan in 2024, with a significant surge post-inclusion in the national medical insurance directory [4]. Investment and Shareholding - Anshi Biotechnology has attracted investments from several prominent institutions, with Bain Capital being the largest shareholder, holding 17.04% before the IPO [7]. - Other institutional shareholders include Weichuang Capital, Advanced Manufacturing Fund, and Chunhua, among others, with a post-investment valuation of 5.25 billion yuan following a B+ round of financing in December 2024 [7].

Core Viewpoint - Beijing Anshi Biotechnology Co., Ltd. has successfully submitted its IPO application to the Sci-Tech Innovation Board, aiming to raise 2.45 billion yuan for new drug development and operational funding [1][10] Company Overview - Anshi Biotechnology is an innovative biopharmaceutical company focused on addressing significant unmet clinical needs in oncology, with its main product, Wanbi Rui (Bertinib), already commercialized [6] - The company has a drug pipeline that includes Bertinib, which has been approved for multiple indications, and other candidates in various stages of clinical research [6][8] Financial Performance - Anshi Biotechnology has not yet achieved profitability, with reported revenues of approximately 0, 12.96 million yuan, 71.66 million yuan, and 64.04 million yuan for the years 2022 to 2025 Q1, respectively [8] - The company has incurred significant net losses, amounting to approximately -163.68 million yuan, -282.72 million yuan, -478.71 million yuan, and -91.65 million yuan for the same periods [8] Goodwill and Acquisitions - The company reported a substantial goodwill of 927 million yuan, which constitutes 56.64% of its total assets, primarily due to the acquisition of Beijing Purunao [1][9] - The acquisition of Beijing Purunao, which is responsible for the development of Bertinib, has raised concerns regarding potential goodwill impairment if the subsidiary's performance deteriorates [9] IPO Details - The IPO application was accepted on September 26, 2023, under the fifth set of listing standards of the Sci-Tech Innovation Board, indicating ongoing support for innovative pharmaceutical companies in the capital market [6][7] - The funds raised from the IPO will be allocated to new drug research and operational funding, with 1.95 billion yuan and 500 million yuan designated for each purpose, respectively [10]

Core Viewpoint - Anshi Biotech has been accepted for IPO on the Sci-Tech Innovation Board, aiming to raise 2.45 billion yuan, and is transitioning into a comprehensive innovative pharmaceutical company while currently operating at a loss [1][4]. Group 1: Company Overview - Anshi Biotech is an innovative biopharmaceutical company focused on oncology and other diseases with significant unmet clinical needs, aiming to provide high-quality innovative anti-tumor drugs through efficient self-research [4]. - The company has a drug pipeline that includes Wanbirui (Bertinib), which has been commercialized, and Andai Aitini, which is in the new drug listing review stage, along with two other drugs (ANS01 and ANS03) in clinical research [4]. Group 2: Financial Performance - As of the report date, Anshi Biotech has not yet achieved profitability, with a cumulative unabsorbed loss of 782 million yuan. The projected net profits (before and after non-recurring losses) for 2022 to Q1 2025 are -164 million yuan, -283 million yuan, -479 million yuan, and -91.65 million yuan respectively [4]. - The company completed a B+ round of equity financing in December 2024, with a post-investment valuation of 5.25 billion yuan [5]. Group 3: Recent Developments - Since the B+ round financing, Anshi Biotech's main product Wanbirui (Bertinib) received conditional approval for treating MET-amplified NSCLC, and Andai Aitini successfully submitted a new drug application with priority review status [5]. - The company has initiated a Phase III clinical trial for the combination of Bertinib and Andai Aitini for treating EGFR-TKI treatment failure with MET amplification/overexpression NSCLC, which has been granted breakthrough therapy designation [5]. Group 4: IPO Purpose - The IPO aims to raise 2.45 billion yuan for new drug research and development projects, as well as to supplement working capital [6].

Core Viewpoint - Ansh Biotechnology Co., Ltd. has received acceptance for its IPO on the Sci-Tech Innovation Board, aiming to raise 2.45 billion yuan, focusing on innovative anti-tumor drugs to meet significant unmet clinical needs [1] Company Overview - Ansh Biotechnology is an innovative biopharmaceutical company that has entered the commercialization stage, specializing in diseases like cancer with high unmet clinical needs [1] - The company aims to enhance the quality of life for patients through efficient self-research and development of high-quality innovative anti-tumor drugs [1] Financial Performance - The financial data for Ansh Biotechnology shows the following projected revenues and net profits: - 2022: Revenue of approximately 0 million yuan, net profit of -163.68 million yuan - 2023: Revenue of approximately 12.96 million yuan, net profit of -282.72 million yuan - 2024: Revenue of approximately 71.66 million yuan, net profit of -478.71 million yuan - Q1 2025: Revenue of approximately 64.04 million yuan, net profit of -91.65 million yuan [1] Product Development - As of the signing date of the prospectus, Ansh Biotechnology's main product, Wanbi Rui (Bertinib), has received approval for three indications in China - The company has also successfully submitted a new drug application for Andai Aitini and has been granted priority review and approval status [1]

Core Viewpoint - Ansh Biotechnology Co., Ltd. has received acceptance for its IPO on the Sci-Tech Innovation Board, aiming to raise 2.45 billion yuan for its innovative biopharmaceuticals focused on unmet clinical needs in oncology [1] Company Overview - Ansh Biotechnology is an innovative biopharmaceutical company that has entered the commercialization stage, focusing on high-quality innovative anti-tumor drugs to improve patients' quality of life [1] - The company has chosen to apply for listing under the criteria specified in Article 2.1.2 (5) of the Sci-Tech Innovation Board listing rules [1] Financial Performance - The financial data for Ansh Biotechnology shows the following projected revenues and net profits: - 2022: Revenue of approximately 0 million yuan, net profit of approximately -163.68 million yuan - 2023: Revenue of approximately 12.96 million yuan, net profit of approximately -282.72 million yuan - 2024: Revenue of approximately 71.66 million yuan, net profit of approximately -478.71 million yuan - Q1 2025: Revenue of approximately 64.04 million yuan, net profit of approximately -9.17 million yuan [1] Product Development - As of the date of the prospectus, Ansh Biotechnology's main product, Wanbi Rui (Bertinib), has received approval for three indications in China, while another product, Andai Aitini, has successfully submitted a new drug application and has been granted priority review status [1]