Asieris(688176)2024-04-17 13:40Stock Incentive Plan - The company implemented a restricted stock incentive plan in 2022, granting a total of 9,790,800 shares, accounting for 1.72% of the total shares, to 151 employees, representing 38.32% of the total workforce[4] - In 2023, the company granted an additional 1,925,000 restricted shares to 18 employees at a price of 6.79 RMB per share, with 4.22 million shares remaining unallocated and automatically expired[5][8] - The total share-based payment expense recognized in the reporting period for the 2022 restricted stock incentive plan was 16,400,970.53 RMB[9] - Key executives and core technical personnel, including the Chairman and CEO, were granted restricted shares, with the Chairman receiving 1.3 million shares and other executives receiving between 22,500 to 130,000 shares each[12] Financial Performance - Revenue for 2023 reached 13,753,343.12 yuan, a significant increase compared to 2022's 26,095.32 yuan[18] - Net profit attributable to shareholders in 2023 was -400,434,603.65 yuan, a decrease from -246,549,785.26 yuan in 2022[18] - Operating cash flow for 2023 was -398,186,688.82 yuan, down from -241,960,907.88 yuan in 2022[18] - Total assets at the end of 2023 were 2,632,270,467.20 yuan, a decrease of 8.41% compared to 2022[18] - Basic earnings per share for 2023 were -0.70 yuan, compared to -0.43 yuan in 2022[19] - Weighted average return on equity for 2023 was -15.52%, down from -8.52% in 2022[19] - Revenue in Q4 2023 was 10,757,271.87 yuan, the highest among all quarters[23] - Net profit attributable to shareholders in Q4 2023 was -132,390,991.55 yuan, the lowest among all quarters[23] - Government subsidies in 2023 amounted to 6,953,033.26 yuan, an increase from 5,929,193.05 yuan in 2022[24] - Non-recurring gains and losses in 2023 totaled 31,788,811.50 yuan, a decrease from 63,493,965.12 yuan in 2022[27] Asset and Investment Changes - The company's trading financial assets decreased by 1,108,968,660.80 RMB, from 1,703,276,190.24 RMB to 594,307,529.44 RMB, impacting the current profit by 23,932,781.55 RMB[31] - The company's other current assets increased by 14,544,364.54 RMB, impacting the current profit by 1,459,111.24 RMB[31] - The company's other equity instrument investments increased by 805,424.10 RMB, from 15,336,049.20 RMB to 16,141,473.30 RMB[31] Product Development and Clinical Trials - The company has 2 marketed products and 13 products in clinical and preclinical development, including 6 in clinical development, with APL-1702 and APL-1202 being global first-in-class drugs[38] - The company's APL-1202, in combination with tislelizumab, showed a significant increase in histological response rate in a Phase II clinical trial for muscle-invasive bladder cancer[35] - The company is preparing to submit an NDA for APL-1702 to the NMPA and is discussing a Phase III clinical trial plan with the FDA for the US market[35] - APL-1202 combined with chemotherapy for recurrent NMIBC did not meet the primary endpoint in the ACCRUE study, leading to the termination of further development in this indication[75] - In the ASCERTAIN study, APL-1202 monotherapy showed similar non-recurrence rates compared to chemotherapy in untreated intermediate-risk NMIBC patients, with 8 out of 21 patients completing over 1 year of treatment[78] - APL-1202 combined with Tislelizumab in the ANTICIPATE study showed a pCR rate of 39% vs 21% for Tislelizumab alone, with promising efficacy signals in MIBC patients[79] - The ANTICIPATE study is expected to release top-line Phase II data in Q3 2024, with plans to prioritize clinical development in China for advanced bladder cancer[80] - APL-1501, a second-generation product of APL-1202, is undergoing Phase I trials in Australia, aiming to improve efficacy and reduce side effects with better pharmacokinetic properties[83] - The company plans to initiate clinical studies in the US for APL-1501 combined with immune checkpoint inhibitors for BCG-unresponsive NMIBC patients, with discussions with FDA planned for 2024[83] - APL-1202 combined with immune checkpoint inhibitors is expected to improve the efficacy of advanced bladder cancer patients, with a current single-agent ORR of only around 25%[84] - APL-1706, a diagnostic imaging agent for bladder cancer, has been approved in over 30 countries and completed Phase III clinical trials in China, showing a 43.3% additional detection rate of bladder cancer lesions compared to standard white light cystoscopy[85] - APL-1706's Phase III clinical trial demonstrated an additional detection rate of ≥1 CIS lesion in 9.6% of subjects, with real-world studies showing a 7.1% additional detection rate[85] - APL-1706's New Drug Application (NDA) was accepted by the National Medical Products Administration in November 2023, with expected approval by June 2025[88] - APL-1702 showed a significant improvement in response rate by 89.4% compared to placebo (41.1% vs. 21.7%, p = 0.0001) in its Phase III clinical trial[90] - APL-1702 demonstrated a 41.4% improvement in HPV clearance rate in the mITT population (28.0% vs. 19.8%) and a 103.9% improvement for high-risk HPV16 and/or HPV18 (31.4% vs. 15.4%)[90] - APL-1702's Phase III clinical trial results were selected for oral presentations at the 2024 EUROGIN and SGO conferences[91] - APL-1702 Phase III clinical trial enrolled 402 patients from multiple countries including China, Germany, and the Netherlands[120] - The trial evaluates the efficacy and safety of APL-1702 for HSIL, with primary endpoint being response rate at 6 months post-treatment[120] - Response rate and HPV16+/HPV18+ clearance rate were compared between APL-1702 and placebo groups[121] - APL-1702 is expected to redefine the treatment goals for cervical precancerous lesions, shifting focus from one-time surgical outcomes to long-term disease management, aiming to balance treatment risks and benefits while avoiding or delaying invasive surgeries[123] - The company plans to submit a pre-submission communication to the European Medicines Agency (EMA) for APL-1702 in Q3 2024 and aims to discuss registration clinical trial designs with the US FDA for the North American market in 2024[123] - APL-1401, a novel oral drug for ulcerative colitis (UC), is undergoing Ib phase clinical trials in 12 centers across China and the US, with completion expected in 2025[124] - APL-2301, a novel antibacterial drug for Acinetobacter baumannii infections, has been approved for Phase I clinical trials in Australia, focusing on safety, tolerability, and pharmacokinetics[128] - The company is developing APL-2302, a USP1 inhibitor, which has shown strong tumor-killing effects in preclinical studies and is planned for clinical trial applications in 2024[129][130][131] - APLD-2304, a portable blue-light bladder soft scope, is being developed to improve specificity and reduce false positives in bladder cancer diagnosis, with ongoing exploration of overseas commercialization opportunities[132][135] - AT-014, a high-selective growth factor receptor inhibitor, is being optimized using AI technology for treating bladder cancer and other advanced solid tumors[136] - AT-017, an epigenetic-related small molecule oral drug, is being developed for urogenital system tumors, with ongoing lead compound optimization using TAIDD platform[137] - AT-018 is a self-developed small molecule oral drug targeting cell cycle-related pathways, specifically for treating female-related cancers such as breast cancer, ovarian cancer, and endometrial cancer. The company utilizes the TAIDD platform for multi-conformation simulation and AI for compound optimization[138] - AT-020 is a next-generation ADC drug targeting new tumor antigens, with potential to address unmet clinical needs in bladder and breast cancers. Existing ADC drugs like Enfortumab Vedotin show an ORR of 50%-60% in advanced urothelial cancer, indicating significant room for improvement[139] - AT-021 is an ADC drug aimed at enhancing anti-tumor immunity by combining self-developed immune-boosting small molecules with targeted antibodies. It aims to improve efficacy and reduce side effects of current immunotherapies like CTLA-4 and PD-1 antibodies[140] - APL-1702, a photodynamic medical device combination product, is being developed for cervical high-grade squamous intraepithelial lesions, with plans to submit a Phase III clinical trial application to the FDA[146] - APL-1202, targeting MetAP2, is in development for untreated intermediate-risk NMIBC and as a neoadjuvant therapy for MIBC in combination with tislelizumab[146] - APL-1501, a second-generation APL-1202, is being developed for urological tumors, with clinical trials planned in Australia[146] - AT-014 and AT-020 are in development for urological tumors and various solid tumors, respectively, leveraging the TAIDD and ADC platforms[146] - APL-2302, targeting USP1, is being developed for ovarian and breast cancers, with global rights[146] Commercialization and Market Access - The company's oncology division has rapidly built a nearly 200-person commercialization team, aiming for over 100 million RMB in sales and internal break-even in 2024[39] - The company's HCCM platform has over 8,000 users, with more than 85% of registered doctors being from relevant fields, and nearly 1,500 interactions in the breast cancer field[40] - The company achieved sales of 9.2892 million yuan for its oncology products, including Dypate and Ouyoubi, by the end of the reporting period[63] - The company's oncology products, Dypate and Ouyoubi, achieved coverage in 80% of target cities by Q4 2023 and 100% by Q1 2024[68] - Dypate achieved sales in over 70% of target key hospitals within six months of launch, while Ouyoubi connected with major customers and benefited over 1,000 patients within three months of launch[68] - The company's market access team achieved 90% provincial bidding and dual-channel access for its oncology products[68] - The company established a Women's Health Division in early 2024 to focus on the commercialization of APL-1702 and expand its gynecological product pipeline[72] - The company is actively promoting the overseas development and collaboration opportunities for APL-1202/APL-1501 and exploring commercialization opportunities for a disposable blue-light cystoscope in the US clinic market[66] - The company is focusing on localizing production of imported drugs and devices to establish a reliable and agile supply chain while reducing costs[93] - The company is committed to providing optimal diagnostic and therapeutic solutions for bladder cancer, with a product portfolio covering NMIBC diagnosis, surgery, treatment, and follow-up[96] Environmental and Social Responsibility - The company invested 692,300 yuan in environmental protection during the reporting period[49] - The company consumed 1,921.52 tons of water and 908,100 kWh of electricity during the reporting period[51] - The company has implemented strict environmental management systems, including waste classification and hazardous waste disposal through qualified third-party companies[55][56] - The company released its first ESG report in 2023, integrating environmental, social, and governance factors into its strategic development to provide more decision-making information for investors[142] Shareholder and Employee Commitments - Employee stock ownership accounts for 4.28% of the total share capital[102] - Number of employees holding shares is 43, representing 10.91% of the total workforce[103] - Total employee shareholding is 2,437,600 shares[103] - The company has committed to not transferring or entrusting others to manage its shares for 36 months from the date of listing, and will not propose the company to repurchase these shares[155] - If the company's stock price remains below the issue price for 20 consecutive trading days within 6 months of listing, the lock-up period for pre-listing shares will be automatically extended by 6 months[155] - In the event of major illegal activities leading to delisting, shareholders commit not to sell their shares from the date of the administrative penalty or judicial decision until the stock is delisted[155] - Shareholders who violate the share lock-up commitments must publicly explain the reasons and apologize to shareholders and the public, with any illegal gains from share sales to be returned to the company[155] - Certain shareholders, including Pan-Scientific, have committed to a 36-month lock-up period from the listing date, with similar penalties for violations[155] - Other shareholders, such as Taizhou Donghong and Taizhou Yahong, also have a 36-month lock-up period from the listing date, with additional commitments in case of delisting due to illegal activities[157] - Some shareholders, including Nanjing Ruike and QM139, have a lock-up period of 12 months from the listing date or 36 months from the completion of the industrial and commercial registration changes, whichever is longer[157] - Directors and senior management have a 12-month lock-up period from the listing date, with additional restrictions if the company is not profitable at the time of listing[160] - If the company is not profitable at the time of listing, directors and senior management cannot sell their pre-listing shares for 3 full fiscal years, and must comply with relevant regulations even after leaving the company[160] - In case of stock price falling below the issue price for 20 consecutive trading days within 6 months of listing, the lock-up period for directors and senior management will be automatically extended by 6 months[160] - The company's core technical personnel are subject to a 12-month lock-up period from the date of listing, and a 6-month lock-up period after resignation, during which they cannot transfer or entrust others to manage their shares[166] - Core technical personnel can only transfer up to 25% of their pre-IPO shares annually for 4 years after the lock-up period expires[166] - The company's directors, supervisors, and senior management are restricted from transferring more than 25% of their total shares annually after the lock-up period[163] - If the company is not profitable at the time of listing, core technical personnel cannot reduce their pre-IPO shares for 3 full fiscal years[166] - The company's directors, supervisors, and senior management cannot reduce their shares if the company is not profitable at the time of listing for 3 full fiscal years[163] - The company's directors, supervisors, and senior management cannot reduce their shares within 6 months after resignation[163] - The company's core technical personnel cannot reduce their shares within 6 months after resignation[166] - The company's directors, supervisors, and senior management cannot reduce their shares if the company is involved in major illegal activities that trigger delisting[163] - The company's core technical personnel cannot reduce their shares if the company is involved in major illegal activities that trigger delisting[166] - The company's directors, supervisors, and senior management must publicly explain and apologize if they violate the share reduction commitments[163] - The company plans to reduce its shareholding by no more than 100% of its total shares within two years after the lock-up period expires, with the selling price not lower than the audited net asset value per share at the end of the previous fiscal year[173] - The company will initiate stock price stabilization measures if the stock price remains below the audited net asset value per share for 20 consecutive trading days within three years of listing[172] - The company will hold a board meeting within 10 days to pass a resolution on stock repurchase and submit it to the shareholders' meeting for approval if the stock price stabilization conditions are met[172] - The company will use its own funds for stock repurchase, with the repurchase price not exceeding the latest audited net asset value per share[172] - The company will repurchase shares through centralized bidding, tender offers, or other methods approved by securities regulators, with the annual repurchase amount not exceeding 50% of the net profit attributable to the parent company's shareholders in the most recent audited fiscal year[175] - If the company's stock price remains above the audited net asset value per share for three consecutive trading days, the repurchase plan will be terminated[175] - The controlling shareholder's share purchase plan will not exceed 20% of the after-tax cash dividends received from the company in the previous year, and the purchase price will not exceed the audited net asset value per share in the most recent fiscal year[175] - Directors and senior management will purchase shares within 90 days after the controlling shareholder's plan is completed, with the purchase amount not exceeding 20% of their after-tax compensation from the company in the previous year[178] - The company will cancel repurchased shares within 10 days after the completion or termination of the repurchase plan and proceed with the capital reduction process[175] - The company will extend the period for six months after expiration and return the after-tax cash dividends received from the company in the most recent fiscal year. If not returned on time, the company may deduct from future cash dividends until the cumulative deduction reaches the total after-tax cash dividends received in the most recent fiscal year[181] - If directors or senior management fail to fulfill their commitments to stabilize stock prices within three years of listing, they must publicly explain the reasons, apologize, and propose supplementary or alternative commitments. Additionally, 20% of their monthly after-tax salary will be deducted until the cumulative deduction reaches 20% of their after-tax salary from the most recent fiscal year[181] - In case of false statements or major omissions in the prospectus that significantly affect the company's compliance with legal issuance conditions, the company will repurchase all newly issued shares. The repurchase price will be determined according to regulatory documents and will not be lower than the market price at the time of repurchase[181] - If the company violates